ИПС "Әділет"

Unofficial translation

Throughout the whole text, words “preventive control and supervision” were prescribed to replace by words “preventive control” in accordance with the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

SECTION 1. GENERAL PROVISIONS

Chapter 1. PRINCIPAL PROVISIONS

Article 1. Basic concepts used in this Code

1. The following basic concepts are used in this Code:

1) human habitat (hereinafter - the habitat) - a set of natural, anthropogenic and social environmental factors (natural and artificial) that determine the conditions of human life;

2) HIV infection - a chronic infectious disease caused by the human immunodeficiency virus, characterized by a specific damage to the immune system and leading to its slow destruction until the formation of acquired immunodeficiency syndrome;

3) a certified first aid trainer - a person who has passed additional training in first aid and basic cardiopulmonary resuscitation;

4) anonymous examination - voluntary medical examination of a person without personal identification;

5) disaster medicine - the field of medicine aimed at preventing and eliminating the medical and sanitary consequences of emergencies of a social, natural and man-made nature (hereinafter - emergencies), including the prevention and treatment of diseases of the population, sanitary-anti-epidemic and sanitary-preventive measures, preservation and restoration of health of participants in the liquidation of emergency situations, as well as medical assistance to employees of emergency services;

6) social health insurance fund - a non-profit organization that accumulates allocations and contributions, as well as purchases and pays for the services of healthcare entities providing medical care in the volumes and on the terms provided for by the contract for the purchase of healthcare services , and other functions determined by the laws of the Republic of Kazakhstan;

7) military medicine is the field of medicine and healthcare, which is a system of scientific knowledge (a complex of scientific and practical disciplines) and practical activities of the military medical service, which has as its goal the comprehensive medical support of troops, units and departments of special state and law enforcement agencies in peaceful and military time;

8) military medical service - a set of military-medical (medical) units, in which the laws of the Republic of Kazakhstan provide for military service or a special type of public service, intended for military-medical (medical) support of the activities of these bodies;

9) military-medical (medical) subdivisions - structural subdivisions of the central executive bodies and other central state bodies and their territorial subdivisions, as well as military-medical (medical) institutions (organizations), other subdivisions providing military-medical (medical) support;

10) enrichment (fortification) - the introduction of vitamins, minerals and other substances into food products in the course of their production or processing in order to increase the nutritional and biological value, as well as to prevent diseases caused by their deficiency in humans;

11) child (children) - a person under eighteen years of age (age of majority);

12) specialized professional - a medical worker with a diploma of higher medical education who has a certificate in the field of healthcare;

13) established (final) sanitary protection zone - the territory of the sanitary protection zone, determined on the basis of the results of the annual cycle of field studies and measurements to confirm the calculated (preliminary) sanitary protection zone;

14) a list of pharmaceuticals and medical devices for free and (or) preferential outpatient provision of certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions) - a list of pharmaceuticals, medical devices and specialized medical products purchased at the expense of budget funds and (or) assets fund of social health insurance within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance in the provision of primary healthcare and specialized medical care on an outpatient basis, including the names and characteristics of drugs, medical devices and specialized medical products in the context of certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions);

15) similar biological medicinal product (biosimilar, follow-on biologic, biosimilar) - a biological medicinal product, which contains a version of the active ingredient of the registered biological original medicinal product or the reference product and which demonstrated similarity (likeness) on the basis of comparative studies on the quality indicators, biological activity, safety and efficiency;

16) biobank - a specialized storage of biological materials for scientific and medical purposes;

17) biologically active substances - substances of natural origin or their synthetic analogs that normalize pathologically altered body functions in animals and humans;

18) biological medicinal product - a medicinal product, the active substance of which is produced or isolated from a biological source and for the description of the properties and quality control of which it is necessary to combine biological and physicochemical methods of analysis with an assessment of the production process and methods of its control;

19) medicinal products of biological origin - preparations containing biological substances (hormones, cytokines, blood coagulation factors, insulins, monoclonal antibodies, enzymes, colony-stimulating factors, preparations based on tissue cells, and others obtained using biotechnological methods);

20) biomedical research - research, the purpose of which is to obtain by scientific methods new knowledge about life, human health, diseases, their diagnosis, treatment or prevention, as well as genetic and environmental factors associated with life processes, diseases and health;

21) biotechnological medicinal product - a medicinal product produced using biotechnological processes and application of methods using recombinant deoxyribonucleic acid technology, controlled expression of genes encoding the production of biologically active proteins, hybridoma technologies, monoclonal antibodies or other biotechnological processes;

22) bioethics - an interdisciplinary scientific direction that combines biomedical and humanitarian sciences in order to analyze the moral, social, legal aspects of the application of the latest achievements of the life sciences;

23) childbirth - natural or artificial (instrumental, manual, medication) completion of the accouchement;

24) the maximum price for the trade name of a medicine for retail sale – - the price for the trade name of a medicine, included into the list of medicines that are subject to price regulation, above which its retail sale cannot be carried out;

25) original medicinal product - a medicinal product with a new active substance, which was the first to be registered and placed on the world pharmaceutical market on the basis of a dossier containing the results of full preclinical (nonclinical) and clinical studies confirming its safety, quality and efficacy;

26) co-payment - payment of the difference in the cost of pharmaceuticals, medical devices and the established maximum price for their reimbursement within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance at the outpatient level, carried out on a voluntary basis;

27) a single distributor - a legal entity operating within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance in accordance with Article 247 of this Code;

28) vaccines - medicinal products for specific prophylaxis of infectious diseases, providing a preventive effect through the immune system;

29) hematopoietic stem cells - hematopoietic cells of the human bone marrow that have pluripotency and are in the process of life in the bone marrow, peripheral blood and umbilical cord blood;

30) register of donors of hematopoietic stem cells (bone marrow) - a list of persons agreeing to donation of hematopoietic stem cells (bone marrow) and typed according to the HLA system;

31) genetically modified objects - raw materials and products of plant and (or) animal origin obtained using methods of genetic engineering, including genetically modified sources, organisms;

32) homeopathic medicinal product - a medicinal product produced according to homeopathic technology using homeopathic raw materials in accordance with the requirements of the Pharmacopoeias of the Republic of Kazakhstan and (or) the Eurasian Economic Union or, in their absence, in accordance with the requirements of homeopathic pharmacopoeias;

33) pharmaceutical product - a product that is or contains a substance or a combination of substances that comes into contact with the human body, intended for the treatment, prevention of human diseases or recovery, correction or change of its physiological functions through pharmacological, immunological or metabolic effects, or for diagnostics diseases and human conditions;

34) marginal price for a pharmaceutical product - a price above which the sale of a pharmaceutical product cannot be carried out;

35) circulation of pharmaceuticals - activities that include development processes, preclinical (non-clinical) studies, trials, clinical trials, expertise, registration, pharmacovigilance, quality control, production, manufacturing, storage, transportation, import and export, release, sale, transfer, use, destruction of pharmaceuticals;

36) good pharmaceutical practices in the field of drug circulation (hereinafter referred to as good pharmaceutical practices) - health standards that apply to all stages of the life cycle of drugs: good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP), Good Pharmacovigilance Practice (GVP) and other Good Pharmaceutical Practices;

37) the manufacturer of pharmaceuticals - an organization engaged in the production of pharmaceuticals and having a license to manufacture pharmaceuticals;

38) the register of authorized persons of drug manufacturers - an electronic information resource of the authorized body containing information on authorized persons of drug manufacturers;

39) an authorized person of a manufacturer of pharmaceuticals - a person responsible for ensuring and controlling the quality of pharmaceuticals produced by the manufacturer in accordance with the legislation of the Republic of Kazakhstan in the field of healthcare, and included in the register of authorized persons of manufacturers of pharmaceuticals;

40) rational use of pharmaceuticals - drug treatment that meets clinical indications, in doses that meet the individual needs of the patient for a sufficient period of time and at the lowest cost;

41) long-term contract for the supply of medicines and medical products – a civil contract concluded by a single distributor for up to ten years with the right to extend up to three years with a manufacturer of medicines or medical products located on the territory of the Republic of Kazakhstan or with a customer for the contract production of original patented medicines, as well as with customers of the contract production of medical products for the supply of medicines or medical products or with a subject in the field of circulation of medicines and medical products, having the intention to establish production or modernize the existing production of medicines and medical products located on the territory of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan;

42) retail sale of pharmaceuticals and medical devices - pharmaceutical activities related to the acquisition (except for import), storage, distribution, sale (except for export) to the end consumer, destruction of pharmaceuticals and medical devices;

43) contract manufacturing of pharmaceuticals and medical devices (hereinafter - contract manufacturing) - the production of pharmaceuticals and medical devices on a contract basis at the production facilities of manufacturers of pharmaceuticals and medical devices located in the Republic of Kazakhstan, which ensure full compliance with the requirements of good manufacturing practice (GMP) for pharmaceuticals and the international quality management system standard (ISO 13485) for manufacturers of medical devices;

44) web portal for the procurement of pharmaceuticals and medical devices, services from healthcare entities - an information system that provides a single point of access to electronic services for the purchase of pharmaceuticals and medical devices, services from healthcare entities within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

45) a single operator in the field of procurement of pharmaceuticals and medical devices, services from healthcare entities (hereinafter - a single operator) - a legal entity determined by the authorized body in agreement with the authorized body in the field of public procurement;

46) wholesale of pharmaceuticals and medical devices - pharmaceutical activities related to the purchase (acquisition), storage, import, export, sale (except for the sale to the population) without limiting the volume, transportation and destruction of pharmaceuticals and medical devices;

47) a state body in the field of circulation of pharmaceuticals and medical devices - a state body that exercises leadership in the field of circulation of pharmaceuticals and medical devices, control over the circulation of pharmaceuticals and medical devices;

48) a state expert organization in the field of circulation of pharmaceuticals and medical devices - a state monopoly entity carrying out production and economic activities in the field of public health to ensure the safety, efficiency and quality of pharmaceuticals and medical devices;

49) objects in the field of circulation of medicines and medical products – pharmacy, including those selling via the Internet, pharmacy in healthcare organizations and mobile pharmacy for rural settlements, pharmacy (distribution) warehouse, temporary storage warehouse of medicines, medical products, optics store, medical products store, medical products warehouse, organizations for production of medicines and medical products;

50) entities in the field of circulation of pharmaceuticals and medical devices - individuals or legal entities engaged in pharmaceutical activities;

51) The State Register of Pharmaceuticals and Medical Devices is an electronic information resource containing information on pharmaceuticals and medical devices registered and permitted for medical use in the Republic of Kazakhstan;

52) a long-term contract for the storage and transportation of pharmaceuticals and medical devices - a civil law contract for the provision of services, concluded by a single distributor with an entity in the field of circulation of pharmaceuticals and medical devices - a resident of the Republic of Kazakhstan, which meets the requirements of good distribution practice (GDP);

53) state re-registration of a pharmaceutical product or medical device - the procedure for extending the validity period of state registration of a pharmaceutical or medical device with the issuance of an unlimited document certifying state registration (hereinafter - registration certificate), under the previous registration number and making a corresponding entry in the State Register of Pharmaceuticals and Medical Devices;

54) state registration of a pharmaceutical product or medical device - the procedure for obtaining permission to circulate pharmaceuticals or medical devices in the territory of the Republic of Kazakhstan and entering a pharmaceutical product or medical device for a specified period in the State Register of Pharmaceuticals and Medical Devices;

55) shelf life of a pharmaceutical product - the date after which the pharmaceutical product is not subject to use;

56) packaging of a pharmaceutical product - a product or a set of products that ensure the process of circulation of pharmaceuticals by protecting them from damage and loss, as well as protecting the environment from pollution;

57) bulk - a product of a pharmaceutical product or medical device - a dosed finished drug or a finished medical device that has passed all stages of the technological process, except for the final packaging;

58) making changes to the registration dossier of a pharmaceutical product or medical device - a procedure carried out on the basis of an examination of the changes made to the registration dossier during the validity of the registration certificate;

59) quality of a pharmaceutical product - a set of properties and characteristics of a pharmaceutical substance (active pharmaceutical ingredient) and a medicinal product, ensuring their compliance with the intended purpose;

60) regulatory document on the quality of a pharmaceutical product - a document that establishes requirements for quality control of a pharmaceutical product in the post-registration period on the basis of an expert examination of a pharmaceutical product during its registration and contains a specification, a description of analytical methods and tests of a pharmaceutical product or references to such tests, as well as relevant acceptance criteria for quality indicators;

61) trade name of a pharmaceutical product - the name under which the pharmaceutical product is registered;

62) international non-proprietary name of a pharmaceutical product - the name of a pharmaceutical product recommended by the World Health Organization;

63) quality of drug supply - the level of compliance with the requirements of healthcare standards governing the production, import, storage, timely delivery of drugs and pharmacovigilance;

64) dosage formulation - the state of a pharmaceutical product corresponding to the methods of its administration, use and ensuring the achievement of the required therapeutic effect;

65) medicinal plant raw materials - fresh or dried plants, algae, mushrooms or lichens or parts thereof, whole or crushed, used for the production of pharmaceuticals;

66) pharmaceutical product - a pharmaceutical product in the form of a dosage formulation;

67) manufacturing of pharmaceutical products - pharmaceutical activities related to the manufacture of pharmaceutical products in pharmacies, the purchase of pharmaceutical substances (active pharmaceutical ingredients) for pharmaceutical use, storage, quality control, registration and sale of manufactured pharmaceutical products;

68) safety of a pharmaceutical product - the absence of an unacceptable risk when using a pharmaceutical product associated with the possibility of harming life, human health and the environment;

69) efficacy of a pharmaceutical product - a set of characteristics of a pharmaceutical product that ensure the achievement of a prophylactic, diagnostic or therapeutic effect or restoration, correction or modification of physiological function;

70) medicinal raw materials - substances of plant, mineral, animal origin or products of the chemical industry used for the production and manufacture of pharmaceuticals;

71) disinsection - a set of preventive and exterminating measures for the destruction of insects and arthropods in order to protect humans, animals, premises and territory from them;

72) disinfection - a set of special measures aimed at destroying pathogens of infectious and parasitic diseases in the external environment;

73) health - a state of complete physical, spiritual (mental) and social well-being, and not just the absence of diseases and physical defects;

74) healthcare - a system of measures of a political, economic, legal, social, cultural, medical nature aimed at preventing and treating diseases, maintaining public hygiene and sanitation, maintaining and strengthening the physical and mental health of each person, maintaining his/her active long-term life, providing him/her medical assistance in case of loss of health;

75) healthcare system - a set of state bodies and healthcare entities the activities of which are aimed at ensuring the rights of citizens of the Republic of Kazakhstan to health protection;

76) regional long-term plan for the development of healthcare infrastructure - a long-term plan for the development of the infrastructure of the region, reflecting information on the existing network of healthcare organizations, planned restructuring (opening, merging, closing, re-orientation), as well as information on the need for new healthcare facilities and investment planning;

77) certification of scientific and pedagogical personnel of educational organizations in the field of public health - the procedure for determining the level of pedagogical and professional competence of scientific and pedagogical personnel of educational organizations in the field of healthcare;

78) organization of education in the field of public health - an organization of education that implements educational programs in the areas of training "Healthcare" and (or) "Interdisciplinary Programs Related to Healthcare and Social Security (Medicine)";

79) clinic of educational organization in the field of public health - a structural subdivision of an educational organization or a healthcare organization, on the basis of which educational programs of technical and professional, post-secondary, higher, postgraduate and additional medical education are implemented on the basis of modern achievements of science and practice;

80) scientific organization in the field of public health - a national center, scientific center or research institute carrying out scientific, scientific and technical and innovative activities in the field of healthcare, as well as medical, pharmaceutical and (or) educational activities;

81) professional standard in the field of public health - a standard that determines the requirements for the level of qualifications, content, quality and working conditions of specialists in the field of healthcare;

82) certification of a healthcare specialist - a procedure for determining the compliance of an individual's qualifications with the qualification requirements established by the industry qualifications framework and professional standards in healthcare, as well as determining the readiness for professional activities in the healthcare sector, including readiness for clinical or pharmaceutical practice, or activities in the sphere of sanitary and epidemiological welfare of the population;

83) certificate of a healthcare specialist - a document of the established form confirming the qualifications of an individual and his/her readiness for professional activities in the field of healthcare, including readiness for clinical or pharmaceutical practice, or activities in the field of sanitary and epidemiological well-being of the population;

84) manager in the field of public health - the first head who manages a state medical organization;

85) certificate of a healthcare manager - a document of the established form for engaging in activities for the management of a state medical organization;

86) examination in the field of public health - a set of organizational, analytical and practical measures aimed at determining the effectiveness and quality of means, methods, technologies, educational and scientific programs, services in various areas of healthcare, as well as determining temporary disability, professional fitness for health reasons in accordance with the legislation of the Republic of Kazakhstan;

87) standard in the field of public health (hereinafter referred to as the standard) - a regulatory legal act that establishes the rules, general principles and characteristics to ensure standardization in the field of public health in the field of medical, pharmaceutical activities, educational and scientific activities in the field of healthcare, digital healthcare;

88) standardization in the field of public health (hereinafter - standardization) - activities aimed at achieving the optimal degree of streamlining the characteristics of processes, technologies and healthcare services through the development, implementation and enforcement of standards, requirements, norms, instructions, rules;

89) an authorized body in the field of public health (hereinafter referred to as an authorized body) is a central executive body that carries out management and inter-sectoral coordination in the field of health protection of citizens of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological well-being of the population, circulation of pharmaceuticals and medical devices, the quality of healthcare services (assistance);

90) national operator in the field of public health - a legal entity carrying out activities in the field of healthcare, including the development of healthcare infrastructure;

91) health technology assessment - a comprehensive assessment of the comparative proven clinical and clinical and economic (pharmacoeconomic) effectiveness and safety of health technologies, as well as the economic, social and ethical consequences of their use, carried out for decision-making in the field of healthcare;

92) healthcare technology - the application of knowledge and skills that are used to promote health, prevention, diagnosis, treatment of illness, rehabilitation of patients and the provision of palliative care, including vaccines, drugs and medical devices, procedures, manipulations, operations, screening , preventive programs , including information systems;

93) healthcare organization - a legal entity carrying out activities in the field of healthcare;

94) pharmaceutical formulary of a healthcare organization - a list of pharmaceuticals for the provision of medical care within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance, formed on the basis of the Kazakhstan National Drug Formulary and approved by the head of the healthcare organization in the manner determined by the authorized body;

95) joint responsibility for health - the division of responsibility between the members of society: the state, the employer and the citizen himself for the preservation and strengthening of individual and public health, reducing the risk of disease;

96) deratization - a set of preventive and exterminatory measures aimed at destroying or reducing the number of rodents;

97) detoxification - a complex of medical measures aimed at removing toxic substances of endogenous or exogenous origin from the human body;

98) diagnostics - a set of healthcare services aimed at establishing the presence or absence of a disease;

99) dynamic observation - systematic observation of the patient's health, as well as the provision of the necessary medical care based on the results of this observation;

100) donor - a person, a human corpse, an animal from which donor blood, its components, other donor material (including sperm, eggs, tissue of reproductive organs, reproductive cells, embryos), as well as the removal of organs (parts of an organ) and/or tissues (parts of tissue) for transplantation to a recipient;

101) donor organization - a healthcare organization in which the removal and conservation of organs (parts of an organ) and (or) tissues (parts of tissue) from corpses is carried out for the purpose of transplantation;

102) donor function - the donor's voluntary medical examination and allogeneic donation of blood and its components;

103) treatment - a complex of healthcare services aimed at eliminating, stopping and (or) alleviating the course of the disease, as well as preventing its progression;

104) attending physician - a doctor who provides medical care to a patient during the period of his/her observation and treatment in a medical organization;

105) voluntary treatment - treatment carried out with the consent of the patient or his/her legal representative;

106) calculated (preliminary) sanitary protection zone - the territory of the sanitary protection zone, determined on the basis of the project with calculations of dispersion of atmospheric air pollution, physical (noise, vibration, non-ionizing radiation) and (or) radiation effects on human health;

107) undesirable reaction - an unintentional, adverse reaction of the body associated with the use of a medicinal (investigational) drug and suggesting the presence of a possible relationship with the use of this medicinal (investigational) drug;

108) counterfeit pharmaceuticals and medical devices - pharmaceuticals, medical devices, unlawfully and intentionally supplied with false information about their composition or configuration and (or) manufacturer, as well as about supplies, including records and documents concerning the used supply channels;

109) personal medical record - a personal document in which the results of mandatory medical examinations are entered with a mark on admission to work;

110) high-tech medical service - a service provided by specialized professionals for diseases requiring the use of innovative, resource-intensive and (or) unique methods of diagnosis and treatment;

111) artificial termination of pregnancy - termination of pregnancy prior to the term of fetal viability using medication or surgical methods, carried out by medical workers with higher medical education in the relevant profile;

112) mobile medical complexes - mobile clinics (offices) based on road transport, equipped with the necessary medical equipment, which are used to ensure the availability and expansion of the list of healthcare services provided to the population of rural areas and remote settlements or in the interests of defence and national security;

113) sexually transmitted infections - infectious diseases, the most frequent route of infection of which is sexual contact;

114) person with gender identity disorders - a person seeking to live and be accepted as a person of the opposite sex;

115) immunological pharmaceutical product (immunobiological medicinal product) - a medicinal product intended for the formation of active or passive immunity or diagnosis of the presence of immunity, or diagnosis (development) of a specific acquired change in the immunological response to allergenic substances;

116) system of immunological typing (hereinafter referred to as the HLA system) - a system of antigens located on human leukocytes and determining the tissue compatibility of the donor and recipient during organ (part of an organ) and (or) tissue (part of tissue) transplantation;

117) invasive methods - methods of diagnosis and treatment, carried out by penetration into the internal environment of the human body;

118) innovative medical technologies - a set of methods and means of scientific and scientific and technical activities, the implementation of which in the field of medicine (biomedicine), pharmacy and digitalization of healthcare is socially significant and (or) cost effective;

119) an integrated academic medical center - an association of an organization of higher and (or) postgraduate medical education with scientific organizations in the field of public health and health organizations in order to share resources to improve the quality of healthcare services through the integration of education, research and clinical practice;

120) non-interventional clinical research - a research that is carried out after the state registration of a pharmaceutical product or medical device and is assigned within the framework of medical practice;

121) interventional research - a research involving a human being as a clinical trial participant, in which a research doctor, on the basis of an interventional clinical research protocol, corresponding to the procedure for conducting clinical research, prescribes a special intervention to the clinical trial participant;

122) epidemiological surveillance of non-communicable diseases - the activities of state bodies and organizations of the sanitary and epidemiological service to monitor risk factors from the impact of environmental objects affecting the health of the population, including production factors, occupational diseases with temporary disability, minimization and control over the implementation chronic noncommunicable disease management programs;

123) infectious and parasitic diseases - human diseases, the appearance and spread of which are caused by the impact of biological factors of the environment on humans and the possibility of transmission of the disease from a sick person, animal to a healthy person;

124) iodine deficiency disease - a pathological process of the body caused by dysfunction of the thyroid gland associated with insufficient intake and assimilation of iodine in the body;

125) occupational disease - an acute or chronic disease caused by exposure of an employee to harmful production factors in connection with the performance of his/her labor (official) duties;

126) biological material of preclinical (nonclinical) and clinical studies - samples of biological fluids, tissues, secretions and waste products of humans and animals, biopsy material, histological sections, smears, scrapings, swabs obtained during preclinical (nonclinical) and clinical studies and intended for laboratory research;

127) preclinical (nonclinical) research - chemical, physical, biological, microbiological, pharmacological, toxicological and other experimental research or a series of studies to study an investigated substance (drug) by applying scientific assessment methods in order to study a specific action and (or) obtain evidence safety for human health;

128) clinical base - a healthcare organization, which is used by an educational organization for training and advanced training of personnel in the field of public health under an agreement on joint activities;

129) clinical research - a study with human participation as a clinical trial participant, conducted to identify or confirm the safety and efficacy of means, methods and technologies for the prevention, diagnosis and treatment of diseases;

130) clinical nursing guidance - a document containing scientifically proven recommendations for nursing personnel on patient care, suggesting the use of preventive, diagnostic, therapeutic and rehabilitation measures in the management of patients;

131) clinical pharmacologist - a specialist with higher medical education in the field of “General Medicine”, “Pediatrics”, “General Medicine”, who has mastered the program of residency or retraining in clinical pharmacology and has a certificate of a healthcare specialist;

132) clinical protocol - scientifically proven recommendations for the prevention, diagnosis, treatment, medical rehabilitation and palliative care for a specific disease or condition of the patient;

133) concilium - a medical examination of a person in order to establish a diagnosis, determine treatment tactics and prognosis of a disease with the participation of at least three doctors;

134) contraception - methods and means of preventing unwanted pregnancy;

135) the maximum price for a trade name of a medicine for wholesale – the price for the trade name of a medicine, included into the list of medicines that are subject to price regulation, above which its wholesale cannot be carried out;

136) Kazakhstan National Drug Formulary - a list of pharmaceuticals with proven clinical safety and efficacy, as well as orphan (rare) medicinal products, which is a mandatory basis for the development of medicinal formularies of medical organizations and the formation of lists for the purchase of pharmaceuticals within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

137) the nomenclature of medical devices of the Republic of Kazakhstan - a systematized nomenclature classifier of types of medical devices, harmonized with the Global Medical Device Nomenclature (GMDN) and used in the Republic of Kazakhstan;

138) State Pharmacopoeia of the Republic of Kazakhstan - a set of minimum requirements for the safety and quality of pharmaceuticals and medical devices;

139) the register of pharmaceutical inspectors of the Republic of Kazakhstan - an electronic information resource of the authorized body containing information about pharmaceutical inspectors of the Republic of Kazakhstan;

140) a generic medicinal product (generic) is a medicinal product that has the same quantitative and qualitative composition of active ingredients and the same dosage form as the original medicinal product, and the bioequivalence of which to the original medicinal product is confirmed by appropriate bioavailability studies. Various salts, esters, isomers, mixtures of isomers, complexes or derivatives of an active ingredient are recognized as the same active ingredient if their safety and efficacy do not differ significantly. Different immediate-release oral dosage forms are recognized in bioavailability studies for the same dosage form;

141) allogeneic donation of blood and its components - donation of blood and its components for medical use from one person to another;

142) pre-exposure prophylaxis - antiretroviral therapy applied to uninfected people to prevent HIV infection;

143) post-exposure prophylaxis - antiretroviral therapy used to reduce the risk of contracting HIV infection after a possible infection;

144) public health - a comprehensive characteristic of the mental, physical and social well-being of the population, reflecting the efforts of society to maintain a healthy lifestyle by the citizens of the Republic of Kazakhstan, including healthy eating, to prevent diseases and injuries, as well as to prevent the influence of adverse environmental factors;

145) research in the field of public health - a study conducted on the basis of the collection and generalization of clinical and epidemiological data and other medical information to identify the main factors that affect health and determine the development of the healthcare system, develop methods of targeted influence and management of these factors;

146) adverse event - any malfunction and (or) deterioration in the performance or malfunction of a medical device, or inadequacy or inaccuracy of accompanying information (documentation) for a medical device, side effects or an unwanted reaction not specified in the instructions for use or operating instructions, which directly or indirectly led or could lead to the death or serious deterioration of the health of users or third parties;

147) applied biomedical research - biomedical research aimed at achieving specific goals in the field of diagnosis, treatment or prevention of diseases, ensuring public health;

148) hookah - a device used for inhalation of aerosol, vapor or smoke arising from smoldering and (or) heating of tobacco, as well as products that do not contain tobacco leaves, and in which aerosol, vapor or smoke passes through a vessel with liquid;

149) hookah tobacco - a type of smoking tobacco product intended for smoking using a hookah and consisting of a mixture of cut or torn raw materials with or without the addition of non-tobacco raw materials and other ingredients;

150) hookah mix - a product made without using tobacco leaf as a raw material, prepared in such a way as to be used for consumption using a hookah;

151) excipient - a substance, with the exception of pharmaceutical substances (active pharmaceutical ingredients), which is a part of a medicinal product to give it the necessary properties;

152) confidential medical examination - examination based on the observance of the secrecy of the medical worker and the preservation of information on the identity of the examined person;

153) compulsory medical treatment - treatment of a patient, carried out on the basis of a court decision;

154) medical worker - an individual with a professional medical education carrying out medical activities;

155) medical aviation - the provision of emergency medical care to the population with the involvement of air transport;

156) medical information - information about patients and diseases arising in the process of providing medical care and reflected in medical documents and medical information systems, as well as information on health issues;

157) medical intervention - direct or indirect impact and (or) other manipulation performed by a medical worker in the provision of medical care to patients for the purpose of prevention, prophylaxis, diagnosis, treatment, rehabilitation, research and aimed at restoring or improving health;

158) medical and social assistance is medical and social and psychological assistance provided to persons with socially significant diseases, the list of which is determined by the authorized body;

159) medical and social rehabilitation – a set of measures to restore the health of patients and persons with disabilities using medical, social and professional-labor measures for introduction to work, inclusion in family and social life;

160) biomedical experiment – a study based on the reproduction (modeling) of the structural and functional complex of the studied condition or disease in a simplified form on experimental (laboratory) animals to clarify the causes, conditions and mechanisms of the onset of the condition or development of the disease, the development of methods of treatment and prevention;

161) medical devices - medical devices and medical equipment;

162) consumables for medical devices - products and materials consumed when using medical devices, ensuring manipulations in accordance with the functional purpose of the medical device, operational characteristics, the manufacturer's service manual;

163) circulation of medical devices - design, development, creation of prototypes, technical testing, research (testing) assessment of the biological effect of medical devices, clinical studies, examination of the safety, quality and effectiveness of medical devices, registration, production (manufacturing), storage, transportation, implementation, installation, adjustment, application (operation), maintenance, repair and disposal of medical devices;

164) studies (tests) for assessing the biological effect of medical devices - studies (tests) conducted in order to determine the compliance of medical devices with the general requirements for the safety and effectiveness of medical devices, the requirements for their labeling and operational documentation for them;

165) Global Medical Device Nomenclature (GMDN) - a systematized nomenclature classifier of types of medical devices used to identify medical devices;

166) type of medical devices - a group of medical devices with a similar purpose, similar application technologies, design features and a common digital designation in the nomenclature of medical devices of the Republic of Kazakhstan;

167) monitoring of the safety, quality and effectiveness of medical devices - collection, registration, analysis of information on adverse events;

168) manufacturer of a medical device - an entity in the field of circulation of pharmaceuticals and medical devices, responsible for the development and manufacture of a medical device, making it available for use on its own behalf, regardless of whether it is developed and (or) manufactured by this entity or on its behalf by another entity/individual (entities/individuals), and responsible for its safety, quality and effectiveness;

169) component of a medical device - a part of a medical device that is not an independent medical device, including blocks, parts, elements of a product, materials, spare parts provided by the manufacturer for use in accordance with the functional purpose, performance characteristics, the manufacturer's service manual;

170) safety of a medical device - the absence of an unacceptable risk when using a medical device associated with causing harm to life, human health and the environment;

171) the quality of a medical device - the degree of compliance of the set of properties and characteristics of a medical device with the purposes of its intended use;

172) trade name of a medical device - the name under which a medical device is registered;

173) the effectiveness of a medical device - a set of properties and characteristics of a medical device that ensure the achievement of the intended purpose established by the manufacturer of the medical device and confirmed by the practice of its use;

174) medical education - a system of training and advanced training of medical workers, as well as a set of knowledge and skills necessary for a medical worker, obtained during training under training programs for advanced training in medical specialties, confirmed by an official document on the completion of training;

175) assessment of knowledge and skills of students under medical education programs - assessment of the quality of mastering by students of educational programs and the formation of knowledge, skills and abilities in accordance with the stage of training;

176) assessment of the professional qualifications of graduates of medical education programs - a procedure for assessing knowledge and skills, carried out in order to determine whether the qualifications of a graduate of a medical education program meet the requirements of a professional standard in the field of healthcare;

177) strategic partnership in the field of medical education and science is a form of medium-term or long-term cooperation between scientific organizations and educational organizations in the field of healthcare, and foreign organizations of higher and (or) postgraduate education, and medical organizations in the field of medical education and science for implementation and adaptation international standards of education, science and clinical practice on the basis of an agreement;

178) organization of medical education - an organization of education that implements educational programs majoring in "Healthcare";

179) medical care - a complex of healthcare services aimed at maintaining and restoring the health of the population, including drug provision;

180) quality of medical care - the level of compliance of the provided medical care with the standards of medical care;

181) healthcare services - actions of healthcare entities with a preventive, diagnostic, therapeutic, rehabilitation and palliative orientation in relation to a specific person;

182) independent expertise of the quality of healthcare services (care) - a procedure carried out by independent experts within the framework of internal and external examinations in order to make an opinion on the level of quality of healthcare services (assistance) provided by healthcare entities, using indicators reflecting the indicator of efficiency, completeness and compliance of the provided healthcare services (assistance) with standards;

183) medical examination - examination of an individual in order to establish or confirm the fact of the presence or absence of a disease, to determine the state of health;

184) medical activity - the professional activity of individuals who have received technical and vocational, post-secondary, higher and (or) postgraduate medical education, as well as legal entities, aimed at protecting the health of the population of the Republic of Kazakhstan;

185) a state body in the field of healthcare services (assistance) - a state body that exercises leadership in the provision of healthcare services (assistance), control over the quality of healthcare services (assistance);

186) medical devices - materials, products, solutions, reagents, packages, kits used to provide medical care in accordance with the functional purpose and manufacturer's instructions;

187) medical rehabilitation - a complex of healthcare services aimed at preserving, partial or complete restoration of the impaired and (or) lost functions of the patient's body;

188) medical trains - mobile clinics on railway transport, equipped with the necessary medical equipment, used to ensure the availability and expansion of the list of healthcare services provided to the population living near railway stations (tracks) and in the territories adjacent to them;

189) medical equipment - apparatuses, devices, equipment, complexes, systems used separately or in combination with each other to provide medical care in accordance with the functional purpose and operational characteristics established by the manufacturer;

190) medical organization - a healthcare organization, the main activity of which is the provision of medical care;

191) nursing care – a set of medical services provided by nurses and nurses of extended practice to persons of all ages, groups and communities, sick or healthy, including health promotion, disease prevention and care for the sick, persons with disabilities and dying people;

192) preschool and school medicine - the field of medicine, which includes the organization of the provision of medical care to children of preschool and school age, aimed at protecting and promoting health and preventing diseases;

193) state pharmaceutical inspector - an official of a state body exercising state control in the field of circulation of pharmaceuticals and medical devices;

194) multidisciplinary group - a group of different professionals, formed depending on the nature of the violation of the functions and structures of the patient's body, the severity of his/her clinical condition;

195) nicotine - an alkaloid found in tobacco leaves and tobacco smoke;

196) advanced therapy pharmaceuticals - pharmaceuticals obtained through biotechnology or bioengineering that offer new opportunities for treatment of diseases and injuries, including means for gene therapy, somatic cell therapy, tissue engineering;

197) rehabilitation potential - a clinically justified probability of the prospect of partial or complete restoration of the impaired and (or) lost functions of the patient's body in a certain period of time;

198) family therapist - a therapist who has undergone special multidisciplinary training in the provision of primary healthcare to family members and has a certificate of a healthcare professional;

199) focal disinfection - disinfection carried out in outbreaks in order to prevent and (or) eliminate infectious and parasitic diseases;

200) manufacturer's maximum price – the price for a trade name of a pharmaceutical product provided by the manufacturer, which is the base price for calculating the maximum wholesale and retail prices for a trade name of a medicine, included into the list of medicines that are subject to price regulation, in accordance with the Rules for the regulation of prices for medicines, as well as for medical products within the guaranteed volume free medical care and (or) in the compulsory social health insurance system;

201) production site - a territorially separate complex of a manufacturer of pharmaceuticals, medical devices, designed to perform the entire process of manufacturing pharmaceuticals, medical devices or certain stages thereof;

202) production control - a set of measures, including laboratory research and testing of products, works and services performed by an individual entrepreneur or legal entity, aimed at ensuring safety and (or) harmlessness to humans and the environment;

203) certificate of state registration of products - a document confirming the safety of products (goods), certifying the compliance of products (goods) with technical regulations and (or) unified sanitary and epidemiological and hygienic requirements of the Eurasian Economic Union and issued by a state body in the field of sanitary and epidemiological welfare of the population in a single form;

204) product safety monitoring - a system of measures aimed at identifying, preventing and suppressing the import, production, use and sale of products that do not meet the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population;

205) patented pharmaceuticals - pharmaceuticals that have received legal protection in accordance with the legislation of the Republic of Kazakhstan in the field of intellectual property;

206) patient - an individual who is (was) a consumer of healthcare services , regardless of the presence or absence of a disease or condition requiring medical care;

207) prophylaxis - a complex of medical and non-medical measures aimed at preventing the occurrence of diseases, progression in the early stages of diseases and control of already developed complications, damage to organs and tissues;

208) psychoactive substances - substances of synthetic or natural origin (alcohol, narcotic drugs, psychotropic substances, their analogues, other intoxicating substances), which, when taken once, have an effect on mental and physical functions, human behavior, and with prolonged use, cause mental and physical dependence;

209) mental health - a state of well-being, in which each person can fulfill his/her own potential, cope with ordinary life stresses, work productively and fruitfully, and also contribute to the life of their community;

210) medical assistance in the field of mental health - prevention, diagnosis, treatment, medical and social assistance and medical and social rehabilitation of persons with mental, behavioral disorders (diseases);

211) mental, behavioral disorders (diseases) - a group of diseases according to the international classification of diseases characterized by mental impairment;

212) psychological assistance - a set of measures aimed at:

assistance to a person in the prevention, resolution of psychological problems, overcoming difficult life and crisis situations and their consequences, contributing to the maintenance of mental and somatic health, optimization of mental development, adaptation and improving the quality of life, including by activating a person's own capabilities;

informing people about the causes of psychological problems, ways to prevent and resolve them;

personal enhancement, self-improvement and self-actualization;

213) psychological problem - a state of mental discomfort of a person caused by dissatisfaction with himself/herself, his/her activities, interpersonal relationships, the situation in the family and (or) other problems of personal life;

214) radiopharmaceutical medicinal product - a medicinal product containing, in a ready-to-use state, one or more radionuclides (radioactive isotopes) as an active substance or as part of an active substance;

215) resident physician - a physician who studies within the educational residency program and works in a medical organization under the supervision of a mentor;

216) residency - the level of postgraduate medical education, the purpose of which is to acquire or change the professional qualifications of a medical specialist in the relevant specialty for admission to independent clinical practice;

217) residency base - a clinic of an educational organization in the field of healthcare, a university hospital, a national center, a scientific center or a research institute, accredited as a medical organization, on the basis of which residency programs are implemented in the manner prescribed by the authorized body;

218) reproductive health - human health, reflecting the ability of an individual to reproduce full-fledged offspring;

219) antiretroviral therapy - a method of treating HIV infection through the use of short and long courses of taking antiretroviral drugs in order to restore the immune system, reduce the risk of developing severe life-threatening diseases, reduce the number of complications and prolong the life of those infected with HIV;

220) reference laboratory - a laboratory of a healthcare organization that carries out organizational and methodological work to implement an external quality assessment system and conduct research in diagnostically complex and expert cases in a certain area of laboratory diagnostics;

221) reference medicinal product - a medicinal product that is used as a comparison drug and is a standard by which the properties of a medicinal product are determined (normalized);

222) recipient - a patient who has undergone a transfusion of donor blood or components and (or) drugs isolated from it, the introduction of male or female donor material (sperm, egg cells, embryos) or organ transplantation (part of an organ) and (or) tissues (part of tissue)) from a donor, as well as artificial organs (parts of organs);

223) health resort treatment - a type of medical rehabilitation carried out in the conditions of temporary stay of persons in a sanatorium organization;

224) health resort organizations - organizations that provide health resort services for the improvement and restoration of human health with the use of medical and other services, natural healing factors, located at resorts or in health-improving areas: a sanatorium (for adults, adults and children, children), student sanatorium-preventorium, children's rehabilitation and health center;

225) sanitary and quarantine control - a type of state control and supervision in the field of sanitary and epidemiological well-being of the population in relation to persons, vehicles and products (goods) controlled by state sanitary and epidemiological control and supervision at checkpoints across the customs border of the Eurasian Economic Union, at interstate transfer railway stations or butt stations in order to prevent the import of products (goods) potentially hazardous to human health, the delivery, emergence and spread of infectious and mass non-infectious diseases (poisoning);

226) sanitary protection zone - a territory separating special-purpose zones, as well as industrial organizations and other production, utilities and storage facilities in a settlement from nearby residential areas, buildings and structures for housing and civil purposes in order to mitigate the impact of adverse factors on them;

227) sanitary and preventive measures - organizational, administrative, engineering and technical, medical and sanitary, preventive and other measures aimed at assessing the risk, harmful effects on humans of environmental factors, eliminating or reducing such risk, preventing the emergence and spread of infectious and mass non-communicable diseases (poisoning) and their elimination;

228) sanitary and epidemiological audit - an alternative form of control of epidemiologically significant facilities subject to state control and supervision in the field of sanitary and epidemiological well-being of the population, in order to identify and assess sanitary and epidemiological risks and develop recommendations for bringing these facilities into compliance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

229) sanitary and epidemiological situation - the state of health of the population and the environment in a certain territory at a certain time;

230) sanitary and epidemiological conclusion - a document certifying compliance with regulatory legal acts in the field of sanitary and epidemiological well-being of the population of facilities of state sanitary and epidemiological control and supervision;

231) sanitary and anti-epidemic measures - measures taken in order to localize and eliminate the emerging foci of infectious, parasitic diseases, poisoning among the population;

232) confidential counseling service- a specially organized service point where preventive services are provided to key populations on a free basis on the basis of anonymity, voluntariness and confidentiality;

233) simulation room (center) - a structural unit of the organization of education in the field of health, on the basis of which the training and delivery of practical skills by students are carried out in the conditions of imitation of clinical practice in a safe learning environment using simulation technologies: mannequins, simulators, computer modeling, virtual reality technologies and specially trained actors trained to portray patients;

234) screening studies - a complex of medical examination of a population that does not have clinical symptoms and complaints, in order to identify and prevent the development of various diseases at an early stage, as well as risk factors for their occurrence;

235) sports medicine - the field of medicine responsible for the biomedical support of the training of athletes and includes medical and functional control in sports, including the admission of athletes to elite sports, functional and medical rehabilitation of athletes, improving sports performance, therapy of somatic diseases of athletes, sports traumatology, emergency medical care in sports and sports hygiene;

236) standard sample - an identified homogeneous substance or mixture of substances intended for use in chemical, physical and biological research, in which its properties are compared with the properties of the investigational medicinal product, and have a purity level sufficient for the respective application;

236-1) strategically important medicines and medical devices – medicines and medical devices intended for medical use in conditions of:

military operations and elimination of their consequences;

occurrence, prevention and elimination of consequences of emergency situations;

threats of emergence, spread of new especially dangerous infectious diseases and elimination of their consequences;

prevention, diagnosis, treatment of diseases and lesions resulting from exposure to adverse chemical, biological, radiation factors, as well as the elimination of their consequences;

absence or threat of absence of medicines or medical products on the markets of the member states of the Eurasian Economic Union in the context of the introduction of restrictive economic measures against at least one of the member states;

237) bone marrow - a tissue that carries out hematopoiesis, located in the inner part of the bones and including hematopoietic stem cells, stroma and other components of the microenvironment;

238) biologically active food additives - natural and (or) identical to natural biologically active substances, as well as probiotic microorganisms intended for consumption simultaneously with food or for introduction into food products;

239) internship - a form of non-formal education aimed at the formation and consolidation in practice of professional knowledge, skills and abilities obtained as a result of theoretical training, as well as the study of the specifics of work, advanced experience for further professional activity;

240) mentor - a medical worker with at least five years of experience, appointed by the head of a medical organization or organization of medical education to provide practical assistance in the professional adaptation of students under medical education programs and young specialists, carrying out activities on the basis of the trinity of education, science and practice;

241) risk-oriented approach - a form of quality control of pharmaceuticals and medical devices through annual selection from the market, including in medical organizations;

242) risk assessment - substantiation of the probability of penetration and spread of pathogens or vectors of infectious and parasitic diseases, as well as the negative impact of environmental factors on the health of the population and the associated potential medico-biological and economic consequences;

243) independent expert - an individual who meets the requirements determined by the authorized body and is included in the register of independent experts;

244) guaranteed volume of free medical care - the volume of medical care provided at the expense of budgetary funds;

245) the maximum price for the trade name of a medicine or medical product within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance – the price for the trade name of a medicine or medical product, registered in the Republic of Kazakhstan, above which procurement cannot be made within the guaranteed the volume of free medical care and (or) in the compulsory social health insurance system;

246) the maximum price for the international nonproprietary name of the medicine or the technical characteristics of the medical product within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance – the price of the international nonproprietary name of the medicine or the technical characteristics of the medical product, or the technical characteristics of the medical product above which it cannot to be procured within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

247) tobacco - a plant of genus Nicotiana of the family of nightshade of species Nicotiana Tabacum and Nicotiana Rustica, used for the production of tobacco products;

248) tobacco products - products completely or partially made from tobacco leaf and (or) other parts of a tobacco plant as raw materials prepared in such a way as to be used for smoking, sucking, chewing, sniffing or other methods of consumption, including using systems for heating tobacco or any other device;

249) consumption of tobacco products - the process of consuming a tobacco product, hookah mixture and tobacco for hookah, including the use of a hookah, systems for heating tobacco and any other consumption systems that cause dependence of the human body on nicotine, negatively affecting its health, and on the health of non-tobacco users and polluting the environment;

250) ingredient of a tobacco product - a substance (with the exception of tobacco leaf and other parts of tobacco) used in the manufacture of a tobacco product and present in a finished tobacco product, including in a modified form;

251) packaging of a tobacco product - a unit of group consumer packaging containing a certain number of packs of tobacco products;

252) pack of tobacco products - a unit of consumer packaging made of cardboard or paper or other material, containing a certain amount of tobacco products;

253) consumer packaging of a tobacco product - packaging intended for sale or primary packaging of tobacco products sold to the end consumer;

254) tobacco sponsorship - any type of contribution to any event, event or individual with the purpose, result or probable result of promoting the sale of a tobacco product or tobacco use, directly or indirectly, with the exception of payments and contributions provided for by the legislation of the Republic of Kazakhstan;

255) system for heating tobacco - a device used to heat tobacco to form an aerosol containing nicotine;

256) tobacco products - a tobacco product packed in consumer packaging;

257) pharmaceutical inspector for good pharmaceutical practices - a person authorized to exercise the functions of conducting pharmaceutical inspection for good pharmaceutical practices and included in the register of pharmaceutical inspectors of the Republic of Kazakhstan;

258) pharmaceutical inspection for good pharmaceutical practices (hereinafter - pharmaceutical inspection) - an assessment of a facility in the field of drug circulation in order to determine its compliance with the requirements of good pharmaceutical practices of the Republic of Kazakhstan and (or) the Eurasian Economic Union;

259) transplantation - spare-part surgery of organs (part of an organ) and (or) tissues (part of tissue) to another place in the body or into another organism;

260) infectious form of tuberculosis - a form of tuberculosis that poses a danger to others in connection with the release of tuberculosis bacteria into the external environment;

261) electronic consumption systems - electronic systems for the delivery of nicotine and electronic delivery systems for non-nicotine products - devices (including electronic cigarettes) that use electronic technology (battery) to heat liquid (in cartridges, tanks and other containers) from with or without nicotine, other chemicals, fragrances with the formation of an aerosol inhaled by the user;

262) graduate - a person who has mastered the educational program of medical and (or) pharmaceutical education, another educational program in the field of healthcare;

263) tissue - a set of cells and intercellular substance that have the same structure, function and origin;

264) tissue compatibility - the similarity of tissues of a donor and a potential recipient for specific antigens of the HLA system, which determines the compatibility of a donor and a recipient in organ transplantation (part of an organ) and (or) tissues (part of tissue);

265) medical devices for diagnostics outside of a living organism (in vitro) - any instruments, apparatus, devices, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes separately or in combination with each other, as well as together with accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer of the medical device for use in research outside a living organism (in vitro) of samples of human biological materials to obtain information on the physiological or pathological state, congenital pathology, predisposition to a certain clinical condition or disease, tissue compatibility with a potential recipient, predicting responses to therapeutic interventions, choosing therapeutic agents and/or monitoring treatment;

266) temporary adaptation - the process of removing a person from the state of intoxication and adapting it to the conditions of the environment;

267) a center for temporary adaptation and detoxification - a center designed to provide specialized medical care to persons in a state of alcohol inebriation (intoxication), and which is a structural subdivision of an organization providing medical care in the field of mental health;

268) poisoning - a disease (condition) that occurs during acute (one-time) or chronic (long-term) exposure to a person of chemical, biological and other environmental factors;

269) university hospital - a multidisciplinary medical and preventive structural subdivision of the organization of higher and postgraduate education or a multidisciplinary medical and preventive organization, on the basis of which educational programs of higher, postgraduate and additional medical education are implemented on the basis of modern achievements of science and practice;

270) pharmacovigilance - a type of activity aimed at identifying, analyzing, assessing and preventing unwanted consequences of the use of medicinal products;

271) pharmacovigilance system - a system organized by the holders of registration certificates for medicinal products and the authorized body to perform tasks and responsibilities for pharmacovigilance, designed to monitor the safety of medicinal products, timely identify all changes in the assessment of the “benefit-risk” ratio of medicinal products, develop and implement measures to ensure the use of medicinal products when the benefit exceeds the risk;

272) pharmaceutical workers - individuals with pharmaceutical education carrying out pharmaceutical activities;

273) pharmaceutical education - a system of training and advanced training of pharmaceutical workers, as well as a set of knowledge and skills necessary for a pharmaceutical worker, obtained during training under training and advanced training programs in pharmaceutical specialties, confirmed by an official document on completion of training;

274) pharmaceutical service - the activities of entities in the field of circulation of pharmaceuticals and medical devices related to outpatient drug provision of the population, including the purchase, transportation, storage, accounting and sale of pharmaceuticals and medical devices, within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

275) pharmaceutical activities - activities carried out in the field of public health for the production and (or) manufacture, and (or) wholesale and (or) retail sale of pharmaceuticals and medical devices, related to the purchase (acquisition), storage, import, export, transportation, quality control, design, distribution, use and disposal of pharmaceuticals and medical devices, as well as ensuring their safety, quality and effectiveness;

276) certificate of pharmaceutical product (CPP) - a document issued by an authorized body for the registration of domestic pharmaceuticals abroad and their export;

277) pharmaceutical substance (active pharmaceutical substance) - a medicine intended for the production and manufacture of medicinal products;

278) formulary system - a system of periodic assessment and selection of pharmaceuticals for medicinal formularies, maintaining medicinal formularies and providing information in the form of an appropriate guideline and a list, aimed at the rational use of pharmaceuticals;

279) informed consent - a procedure for a person's written voluntary confirmation of his/her consent to receive medical care and (or) participation in a specific study after receiving information about all aspects of medical care and (or) research that are significant for his/her decision-making. The informed written consent shall be drawn up in the form approved by the authorized body;

280) decreed population group - persons working in the field of public services and posing the greatest danger to infecting people around with infectious and parasitic diseases;

281) key population groups - population groups that are at increased risk of contracting HIV infection due to the characteristics of their lifestyle;

282) products that pose a danger to the life and health of the population - the condition of the product, indicating the presence of a risk associated with harmful effects on human health during its use or consumption, recognized as not meeting the safety requirements established by technical regulations, hygiene standards; products that do not have manufacturer's (supplier's) documents confirming their traceability and safety; the marking of which does not meet the requirements of regulatory legal acts; with an unknown or expired shelf life; counterfeit products;

283) sanitary and epidemiological well-being of the population - the state of health of the population, the environment, in which there is no harmful effect on the person of environmental factors and favorable conditions for his/her life are provided;

284) activities in the field of sanitary and epidemiological well-being of the population - the activities of state bodies and organizations in the field of sanitary and epidemiological well-being of the population, aimed at protecting the health of citizens of the Republic of Kazakhstan, including state control and supervision in the field of sanitary and epidemiological well-being of the population, sanitary and epidemiological monitoring, sanitary and epidemiological regulation, state registration of products, sanitary and epidemiological expertise, hygienic training, sanitary and epidemiological audit, disinfection, disinsection and deratization, assessment of the degree of risks in the field of sanitary and epidemiological well-being of the population;

285) state control and supervision in the field of sanitary and epidemiological well-being of the population - the activities of state bodies in the field of sanitary and epidemiological well-being of the population, aimed at preventing, detecting, suppressing and eliminating violations of regulatory legal acts in the field of sanitary and epidemiological well-being of the population, as well as control and supervision of their observance in order to protect health, the environment of the population and the safety of products, processes, services;

286) state body in the field of sanitary and epidemiological welfare of the population - a state body that implements state policy in the field of sanitary and epidemiological welfare of the population, control and supervision over compliance with the requirements established by regulatory legal acts in the field of sanitary and epidemiological welfare of the population and other legislative acts of the Republic of Kazakhstan;

287) surgical sterilization - a method of contraception with the use of medical intervention, as a result of which a woman or a man loses reproductive capacity;

288) live birth and stillbirth of the fetus - the condition of a newborn child (fetus), determined according to the relevant international criteria of the World Health Organization of live birth and stillbirth;

289) smokeless tobacco (nicotine-containing) products - products containing nicotine, completely or partially made from tobacco leaf and (or) other parts of a tobacco plant as raw materials and their synthetic analogs, prepared in such a way as to be used for sucking, chewing, sniffing;

290) restrictive measures, including quarantine, are measures aimed at preventing the spread of infectious and parasitic diseases and providing for a special regime for entrepreneurial and (or) other activities;

291) potentially hazardous chemical and biological substances - substances that, under certain conditions and in certain concentrations, can have a harmful effect on human health or the future generation, the application and use of which is regulated by regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

292) potential recipient - a patient who needs transplantation of tissues (part of tissue) and (or) organs (part of an organ);

293) fundamental biomedical research - biomedical research conducted with the aim of expanding basic knowledge and understanding of the physical, chemical and functional mechanisms of life processes and diseases;

294) euthanasia - the satisfaction of a request to accelerate the death of an incurable patient by any actions or means, including the introduction of drugs or other means, as well as the termination of artificial measures to maintain his/her life in cases of an unfavorable outcome of the disease;

295) epidemic - a massive spread of an infectious disease, significantly exceeding the usually registered morbidity rate;

296) epidemically significant facilities - facilities, manufactured products and (or) activities of which, in violation of the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population, can lead to food poisoning and (or) infectious, parasitic diseases among the population and (or) inflict harm to public health from physical factors, industrial and radioactive contamination;

297) nuclear medicine is a field of medicine in which radioactive elements and ionizing radiation are used for the prevention, diagnosis and treatment of various diseases of human organs and systems, including oncological diseases.

2. The concepts "mental illness", "mental disorder", used in other branches of the legislation of the Republic of Kazakhstan, shall be equivalent to the concept "mental, behavioral disorder (disease)", unless otherwise provided by this Code.

3. The content of other terms shall be determined by separate articles of this Code.

Footnote. Article 1 as amended by the laws of the Republic of Kazakhstan dated 30.12.2021 No. 98-VII (shall be enforced upon expiry of sixty calendar days from the date of its first official publication); dated 03.01.2022 No. 101-VII (shall be enforced upon expiry of sixty calendar days from the date of its first official publication); dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication); dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication); dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication.

Article 2. Legislation of the Republic of Kazakhstan in the field of healthcare

1. The legislation of the Republic of Kazakhstan in the field of public health shall be based on the Constitution of the Republic of Kazakhstan and shall consist of this Code and other regulatory legal acts of the Republic of Kazakhstan.

2. If an international treaty ratified by the Republic of Kazakhstan establishes other rules than those contained herein, then the rules of the international treaty shall apply.

Article 3. Relations regulated by this Code

1. This Code shall regulate public relations in the field of public health in order to implement the constitutional right of citizens of the Republic of Kazakhstan to health protection.

2. Legal relations regulated by the legislation of the Republic of Kazakhstan in the field of public health shall not be subject to the legislation of the Republic of Kazakhstan on public procurement in terms of procurement:

1) services from healthcare entities for the provision of medical care within the guaranteed volume of free medical care, additional volume of free medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance, except for cases when such procurement is carried out by medical departments of special state bodies;

2) medicines and medical products within the guaranteed volume of free medical care, additional volume of free medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance, except for cases when such procurement is carried out by medical units of special state bodies;

3) services for the storage and transportation of medicines and medical products within the guaranteed volume of free medical care, additional volume of free medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance;

4) goods and services for the examination of state registration, re-registration and amendments to the registration dossier of pharmaceuticals, medical devices and assessment of their safety and quality;

5) pharmaceutical services;

6) services for the registration and sale of pharmaceuticals and medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance.

3. Requirements for medical inspection, medical examination in the field of civil aviation for aviation personnel, as well as the categories of persons subject to mandatory medical inspection and medical examination, shall be established by the legislation of the Republic of Kazakhstan on the use of the airspace of the Republic of Kazakhstan and aviation activities.

Footnote. Article 3 as amended by the law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022).

Article 4. Purpose and objective of the legislation of the Republic of Kazakhstan in the field of healthcare

1. The purpose of the legislation of the Republic of Kazakhstan in the field of public health shall be to ensure the exercise by citizens of the right to health protection, including affordable and high-quality medical care to preserve and strengthen the health of the population of the Republic of Kazakhstan.

2. The objective of the legislation of the Republic of Kazakhstan in the field of public health shall be to create legal conditions aimed at improving the health of citizens of the Republic of Kazakhstan.

Article 5. Principles of the legislation of the Republic of Kazakhstan in the field of healthcare

Legal regulation of relations in the field of public health shall be based on the principles:

1) ensuring the equality of the rights of citizens of the Republic of Kazakhstan to receive safe, effective and high-quality medical care;

2) joint responsibility of the state, employers and individuals for the preservation and strengthening of individual and public health;

3) protection of motherhood and childhood;

4) ensuring the guaranteed volume of free medical care;

5) classifying public health, safety, quality and efficacy of pharmaceuticals as factors of ensuring national security;

6) ensuring the availability of safe, high-quality and effective pharmaceuticals, medical devices and their rational use;

7) social orientation of healthcare, aimed at meeting the needs, demands of the population and improving the quality of life;

8) assistance in the formation of a healthy lifestyle and healthy diet;

9) priority of preventive activities in the healthcare system;

10) availability of medical care;

11) continuous improvement of the quality of medical care;

12) participation of public associations in ensuring the rights of citizens of the Republic of Kazakhstan to health protection;

13) ensuring the sanitary and epidemiological well-being of the population;

14) succession of the activities of healthcare entities in the provision of medical care;

15) ensuring the continuity and succession of educational activities in the field of public health using modern teaching technologies;

16) state support for domestic medical and pharmaceutical science, the introduction of advanced achievements of science and technology in the field of prevention, diagnosis, treatment and medical rehabilitation, innovative development of new pharmaceuticals and technologies, as well as world experience in the field of healthcare;

17) encouraging voluntary gratuitous donation;

18) state support for domestic developments and the development of a competitive medical and pharmaceutical industry;

19) empowering society in matters of health protection;

20) coverage of measures to protect and promote health of all categories and groups of the population.

Chapter 2. STATE REGULATION AND GOVERNANCE IN THE FIELD OF HEALTHCARE

Article 6. Competence of the Government of the Republic of Kazakhstan

Government of the Republic of Kazakhstan shall:

1) develop the main directions of state policy in the field of healthcare;

      2) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      3) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      4) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      5) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      6) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      7) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      8) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);
      9) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).
      Footnote. Article 6 as amended by the law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 7. Competence of an authorized body

An authorized body shall:

1) implement the state policy in the field of healthcare;

1-1) formulates and implements the state policy in the field of healthcare;

2) organize the formation of a healthy lifestyle and healthy nutrition;

3) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);

4) introduce new methods of prevention, diagnosis, treatment of diseases and conditions of medical rehabilitation, as well as control over them;

5) carry out monitoring in the field of healthcare;

6) form a list of the guaranteed volume of free medical care;

7) form a list of medical care in the compulsory social health insurance system;

7-1) determines the procedure, types and volume of medical assistance to the population in emergency situations, the introduction of a state of emergency;

8) carry out international cooperation in the field of healthcare, including on educational and scientific activities in the field of healthcare;

9) implement international projects in the field of healthcare;

9-1) defines the national operator in the field of healthcare, its functions and powers;

9-2) defines a single distributor;

10) carry out cross-sectoral coordination of activities for the introduction and implementation of international health regulations;

10-1) develops and approves the list of diseases that are the basis for exemption from fingerprint registration, in coordination with the Ministry of Internal Affairs of the Republic of Kazakhstan;

11) develop and approve the rules for determining cases (events) of a medical incident, recording and analyzing them;

12) recognize the requirements of the world's leading pharmacopoeias as valid in the territory of the Republic of Kazakhstan;

13) carry out state regulation of prices for pharmaceuticals;

14) carry out state regulation of prices for medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

15) determine the list of pharmaceuticals and medical devices purchased from a single distributor;

15-1) determines the procedure for organizing and conducting the purchase of medicines, medical products and specialized medical products within the guaranteed volume of free medical care, additional volume of medical care for persons held in pre-trial detention facilities and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance, pharmaceutical services;

15-2) determines the procedure for the purchase of services for the storage and transportation of medicines and medical products, services for the registration and sale of medicines and medical products by a single distributor within the guaranteed volume of free medical care, additional volume of medical care for persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance;

16) determine the priority areas of biomedical research;

17) ensure the development of medical and pharmaceutical science, medical and pharmaceutical education and coordinate scientific and educational activities in the field of healthcare;

18) place a state educational order for training and advanced training of personnel in the field of healthcare;

19) conduct certification for professional competence of the persons specified in paragraph 3 of Article 26 of this Code;

20) participate in the development of a list of professions, works and specialties employed in jobs with harmful working conditions, in favor of which mandatory professional pension contributions are made by agents for the payment of mandatory professional pension contributions at their own expense;

21) form a single long-term plan for the development of healthcare infrastructure;

22) coordinate regional long-term plans for the development of health infrastructure;

23) carry out coordination and methodological guidance of local executive bodies in the field of healthcare;

24) excluded by the Law of the Republic of Kazakhstan dated 30.12.2022 No. 177-VII (shall be enforced ten calendar days after the date of its first official publication);

25) coordinate the activities of healthcare entities;

26) carries out measures to equip state healthcare organizations;

27) coordinate and monitor corporate governance activities in state legal entities in the field of healthcare;

28) determine a unified methodology for organizations entitled to conduct a risk assessment and establish the procedure for conducting a risk assessment;

29) develop and approve a strategy for digitalization of healthcare;

30) create and ensure the functioning of electronic information resources and information systems, information and communication networks in the field of healthcare, organization of access to them for individuals and legal entities in accordance with the legislation of the Republic of Kazakhstan in the field of informatization;

31) develop and approve, within its competence, regulatory legal acts and forms of accounting and reporting documentation in the field of healthcare;

32) develop and approve standards in the field of healthcare;

33) develop and approve instructions, algorithms and regulations in the field of healthcare;

34) develop and approve the rules for the use of technical control devices, observation and fixation devices, photo and video equipment used in medical organizations in order to ensure the protection of the rights of patients and medical workers;

35) develop and approve the rules for awarding honorary titles in the field of healthcare;

36) develop and approve the rules of the industry system of incentives;

37) develop and approve a standard system of remuneration for employees of state enterprises on the basis of the right of economic management in the field of healthcare;

38) determine the procedure for attestation of professional competence of health professionals;

39) develop and approve the minimum standards for the provision of regions with medical workers;

40) develop and approve the regulation on the national coordinator for human resources for health;

41) develop and approve the rules for confirming the results of continuous professional development of healthcare workers;

42) develop and approve the nomenclature of specialties and specializations in the field of healthcare, the nomenclature and qualification characteristics of the positions of healthcare workers;

43) develops and approves a list of medicines and medical products purchased by a single distributor under long-term contracts for the supply of medicines and medical products;

44) develop and approve the rules for assessing the quality of pharmaceuticals and medical devices registered in the Republic of Kazakhstan;

45) develop and approve the rules for the formation of the register of healthcare entities engaged in wholesale and retail sales of medical products, in a notification procedure;

46) develop and approve the Kazakhstan National Drug Formulary;

47) develop and approve the rules for the formation of the Kazakhstan National Drug Formulary, the list of pharmaceuticals and medical devices for free and (or) preferential outpatient provision of certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions), as well as the rules for the development of medicinal forms of healthcare organizations;

48) develop and approve the rules for assessing the rational use of pharmaceuticals;

49) develop and approve the Rules for the provision with medicines and medical products within the guaranteed volume of free medical care, additional volume of free medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance;

50) develop and approve the rules for the formation of a list of procurement of pharmaceuticals and medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

51) develop and approve the rules for regulating prices for pharmaceuticals, as well as for medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

52) develop and approve the rules for the implementation of service maintenance of medical devices in the Republic of Kazakhstan;

53) develop and approve a methodology for an expert assessment of optimal technical characteristics and clinical and technical justification of medical devices;

54) develop and approve the rules for interaction on contractual fractionation;

55) develop and approve the composition of the first aid kit;

56) develop and approve the rules for the procurement of goods and services for the implementation of expertise during the state registration of pharmaceuticals and medical devices and assessment of their safety and quality;

57) develop and approve a list of pharmaceuticals and medical devices necessary for the provision of emergency and urgent medical care in healthcare organizations;

58) develop and approve regulations on the national coordinator for international health regulations;

59) develop and approve the standard form of the contract for the provision of paid healthcare services (assistance);

59-1) develop and approve the Rules for organizing the provision of medical care to persons with tuberculosis, held in institutions of the penal (penitentiary) system, in agreement with the Ministry of Internal Affairs of the Republic of Kazakhstan;

59-2) develop and approve the Rules for conducting a medical examination of convicts who are presented for release from serving a sentence due to illness, and determines the list of diseases that are the basis for release from serving a sentence, in agreement with the Ministry of Internal Affairs of the Republic of Kazakhstan;

59-3) determine the procedure for procurement and payment for services of healthcare entities on provision of medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budget funds;

59-4) develop and approve model personnel establishment and staff normative standards of medical organizations, providing medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budget funds;

59-5) develop and approve the Rules and methodology for formation of tariffs for medical services, provided within the additional volume of medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budget funds;

59-6) develop and approve minimum standards for equipping with medical equipment and medical devices for medical organizations providing medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budget funds;

60) develop and approve the rules for sending citizens of the Republic of Kazakhstan for treatment abroad and (or) attracting foreign specialists for treatment in domestic medical organizations within the guaranteed volume of free medical care;

60-1) develop and approve the rules for the use of lump-sum pension payments for treatment;

61) develop and approve the methodology for the formation (calculation) of indicators in the field of healthcare;

62) develop and approve the rules for the procurement of services from healthcare entities for the provision of medical care within the guaranteed volume of free medical care and (or) in the compulsory social health insurance system;

63) develop and approve the rules for planning the volume of healthcare services within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

64) develop and approve the rules and methodology for the formation of tariffs for healthcare services provided within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

65) develop and approve tariffs for healthcare services provided within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

66) develop and approve the rules for keeping records of consumers of healthcare services and granting the right to receive medical care in the system of compulsory social health insurance;

67) develop and approve the rules for keeping records of healthcare entities providing medical care within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

68) develop and approve the state standard for the network of healthcare organizations;

69) develop and approve the rules for the formation, coordination and approval of a single long-term plan for the development of health infrastructure;

70) develop and approve the nomenclature of healthcare organizations and regulations on their activities;

71) develop and approve the minimum standards for equipping healthcare organizations with medical devices;

72) develops and approves professional standards in the field of healthcare;

73) develop and approve the rules for conducting medical examinations of persons applying for the right to drive vehicles;

74) develop and approve the rules for conducting a medical examination to establish the fact of the use of a psychoactive substance and the state of intoxication;

75) develop and approve the rules for the collection, storage and use of blood and tissues of persons exposed to ionizing radiation;

76) develop and approve a list of diseases associated with exposure to ionizing radiation, and the rules for establishing a causal relationship;

77) develop and approve a list of medical contraindications for persons with mental, behavioral disorders (diseases) associated with the use of psychoactive substances, for which referral to an organization providing medical care in the field of mental health is not applied;

78) develop and approve the rules for the development and revision of clinical protocols;

79) develop and approve a methodology for the implementation and assessment of the effectiveness of the implementation of clinical protocols in practical healthcare;

80) develop and approve qualification requirements for medical and pharmaceutical activities;

81) develop and approve the rules for the provision of medical care by means of mobile medical complexes and medical trains;

82) develop and approve the rules for the provision of medical care in accordance with the types established by Article 120 of this Code;

83) develop and approve the rules for providing audiological care to the population of the Republic of Kazakhstan;

84) develop and approve the nomenclature, rules for the procurement, processing, quality control, storage, sale of blood and its components, as well as the rules for transfusion of blood and its components;

85) develop and approve the rules and conditions for the removal, procurement, storage, conservation, transportation, transplantation of organs (part of an organ) and (or) tissues (part of tissue) from a donor to a recipient;

86) develop and approve the rules for connecting electronic information resources containing personal medical data to telecommunication networks connecting them with other databases in the field of healthcare, in coordination with the authorized body in the field of information security;

87) develop and approve standards, classification systems, reference books and nomenclatures in the field of digital health;

88) develop and approve the minimum requirements for medical information systems in the field of healthcare;

89) develop and approve the requirements for electronic information resources for remote healthcare services ;

90) develop and approve instructions for coding morbidity and mortality, instructions for the use of international classifiers;

91) approve the methodology for the formation of the cost of training for education programs in the field of health in agreement with the authorized body in the field of education;

92) determine the procedure and methodology for formation of the demand in medicines and medical products within the guaranteed volume of free medical care, additional volume of free medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budgetary funds and (or) in the system of compulsory social health insurance;

93) develop and approve the rules for making co-payment;

94) develop and approve the rules for the formation of maximum prices and markups for pharmaceuticals and (or) medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

95) form and approve the maximum prices and markups for pharmaceuticals and (or) medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

96) develop and approve the maximum prices for the trade name of the pharmaceutical product for retail and wholesale;

97) carries out activities for the formation, monitoring of the process and evaluation of the results of the state social order in the field of public health protection for non-governmental organizations, including for key population groups;

98) determine the list of occupational diseases;

99) develop and approve the rules for monitoring the fulfillment of the terms of the contract for the purchase of healthcare services from healthcare entities within the guaranteed volume of free medical care and (or) in the compulsory social health insurance system;

100) develop and approve the rules for encouraging employees of healthcare entities providing healthcare services within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

101) participate in the formation and implementation of state policy in the field of the medical and pharmaceutical industry;

101-1) defines cases of importation into the territory of the Republic of Kazakhstan as humanitarian aid of medicines and medical products that have not passed state registration in the Republic of Kazakhstan;

101-2) approves the list of potent substances that have a harmful effect on human life and health;

102) develop and approve the rules for organizing the provision of medical care for the period of the imposed state of emergency in accordance with the Law of the Republic of Kazakhstan "On the State of Emergency";

103) develop and approve the food standards in healthcare and education organizations;

104) develop and approve the rules for conducting a confidential audit in medical organizations;

104-1) defines the list of strategically important medicines and medical products;

105) perform other functions provided for by this Code, other laws of the Republic of Kazakhstan, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

Footnote. Article 7 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (the procedure for enactment see Art.2); dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication); dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication); dated 30.12.2022 No. 177-VII (shall be enforced ten calendar days after the day of its first official publication); dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication); dated 04.07.2023 No. 15-VIII (effective sixty calendar days from the date of its first official publication); dated 23.12.2023 No. 50-VIII (effective from 01.01.2024).

Article 8. Competence of the state body in the field of healthcare services (assistance)

The state body in the field of healthcare services (assistance) shall:

1) implement state policy in the provision of healthcare services (assistance);

2) develop and approve, within its competence, legal acts and forms of accounting and reporting documentation in the field of healthcare services (assistance);

3) carry out state control in the field of healthcare services (assistance);

4) consider cases of administrative offenses in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses;

5) carry out licensing of medical activities, with the exception of forensic medical, forensic narcological, forensic psychiatric examinations, in accordance with the Law of the Republic of Kazakhstan "On Permissions and Notifications";

6) coordinate the activities of healthcare organizations on control issues in the provision of healthcare services (assistance);

7) organize the certification of professional competence of healthcare professionals;

8) interact with public associations on issues of state control in the field of healthcare services (assistance);

9) develop and approve the rules for accreditation in the field of healthcare;

10) develop and approve the rules, timing of post-accreditation monitoring and revocation of the certificate of accreditation in the field of healthcare;

11) develop and approve the rules for payment for an independent examination of the quality of healthcare services (assistance), carried out by accredited healthcare entities;

12) carry out the issuance of a license for the import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (parts of an organ) and (or) tissues (parts of tissue) of a person, blood and its components;

13) determine the procedure for issuing conclusions (permits) for the import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of samples of human biological materials, hematopoietic stem cells, bone marrow, donor lymphocytes for the purpose of unrelated transplantation, germ cells and embryos;

14) carry out the issuance of statements (permits) for the import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and the export from the territory of the Republic of Kazakhstan to these states of organs (parts of an organ) and (or) tissues (parts of tissue) of a person, blood and its components, samples of human biological materials, hematopoietic stem cells, bone marrow, donor lymphocytes for the purpose of unrelated transplantation, germ cells and embryos;

15) develop and approve the rules for engaging independent experts in the examination of the quality of healthcare services (assistance);

16) develop and approve the requirements for healthcare entities for the provision of services for an independent examination of the quality of healthcare services (assistance);

17) develop and approve the rules for the provision of information (emergency notification) on the cases of death of pregnant women, women in labor, as well as in case of death of women in childbirth within forty-two calendar days after childbirth, sudden death of patients when they are provided with routine medical care (primary healthcare and specialized care, including high-tech healthcare services );

18) develop and approve the rules for maintaining the register of independent experts, as well as the grounds for inclusion in the unified register of independent experts and exclusion from it;

19) forms a state social order, monitors its progress and evaluates the results of citizens' satisfaction with the level and quality of medical care provided in accordance with the legislation of the Republic of Kazakhstan on the state social order, the state order for the implementation of strategic partnership, grants and awards for non-governmental organizations in the Republic of Kazakhstan;

20) monitor the observance by local public health authorities of regions, cities of republican significance and the capital of the state standard of a network of health organizations;

21) carry out state control when health entities appeal the results of monitoring contractual obligations on the quality and volume of healthcare services carried out by the social health insurance fund;

22) develop and approve the rules for organizing the activities of a unified medical information call- center and the regulations for its activities;

23) carry out other functions provided for by this Code, other laws of the Republic of Kazakhstan, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

Footnote. Article 8 as amended by the Law of the Republic of Kazakhstan dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication).

Article 9. Competence of the state body in the field of sanitary and epidemiological welfare of the population

The state body in the field of sanitary and epidemiological welfare of the population shall:

1) implement state policy in the field of sanitary and epidemiological welfare of the population;

2) develop and approve, within its competence, legal acts and forms of accounting and reporting documentation in the field of sanitary and epidemiological welfare of the population;

3) develop and approve the rules for the examination of establishing the connection between occupational disease and the performance of labor (official) duties;

4) carry out sanitary and epidemiological monitoring;

5) exercise state control and supervision in the field of sanitary and epidemiological welfare of the population;

6) coordinate the activities of healthcare organizations operating in the field of sanitary and epidemiological welfare of the population;

7) provide departmental statistical monitoring in the field of sanitary and epidemiological welfare of the population;

8) create and ensure the functioning of electronic information resources and information systems, information and communication networks in the field of sanitary and epidemiological well-being of the population, organizing access to them for individuals and legal entities in accordance with the legislation of the Republic of Kazakhstan on informatization;

9) excluded by the Law of the Republic of Kazakhstan dated 30.12.2022 No. 177-VII (shall be enforced ten calendar days after the date of its first official publication);

10) determine the procedure for conducting sanitary and epidemiological expertise;

11) determine the procedure for maintaining a register of potentially hazardous chemical, biological substances prohibited for use in the Republic of Kazakhstan;

12) determine the hazard class of waste according to the degree of their impact on humans and the environment (according to the degree of toxicity);

13) develop and approve the rules for providing information on medical waste;

14) develop and approve the rules for providing information (emergency notification) about cases of infectious diseases, poisoning to the state body in the field of sanitary and epidemiological welfare of the population;

15) implement joint international projects in the field of sanitary and epidemiological welfare of the population;

16) organize hygienic education of the population;

17) organize and carry out, within its competence, sanitary-anti-epidemic and sanitary-preventive measures for food poisoning, infectious, parasitic, occupational diseases;

18) issue sanitary and epidemiological conclusions on the compliance of the object of state sanitary and epidemiological control and supervision, draft regulatory documents on maximum permissible emissions and maximum permissible discharges of harmful substances and physical factors into the environment, sanitary protection zones and sanitary protection zones, for new types raw materials and products to regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

19) carry out epidemiological control over infectious and parasitic diseases, over the resistance of pathogens of infectious diseases to antimicrobial drugs, carrying out preventive vaccinations to the population;

20) consider cases of administrative offenses in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses;

21) identify territories (parts of it) free from diseases or with a low level of prevalence of diseases;

22) create sanitary and quarantine points at checkpoints across the State border of the Republic of Kazakhstan, coinciding with the customs border of the Eurasian Economic Union;

23) develop and approve a list of epidemically significant facilities;

24) monitor compliance with the requirements established by technical regulations;

25) develop and approve the rules of hygienic training for persons of the decreed population group;

26) determine the procedure for assigning registration numbers to food production facilities subject to state control and supervision in the field of sanitary and epidemiological well-being of the population, and maintaining their register;

27) receive notifications of the beginning or termination of activities specified in subparagraphs 1), 2) and 3) of paragraph 1 of Article 24 of this Code, in the manner prescribed by the Law of the Republic of Kazakhstan "On Permissions and Notifications", and also maintain the state electronic register of permits and notifications;

28) determine the procedure for state registration of products, determined by the regulatory legal acts of the Eurasian Economic Union;

29) develop and approve the rules for maintaining a register of products that do not meet the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population;

30) develop and approve the rules for interaction of state bodies in the conduct of sanitary-anti-epidemic and sanitary-preventive measures;

31) carry out radiation control over compliance with sanitary and epidemiological requirements to ensure the radiation safety of the population;

32) exercise state control and supervision over products subject to state sanitary and epidemiological control and supervision, including food products;

33) develop and approve a list of certain types of food products subject to state control and supervision in the field of sanitary and epidemiological welfare of the population, in the production of which non-iodized salt is used;

34) carry out state regulation in the field of prevention of iodine deficiency diseases;

35) take product samples in accordance with the requirements of regulatory documents;

36) interact with public associations in the field of prevention of non-infectious diseases associated with micronutrient deficiency, including iodine deficiency and iron deficiency diseases;

37) regulate the procedure for the collection, storage, transportation and disposal of medical waste;

38) exercise control over the circulation of medical waste;

39) carry out epidemiological surveillance of non-communicable diseases;

40) develop and approve a list of medical contraindications for concluding an employment contract for heavy work, work with harmful and (or) dangerous working conditions, for underground work, as well as for admission to work of a person belonging to a decreed population group;

40-1) develops and approves qualification requirements for the licensed type of activity for the provision of disinfection, disinsection, deratization services in the field of healthcare;

40-2) issues a license for provision of disinfection, disinsection, deratization services in the field of healthcare in accordance with the Law of the Republic of Kazakhstan "On permits and notifications";

40-3) develops and approves the rules for the formation, record and maintenance of working collections of pathogenic and industrial microorganisms used in the field of sanitary and epidemiological welfare of the population;

40-4) develops and approves the rules for the issuance, renewal, re-issuance, termination of permits for handling of pathogenic biological agents and annexes to them;

40-5) develops and approves qualification requirements for handling pathogenic biological agents;

41) perform other functions provided for by this Code, other laws of the Republic of Kazakhstan, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

Footnote. Article 9 as amended by the Laws of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication); dated 30.12.2022 No. 177-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 10. Competence of the state body in the field of circulation of pharmaceuticals and medical devices

The state body in the field of circulation of pharmaceuticals and medical devices shall:

1) implement the state policy in the field of circulation of pharmaceuticals and medical devices;

2) exercise state control and supervision in the field of circulation of pharmaceuticals, medical devices, as well as over the circulation of narcotic drugs, psychotropic substances and precursors in the field of healthcare;

3) develop and approve, within its competence, legal acts and forms of accounting and reporting documentation in the field of circulation of pharmaceuticals and medical devices;

4) consider cases of administrative offenses in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses;

5) carry out licensing of the types of pharmaceutical activities specified in subparagraphs 1), 2), 3), 4), 5) and 7) of Article 230 of this Code, as well as types of activities related to the circulation of narcotic drugs, psychotropic substances and precursors in the field healthcare;

6) coordinate the activities of healthcare organizations in the field of circulation of pharmaceuticals and medical devices;

7) carry out state registration, re-registration and amendments to the registration dossier, revoke the decision on state registration of pharmaceuticals and medical devices, maintain the State Register of Pharmaceuticals and Medical Devices;

8) coordinate the import (export) of pharmaceuticals and medical devices registered and not registered in the Republic of Kazakhstan;

9) develop and approve the standards of good pharmaceutical practices;

10) receive notifications of the beginning or termination of the activities specified in subparagraphs 4), 5) and 6) of paragraph 1 of Article 24 of this Code, in the manner prescribed by the Law of the Republic of Kazakhstan "On Permissions and Notifications", and also maintain the state electronic register permissions and notifications;

11) issue a certificate for a pharmaceutical product (CPP);

12) issue a permit to conduct an interventional clinical trial of a medicinal product, medical device;

13) make decisions on the suspension of medical use of a pharmaceutical product, medical device by suspending the registration certificate of a pharmaceutical product, medical device, as well as prohibiting medical use and withdrawing from circulation or suspending medical use of a series (batch) of medicinal products and medical devices;

14) conduct accreditation of testing laboratories carrying out monopoly activities for the examination and assessment of the safety and quality of pharmaceuticals and medical devices;

15) develop and approve the rules for the wholesale and retail sale of pharmaceuticals and medical devices;

16) develop and approve checklists, risk assessment criteria and semi-annual schedules for conducting inspections in a regulated area in accordance with the Entrepreneurial Code of the Republic of Kazakhstan;

17) develop and approve the rules for conducting inspections in the field of circulation of pharmaceuticals and medical devices;

18) carry out pharmaceutical inspections;

19) develop and approve the rules for the formation of the pharmaceutical inspectorate, maintaining the register of pharmaceutical inspectors of the Republic of Kazakhstan;

20) develop and approve the rules for selection from the market, including in medical organizations, of pharmaceuticals and medical devices subject to quality control taking into account a risk-based approach;

21) participate in determining the procedure for marking goods and the procedure for exercising control over the circulation of goods subject to marking;

22) perform other functions provided for by this Code, other laws of the Republic of Kazakhstan, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

Article 11. Competence of central executive bodies and other central state bodies with military medical (medical), forensic medical, forensic narcological, forensic psychiatric subdivisions

1. Central executive bodies and other central state bodies with military medical (medical), forensic medical, forensic narcological, forensic psychiatric subdivisions, within their competence shall:

1) implement the state policy in the field of healthcare;

2) provide advanced training for employees of military medical (medical) units in accordance with the rules approved by the authorized body;

3) manage the activities of military medical (medical), forensic medical, forensic narcological, forensic psychiatric units;

4) develop and approve the rules of military medical (medical) support;

5) appoint and dismiss the heads of military medical (medical), forensic medical, forensic narcological, forensic psychiatric units;

6) ensure the creation and operation of departmental electronic information resources and information systems, information and communication networks in the field of healthcare;

7) develop and approve the structure of military medical (medical) units, regulations on their activities, unless otherwise provided by the laws of the Republic of Kazakhstan;

8) develop and approve standard staffs and staff standards for military medical (medical), forensic medical, forensic narcological, forensic psychiatric units, unless otherwise provided by the laws of the Republic of Kazakhstan;

9) establish (cancel) restrictive measures, including quarantine, on the territory of troops, units and departmental organizations with simultaneous notification of the state body in the field of sanitary and epidemiological welfare of the population and its territorial subdivision;

10) develop and approve the rules for conducting military medical expertise and regulations on the commissions of military medical expertise in agreement with the authorized body;

11) develop and approve the requirements for the state of health of persons for service in the Armed Forces, other troops and military formations of the Republic of Kazakhstan, state aviation, special state and law enforcement agencies, in agreement with the authorized body;

12) establish the procedure and frequency of medical examinations of the corresponding contingent in military medical (medical) units (organizations);

13) develop and approve forms of departmental military medical (medical) statistical reporting;

14) carry out other functions provided for by the laws of the Republic of Kazakhstan, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

2. The Ministry of Defense of the Republic of Kazakhstan shall develop and approve the requirements for the state of health of persons for service:

1) in the Armed Forces, other troops and military formations of the Republic of Kazakhstan;

2) in the state aviation of the Republic of Kazakhstan.

3. The Ministry of Internal Affairs of the Republic of Kazakhstan shall:

1) develop and approve the rules for conducting military medical expertise in law enforcement agencies and the state courier service of the Republic of Kazakhstan and the regulation on military medical expertise commissions in internal affairs bodies in agreement with the authorized body;

2) develop and approve the requirements for the state of health of persons for service in law enforcement agencies and the state courier service of the Republic of Kazakhstan, in agreement with the law enforcement agencies of the Republic of Kazakhstan.

4. The National Security Committee of the Republic of Kazakhstan shall develop and approve the requirements for the state of health of persons for service in the national security bodies of the Republic of Kazakhstan.

5. The Administrative Department of the President of the Republic of Kazakhstan shall develop and approve:

1) the rules for the provision of medical care, including medical rehabilitation, in subordinate organizations;

2) the rules for sending medical specialists from subordinate organizations for training, advanced training abroad;

3) rules for conducting educational events, attracting foreign consultants;

4) other regulatory legal acts in accordance with the legislation of the Republic of Kazakhstan.

Article 12. Competence of local representative and executive bodies of regions, cities of republican status and the capital

1. Local representative bodies of regions, cities of republican significance and the capital shall:

1) determine the system of social support measures for medical and pharmaceutical workers sent to work in rural areas and settlements, cities of district and regional significance, as well as the procedure and amount of social support to them at the expense of budgetary funds;

2) approve local budgets of healthcare and medical education and reports on their implementation;

3) make a decision on the provision of free or reduced fare travel to citizens of the Republic of Kazakhstan outside the settlement of permanent residence to receive high-tech healthcare services within the guaranteed volume of free medical care and (or) medical care in the system of compulsory social health insurance;

4) take measures to provide transport in the event of a traveling nature of the provision of medical care to the population within the framework of the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance or reimbursement of transportation costs when leaving for the provision of medical care in rural areas;

5) make a decision on the additional provision of a guaranteed volume of free medical care, including pharmaceuticals, specialized medical products, medical devices to certain categories of citizens of the Republic of Kazakhstan with outpatient treatment free of charge and (or) on preferential terms;

6) approve measures aimed at the development and operation of healthcare organizations, including organizations, providing medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system;

7) determine measures for staffing state healthcare organizations based on the population size in the corresponding administrative-territorial units;

8) take a decision on the provision of additional incentives to donors;

9) make a decision on additional staffing and material and technical support of state healthcare organizations in excess of the minimum standard of provision of the region with medical workers approved by the authorized body to provide the population with medical care;

10) carry out planning of the staffing of the region with medical workers and place an order for the training of medical workers in medical education organizations;

11) monitor the provision of social support measures, as well as the training and retention of young professionals who have arrived from medical education organizations;

12) promote the formation of a healthy lifestyle and healthy diet;

13) approve the costs of carrying out measures for the prevention of iodine deficiency diseases as part of local budgets;

14) hear information from the heads of local executive bodies of regions, cities of republican status and the capital, healthcare organizations on the state of work on the prevention of iodine deficiency diseases;

15) exercise other powers to ensure the rights and legitimate interests of citizens of the Republic of Kazakhstan in accordance with the legislation of the Republic of Kazakhstan.

2. Local executive bodies of regions, cities of republican status and the capital shall:

1) implement the state policy in the field of public health in the territory of the corresponding administrative-territorial unit;

2) ensure the implementation of the rights of individuals to receive a guaranteed volume of free medical care;

3) exercise control over the maintenance of persons in temporary adaptation and detoxification centers;

4) ensure the activities of healthcare organizations that are communal legal entities;

5) organize a set of activities to stimulate a healthy lifestyle;

6) ensure effective planning and use of healthcare resources;

6-1) create medical rehabilitation centers (departments) for children with disabilities in the cities of republican and regional significance, the capital, as well as district centers, including at the facilities of the existing infrastructure of health objects of these settlements, in order to provide rehabilitation services in accordance with the standard of organization of medical rehabilitation, the rules of medical care

7) take measures to improve the quality of healthcare services ;

8) ensure access of the population to information on health issues;

9) ensure the implementation of measures for the development of voluntary gratuitous donation of blood and its components;

10) pay for travel within the country according to the list determined by the local representative bodies of regions, cities of republican status and the capital, to certain categories of citizens of the Republic of Kazakhstan who travel outside the settlement of permanent residence to receive high-tech healthcare services within the guaranteed volume of free medical care and (or) medical care in the compulsory social health insurance system;

11) create local government health authorities;

12) appoint and dismiss the heads of local public health administration bodies of regions, cities of republican status and the capital in agreement with the authorized body;

13) organize control over staffing of state healthcare organizations;

14) take measures for staffing state healthcare organizations, including measures of social support and retention of young professionals;

15) take measures for the construction and development of a network of healthcare organizations, their financial and logistical support, including the development of a state network of pharmacies and the creation of pharmacy warehouses;

16) coordinate the activities of healthcare entities within the relevant administrative-territorial unit;

17) ensure the provision of free medical care with pharmaceuticals and medical devices in emergency situations, the introduction of a state of emergency;

18) carry out interregional cooperation in the field of healthcare;

19) provide training and advanced training of personnel in the field of healthcare;

20) carry out activities necessary for health promotion, prevention of diseases, formation of a healthy lifestyle and healthy nutrition;

21) organize the provision of medical care to the population, including the prevention and treatment of socially significant diseases and diseases that pose a danger to others, including drug provision within the guaranteed volume of free medical care;

21-1) organize provision of medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, including preventive measures and treatment of socially significant diseases and diseases that pose a danger to others, including provision with medicines;

21-2) organize the provision of medicines and medical products in rural settlements where there are no pharmacies;

22) ensure the referral of children with disabilities to psychological, medical and pedagogical consultations with the consent of parents or other legal representatives;

23) within the limits of their competence, exercise state control in the field of healthcare;

24) excluded by the Law of the Republic of Kazakhstan dated 30.12.2022 No. 177-VII (shall be enforced ten calendar days after the date of its first official publication);

25) assist in the execution of the court decision on the direction of citizens of the Republic of Kazakhstan, patients with tuberculosis, for compulsory treatment;

26) organize and carry out preventive disinsection and deratization with an assessment of their effectiveness (except for disinsection and deratization on the territory of natural foci of infectious and parasitic diseases, as well as in foci of infectious and parasitic diseases);

27) conduct training of specialists with medical education to sell medicines and medical products in rural settlements through pharmacy points in healthcare organizations providing primary health care, specialized medical care in outpatient settings, and mobile pharmacy points in the absence of a specialist with pharmaceutical education;

28) ensure the implementation of measures for the development of voluntary gratuitous donation of organs (part of an organ) and (or) tissues (part of tissue);

29) develop and approve a regional long-term plan for the development of health infrastructure in agreement with the authorized body;

30) create medical commissions for medical examination of citizens of the Republic of Kazakhstan in the interests of military service and ensure their activities;

31) organize the provision of preschool organizations, educational organizations, healthcare and social protection of the population with iodized food salt and other food products enriched with iodine compounds;

32) carry out activities for the formation, monitoring of the progress and evaluation of the results of the state social order in the field of public health protection for non-governmental organizations, including for key population groups;

33) place a state social order for the provision of palliative care, with the exception of palliative care;

34) assign the nominations "the best professional";

35) ensure the creation of conditions for the placement of interns and resident doctors in healthcare organizations of the corresponding administrative-territorial unit, including the provision of a place of residence and the provision of medical care to interns and resident doctors (if the healthcare organization is located in another settlement with a higher and ( or) postgraduate education);

36) organize the safe disposal of medical waste;

37) carry out the development of a network of healthcare organizations and the implementation of regional long-term plans for the development of healthcare infrastructure;

38) ensure the implementation of state programs for the development of the healthcare system, as well as the implementation of measures in the field of public health and decisions of the National Coordination Council for Health Protection under the Government of the Republic of Kazakhstan;

39) ensure the creation and operation of regional electronic information resources and information systems, information and communication networks in the field of healthcare;

40) exercise, in the interests of local government, other powers assigned to local executive bodies by the legislation of the Republic of Kazakhstan.

Footnote. Article 12 as amended by the law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 03.05.2022 No. 118-VII (shall be enforced ten calendar days after the date of its first official publication); dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication); dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the day of its first official publication); dated 30.12.2022 No. 177-VII (shall be enforced ten calendar days after the day of its first official publication).

Article 13. Competence of local government health authorities in regions, cities of republican status and the capital

Local government health authorities of regions, cities of republican status and the capital shall, within their competence:

1) implement the state policy in the field of healthcare;

2) ensure the implementation of the legislation of the Republic of Kazakhstan in the field of healthcare;

3) ensure the implementation of the rights of individuals to receive a guaranteed volume of free medical care;

4) organize and carry out monitoring and control over the activities of healthcare entities, with the exception of healthcare organizations operating in the field of sanitary and epidemiological welfare of the population;

5) carry out the procurement of pharmaceutical services;

6) carry out the purchase and storage of pharmaceuticals, prophylactic (immunobiological, diagnostic, disinfecting) drugs, medical devices within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

7) organize the purchase of medical devices, sanitary transport, as well as services for the overhaul of state health organizations;

8) organize the provision of the region with personnel in the field of healthcare;

9) ensure the maintenance and operation of state medical organizations in accordance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

10) provide clinical bases in communal legal entities in the field of public health for educational organizations in the field of healthcare;

11) organize the provision of free medical care, the provision of pharmaceuticals and medical devices in emergency situations;

12) organize and coordinate activities for training and advanced training of personnel in the field of healthcare;

13) organize hygienic training, promotion and formation of a healthy lifestyle and healthy nutrition;

14) inform the population about the spread of socially significant diseases and diseases that pose a danger to others;

14-1) carry out, together with youth resource centers, information and explanatory, advisory work with young people on issues of reproductive health and family planning, the dangers of gambling addiction (ludomania);

15) interact with international and non-governmental public associations on health protection of citizens of the Republic of Kazakhstan;

16) carry out departmental statistical observations in the field of public health within the relevant administrative-territorial unit in compliance with the requirements of statistical methodology;

17) develop and approve the personal composition of medical commissions created to conduct medical examination of citizens of the Republic of Kazakhstan in the interests of military service, and organize their activities;

18) submit to the authorized body a quarterly report on the implementation of state programs for the development of the healthcare system, as well as on the main quantitative and qualitative indicators of healthcare;

19) make proposals to the authorized body to improve the performance of the healthcare system within the relevant administrative-territorial unit, including on the development of primary healthcare, protection of mothers and children and the implementation of a program for socially significant diseases;

20) organize staffing of the heads of state healthcare organizations in agreement with the authorized body;

21) organize and carry out preventive vaccinations for the population;

21-1) form a special medical commission to conduct a medical examination of convicts on the list of diseases that are the basis for release from serving a sentence;

21-2) provide medical care to persons held in pre-trial detention centers and institutions of the penal (penitentiary) system;

21-3) develop and approve tariffs for medical services provided as part of the additional volume of medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of budget funds;

21-4) organizes preventive vaccinations for the population;

21-5) coordinates and monitors activities on corporate governance issues in state legal entities in the field of healthcare in the relevant administrative-territorial units, with the exception of organizations subordinate to the authorized body;

21-6) carries out activities for the formation, monitoring of the implementation and evaluation of the results of the state social order in the field of public health protection for non-governmental organizations, including for key population groups, with the exception of organizations subordinate to the authorized body;

22) exercise, in the interests of local government, other powers assigned to local government health authorities of regions, cities of republican status and the capital by the legislation of the Republic of Kazakhstan.

Footnote. Article 13 as amended by the law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 26.12.2022 No. 168-VII (shall be enforced sixty calendar days after the date of its first official publication); dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 14. Power and authority of the national healthcare operator

The national healthcare operator shall implement investment projects and public-private partnership projects in the healthcare sector.

Article 15. Joint commission on the quality of healthcare services

1. The Joint Commission on the Quality of Healthcare services shall be created with the aim of developing recommendations for improving standardization, clinical protocols, standards for quality control and accessibility of healthcare services, as well as accreditation of entities in accordance with Article 25 of this Code.

2. The Joint Commission on the Quality of Healthcare services shall be formed of representatives of state bodies, non-governmental organizations, state and non-state healthcare organizations.

3. The procedure for the formation of a Joint Commission on the Quality of Healthcare services and the regulation on its activities shall be determined by the authorized body.

Article 16. Interdepartmental interaction of state bodies and public associations in the field of healthcare

1. Interdepartmental interaction of state bodies, public associations and other interested legal entities shall be aimed at reducing risk factors for the occurrence of infectious and non-infectious diseases, and the implementation of measures in emergency situations.

2. An advisory board, the National Coordination Council on Health Protection shall be established to ensure interaction of state bodies, public associations and other interested legal entities under the Government of the Republic of Kazakhstan.

The main task of the National Coordination Council on Health Protection shall be to develop proposals to ensure the implementation of measures provided for by strategic and program documents on health protection of citizens in the Republic of Kazakhstan, to improve state policy, legislation of the Republic of Kazakhstan in the field of healthcare, as well as to determine the main directions in healthcare.

The National Coordination Council on Health Protection shall be created by the Prime Minister of the Republic of Kazakhstan.

3. Local executive bodies shall create regional coordination councils headed by akims of the corresponding administrative-territorial units.

The composition of the regional coordination councils shall be approved by the local representative bodies of the corresponding administrative-territorial unit.

Regional coordination councils on a mandatory and regular basis shall report on their work to the National Coordination Council on Health Protection.

4. The authorized body shall carry out interdepartmental coordination of activities on health protection of citizens of the Republic of Kazakhstan and the maintenance of national records of health personnel resources.

5. State bodies shall interact and implement functions aimed at protecting the health of the population of the Republic of Kazakhstan, within the competence established by the legislation of the Republic of Kazakhstan.

6. Protection of public health shall be carried out with the involvement of local governments, non-governmental organizations and associations through the implementation of social projects and grants at the expense of budget funds, as well as additional sources of funding not prohibited by the legislation of the Republic of Kazakhstan.

7. Public associations for the protection of citizens' rights in the field of health protection shall not be entitled to advertise specific trade names of pharmaceuticals, biologically active food supplements, medical devices, specialized medical food products and breast milk substitutes.

8. Public associations and other non-profit organizations shall deal with the issues of prevention of socially significant diseases, diseases that pose a danger to others, as well as the promotion and formation of a healthy lifestyle.

9. State bodies that have departmental healthcare services shall ensure the submission of departmental reports on the activities of subordinate organizations (subdivisions) of healthcare and the state of health of the assigned contingent to local government bodies of healthcare, with the exception of cases provided for by the laws of the Republic of Kazakhstan.

Chapter 3. PERMITS AND NOTIFICATIONS IN THE FIELD OF PUBLIC HEALTH

Paragraph 1. Licensing in the field of public health

Article 17. Licensing of activities in the field of public health

1. The following types of activities shall be licensed in the field of public health:

1) medical activities;

2) pharmaceutical activities;

3) activities related to the circulation of narcotic drugs, psychotropic substances and precursors in the field of healthcare;

4) import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (parts of an organ) and (or) tissues (parts of tissue) of a person, blood and its components;

5) provision of disinfection, disinsection, deratization services in the field of healthcare.

2. The procedure and conditions for issuing and reissuing a license and (or) annex to a license and a duplicate of a license and (or) an annex to a license, exercising permits control, suspension, renewal and termination of a license and (or) annexes to a license to practice medical or pharmaceutical activities shall be established by the laws of the Republic of Kazakhstan "On Permissions and Notifications" and "On Narcotic Drugs, Psychotropic Substances, Their Analogues and Precursors and Counter Measures of Their Illegal Turnover and Their Abuse".

3. The procedure and conditions for the issuance and renewal of a license and a duplicate license, the implementation of permissive control, suspension, renewal and termination of the license for the provision of disinfection, disinsection, deratization services in the field of healthcare are established by the Law of the Republic of Kazakhstan "On permits and notifications".

Footnote. Article 17 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 18. Licensing of the import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (parts of an organ) and (or) tissues (parts of tissue) of a person, blood and its components

1. Import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (parts of an organ) and (or) tissues (parts of tissue) of a person, blood and its components if they are placed under the customs procedure of export or release for domestic consumption shall be carried out on the basis of a license issued in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permissions and Notifications".

2. The authorized body, within three working days, shall make a decision on the issue or refusal to issue a license for the import, export of human tissues (parts of tissue), blood and its components, and for the import, export of human organs (parts of an organ) - within one work day.

Paragraph 2. Permitting procedure and notification procedure in the field of public health

Article 19. Permits in the field of public health

1. Permitting documents in the field of public health shall be:

1) a sanitary and epidemiological conclusion on the compliance of the facility of high epidemic significance with regulatory legal acts in the field of sanitary and epidemiological well-being of the population;

2) permission to handle pathogenic biological agents and its annex;

3) certificate of state registration of products;

4) registration certificate for a pharmaceutical product and medical device;

5) permission to conduct an interventional clinical trial of a pharmaceutical product, medical device;

6) certificate of healthcare specialist .

2. The terms of validity of permits in the field of public health shall be established by the Law of the Republic of Kazakhstan "On Permissions and Notifications".

3. In case of non-fulfillment of the order to eliminate violations of the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare, the officials who issued the permitting document shall suspend its validity on the grounds and in the manner provided for by this Code and the laws of the Republic of Kazakhstan.

4. In case of failure to submit an application for the elimination of violations by the holder of the permit before the expiry of the period for suspension of the permit in the field of public health, the officials who issued the permit shall initiate the revocation of the permit in court within ten working days from the expiration of the specified period.

5. Re-issuance of permits shall be allowed without additional or repeated research (tests), except for subparagraphs 4) and 5) of paragraph 1 of this article, in the following cases:

1) detection of mistakes (misprints) in the document;

2) re-registration of an individual entrepreneur - applicant, change of his/her name or legal address;

3) changes in the name and (or) location of the legal entity - the applicant, manufacturer of products;

4) changing the address of the location of the object without physical displacement.

Footnote. Article 19 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 20. Issuance of a sanitary and epidemiological conclusion

A sanitary and epidemiological conclusion shall be issued by a state body in the field of sanitary and epidemiological well-being of the population or a structural subdivision of other state bodies operating in the field of sanitary and epidemiological well-being of the population, based on the results of preventive control and (or) sanitary and epidemiological expertise for:

1) industrial and civil facilities;

2) drafts of regulatory documents on maximum permissible emissions and maximum permissible discharges of harmful substances and physical factors into the environment, zones of sanitary protection;

3) projects for the establishment of calculated (preliminary) and established (final) sanitary protection zones;

4) raw materials and products;

5) materials on chemical, biological, toxicological, radiological load on soil, water bodies and atmospheric air.

Article 21. Issuance of a permit for handling of pathogenic biological agents and its annex

Footnote. Title of Article 21 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

1. A state body in the field of sanitary and epidemiological welfare of the population shall issue a permit for the handling of pathogenic biological agents and an appendix to it to microbiological laboratories, regardless of ownership forms, based on the conclusion of the commission for monitoring compliance with requirements in the field of biological safety (regime commission).

2. The regulations on the commission for monitoring compliance with requirements in the field of biological safety (regime commission) and its composition are approved by the state body in the field of sanitary and epidemiological welfare of the population.

3. For carrying out research, experimental, production, field and diagnostic work with pathogenic biological agents, subject to laboratory containment measures, including engineering, operational and technical requirements (the level of biological safety of the laboratory), a permit is issued for handling pathogenic biological agents and an appendix to it, depending on the risk group used in the work of pathogenic biological agents.

For each facility (stationary or mobile) where activities for handling of pathogenic biological agents will be carried out, a permit for the handling of pathogenic biological agents and an appendix to it, taking into account the pathogenicity group and the degree of danger, indicating the names of pathogenic biological agents, is issued.

4. The basis for issuing a permit for the handling of pathogenic biological agents and its appendices is the compliance of the activities of the entity handling pathogenic biological agents with the qualification requirements for this activity.

5. The grounds for refusal to issue a permit for the handling of pathogenic biological agents and its annexes are:

1) failure to submit or submission of false documents and information necessary to obtain permission to handle pathogenic biological agents and its appendices;

2) the absence of a sanitary and epidemiological conclusion on an object of high epidemic significance;

3) a negative conclusion of the commission for monitoring compliance with requirements in the field of biological safety (regime commission) on the basis of non-compliance with the qualification requirements for handling pathogenic biological agents.

6. The grounds for revoking the permission to handle pathogenic biological agents and its appendices are:

1) failure to eliminate within the prescribed period the violation that was the basis for suspension of the permit for handling of pathogenic biological agents and its annexes;

2) a repeated detection within the last twelve calendar months of a violation that has a dangerous impact on the health of people, animals, plants and the environment, which served as the basis for the suspension of the permit for the handling of pathogenic biological agents and its annexes;

3) other cases provided for by the laws of the Republic of Kazakhstan.

Deprivation or suspension of the permit to handle pathogenic biological agents and its appendices is carried out in accordance with the Code of the Republic of Kazakhstan on administrative offenses.

7. The grounds for termination of the permit for handling of pathogenic biological agents and its annexes are:

1) deprivation of permission to handle pathogenic biological agents and its appendices;

2) cancellation of the permissive order;

3) termination of activity, liquidation of a legal entity;

4) voluntary application of the applicant for termination of the permit for handling pathogenic biological agents and its appendices;

5) other cases provided for by the laws of the Republic of Kazakhstan.

From the moment of termination of the permit for handling of pathogenic biological agents and its annex, it is not allowed to carry out activities for handling of pathogenic biological agents.

Footnote. Article 21 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 22. Issuance of a certificate of state registration of products

1. Products determined by the decisions of the Eurasian Economic Union shall be subject to state registration of products in the manner determined by the state body in the field of sanitary and epidemiological welfare of the population.

2. State registration of products shall be carried out on the basis of:

1) expert assessment of the impact on the population and the environment;

2) sanitary and epidemiological expertise for compliance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

3) development of special measures, including the conditions for disposal and destruction of substances and certain types of products, to prevent their harmful effects on the population and the environment.

3. Based on the positive results of the sanitary and epidemiological examination of the submitted documentation and the results of laboratory studies (tests) of products, state registration of products shall be carried out with the issuance of a certificate of state registration of products in terms of their compliance with technical regulations and (or) uniform sanitary and epidemiological and hygienic requirements for goods and technical regulations of the Eurasian Economic Union.

4. The issuance of a certificate of state registration of products shall be denied in the following cases:

1) non-compliance of products with technical regulations and (or) uniform sanitary-epidemiological and hygienic requirements for goods and technical regulations of the Eurasian Economic Union;

2) submission of documents and (or) information containing false information;

3) lack of rights, provided for by the decision of the Eurasian Economic Union or the legislation of the Republic of Kazakhstan, to carry out state registration, as well as the grounds for issuing and issuing a certificate of state registration of products;

4) the impossibility of establishing safety requirements for products and the conditions for their manufacture and circulation, as well as the lack of methods for determining and measuring hazardous factors of such products in products and the environment;

5) the availability of substantiated information obtained within the framework of the accession of a member state to international conventions and treaties on cases of harmful effects of products on human health and the environment during the manufacture, circulation and use (use) of products.

5. The costs associated with the sanitary and epidemiological expertise and scientific substantiation of products subject to state registration shall be borne by the applicants.

6. In addition to the general grounds provided for by the Code of the Republic of Kazakhstan on Administrative Offenses and the Law of the Republic of Kazakhstan "On Permissions and Notifications", the certificate of state registration of products shall be suspended with an indication of the deadline to eliminate the reasons for non-compliance in the following cases:

1) establishment of the fact of non-compliance of products with technical regulations and (or) unified sanitary-epidemiological and hygienic requirements for goods of the Eurasian Economic Union, not related to violations of the conditions of transportation, storage and sale of controlled products;

2) the adoption by the Eurasian Economic Commission of changes in the safety indicators of controlled products, based on the results of the development of the modern level of scientific knowledge;

3) receipt of information from the authorized bodies of the member states of the Eurasian Economic Union, carrying out and (or) coordinating work on technical regulation, sanitary, veterinary and phytosanitary measures, international organizations or states that are not members of the Eurasian Economic Union, on the revealed non-compliance of products with technical regulations and (or) uniform sanitary-epidemiological and hygienic requirements, as well as that the products pose a danger to human life and health.

7. Information on suspension, deprivation (revocation), renewal or termination of the certificate of state registration of products due to its non-compliance with technical regulations and (or) unified sanitary-epidemiological and hygienic requirements for goods of the Eurasian Economic Union shall be immediately sent to the heads (their deputies) authorized bodies of the member states of the Eurasian Economic Union and entered into the Unified Register of Certificates of State Registration of Products.

8. In addition to the general grounds provided for by the Law of the Republic of Kazakhstan "On Permissions and Notifications", the certificate of state registration of products shall be reissued without additional or repeated studies (tests) in the following cases:

1) changes in the legal address of the manufacturer of the product or the applicant;

2) issuance of a new regulatory legal act of the Eurasian Economic Union, which establishes the requirements for products, the adoption of which does not entail changes in the indicators of hygienic safety, the composition of products.

9. The unified register of certificates of state registration of products shall be subject to placement on the Internet resource of the state body in the field of sanitary and epidemiological welfare of the population.

Article 23. Issuance of a registration certificate for a pharmaceutical product or medical device

1. Pharmaceuticals and medical devices produced in the Republic of Kazakhstan, as well as imported into its territory, shall be subject to state registration, including:

1) pharmaceuticals under trade names indicating the dosage formulation, dosage, packaging from each production site;

2) medical devices under trade names from each production site;

3) consumables for medical devices, except for those specially designed by the manufacturer of the medical device for use with medical devices that can function only with these consumables;

4) medical devices that are part of a specialized vehicle for the provision of medical care;

5) excluded by the Law of the Republic of Kazakhstan dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication);

6) advanced therapy pharmaceuticals manufactured under industrial conditions;

7) medical devices for diagnostics outside of a living organism (in vitro).

1-1. State registration of strategically important medicines and medical devices is carried out in accordance with the procedure determined by the authorized body.

2. The following shall not be subject to state registration:

1) pharmaceuticals manufactured in pharmacies;

2) pharmaceutical substances (active pharmaceutical ingredients) produced under conditions of good manufacturing practice;

3) pharmacopoeial medicinal plant raw materials, including in the composition of fees and consumer packaging;

4) medical devices made according to individual orders of patients exclusively for personal use, to which special requirements are imposed in accordance with the appointment issued by a medical professional;

5) pharmaceuticals and medical products manufactured in the Republic of Kazakhstan only for export;

6) exhibition samples of pharmaceuticals and medical devices for holding exhibitions without the right to their further sale;

7) samples of pharmaceuticals and medical devices received for preclinical (nonclinical) and clinical studies and (or) trials;

8) laboratory devices not used for the diagnosis of diseases;

9) components that are part of medical devices and are not used as an independent product or device;

10) radiopharmaceutical medicinal products manufactured directly in healthcare organizations at the place of their use;

11) samples of pharmaceuticals and medical devices for examination during state registration;

12) pharmaceuticals of advanced therapy manufactured for individual use using autologous biological materials of a patient or his/her donor, selected directly for him/her.

13) bulk-products of medicines or medical devices.

3. State registration, re-registration of a pharmaceutical product or medical device, amendments to the registration dossier of a pharmaceutical product or medical device shall be carried out by the state body in the field of circulation of pharmaceuticals and medical devices in the manner determined by the authorized body.

4. A prerequisite for state registration, re-registration and amendments to the registration dossier of a pharmaceutical product or medical device shall be the expertise of the pharmaceutical product or medical device, carried out in the manner determined by the authorized body.

5. A registration dossier shall be submitted to the expert organization containing documents, the list of which is determined by the authorized body, as well as samples of a pharmaceutical product or medical device, standard samples of pharmaceutical substances (active pharmaceutical ingredients) and their impurities in quantities sufficient for threefold analysis, specific reagents and consumables, in exceptional cases and subject to return.

6. The costs associated with the examination of the pharmaceutical product or medical device during their state registration, re-registration and amendments to the registration dossier shall be borne by the applicants.

7. State registration, re-registration, amendments to the registration dossier of a medicinal product or medical device shall be carried out on the basis of an application and a positive opinion of an expert organization on the safety, quality and efficacy of a pharmaceutical product or medical device issued based on the results of the examination.

8. An application for state registration and re-registration, amendments to the registration dossier of a pharmaceutical product or medical device shall be submitted by the developer or manufacturer of the pharmaceutical product or medical device, or their authorized representative.

For state registration, re-registration and issuance of a duplicate of the registration certificate of a pharmaceutical product or medical device, a fee shall be charged in the manner determined by the tax legislation of the Republic of Kazakhstan.

9. Accounting and systematization of documents submitted by the applicant during state registration, re-registration and amendments to the registration dossier of a pharmaceutical product or medical device shall be carried out in the manner determined by the authorized body.

10. By decision of the authorized body, a pharmaceutical product or medical device may be registered under an accelerated expertise procedure.

The order of the accelerated procedure for the examination of a pharmaceutical product or medical device shall be determined by the authorized body.

11. The applicant shall be denied state registration and re-registration and amendments to the registration dossier of a pharmaceutical product or medical device in cases of a negative conclusion based on the results of the expertise of pharmaceuticals and medical devices and failure to submit a full package of documents established in the manner determined by the authorized body.

12. Based on the results of state registration and re-registration of a pharmaceutical product or medical device, a registration certificate shall be issued in the form established by the authorized body.

During the validity period of the registration certificate, the holder of the registration certificate of the pharmaceutical product or the manufacturer of the medical device shall be responsible for the safety, quality and effectiveness of registered pharmaceuticals or medical devices, which must correspond to the registration dossier submitted for the expertise of pharmaceuticals or medical devices for the purposes of state registration, re-registration, introduction of amendments to the registration dossier of a pharmaceutical product or medical device.

13. The decision on state registration of a pharmaceutical product or medical device may be revoked in the manner determined by the authorized body.

14. Pharmaceuticals and medical devices intended for circulation in the customs territory of the Eurasian Economic Union shall be subject to registration according to uniform rules in accordance with the regulatory legal acts of the Eurasian Economic Union.

For registration of domestic pharmaceuticals abroad, the authorized body shall issue a certificate for a pharmaceutical product (CPP) in the manner determined by the authorized body.

15. The state expert organization in the field of circulation of pharmaceuticals and medical devices and the state body in the field of circulation of pharmaceuticals and medical devices shall prohibit, without the consent of the applicant, the disclosure and use for commercial purposes of the confidential information provided for state registration of the pharmaceutical product contained in the application for state registration, materials of the expertise of the pharmaceutical product, as well as the registration dossier of the pharmaceutical product containing new chemical substances, within six years from the date of state registration of the pharmaceutical product.

16. The provisions stipulated in paragraph 15 of this article, which do not allow the disclosure and use of confidential information for commercial purposes, shall not apply to:

1) individuals or legal entities who have been issued a compulsory license to use the pharmaceutical product in accordance with the Patent Law of the Republic of Kazakhstan;

2) use, production, import, export or distribution of a pharmaceutical product for non-commercial purposes.

17. On the basis of a court decision, the disclosure and use of the information specified in paragraph 15 of this article shall be allowed without the consent of the applicant, in the presence of one of the following cases:

1) if the supply of the pharmaceutical product is insufficient to meet the needs of the population within twelve months from the date of registration in the Republic of Kazakhstan;

2) revealing of actions that violate the requirements of the legislation of the Republic of Kazakhstan in the field of competition protection.

Footnote. Article 23 as amended by the Law of the Republic of Kazakhstan dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication).

Article 24. Notifications in the field of public health

1. The following activities in the field of public health shall be carried out upon notification:

1) hygienic training of decreed population groups;

2) activities (operation) of an object of insignificant epidemic significance;

3) conducting a sanitary and epidemiological audit;

4) wholesale of medical devices;

5) retail sale of medical devices;

6) conducting non-interventional clinical trials.

2. Notification on the beginning or termination of the activities specified herein shall be submitted in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permissions and Notifications".

Chapter 4. ACCREDITATION, ASSESSMENT AND CERTIFICATION IN THE FIELD OF PUBLIC HEALTH

Article 25. Accreditation in the field of public health

1.The following shall be subject to accreditation in the field of public health, carried out by a state body in the provision of healthcare services (assistance):

1) healthcare entities accrediting medical organizations in order to recognize the compliance of the provided healthcare services with the established requirements and standards in the field of public health;

2) organizations that assess the knowledge and skills of students, graduates of professional preparedness and health professionals;

3) healthcare entities, carrying out independent expertise in the field of public health;

4) legal entities that confirm readiness for management activities for certification of health managers;

5) excluded by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication);

6) professional medical associations and public associations that carry out activities in the field of public health.

2. Based on an external comprehensive assessment for compliance with accreditation standards, medical organizations shall be subject to accreditation in the field of public health, carried out by healthcare entities accredited by a state body in the field of healthcare services (assistance).

3. Individuals and legal entities for conducting a sanitary and epidemiological audit shall be subject to accreditation in the field of public health, carried out by professional associations in the field of sanitary and epidemiological well-being of the population accredited by the state body in the field of sanitary and epidemiological well-being of the population.

4. Accreditation in the field of public health shall be carried out on a voluntary basis.

5. Accreditation of medical organizations shall be carried out at the expense of a medical organization and shall be an instrument of material and non-material incentives for medical organizations.

Accreditation of medical organizations shall be carried out on the basis of an external comprehensive assessment for compliance with accreditation standards approved by the authorized body, and shall be taken into account when placing the volume of healthcare services for the provision of a guaranteed volume of free medical care and (or) medical care in the system of compulsory social health insurance, when allocating a state order for training and advanced training of personnel in the field of public health in clinical specialties in higher colleges and organizations of higher and (or) postgraduate medical education.

6. Accreditation of testing laboratories carrying out monopoly activities for the examination and assessment of the safety and quality of pharmaceuticals and medical devices shall be carried out in the manner determined by the authorized body.

7. Individuals specified in paragraphs 1, 2 and 3 of this article, who have passed accreditation in the field of public health, shall be subject to post-accreditation monitoring.

Footnote. Article 25 as amended by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 26. Assessment of professional competence of healthcare specialists

1. Assessment of professional competence of health specialists shall be a periodically carried out procedure for determining the level of professional competence.

2. Assessment commissions shall be created for the purpose of objective and competent implementation of assessment by the authorized body, local executive bodies, as well as the state body in the field of sanitary and epidemiological welfare of the population.

3. The authorized body shall carry out assessment of the heads of local public health authorities of regions, cities of republican status and the capital and their deputies, heads of organizations subordinate to the authorized body, their deputies.

4. Local government health authorities of regions, cities of republican status and the capital shall carry out assessment of the heads of healthcare organizations subordinate to them.

5. The state body in the field of sanitary and epidemiological welfare of the population shall carry out assessment of the heads of health organizations operating in the area of sanitary and epidemiological welfare of the population.

6. Individuals subjected to assessment shall undergo assessment every three years, but not earlier than one year from the date of holding the relevant position.

Article 27. Certification of a healthcare specialist and a manager

1. Certification of a healthcare specialist shall be carried out by:

1) a state body in the field of providing healthcare services (assistance) in relation to medical workers;

2) a state body in the field of circulation of pharmaceuticals and medical devices in relation to pharmaceutical workers;

3) a state body in the field of sanitary and epidemiological welfare of the population in relation to specialists of the sanitary and epidemiological service.

The list of specialties and specializations of healthcare specialists subject to certification shall be determined by the authorized body.

2. The healthcare specialist certification shall be subject to confirmation every five years.

3. Individuals who have a certificate of a healthcare specialist, with a break of work experience in a specialty for more than three years, shall be allowed to work in a relevant specialty after advanced training, internship and assessment of professional preparedness in an organization accredited by the authorized body.

4. Without an appropriate certificate of a healthcare specialist, the following shall be prohibited:

1) engaging in clinical practice, with the exception of resident doctors, who are admitted to clinical practice (work with patients) under the supervision of a mentor and foreign specialists who have recognized documents on education;

2) engaging in pharmacy practice;

3) implementation of activities in the field of sanitary and epidemiological welfare of the population.

5. Foreign specialists shall be allowed to carry out professional medical activities at Nazarbayev University or its medical organizations, medical organizations of the Department for Presidential Affairs of the Republic of Kazakhstan, as well as for the purpose of training in the organization of higher and (or) postgraduate education, national and scientific centers, scientific -research institutes and higher medical colleges that implement educational curricula of additional education and have passed institutional accreditation by accreditation bodies entered in the register of recognized accreditation bodies on the basis of accredited university hospitals, clinics of educational organizations in the field of public health and the residency base in the manner determined by the authorized body.

6. The rules for certification of a healthcare specialist, confirmation of the validity of a certificate of a healthcare specialist, including foreign specialists, as well as conditions for admission to certification of a healthcare specialist of a person who has received medical education outside the Republic of Kazakhstan shall be developed and approved by the authorized body.

7. Certification of healthcare managers shall be carried out by the state body in the field of healthcare services (assistance) and shall be valid regardless of the implementation of management activities.

8. Certification of a healthcare manager shall be subject to confirmation every five years.

Confirmation of the certificate of a healthcare manager shall be carried out by the state body in the field of healthcare services (assistance).

9. The rules for certification of a healthcare manager, confirmation of the validity of a healthcare manager certificate shall be developed and approved by the authorized body.

10. Suspension or deprivation (revocation) of a certificate of a healthcare specialist shall be carried out in accordance with the laws of the Republic of Kazakhstan.

Footnote. Article 27 as amended by the Law of the Republic of Kazakhstan dated 08.01.2021 No. 410-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ).

Chapter 5. STATE CONTROL AND SUPERVISION IN THE FIELD OF PUBLIC HEALTH

Article 28. General provisions on state control and supervision in the field of public health

1. The implementation of the state policy on state control and supervision in the field of public health shall be recognized as a set of measures aimed at verifying satisfaction and compliance with the requirements of the legislation of the Republic of Kazakhstan, as well as at preventing, detecting, suppressing and eliminating offenses in the field of healthcare.

2. State control and supervision shall be carried out in the areas of:

1) the provision of healthcare services (assistance);

2) sanitary and epidemiological welfare of the population;

3) circulation of pharmaceuticals and medical devices.

3. State supervision in the field of healthcare is carried out in accordance with this Code and the Entrepreneurship Code of the Republic of Kazakhstan.

State control in the field of healthcare is carried out in the form of inspection and preventive control.

Inspection and preventive control with a visit to the entity (object) subject to control shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

Preventive control without visiting the entity (object) subject to control shall be carried out in accordance with this Code and the Entrepreneurial Code of the Republic of Kazakhstan.

Footnote. Article 28 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 29. Procedure for considering a complaint by the appeal commission

1. Acts on the results of the inspection and an order to eliminate the identified violations issued by officials exercising state control over the provision of healthcare services (assistance), sanitary and epidemiological well-being of the population, circulation of pharmaceuticals and medical devices may be appealed to a higher authority.

2. A complaint against the act on the results of the inspection and the order to eliminate the revealed violations shall be submitted to the name of the head of a higher state body.

3. To consider a complaint on the act following the results of the inspection and the order to eliminate the identified violations, the higher state body shall create an appeal commission, which includes representatives of state bodies in the areas of healthcare services (assistance), sanitary and epidemiological well-being of the population, circulation of pharmaceuticals and medical products and non-governmental organizations of the Republic of Kazakhstan.

The regulations, provisions and composition of the appeal commissions shall be determined, respectively, by state bodies in the areas of healthcare services (assistance), sanitary and epidemiological welfare of the population, circulation of pharmaceuticals and medical devices.

4. A complaint against the act on the results of the inspection and the order to eliminate the violations revealed by state bodies in the provision of healthcare services (assistance), sanitary and epidemiological well-being of the population, circulation of pharmaceuticals and medical devices shall be considered by the appeal commission within the scope of the contested issues.

5. A complaint against the act on the results of the inspection and the order to eliminate the revealed violations shall be submitted within ten working days after the signing of the act on the results of the inspection.

6. The decision of the appeal commission shall be of a recommendatory nature and shall be submitted to the head of a higher state body. Based on the results of the decision of the appeal commission, the head shall have the right to decide on the recognition of the act on the results of the inspection, the conclusion of preventive control with a visit to the entity (object) subject to control and supervision and the order to eliminate violations of the law as invalid and to annul them in accordance with Article 156 of the Entrepreneurial Code of the Republic of Kazakhstan.

7. The appeal commission shall annually summarize the results of consideration of complaints against acts on the results of the inspection and orders to eliminate violations and develop recommendations for improving the legislation of the Republic of Kazakhstan.

8. In case of dissatisfaction with the superior body of the complaint, the act on the results of the inspection and the order to eliminate violations of the law may be appealed to the court.

9. Information constituting commercial and other secrets protected by law, as well as confidential information shall be provided to members of the appeal commissions when considering a complaint against an act on the results of an inspection and an order to eliminate violations of the law in accordance with the rules developed and approved, respectively, by state bodies in the provision of healthcare services (assistance), sanitary and epidemiological well-being of the population, circulation of pharmaceuticals and medical devices, without obtaining the written permission of the individual who filed the complaint.

Paragraph 1. State control over the provision of healthcare services (assistance)

Article 30. State control over the provision of healthcare services (assistance)

1. State control over the provision of healthcare services (assistance) shall be aimed at preventing, detecting, suppressing and eliminating violations of the legislation of the Republic of Kazakhstan in the field of public health by healthcare entities.

2. Entities subject to state control over the provision of healthcare services (assistance) shall be individuals and legal entities that provide healthcare services (assistance).

3. Objects subject to state control over the provision of healthcare services (assistance) shall be divided into two groups:

1) objects of high significance;

2) objects of low significance.

The list of objects of high and low significance subject to state control over the provision of healthcare services (assistance) shall be approved by the state body in the field of healthcare services (assistance) in agreement with the authorized body for entrepreneurship.

4. With regard to objects subject to state control in the field of healthcare services (assistance), control shall be carried out in the form of inspection and preventive control in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

5. Excluded by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced from 01.01.2023).
Footnote. Article 30 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced from 01.01.2023).

Article 31. Officials exercising state control over the provision of healthcare services (assistance)

1. Officials exercising state control over the provision of healthcare services (assistance) shall be:

1) Chief State Healthcare Inspector of the Republic of Kazakhstan and (or) his/her deputy;

2) chief state healthcare inspectors of the relevant administrative-territorial units and their deputies, determined by the head of the state body in the field of healthcare services (assistance);

3) specialists of the state body in the field of healthcare services (assistance).

2. Before a decision is made on the application (complaint) of individuals and (or) legal entities against the actions (inaction) of subordinate officials, the superior chief state healthcare inspector in the relevant field shall have the right to suspend the execution, annul or revoke the acts adopted by them.

Article 32. The rights of officials in the exercise of state control over the provision of healthcare services (assistance)

1. Officials exercising state control in the provision of healthcare services (assistance), in addition to the rights provided for in paragraph 1 of Article 154 of the Entrepreneurial Code of the Republic of Kazakhstan, shall have the right to:

1) involve independent experts in the field of public health in the implementation of state control over the provision of healthcare services (assistance);

2) request and receive from the healthcare entity the necessary information on the provision of healthcare assistance to the population;

3) make copies of the documents necessary for monitoring the provision of healthcare services (assistance), and receive the relevant data (electronic health passports, electronic cards and detailed reports on the changes made to them) from the medical information system of the healthcare entity;

4) initiate the creation of a commission with the involvement of independent experts in the field of public health.

2. Officials exercising state control in the form of preventive control, inspection and investigation are prohibited from making demands and making requests that are not related to the subject of preventive control, inspection or investigation.

3. To make a decision following the results of state control over the provision of healthcare services (assistance), depending on the established violations of the legislation of the Republic of Kazakhstan in the field of public health, officials exercising state control over the provision of healthcare services (assistance) shall issue the following acts:

1) an act on the results of an inspection of a healthcare entity - a document issued by an official exercising state control over the provision of healthcare services (assistance), based on the results of an inspection, preventive control of the entity (object) for its compliance with the requirements of regulatory legal acts in the provision of healthcare services (assistance);

2) an order to eliminate violations of the requirements of regulatory legal acts in the field of healthcare services (assistance);

3) decisions of the chief state healthcare inspectors on:

suspension of execution or annulment or revocation of acts adopted by lower officials;

temporary suspension from work of medical workers;

suspension of activities or certain types of activities of an individual entrepreneur or legal entity in accordance with the laws of the Republic of Kazakhstan.

4. The chief state healthcare inspector of the Republic of Kazakhstan and (or) his/her deputy shall have the right to issue an order to the head of the local government health authority of the region, cities of republican status and the capital, based on the result of the inspection.

Footnote. Article 32 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 33. Special procedure for conducting inspections in the exercise of state control over the provision of healthcare services (assistance)

Footnote. Article 33 is excluded by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 34. Preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control

1. Preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control shall be carried out in the form of desk audit by analyzing and comparing data from information systems, as well as other information on the activities of the entity (object) subject to control.

2. The objectives of preventive control without visiting the entity (object) subject to control shall be the timely detection, suppression and prevention of violations, granting the healthcare entities (objects) the right to independently eliminate violations revealed by the state body in the provision of healthcare services (assistance) based on the results of preventive control without visiting the entity (object) subject to control, and reducing the administrative burden on them.

3. Preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control shall be carried out no more than once a quarter.

4. If violations are revealed based on the results of preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control, a recommendation shall be made to eliminate the revealed violations. The form of recommendations to eliminate the revealed violations shall be established by the state body in the field of healthcare services (assistance).

5. A recommendation on the elimination of detected violations in the course of preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control shall be sent to the entity (object) subject to control no later than seven working days from the date of detection of violations in one of the following ways:

1) by registered mail with notification;

2) shall be handed over to the representative and (or) the official of the entity (object) subject to control under signed receipt;

3) electronically, to the user's personal account on the web portal of "electronic government".

6. The proper elimination of the identified violations specified in the recommendation on elimination of the identified violations in the course of preventive control over the provision of healthcare services (assistance) without visiting the the entity (object) subject to control shall be deemed the implementation of the recommendation by the entity (object) subject to control, within thirty working days from the day following the day of its delivery (receipt).

7. In case of disagreement with the violations specified in the recommendation, the entity (object) subject to control shall have the right to send an objection to the state body in the field of healthcare services (assistance) within five working days from the day following the day of delivery (receipt) of the recommendation.

8. Failure to comply with the recommendation within the prescribed period on the elimination of the identified violations in the course of preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control shall be the basis for the selection of the entity (object) subject to control for preventive control over the provision of healthcare services (assistance) with a visit to the entity (object) subject to control.

The results of preventive control without visiting the entity (object) subject to control shall be subject to registration by the state body in the field of healthcare services (assistance) and its territorial subdivisions in a special register of preventive control without visiting the entity (object) subject to control, which must be numbered, laced up and sealed by the state a body in the field of healthcare services (assistance) or its territorial subdivision.

Article 35. Expertise on the quality of healthcare services (assistance)

1. Expertise on the quality of healthcare services (assistance) - a set of organizational, analytical and practical measures taken to draw conclusions on the level of quality of healthcare services provided by individuals and legal entities, using indicators reflecting the efficiency, completeness and compliance of healthcare services with standards.

2. Expertise on the quality of healthcare services (assistance) shall be divided into internal and external one.

3. A patient support and internal expertise service shall be created in a medical organization to conduct internal expertise.

The patient support and internal expertise service shall conduct a current analysis of the organization of medical care, the clinical activities of the medical organization, the identification of violations of the procedure for the provision of medical care and standards, a medical incident, as well as consideration within a period not exceeding five calendar days of patient requests.

Based on the results of the expertise, the head of the medical organization shall be made proposals to eliminate the identified causes and conditions for the decline in the quality of healthcare services.

4. An external expertise on the quality of healthcare services (assistance) shall be carried out by:

1) the state body in the field of healthcare services (assistance), including with the involvement of independent experts in the field of public health;

2) the social health insurance fund within the framework of monitoring of the fulfillment of contractual obligations on the quality and volume of healthcare services.

In case of disagreement of the healthcare entity with the results of monitoring of contractual obligations on the quality and volume of healthcare services, the results of monitoring may be appealed to the state body in the field of healthcare services (assistance);

2-1) local government health authorities in relation to medical organizations providing medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system.

In case of disagreement of the healthcare entity with the results of monitoring contractual obligations on the quality and volume of medical services, the results of monitoring can be appealed to the state body in the field of medical services (care);

3) independent experts in the field of public health when they are attracted by individuals or legal entities on a contractual basis;

4) the administration of the Department for the Presidential Affairs of the Republic of Kazakhstan in relation to subordinate organizations.

Based on the results of an external expertise on the quality of healthcare services (assistance) carried out by the state body in the field of healthcare services (assistance) and the social health insurance fund, the state body in the field of healthcare services (assistance) shall conduct an analysis to develop proposals for improving the provision of healthcare services (assistance).

5. The procedure for organizing and conducting internal and external expertise on the quality of healthcare services (assistance) shall be established by the authorized body.

Footnote. Article 35 as amended by the law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022).

Paragraph 2. State control and supervision in the field of sanitary and epidemiological welfare of the population

Article 36. State control and supervision in the field of sanitary and epidemiological welfare of the population

1. State control and supervision in the field of sanitary and epidemiological well-being of the population shall be aimed at preventing, detecting, suppressing and eliminating violations of the legislation of the Republic of Kazakhstan in the field of healthcare, including regulatory legal acts in the field of sanitary and epidemiological well-being of the population, by entities subject to control and supervision.

2. Entities (objects) subject to state control and supervision in the field of sanitary and epidemiological well-being of the population shall be individuals and legal entities, buildings, structures, products subject to state control and supervision in the field of sanitary and epidemiological well-being of the population, equipment, vehicles, soil, water, air and other objects, the activity, use, consumption, application and operation of which may harm the state of human health and the environment.

3. Objects subject to state control and supervision in the field of sanitary and epidemiological welfare of the population (epidemically significant objects) shall be divided into two groups:

1) objects of high epidemic significance;

2) objects of low epidemic significance.

The list of products and epidemiologically significant objects subject to state control and supervision in the field of sanitary and epidemiological well-being of the population shall be approved by the state body in the field of sanitary and epidemiological well-being of the population in agreement with the authorized body for entrepreneurship.

4. In relation to subjects (objects) of state control and supervision in the field of sanitary and epidemiological welfare of the population, control and supervision are carried out in the form of inspection, preventive control, investigation and supervision in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

4-1. With respect to potentially dangerous biological objects where pathogenic biological agents of I and (or) II pathogenicity groups are handled, with high epidemic significance, control and supervision in the field of sanitary and epidemiological welfare of the population are carried out taking into account the features provided for by the legislation of the Republic of Kazakhstan in the field of biological safety.

5. Excluded by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).
Footnote. Article 36 as amended by the Laws of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023); dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication);

Article 37. Officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population

1. Officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population shall be:

1) Chief State Sanitary Doctor of the Republic of Kazakhstan and (or) his/her deputy;

2) chief state sanitary doctors of the corresponding administrative-territorial units (in transport), their deputies, determined by the head of the state body in the field of sanitary and epidemiological welfare of the population;

3) specialists of the state body in the field of sanitary and epidemiological welfare of the population;

4) chief state sanitary doctors and their deputies, heads and specialists of structural units of the Ministry of Defence of the Republic of Kazakhstan, national security and internal affairs bodies, administrations of the Department for Presidential Affairs of the Republic of Kazakhstan, operating in the field of sanitary and epidemiological welfare of the population.

2. Before a decision is made on the application (complaint) of individuals and (or) legal entities against the actions (inaction) of lower officials, the superior chief state sanitary doctor in the relevant territory shall have the right to suspend the execution, cancel or revoke the acts adopted by them.

Article 38. The rights of officials in the exercise of state control and supervision in the field of sanitary and epidemiological welfare of the population

1. Officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population, in addition to the rights provided for in paragraph 1 of Article 154 of the Entrepreneurial Code of the Republic of Kazakhstan and other laws of the Republic of Kazakhstan, shall have the right to:

1) prohibit the import, use and sale on the territory of the Republic of Kazakhstan of products intended for use and application by the population, as well as in entrepreneurial and (or) other activities, in case of:

non-compliance with the requirements of technical regulations and (or) the unified sanitary-epidemiological and hygienic requirements of the Eurasian Economic Union;

lack of a certificate of state registration of products;

identification of counterfeit products;

unspecified shelf life and (or) storage, expired shelf life and (or) storage;

detection of insects , rodents and traces of their presence in the product itself;

creating a threat of the emergence and spread of infectious diseases or mass non-infectious diseases and poisoning, including its recognition as dangerous for human health and the environment based on the results of a sanitary and epidemiological examination;

2) prohibit the production of products intended for use, application by the population, as well as in entrepreneurial and (or) other activities, in case of:

inconsistency of objects and production technology with regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

lack of a sanitary and epidemiological conclusion for an object of high epidemic significance;

lack of notification on the activity (operation) of an object of insignificant significance;

lack of production and technological equipment, apparatus, inventory necessary to comply with the technological process of production;

lack of state registration for the first time introduced into production and previously unused substances and materials and preparations made on their basis;

the use of prohibited food additives, ingredients and raw materials;

creating a threat of the emergence and spread of infectious diseases or mass non-infectious diseases and poisoning;

3) make decisions on the temporary suspension from work of persons belonging to the decreed population groups that are a source of infectious and parasitic diseases, as well as those who have not passed mandatory medical examinations in a timely manner, until a laboratory test result and a specialist's conclusion confirming the complete rehabilitation and passing of a mandatory medical examination are received;

4) establish restrictive measures, including quarantine, in the relevant administrative-territorial units (at individual facilities);

5) send persons who are potential sources of the spread of infectious and parasitic diseases, as well as those who have been in contact with infectious patients, for a medical examination with their suspension from work until the results of a laboratory examination confirming the complete sanitation are received;

6) according to indications, send for hospitalization persons who are sources of infectious and parasitic diseases;

7) require mandatory vaccination of the population, preventive and focal disinfection, disinsection and deratization in premises and on vehicles, territories, in foci of infectious and parasitic diseases;

8) suspend, until the elimination of violations of regulatory legal acts in the field of sanitary and epidemiological well-being of the population, hygienic standards and (or) technical regulations, certain types of work, activities (operation) of facilities subject to state control and supervision in the field of sanitary and epidemiological well-being of the population, in accordance with with the legislation of the Republic of Kazakhstan on administrative offenses;

9) prohibit the production, use and sale of new types of raw materials, products, chemicals, technological equipment, mechanisms, processes, tools if they are recognized as dangerous to human life and health;

10) conduct a sanitary and epidemiological examination, request the materials necessary to study the assessment of the impact of the examination object on the environment and public health, as well as take samples and select samples of products in quantities sufficient and not exceeding the required volumes for its conduct, without compensation for cost of these products, with the exception of selection made within the framework of product safety monitoring;

11) specify requirements for bringing legal acts affecting the issues of sanitary and epidemiological well-being of the population in accordance with regulatory legal acts in the field of sanitary and epidemiological well-being of the population;

12) carry out radiation control in the field of sanitary and epidemiological welfare of the population on the territory of the Republic of Kazakhstan;

13) establish sanitary protection zones: preliminary (calculated) for operating facilities, established (final) dimensions, and change their dimensions;

14) apply to court in case of non-fulfillment or improper fulfillment by individuals or legal entities of acts of officials exercising state control and supervision in the field of sanitary and epidemiological well-being of the population;

15) involve specialists from healthcare organizations in the implementation of sanitary and anti-epidemic and sanitary-preventive measures for infectious and parasitic diseases, poisoning of the population in accordance with the rules for attracting specialists approved by the state body in the field of sanitary and epidemiological welfare of the population.

2. To make decisions on the results of state control and supervision in the field of sanitary and epidemiological well-being of the population, depending on the established violations of regulatory legal acts in the field of sanitary and epidemiological well-being of the population, officials, exercising state control and supervision in the field of sanitary and epidemiological well-being of the population, shall issue the following acts:

1) an act on the results of the inspection - a document issued by an official exercising state control and supervision in the field of sanitary and epidemiological welfare of the population, based on the results of an inspection for compliance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

2) an order to eliminate violations of the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

3) decisions of the chief state sanitary doctors on:

carrying out sanitary- anti-epidemic and sanitary-preventive measures;

temporary suspension from work of individuals;

prohibiting the import, production, use and sale of products that have a harmful effect on human health, intended for use and application by the population, as well as in business and (or) other activities;

prohibition of the production, use and sale of new types of raw materials, products, chemicals, technological equipment, mechanisms, processes, tools if they are recognized as dangerous to the life and health of people and the environment;

suspension of a permit in the field of public health;

suspension of activities or certain types of activities of an individual entrepreneur or legal entity in accordance with the laws of the Republic of Kazakhstan;

introduction of restrictive measures, including quarantine, in the relevant administrative-territorial units (at individual sites).

Article 39. Social protection of officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population

Officials of the state body in the field of sanitary and epidemiological well-being of the population, exercising state control and supervision in the field of sanitary and epidemiological well-being of the population, shall have the right to salary uplift in accordance with the unified system of remuneration of workers for all bodies supported by the state budget, approved by the Government of the Republic of Kazakhstan in agreement with the President of the Republic of Kazakhstan.

Article 40. Special procedure for conducting inspections in the implementation of state control and supervision in the field of sanitary and epidemiological welfare of the population

Footnote. Article 40 is excluded by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 41. State control and supervision in the field of sanitary and epidemiological well-being of the population in the form of an unscheduled inspection

1. State control and supervision in the field of sanitary and epidemiological welfare of the population in the form of an unscheduled inspection shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

2. Unscheduled inspections shall be carried out in relation to epidemically significant objects subject to state control and supervision in the field of sanitary and epidemiological welfare of the population.

Article 42. Preventive control in the field of sanitary and epidemiological welfare of the population with a visit to the subject (object) of control and supervision

Preventive control in the field of sanitary and epidemiological welfare of the population with a visit to the subject (object) of control and supervision is carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

Footnote. Article 42 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 43. Selection and implementation of sanitary and epidemiological expertise of products

1. Selection and sanitary and epidemiological expertise of products (goods) shall be carried out to identify, prevent and suppress the import, production, use and sale of products that do not meet the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, without prior notification of the business entity.

The selection of products for sanitary and epidemiological examination shall be carried out by officials of the state body in the field of sanitary and epidemiological well-being of the population and shall be certified by a document confirming the fact of the purchase of products.

Based on the results of sanitary and epidemiological expertise, when revealing products that do not meet the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, the state body in the field of sanitary and epidemiological welfare of the population shall draw up an order to eliminate violations without drawing up a protocol on an administrative offense with a mandatory explanation of the procedure for their elimination, with the exception of cases of detection of products that are dangerous to human life, health and environment, in respect of which an unscheduled inspection of objects shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

2. Based on the results of the selection and sanitary and epidemiological expertise of products aimed at informing the population on the possible risks associated with the consumption and sale of inappropriate products, the Register of Inappropriate Products shall be posted on the official Internet resource of the state body in the field of sanitary and epidemiological welfare of the population.

Article 44. Preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision

1. Preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision is carried out by analyzing and comparing data from information systems, as well as other information about the activities of the subject (object) of control and supervision.

2. The objectives of preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision are:

1) timely detection, suppression and prevention of violations, granting subjects (objects) of control and supervision the right to independently eliminate violations identified by the state body in the field of sanitary and epidemiological welfare of the population based on the results of preventive control without visiting the subject (object) of control and supervision;

2) reducing the administrative burden on them;

3) obtaining reliable information about the impact of the environment on human health in order to make decisions regarding the safety targets of products and services, environmental quality and tools for regulating production processes that potentially have an impact on products, services and the environment;

4) assessment of the effectiveness of measures taken to prevent the occurrence of poisoning and outbreaks of infectious diseases, occupational diseases, the possibility of predicting their occurrence;

5) ensuring compliance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population;

6) prompt proactive response to emergency situations;

7) formation of a higher level of sanitary and hygienic awareness and responsibility of managers and employees;

8) informing the public about the activities of subjects (objects) for protection of public health and risks to public health.

3. Preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision is carried out no more than once a quarter.

4. In case of detection of violations based on the results of preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision, a recommendation is made to eliminate the detected violations, with the exception of desk control. The form of the recommendation on the elimination of identified violations is established by the state body in the field of sanitary and epidemiological welfare of the population.

5. A recommendation on the elimination of detected violations during preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision is sent to the subject (object) of control and supervision no later than seven working days from the date of detection of violations in one of the following ways:

1) by registered mail with notification;

2) is handed over to the representative or official of the subject (object) of control and supervision against receipt;

3) electronically to the user's personal account on the e-government web portal.

6. The implementation of the recommendation by the subject (object) of control and supervision is recognized as the proper elimination of identified violations specified in the recommendation on the elimination of identified violations during preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision, within thirty working days from the day following the day of its delivery (receipt).

7. The subject (object) of control, in case of disagreement with the violations specified in the recommendation on the elimination of the identified violations, has the right to send an objection to the state body in the field of sanitary and epidemiological welfare of the population within five working days from the day following the day of delivery (receipt) of the recommendation on the elimination of the identified violations.

8. Failure to comply within the prescribed period with the recommendation to eliminate the identified violations during preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision is the basis for selecting the subject (object) of control and supervision for preventive control with a visit to the subject (object) of control and supervision.

9. The results of preventive control without visiting the subject (object) of control and supervision are subject to accounting by the state body in the field of sanitary and epidemiological welfare of the population and its territorial divisions in a special register of preventive control without visiting the subject (object) of control and supervision, which must be numbered, laced and sealed by the state body in the field of sanitary and epidemiological welfare of the population or its territorial subdivision.

Footnote. Article 44 - as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 45. Types of preventive control in the field of sanitary and epidemiological welfare of the population without visiting the subject (object) of control and supervision

Footnote. The title of Article 45 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

1. Desk audit shall be carried out on the basis of the study and analysis of information on the participants in foreign economic activities, on the applicants who applied for testing, confirmation of product conformity or registration of a declaration of conformity of products, for recognition of the results of confirmation of conformity, on test results, as well as contained in other documents submitted as evidence of the conformity of products submitted to the state body in the field of sanitary and epidemiological welfare of the population by customs authorities, an authorized body in the field of technical regulation.

The objects of the desk audit shall be the participants in foreign economic activities, bodies for confirmation of conformity, testing laboratories (centers), private entrepreneurs, declaring the conformity of products to the requirements of the legislation of the Republic of Kazakhstan.

The list of data required for the implementation of the desk audit, as well as the procedure for their submission by the customs authorities, the authorized body in the field of technical regulation, conformity assessment bodies and testing laboratories (centers) shall be determined by the state body in the field of sanitary and epidemiological welfare of the population.

Information on the participants in foreign economic activities, imported products and documents on conformity assessment of imported products shall be submitted by customs authorities.

Information on the applicants who have applied for testing, confirmation of product conformity or registration of a declaration of conformity of products, for recognition of the results of confirmation of conformity, on test results, as well as contained in other documents presented as evidence of conformity of products, shall be submitted by the authorized body in the field of technical regulation, bodies for confirmation of conformity and testing laboratories (centers).

Based on the results of the desk audit in case of violation of the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population, hygienic standards and (or) technical regulations, including on the basis of analysis of the comparison of information between imported products and issued, registered, recognized documents on confirmation of conformity for imported products, the state body in the field of sanitary and epidemiological well-being of the population in relation to the entities subject to desk audit shall take the following measures:

1) in relation to the participants in foreign economic activities and private entrepreneurship, declaring the compliance of products with the requirements of the legislation of the Republic of Kazakhstan, engaged in the import and (or) sale of products into the territory of the Republic of Kazakhstan, an order shall be sent to eliminate violations of the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population with mandatory an explanation of the procedure for its elimination;

2) information shall be sent to the authorized body in the field of technical regulation, indicating the facts of violation of the requirements of the legislation of the Republic of Kazakhstan in the field of technical regulation.

2. Monitoring of the results of the sanitary and epidemiological audit shall be carried out for:

1) the information provided on the conducted sanitary and epidemiological audit;

2) the presented audit reports on the compliance of the object with regulatory legal acts in the field of sanitary and epidemiological well-being of the population.

As part of the monitoring of the results of the sanitary and epidemiological audit, an analysis shall be carried on the completeness of filling out the audit report on the compliance of the facility with regulatory legal acts in the field of sanitary and epidemiological welfare of the population.

Monitoring of the results of the sanitary and epidemiological audit shall be carried out once every six months.

3. Monitoring of the results of production control is based on transmitted information on the results of production control at epidemiologically significant facilities and on the results of inspections, preventive control with visits.

The entity (object) shall maintain internal records, form and submit periodic reports on the results of production control in accordance with regulatory legal acts in the field of sanitary and epidemiological welfare of the population.

Production control results shall be monitored once every six months.

4. Monitoring of notifications shall be carried out on the basis of the analysis of the received notifications from individuals and legal entities who notified about the beginning and termination of activities in the manner prescribed by the Law of the Republic of Kazakhstan "On Permissions and Notifications", as well as received applications from individuals or legal entities, the results of inspections and preventive control.

Monitoring of notifications shall be carried out at least once every six months.

5. Sanitary and epidemiological monitoring shall be a state system for monitoring the state of health of the population and the environment, their analysis, assessment and forecast, as well as determining the causal relationships between the state of health of the population and the impact of environmental factors.

Analysis, assessment and prognosis - a reasonable assessment of the probability of penetration and spread of pathogens or vectors of infectious and parasitic diseases, as well as the negative impact of environmental factors on the health of the population and the associated potential biomedical and economic consequences.

Sampling in environmental objects (water, soil, atmospheric air) within the framework of sanitary and epidemiological monitoring shall be carried out at least once a quarter.

Footnote. Article 45 as amended by the Laws of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023); dated 21.05.2022 No. 123-VII (shall be enforced from 01.01.2023).

Article 46. Sanitary and epidemiological expertise

1. Sanitary-epidemiological expertise - a complex of organoleptic, sanitary-hygienic, microbiological, virological, parasitological, sanitary-chemical, immunobiological, molecular-genetic, toxicological, radiological, radiometric, dosimetric measurements, measurements of electromagnetic fields and physical factors, other studies and tests as well as examination of projects in order to assess the compliance of projects, products, objects of entrepreneurial and (or) other activities with regulatory legal acts in the field of sanitary and epidemiological well-being of the population.

2. Sanitary and epidemiological examination shall be carried out by state bodies and organizations of the sanitary and epidemiological service within the competence of the decisions or orders of officials of the sanitary and epidemiological service, customs authorities and applications of individuals or legal entities, with the exception of the sanitary and epidemiological examination of projects.

Sanitary and epidemiological examination shall be carried out to determine the possibility of utilization of food products with an expired shelf life stored in the state material reserve.

Sanitary and epidemiological examination of projects - part of the examination of projects, carried out as part of a comprehensive non-departmental examination of projects (feasibility studies and design estimates) intended for the construction of new or reconstruction (expansion, technical re-equipment, modernization) and overhaul of existing facilities, complex urban planning expertise of urban planning projects.

Sanitary and epidemiological expertise of projects for the construction of epidemically significant objects, as well as urban planning projects shall be carried out by experts certified in the manner prescribed by the legislation of the Republic of Kazakhstan on architectural, urban planning and construction activities.

Sanitary and epidemiological expertise in terms of sanitary and epidemiological laboratory research shall be carried out by state organizations in the field of sanitary and epidemiological welfare of the population.

3. Sanitary and epidemiological expertise of construction projects shall be carried out on:

1) projects (feasibility studies and design estimates with the establishment of the size of the estimated (preliminary) sanitary protection zone) intended for the construction of epidemically significant objects, by state or accredited expert organizations as part of a comprehensive non-departmental examination;

2) urban planning projects subject to approval by the Government of the Republic of Kazakhstan or local representative bodies of regions, cities of republican status and the capital.

4. Sanitary and epidemiological expertise for projects not provided for in paragraph 3 of this article shall be carried out by state bodies in the field of sanitary and epidemiological well-being of the population, structural divisions of other state bodies carrying out activities in the field of sanitary and epidemiological well-being of the population, for:

1) industrial and civil facilities;

2) drafts of regulatory documents on maximum permissible emissions and maximum permissible discharges of harmful substances and physical factors into the environment, sanitary protection zones and health protection areas, for raw materials and products;

3) products subject to state control and supervision in the field of sanitary and epidemiological welfare of the population, including the coordination of shelf life and storage conditions for food products;

4) materials on chemical, biological, toxicological, radiological load on soil, water bodies and atmospheric air.

Article 47. Procedure for conducting sanitary and epidemiological laboratory tests

1. Sanitary and epidemiological laboratory studies shall be the part of the sanitary and epidemiological expertise associated with organoleptic, sanitary and hygienic, microbiological, virological, parasitological, sanitary and chemical, immunobiological, molecular genetic, toxicological, radiological, radiometric, dosimetric measurements, measurements of electromagnetic fields and physical factors, other research and testing.

The list and volumes (number) of sanitary and epidemiological laboratory tests shall be established by the state body in the field of sanitary and epidemiological welfare of the population.

2. Sanitary and epidemiological laboratory tests of food products subject to state control and supervision in the field of sanitary and epidemiological well-being of the population shall not be carried out if:

1) expired shelf life;

2) obvious signs of poor quality (spoilage, decomposition, pollution).

3. Chemical and biological substances recognized as hazardous to human health or future generations based on the results of sanitary and epidemiological expertise and scientific expertise shall be prohibited for use in the Republic of Kazakhstan.

The register of hazardous chemical, biological substances prohibited for use in the Republic of Kazakhstan shall be subject to publication on the official Internet resource of the state body in the field of sanitary and epidemiological welfare of the population.

4. Upon the request of individuals or legal entities to carry out sanitary and epidemiological expertise, they shall provide funding and the necessary documentation.

Article 48. Sanitary and epidemiological audit

1. Sanitary and epidemiological audit shall be carried out by an auditor included in the state electronic register of permits and notifications.

2. A sanitary and epidemiological audit shall be carried out upon the request of the owners of facilities subject to state control and supervision in the field of sanitary and epidemiological well-being of the population, on the basis of an agreement for a sanitary and epidemiological audit concluded between the applicant and the auditor in accordance with the Civil Code of the Republic of Kazakhstan.

3. Annually, by January 10 after the reporting year, auditors shall be obliged to provide the state body in the field of sanitary and epidemiological welfare of the population with information on the audit conducted in the form approved by the state body in the field of sanitary and epidemiological welfare of the population.

4. The results of the sanitary and epidemiological audit shall be reflected in the auditor's report with conclusions on the conformity or non-conformity of the facility.

5. An auditor's report with conclusions on the compliance of the facility with the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population shall be submitted by the auditor to the territorial subdivision of the state body in the field of sanitary and epidemiological well-being of the population no later than five working days from the date of completion of the audit.

6. The results of the sanitary and epidemiological audit cannot be the basis for the exemption of objects of high epidemiological significance from inspections.

Article 49. Requirements to auditors carrying out activities for conducting sanitary and epidemiological audit

1. To conduct a sanitary and epidemiological audit, individuals and legal entities must meet the following qualification requirements:

1) for individuals:

higher medical education of a sanitary and epidemiological specificity;

work experience in the relevant specialty for at least ten years;

accreditation to carry out activities related to sanitary and epidemiological audit;

2) for legal entities - availability of qualified personnel in the staff that meets the requirements established by subparagraph 1) of this paragraph.

2. Before and after the termination of the sanitary and epidemiological audit, individuals and legal entities must notify about it the state body in the field of sanitary and epidemiological welfare of the population in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permissions and Notifications."

3. Auditors carrying out activities for the conduct of a sanitary and epidemiological audit shall be obliged to:

1) ensure a comprehensive, objective, high-quality audit;

2) comply with the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population, other regulatory legal acts;

3) conduct an audit in the field of sanitary and epidemiological welfare of the population on the basis of documents of state regulation.

4. It shall be prohibited to conduct a sanitary and epidemiological audit by the auditor, the executors of which:

1) are in labor relations or are close relatives or in-laws of officials of the audited entity, as well as a shareholder (participant) owning ten or more percent of shares (stakes in the authorized capital) of the audited entity;

2) are associated with personal property interests with the audited entity;

3) dismissed from state bodies and organizations of sanitary and epidemiological supervision for committing corruption offenses.

5. In accordance with the laws of the Republic of Kazakhstan, auditors shall be liable for poor-quality and improper performance of their duties and the audit report issued by them on the compliance of the facility with regulatory legal acts in the field of sanitary and epidemiological welfare of the population.

Article 50. Sanitary-epidemiological auditing procedure

1. The sanitary-epidemiological auditing procedure includes:

1) the registration of an application for a sanitary-epidemiological audit;

2) preliminary analysis of documents submitted by an applicant;

3) the conclusion of an agreement on the sanitary-epidemiological audit;

4) the setting of goals of the sanitary-epidemiological audit;

5) the development of a plan for conducting the sanitary-epidemiological audit;

6) the sanitary-epidemiological audit (inspection of a facility, analytical treatment of materials, comparative analysis and assessment of the level of danger to public health of a planned or ongoing activity, the sufficiency and reliability of rationales for the facility’s sale);

7) preparation of an auditor’s report and its submission to the applicant.

2. To have a sanitary-epidemiological audit conducted, an applicant shall provide funding for it and submit such documents as:

1) an application for a sanitary-epidemiological audit;

2) materials related to the facility, which is subject to the sanitary-epidemiological audit:

certificates of inspections conducted by state bodies for the sanitary-epidemiological welfare of the population for a previous year (if such certificates aren’t available - for previous years);

a sanitary-epidemiological opinion on the facility’s compliance with the requirements of regulatory legal acts in the field of the sanitary-epidemiological welfare of the population or a notice of commencement of business;

3) previous opinions of the sanitary-epidemiological audit, if any, and documentation on the management system of the economic entity;

4) other materials required for the facility’s appraisal

3. Based on the results of the sanitary-epidemiological audit carried out in accordance with the plan, an auditor’s report is drawn up on the facility’s compliance with sanitary rules in the form established by the sanitary-epidemiological auditing procedure.

4. The sanitary-epidemiological auditing procedure is determined by the state body for the sanitary-epidemiological welfare of the population.

5. The results of the sanitary-epidemiological audit are invalidated if the preparation of the auditor’s report was associated with:

1) the violation of the sanitary-epidemiological auditing procedure;

2) a failure to comply with the requirements of regulatory legal acts in the field of the sanitary-epidemiological welfare of the population.

Article 51. Production control

1. Individual entrepreneurs and legal entities operating at facilities, which are subject to control and supervision in the field of the sanitary-epidemiological welfare of the population, shall develop, document, introduce an effective production control system and keep it in good working order.

2. It is the responsibility of an individual entrepreneur or the head of a legal entity to ensure production control.

3. An individual entrepreneur or a legal entity appoints persons responsible for ensuring the timeliness, completeness and reliability of production control.

4. The purpose of production control is to ensure the safety and (or) harmlessness of products, works and services for a person by organizing and conducting self-control, at the facility, over compliance with the requirements of regulatory legal acts in the field of the sanitary-epidemiological welfare of the population.

5. Production control includes:

1) the development of a production control program;

2) the implementation (organization) of laboratory research and measurements in accordance with the requirements of regulatory legal acts in the field of the sanitary-epidemiological welfare of the population;

3) control over the timeliness and completeness of medical examinations;

4) control over the availability of documents confirming products’ safety and conformity;

5) the assessment of risk factors, analysis of identified hazards, safety criteria and (or) harmlessness of industrial and environmental factors, and determination of methods for controlling the safety of processes;

6) keeping records and reporting of documentation related to the implementation of production control;

7) the development of a scheme for informing the population, local executive bodies, the state body for the sanitary-epidemiological welfare of the population on emergency situations, suspension of production, breakdowns in technological processes, mass (three or more cases) infectious and parasitic, occupational diseases related to the facility’s operation and poisoning that pose a threat to the sanitary-epidemiological welfare of the population;

8) control over the implementation of measures specified in the production control program.

6. The production control program is developed by an individual entrepreneur, a legal entity independently or with the involvement of persons carrying out a sanitary-epidemiological audit.

7. The production control program is subject to revision when introducing a new technology, changing the technological process, formula of a food product, and in case of other changes affecting the stability of the sanitary-epidemiological situation and (or) posing a threat to the sanitary-epidemiological welfare of the population.

8. Requirements for the implementation of production control are established in the sanitary rules approved by the state body for the sanitary-epidemiological welfare of the population.

Clause 3. State control in the field of distribution of medicines and medical products

Article 52. State control in the field of distribution of medicines and medical products

1. State control in the field of distribution of medicines and medical products is aimed at preventing, identifying, suppressing and eliminating violations of the legislation of the Republic of Kazakhstan in the field of healthcare and regulatory legal acts in the field of distribution of medicines and medical products by the subjects of control.

2. Healthcare entities selling medicines and medical products, carrying out pharmaceutical activities, as well as legal entities exercising control over the quality of raw materials, medicines and medical products, the state expert organization in the field of distribution of medicines and medical products are subject to state control.

3. State control in the field of distribution of medicines and medical products is carried out in the form of:

1) conducting inspections in accordance with the Entrepreneurial Code of the Republic of Kazakhstan;

2) preventive control with a visit to the subject of control in accordance with the Entrepreneurial Code of the Republic of Kazakhstan;

3) preventive control without visiting the subject (object) in accordance with this Code.

4) inspections carried out for compliance with qualification or licensing requirements for issued permits, requirements for sent notifications in accordance with the Law of the Republic of Kazakhstan "On permits and notifications";

5) investigations.

Footnote. Article 52 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced from 01.01.2023).

Article 53. Officials exercising state control in the field of distribution of medicines and medical products

1. Officials exercising state control in the field of distribution of medicines and medical products are:

1) the Chief State Pharmaceutical Inspector of the Republic of Kazakhstan and (or) his/her deputy;

2) state pharmaceutical inspectors of structural units of the state body for the distribution of medicines and medical products;

3) chief state pharmaceutical inspectors in respective territories, who are appointed by the head of the state body for the distribution of medicines and medical products;

4) state pharmaceutical inspectors of territorial units of the state body for the distribution of medicines and medical products.

2. Given of an application (complaint) for (against) actions (inaction) of lower officials from individuals and (or) legal entities, a higher-ranking chief state pharmaceutical inspector in a relevant field has the right to suspend, cancel or revoke acts issued by lower officials until a decision on such an application (complaint) is made.

Article 54. Rights of officials exercising state control in the field of distribution of medicines and medical products

1. In addition to the rights specified in paragraph 1 of Article 154 of the Entrepreneurial Code of the Republic of Kazakhstan, officials exercising state control in the field of distribution of medicines and medical products are entitled to:

1) select samples of medicines and medical products for examination;

2) withdraw medicines and medical products from distribution in accordance with the legislation of the Republic of Kazakhstan;

3) prohibit and (or) suspend the import, production, manufacture, storage, use and sale in the Republic of Kazakhstan of medicines and medical products that have become unusable, with an expired shelf life, falsified, counterfeit medicines and medical products and those failing to meet the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare;

4) visit facilities operating in the field of distribution of medicines and medical products to check their compliance with the requirements of the legislation of the Republic of Kazakhstan;

5) receive information, departmental statements on the distribution of medicines and medical products from entities in the field of distribution of medicines and medical products.

2. To make a decision on the results of state control in the field of distribution of medicines and medical products depending on identified violations of regulatory legal acts in the field of distribution of medicines and medical product, officials exercising state control in the field of distribution of medicines and medical products issue such acts as:

1) an audit findings report - a document issued by an official exercising state control in the field of distribution of medicines and medical products pursuant to the results of inspection, preventive control of the subject (object) for its compliance with the requirements of regulatory legal acts in the field of distribution of medicines and medical products;

2) an order to eliminate violations of the requirements of regulatory legal acts in the field of distribution of medicines and medical products;

3) decisions of chief state pharmaceutical inspectors on:

prohibiting the import, production, use and sale of medicines and medical products failing to meet the requirements of regulatory legal acts in the field of distribution of medicines and (or) the requirements of the Eurasian Economic Union, posing a threat to human life and (or) health;

suspending a license and (or) annex to a license for pharmaceutical activity and (or) another permit in the field of healthcare in accordance with the laws of the Republic of Kazakhstan;

suspending or canceling or withdrawing acts adopted by lower officials.

3. Officials exercising state control in the form of preventive control, inspection and investigation are prohibited from making demands and making requests that are not related to the subject of preventive control, inspection or investigation.

Footnote. Article 54 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.01.2023).

Article 55. Preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control

1. Preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control is carried out by way of analyzing and comparing data from information systems, as well as other information on the activity of the subject (object) of control.

2. The objectives of preventive control without visiting the subject (object) of control are timely identification, suppression and prevention of violations, enabling the subjects (objects) of control to independently eliminate violations identified by the state body for the distribution of medicines and medical products based on the results of preventive control without visiting the subject (object) control, and reducing the administrative burden on them.

3. Preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control is carried out no more than once a quarter.

4. If violations are identified pursuant to the results of preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control, it is necessary to issue a recommendation to eliminate the identified violations. The form of the recommendation to eliminate the identified violations is established by the state body for the distribution of medicines and medical products.

5. A recommendation on the elimination of violations identified in the course of preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control is sent to the subject (object) of control within seven working days of violations’ identification in one of the following ways:

1) by registered mail with return receipt;

2) it is handed over against receipt to his/her/its representative and (or) an official of the subject (object) of control;

3) electronically to the user’s personal account on the “e-government” web portal.

6. The recommendation shall be deemed as complied with by the subject (object) of control if identified violations, specified in the recommendation on elimination of the violations identified in the course of preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control, are eliminated within thirty working days of a day following the day of its delivery (receipt).

7. In case of disagreement with the violations specified in the recommendation, the subject (object) of control has the right to send an objection to the state body for the distribution of medicines and medical products within five working days of a day following the day of the recommendation’s delivery (receipt).

8. A failure to comply with a recommendation on the elimination of violations identified in the course of preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control within the prescribed period is a ground for selecting the subject (object) of control for preventive control in the field of distribution of medicines and medical products with a visit to the subject (object) of control.

9. The results of preventive control without visiting the subject (object) of control are subject to registration by the state body for the distribution of medicines and medical products and its territorial units in a special register of preventive control without visiting the subject (object) of control, which shall be numbered, bound and bear the seal of the state body for the distribution of medicines and medical products or its territorial unit.

10. Preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control is carried out in relation to:

1) medicines and medical products within the guaranteed volume of free medical care and (or) compulsory social health insurance, as well as medicines subject to co-payment;

2) all medicines.

Chapter 6. HEALTHCARE ADVERTISING

Article 56. Healthcare advertising

1. Medicines and medical products are advertised in the manner prescribed by the state body for the distribution of medicines and medical products.

Biologically active additives are advertised in the manner prescribed by the state body for the sanitary-epidemiological welfare of the population.

Medical services (assistance) are (is) advertised in the manner prescribed by the state body for medical services (assistance).

2. The advertising of medical services, methods and means of prevention, diagnosis, treatment and medical rehabilitation (for the purposes of this article, hereinafter referred to as services), medicines and medical products, biologically active additives shall be reliable, recognizable without special knowledge or the use of special means, exclude comparisons with other services, medicines and medical products, biologically active additives, not mislead consumers by abuse of their trust, also in relation to characteristics, composition, consumer properties, cost (price), intended results of use, research and test results.

3. It is prohibited to:

1) advertise medicines and medical products, biologically active additives, means of prevention that are not registered in the Republic of Kazakhstan;

2) advertise prescription medicines in the media;

3) distribute, for advertising purposes, samples of medicinal products dispensed with medical prescription;

4) use children, their images and voices in advertising medicines and medical products, except for medicines and medical products for children;

5) distribute and place advertisements of medicines and medical products, biologically active additives in public transport vehicles, organizations that are not related to their prescription, use and dispensing, except for advertisements of medicines at medical, pharmaceutical conferences, congresses, symposia and others scientific meetings;

6) place advertising information on industrial products, prescription forms;

7) place outdoor (visual) advertising of medicines and medical products;

8) use healthcare professionals authorized to prescribe medicines and medical products as advertisers, except for the cases of providing reliable information on medicines and medical products for scientific or educational purposes, and also for informing patients;

9) advertise services in the absence of a license for the relevant type of activity;

10) advertise services provided by persons without a certificate of a healthcare specialist, including foreign specialists;

11) indicate, in public advertising, methods of treatment of such diseases as sexually transmitted diseases, oncological, mental, behavioral disorders (diseases), dangerous infectious diseases, HIV infection, TB disease, diabetes mellitus;

12) refer, in advertising, to the recommendations of scientists, healthcare specialists, as well as officials of state bodies, who may encourage the use and (or) prescription of medicines and medical products;

13) present services, medicines and medical products, biologically active additives in advertising as unique, safest and most effective;

14) assert that the safety and efficacy of a medicinal product are due to its natural origin;

15) cause assumptions that the effectiveness of the service provided, of treatment with an advertised medicinal product, biologically active additive is guaranteed, that the use of the product does not develop side effects;

16) provide information in advertising that is not directly related to the advertised service, medicine and medical product;

17) advertise proposals for entering into transactions on human organs (parts of an organ) and (or) tissues (parts of tissue).

4. It is allowed to distribute and place advertisements of services, medicines and medical products in the media, electronic information resources in healthcare organizations.

5. Advertising of medicines shall contain complete (including appropriate restrictions on the use of the medicine) and reliable information, the exclusion of which may entail inappropriate use of medicines or unjustified risk for the consumer.

6. Control over the production, distribution and placement of advertising is carried out by state bodies within their competence.

Chapter 7. DIGITAL HEALTH

Article 57. Fundamental principles of digital health

The principles of digital health are as follows:

1) implementation of healthcare principles through digitalization of data and processes in the industry;

2) the primacy of standards, which are a tool for the implementation of policy and strategy, the basis of the methodology determined by the authorized body;

3) ensuring the protection of the objects of informatization of healthcare, containing personal health data of individuals, the safety and confidentiality of personal health data of individuals, as well as the patient’s access to his/her personal data;

5) support to improve the efficiency of the healthcare system;

6) support to improve the quality of medical services.

Footnote. Article 57 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ).

Article 58. Basic terms used in this chapter

The following basic terms are used in this chapter:

1) digitization of healthcare - the use of digital technologies to transform medical and administrative-managerial processes in healthcare, aimed at increasing the accessibility, efficiency, quality and safety of medical assistance;

2) personal health data - personal data containing information on the health of an individual and medical services provided to him/her, which are recorded on electronic, paper or other physical media;

3) personal health data aggregator - an operator of personal data that collects, processes, stores, protects and provides personal medical data in accordance with the rules approved by the authorized body;

4) the owner of personal health data – the subject of personal medical data (individual) in respect of whom these data are generated;

5) the national telemedicine network of the Republic of Kazakhstan - a network of stationary and mobile telemedicine centers of healthcare organizations under the jurisdiction of the authorized body, which are united by secure telecommunications infrastructure and equipped with hardware and software complexes;

6) telemedicine services - the provision of medical services for the purpose of diagnosis, treatment, medical rehabilitation and prevention of diseases and injuries, conducting research and assessments using digital technologies, providing remote interaction of healthcare professionals with one another, with individuals and (or) their legal representatives, identification of these persons, as well as documenting their actions;

7) medical information system - an information system for electronic maintenance of processes of public health entities;

8) mobile healthcare - the use of mobile devices, including mobile phones, pocket personal computers, medical and other devices for healthcare purposes;

9) wearable medical devices - mobile (wearable) devices designed to collect and transmit indicators of the health status of an individual;

10) telehealth - telemedicine services, including clinical diagnosis and monitoring of an individual’s condition at a distance, as well as other non-clinical functions such as disease prevention, health promotion, public health support, health education and scientific medical research;

11) telemedicine network - a network of stationary and mobile telemedicine centers having medical equipment and united by information and communication technologies into a single information space for the provision of telemedicine services, training and exchange of medical information in electronic format;

12) National electronic health passport - an electronic information resource of the authorized body containing electronic health passports, which is available to both an individual and healthcare workers in accordance with the rules approved by the authorized body;

13) digital health facility - electronic information resources, software, mobile healthcare technologies, healthcare information and communication infrastructure;

14) the owner of a digital health facility- a digital health entity entitled to own and use objects of informatization;

15) digital health entity - individuals and legal entities, state bodies that carry out activities or enter into public relations in the field of digital health;

16) electronic health passport - a set of structured personal health data on the state of health of an individual and medical assistance provided to him/her, which are generated by digital health entities from electronic sources throughout his/her life and available to both an individual and healthcare workers in accordance with the rules approved by the authorized body;

17) electronic medical record - a set of structured personal health data related to a specific case of medical assistance.

Footnote. Article 58 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ).

Article 59. Activities in the field of digital health

1. Activities in the field of digital health include:

1) legal regulation, development and approval of digital health standards;

2) development of information and communication infrastructure of the healthcare industry;

3) provision of individuals and legal entities with data and information in the field of healthcare;

4) collection, processing, storage, protection of personal health data;

5) provision of information and communication services for the collection, processing, storage, protection and provision of personal health data;

6) transition to paperless medicine.

2. Electronic information resources, through which telemedicine services are provided, shall comply with the requirements of the authorized body.

3. The authorized body processes, stores and protects personal health data to be stored at the national level.

4. An individual has the right to delegate the storage and processing, protection of his/her personal health data to digital health entities in accordance with the rules approved by the authorized body.

Article 60. Interaction of digital health facilities and entities

1. Collection, processing and storage of personal health data for the formation of electronic medical records containing personal health data are carried out as part of medical assistance, taking into account the patient’s informed consent to receive medical assistance.

2. Public health entities are obliged to ensure the transfer of data to the National electronic health passport and electronic information resources of the authorized body to the extent and in the frequency determined by the authorized body, except for the cases provided for by the Law of the Republic of Kazakhstan “On State Secrets”.

3. Personal health data are transferred to third parties with the consent of an individual, except for the cases specified in paragraph 4 of this article.

4. Personal health data are transferred to the National electronic health passport and electronic information resources of the authorized body without the consent of an individual, as well as to public health entities, only for the purpose of providing medical assistance and in the cases specified in:

1) paragraph 1 of Article 137 of this Code;

2) the Law of the Republic of Kazakhstan “On Personal Data and Their Protection”.

5. Personal health data aggregators provide information and communication services for the collection, processing, storage, protection of personal health data by public health entities.

6. Digital health entities generate, store, protect electronic medical records in accordance with the rules approved by the authorized body.

7. Wearable medical devices are subject to certification in accordance with the legislation of the Republic of Kazakhstan.

Article 61. Responsibility of digital health entities

1. The right to access the personal health data of an individual with his/her consent is granted to:

1) providers of medical and pharmaceutical services;

2) an organization responsible for reimbursing expenses related to health services delivery in order to reimburse expenses related to health services delivery;

3) the authorized body, local public health authorities of regions, cities of republican significance and the capital, territorial units of the authorized body for social protection of the population, state bodies exercising state control in the field of medical services (assistance), sanitary-epidemiological welfare of the population, distribution of medicines and medical products;

4) military-medical (medical) units of central executive bodies and other central state bodies in relation to the served contingent;

5) legal entities that collect, process, store, protect and provide personal health data in accordance with the legislation of the Republic of Kazakhstan.

These organizations can access personal health data only to the extent required to provide relevant services.

2. In cases of emergency and urgent medical services, it is implied that public health entities providing such forms of medical services are given access to personal health data of an individual.

3. The transfer of personal health data of an individual is prohibited, except for the cases provided for by this Code and the laws of the Republic of Kazakhstan.

4. The persons specified in paragraph 1 of this Article, shall be granted the right to access personal health data of an individual in accordance with the procedure, determined by the rules for delimiting access rights of digital healthcare subjects, approved by the authorized body, in agreement with the authorized body in the field of personal data protection.

5. An individual has the right to access information on his/her health and medical services provided to him/her, which is contained in the National electronic health passport, electronic health passport, and also to track the data access log.

6. The relationship of the health data aggregator with public health entities is regulated by the civil legislation of the Republic of Kazakhstan.

7. Healthcare professionals and workers of public health entities are liable under the laws of the Republic of Kazakhstan for the quality, timeliness, reliability and confidentiality of electronic data entered into the electronic information resources of the authorized body.

8. The persons are liable under the laws of the Republic of Kazakhstan for a failure to comply with measures to protect personal health data, which results in the loss, illegal collection and processing of personal health data relating to the private life of individuals, including those falling under medical confidentiality.

9. For carrying out analytical, statistical activities, scientific and other research, personal health data shall be used in anonymized form.

Footnote. Article 61 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ).

Article 62. Security of personal health data of individuals

1. Security features of electronic information resources containing personal health data shall be established in accordance with the legislation of the Republic of Kazakhstan on informatization and on personal data and its protection.

2. It is not allowed to use electronic information resources containing personal health data for causing pecuniary and (or) non-pecuniary damage, restricting the exercise of rights and freedoms guaranteed by the laws of the Republic of Kazakhstan.

3. Information obtained from electronic information resources containing personal health data of individuals is used solely for performing official duties.

Footnote. Article 62 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ).

Chapter 8. STRUCTURE OF THE HEALTHCARE SYSTEM

Article 63. Public health entities

1. The healthcare system consists of the public and private health sectors.

2. The public health entities are healthcare organizations, as well as individuals engaged in private medical practice and pharmaceutical activities.

3. The public health sector consists of state bodies for healthcare, healthcare organizations set up on the basis of the state property right, as well as military-medical (medical) units and organizations that carry out expertise in the field of forensic (forensic-medical, forensic-narcological, forensic-psychiatric) medicine.

4. The private health sector consists of healthcare organizations set up on the basis of the private property right, as well as individuals engaged in private medical practice and pharmaceutical activities.

5. Individuals have the right to engage in private medical practice if they have a certificate of a healthcare specialist, at least five years of work experience in a relevant specialty and a medical license.

Article 64. Types of medical activities

Medical activities have such types as:

1) medical assistance;

2) laboratory diagnostics;

3) postmortem diagnostics;

4) activities in the field of procurement of blood and its components;

5) activities in the field of sanitary-epidemiological welfare of the population;

6) activities in the field of public health protection;

7) educational and scientific activities in the field of healthcare;

8) expertise in the field of healthcare;

9) other types of activities not prohibited by this Code.

Article 65. Development of the healthcare infrastructure

1. Facilities of healthcare infrastructure are buildings and structures, property complexes used in the implementation of medical, pharmaceutical and educational activities in the field of healthcare.

2. The healthcare infrastructure is developed on the principles of:

1) improving the quality and accessibility of medical care for all groups of the population, including the adaptation of medical facilities for persons with disabilities and other groups of the population with disabilities;

2) using advanced international experience in the design and construction of multidisciplinary stationary complexes;

3) ensuring equal opportunities for public and private investments and increasing the investment attractiveness of the health sector for domestic and foreign investors;

4) strategic planning of the development of the healthcare infrastructure.

3. A single long-term plan for the development of infrastructure is a republican plan, which is developed on the basis of regional long-term plans for the development of healthcare infrastructure and approved by the authorized body. The requirements established as part of the development of regional long-term plans for the development of healthcare infrastructure are:

1) bringing the network of healthcare organizations in line with the state standard for the network of healthcare organizations;

2) bringing public health facilities into compliance with the requirements of regulatory legal acts on the sanitary-epidemiological welfare of the population, architectural, urban planning and construction activities, and equipment standards;

3) bringing the bed capacity of hospitals and the production capacity of organizations providing primary care services and (or) consultative-diagnostic assistance in line with the needs of the population;

4) the opening of healthcare infrastructure facilities based on the needs of the population, ensuring access to medical services.

4. Central state bodies, local executive bodies and the autonomous educational organization take measures to maintain and operate medical facilities under their jurisdiction in accordance with the requirements of regulatory legal acts on the sanitary-epidemiological welfare of the population, architectural, urban planning and construction activities, and equipment standards.

5. Investment planning and development of the network of healthcare organizations are carried out in accordance with regional long-term plans for the development of healthcare infrastructure.

6. Long-term plans for the development of healthcare infrastructure are developed for a ten-year period.

Footnote. Article 65 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 66. Public-private partnership in the field of healthcare

1. The operation of a public health facility created (reconstructed) as a result of implementation of a concession project in the field of healthcare (hereinafter referred to as a concession object) is the use of a concession object, which may provide for technical and functional maintenance, in the manner and on the conditions determined by a concession agreement in the health sector (hereinafter referred to as a concession agreement).

2. The maintenance of a concession object is its use, including the implementation of a complex of technological and organizational measures aimed at keeping the concession object in a good, safe condition suitable for its functional maintenance, as well as its current and (or) major repairs, management, implementation of service and (or) auxiliary activities in the manner and on the conditions determined by a concession agreement.

3. Functional maintenance of a concession object is its use as intended, and also for the production of goods and (or) the performance of works, and (or) the provision of services in the manner and on the conditions determined by a concession agreement.

4. A functional operator in the field of healthcare - a state-owned legal entity or a legal entity with one hundred percent participation of the state or its subsidiary, more than fifty percent of the voting shares (participation shares) of which belongs to it on the basis of the right of ownership, whose statutory activity is the provision of medical care, which are not a party to the concession agreement, intended for the implementation of activities related to functional maintenance of the concession object.

5. The creation (reconstruction) and operation of public health facilities can be carried out through the implementation of public-private partnership projects, including concession projects, in accordance with the legislation of the Republic of Kazakhstan in the field of public-private partnerships and concessions.

6. A concession object can be run not only by a concessionaire, but also by a functional operator in the field of healthcare.

In this case, the concessionaire has the right to the reimbursement of costs and receipt of income for the sale of the goods (works, services) produced as part of the maintenance of the concession object.

7. When implementing concession projects providing for the conclusion of a concession agreement on the basis of subparagraph 1-1) of paragraph 1 of Article 21-1 of the Law of the Republic of Kazakhstan “On Concessions”:

1) the concessor transfers the created concession object under an agreement on the free use of state property to a functional operator in the field of healthcare for the implementation of functional services in the manner specified by the concession agreement;

2) the concessionaire maintains the concession object in the manner and on the conditions provided for by the concession agreement;

3) the functional operator in the field of healthcare, appointed before the tender for the selection of a concessionaire, provides functional services for the concession object in the manner and on the conditions provided for by the concession agreement.

8. The concession agreement, concluded on the basis of subparagraph 1-1) of paragraph 1 of Article 21-1 of the Law of the Republic of Kazakhstan “On Concessions”, shall include provisions on the functional operator in the field of healthcare, as well as the procedure for joint use of the concession object by the concessionaire and the functional operator in the field of healthcare.

9. The functional operator in the field of healthcare shall have permits for such activities provided for by the legislation of the Republic of Kazakhstan or receive them before using the concession object as intended.

10. The functional operator in the field of healthcare can:

1) exercise rights in relation to the concession object on the terms provided for by the agreement on the free use of state property concluded for the purpose of functional maintenance of the concession object;

2) use the concession object together with the concessionaire in the manner and on the conditions provided for by the concession agreement;

3) exercise other rights in accordance with the laws of the Republic of Kazakhstan.

11. The functional operator in the field of healthcare shall:

1) maintain the profile of the concession object;

2) produce goods and (or) perform works, and (or) provide services provided for by the agreement on the free use of state property;

3) comply with the legislation of the Republic of Kazakhstan in the field of labor, public employment and environmental protection;

4) compensate for the damage caused to the concession object through its fault;

5) comply with the conditions of joint use of the concession object with the concessionaire in the manner prescribed by the concession agreement;

6) comply with other requirements and conditions established by the laws of the Republic of Kazakhstan and the agreement on the free use of state property.

12. Under public-private partnership projects of particular importance, involving the creation (reconstruction) and (or) operation of healthcare facilities, including concession projects, thepotential private partners, concessionaires or founders (participants) of a new legal entity (consortium) established for the purpose of implementing project, shall be imposed an additional (special) qualification requirement for experience (experience of one of the founders (participants) in the implementation of projects for the construction or operation of technically complex healthcare facilities.

Footnote. Article 66 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ); dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).

Chapter 9. FINANCIAL SUPPORT FOR THE HEALTHCARE SYSTEM

Article 67. Sources of financial support for the healthcare system

The sources of financial support for the healthcare system are:

1) budgetary funds;

2) assets of the social health insurance fund;

3) voluntary medical insurance funds;

4) funds received for the provision of paid services;

5) funds received from co-payment;

5-1) lump-sum pension payments of individuals in cases provided for by the laws of the Republic of Kazakhstan;

6) funds received as voluntary donations from individuals and legal entities;

7) other sources that do not contradict the legislation of the Republic of Kazakhstan.

Footnote. Article 67 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (вводится в действие с 01.01.2021).

Article 68. Financing of medical care volumes

1. The guaranteed volume of free medical care is financed using:

1) budgetary funds;

2) funds of citizens in case of co-payment.

2. Medical assistance provided within the compulsory social health insurance system is financed using:

1) assets of the social health insurance fund;

2) funds of citizens in case of co-payment.

3. Financial support of the additional volume of medical care is provided in accordance with subparagraph 3) of Article 195 of this Code.

Article 69. The use of sources of financial support for the healthcare system

1. Funds in the field of healthcare go to:

1) the implementation of programs to strengthen and develop public healthcare;

2) the training and advanced training of healthcare personnel;

3) the development and introduction of achievements of medical and pharmaceutical sciences;

4) the payment for services of public health entities within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

4-1) payment for treatment to individuals at the expense of lump-sum pension payments in accordance with the legislation of the Republic of Kazakhstan;

4-2) payment for the services on provision of medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system;

5) the purchase of medicines, medical products, blood and its components, vaccines and other immunobiologicals;

6) ensuring the sanitary-epidemiological welfare of the population;

7) the maintenance of state-run healthcare institutions;

8) material and technical equipment of healthcare organizations;

9) the development of the healthcare infrastructure;

10) cover other expenses not prohibited by the legislation of the Republic of Kazakhstan.

2. The payment for services of public health facilities within the guaranteed volume of free medical care and (or) in the system of compulsory social medical insurance is made with account of the results of the monitoring of contractual obligations for the quality and volume of medical services in the manner prescribed by the authorized body.

2-1. payment for the services of healthcare entities within the additional volume of medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, shall be carried out subject to the results of monitoring of contractual obligations on quality and volume of medical services in accordance with the procedure, determined by the authorized body.

3. Entities operating in the field of distribution of medicines and medical products are paid for pharmaceutical services provided within the guaranteed volume of free medical care and (or) medical assistance in the system of compulsory social health insurance by budget program administrators or the social health insurance fund in the manner prescribed by the authorized body.

4. The services provided by public health entities within the guaranteed volume of free medical care are purchased by the social health insurance fund and (or) budget program administrators.

The services provided by public health entities in the compulsory social health insurance system are purchased by the social health insurance fund.

4-1. Accounting of the healthcare entities providing medical care within the guaranteed volume of free medical care is carried out by the social health insurance fund.

The database of health care subjects applying for the provision of medical care within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance shall be formed by the Social Health insurance fund.

5. The services provided within a guaranteed volume of free medical care are paid for by the social health insurance fund and (or) budget program administrators.

The services of public health entities provided as part of medical assistance within the compulsory social health insurance system are paid for by the social health insurance fund.

5-1. In order to purchase and pay for the services of healthcare entities within the guaranteed amount of free medical care and (or) in the system of compulsory social medical insurance, the social medical insurance fund combines the funds of the target contribution allocated for the guaranteed amount of free medical care and the assets of the fund.

6. Accredited healthcare organizations have a preferential right to conclude contracts within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance.

Footnote. Article 69 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced from 01.01.2021); dated 24.06.2021 No. 52-VII (shall be enforced upon expiration of ten calendar days after the date of its first official publication ); dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 19.04.2023 No. 223-VII (effective from 01.01.2024).

Article 70. National health accounts

1. National health accounts are a system of regular, comprehensive and consistent monitoring of financial flows in the country’s healthcare system, which is used to assess the distribution of healthcare resources with a view to their equal and effective distribution among measures aimed at preventing diseases and treating the population.

2. National health accounts are generated annually on the basis of international methodology using:

1) statistical bulletins of the authorized body for state statistics;

2) data of the central authorized body for budget execution;

3) data of local authorized bodies for budget execution in the context of medical facilities;

4) statistical data published on the official websites of the National Bank of the Republic of Kazakhstan, the World Health Organization and the Organization for Economic Cooperation and Development.

Based on the data specified in part one of this paragraph, the authorized body prepares an analytical report with a description of expenses in the context of services and providers of medical services, as well as information on the sources of their funding.

3. The procedure for the formation and use of data from national health accounts is determined by the authorized body.

Chapter 10. INTERNATIONAL COOPERATION IN THE FIELD OF HEALTHCARE

Article 71. International cooperation in the field of healthcare

1. International cooperation in the field of healthcare is carried out on the basis of generally recognized principles and norms of international law and international treaties of the Republic of Kazakhstan.

2. International cooperation includes interaction on health issues with official representatives of states, international organizations and international integration associations, participation in international events, the development of international treaties.

3. Health management bodies, public health entities have the right to establish direct contacts with health management bodies of foreign states, foreign enterprises, institutions and organizations in accordance with the legislation of the Republic of Kazakhstan and international treaties.

4. Agreements, treaties concluded within the framework of international cooperation in the field of healthcare, including those concluded by health management bodies, public health entities, may not restrict human rights and freedoms and those of citizens of the Republic of Kazakhstan in the field of public health protection.

Article 72. Priority areas of international cooperation in the field of healthcare

The priorities of international cooperation in the field of healthcare are as follows:

1) protection of the interests of citizens of the Republic of Kazakhstan and the interests of the Republic of Kazakhstan in the field of healthcare;

2) participation in international health initiatives;

3) attracting investments and providing technical assistance in the field of healthcare at the interstate level;

4) provision of medical assistance to foreigners, stateless persons;

5) increasing the level of medical assistance by introducing international innovative technologies and modernizing the healthcare system;

6) integration into world medical and pharmaceutical science;

7) assistance in addressing the provision of medical assistance to migrant workers;

8) interstate cooperation on educational activities in the field of healthcare, training and advanced training of medical personnel based on modern achievements of science and practice;

9) provision and receipt of international assistance in the field of healthcare in case of emergencies;

10) exchange of information, technologies with foreign states and international organizations in the field of distribution of medicines, medical products and harmonization of requirements for the safety and quality of pharmaceutical and medical products;

11) sanitary protection of borders in accordance with the requirements of international medical-sanitary rules, ensuring the safety of imported products.

Article 73. Economic and legal basis for international cooperation in the field of healthcare

1. The economic basis of international cooperation in the field of healthcare is:

1) compulsory and voluntary membership fees to international organizations;

2) attraction and use of grants, technical assistance;

3) financing in accordance with concluded international agreements.

2. The legal basis for international cooperation in the field of healthcare is international treaties.

SECTION 2. PUBLIC HEALTH PROTECTION

Chapter 11. GENERAL PROVISIONS OF PUBLIC HEALTH PROTECTION

Article 74. Priority areas of public health protection

1. The priority areas of public health protection are as follows:

1) health promotion through the formation of the population’s medical-social activity and attitudes towards a healthy lifestyle;

2) raising the level of public awareness about main aspects of health and risk factors;

3) epidemiological surveillance of infectious and priority non-communicable diseases;

4) organization of interaction of all concerned state bodies, organizations and departments, public associations, business communities, and other individuals and legal entities.

2. The public health service is the activity of state bodies, individuals and legal entities, public associations aimed at promoting a healthy lifestyle, healthy diet, assessing the impact of behavioral risk factors on health, preventing infectious and non-communicable diseases.

Article 75. Statistical observation in the field of public health

1. Health statistics is a branch of statistics that includes statistical data on public health, activities of public health entities and use of healthcare resources.

2. Statistical observation in the field of healthcare is carried out by the authorized body.

3. The procedure for statistical observation in the field of healthcare, the forms of statistical recording and reporting in the field of healthcare, the procedure for their maintenance, filling out and deadlines for submission are established by the authorized body.

4. Statistical health indicators are used for statistical analysis, resource forecasting and modeling of processes in the field of healthcare, health system policy planning, making managerial decisions.

5. Official statistical information in the field of healthcare is publicly available and is posted by the authorized body in the media, including on its official website.

Chapter 12. RIGHTS AND OBLIGATIONS OF INDIVIDUALS IN THE FIELD OF HEALTHCARE

Article 76. Guarantee of rights in the field of healthcare

1. The state guarantees to citizens of the Republic of Kazakhstan are as follows:

1) equal access to medical assistance;

2) good quality of medical assistance;

3) good quality of drug provision;

4) availability, efficacy and safety of medicines;

5) carrying out measures for the prevention of diseases, the formation of a healthy lifestyle and healthy nutrition;

6) freedom of reproductive choice, protection of reproductive health and observance of reproductive rights;

7) sanitary-epidemiological welfare.

2. The Republic of Kazakhstan guarantees the citizens of the Republic of Kazakhstan protection from any forms of discrimination and stigmatization due to the presence of any diseases and conditions.

Article 77. Rights of citizens of the Republic of Kazakhstan

1. Citizens of the Republic of Kazakhstan have the right to:

1) a guaranteed volume of free medical care;

2) medicines and medical products within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

3) free choice of a physician and a medical facility;

4) medical nutrition in the event of a patient’s treatment in a hospital;

5) additional medical assistance in excess of the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance at the expense of their own funds, funds of organizations, the system of voluntary medical insurance and other sources in accordance with the legislation of the Republic of Kazakhstan;

6) medical and other services on a paid basis;

7) medical assistance provided outside the Republic of Kazakhstan at the expense of budgetary funds, given indications, in the manner prescribed by the authorized body;

8) the receipt and submission of relevant documents certifying the fact of temporary disability, in accordance with the legislation of the Republic of Kazakhstan;

9) free and regular receipt from state bodies, organizations and an attending physician, within their competence, of reliable information on methods of prevention, diagnosis, treatment of the disease and medical rehabilitation, clinical trials, factors affecting health, including the state of the environment, working conditions, life and recreation, healthy diet and food safety;

10) receive information from state bodies, independent expert organizations and entities in the field of distribution of medicines and medical products on the safety, efficacy and good quality of medicines and medical products sold;

11) the protection of information falling under medical confidentiality;

12) compensation for harm caused to health in the provision of medical assistance in accordance with the legislation of the Republic of Kazakhstan;

13) protect their rights and legitimate interests in the field of health protection in accordance with the legislation of the Republic of Kazakhstan;

14) appeal against actions (inaction) of healthcare professionals and pharmaceutical workers in the manner prescribed by the laws of the Republic of Kazakhstan;

15) petition higher authorities for involving independent experts in case of disagreement with the findings of state medical examination;

16) voluntary declaration of will about the opportunity to act as a donor;

17) declaration of will of consent or refusal to remove their tissues (parts of tissue) and (or) organs (parts of an organ) after death for the purpose of transplantation in the manner prescribed by this Code;

18) give informed consent or refusal for treatment and other medical interventions, including preventive vaccinations;

19) co-payment;

20) pain relief in the treatment of chronic incurable diseases;

21) get information in an intelligible form on the state of health, including information on the results of medical examination, diagnosis and prognosis of the disease, methods of providing medical care, associated risk, possible types of medical intervention, its consequences and the results of providing medical assistance;

22) get reliable and timely information on factors that contribute to the preservation of health or have a negative impact on them, including information on the prevention of diseases, sanitary-epidemiological welfare, the state of the environment, the potential danger to human health from the work performed and services provided, rational nutritional standards, quality and safety of products, goods and services;

23) other rights in accordance with the laws of the Republic of Kazakhstan.

1-1. Persons with disabilities (persons with disabilities) have the right to priority care in healthcare organizations.

2. Women have the right to decide on their motherhood and free choice of modern methods of preventing unwanted pregnancy for the purposes of family planning and protecting their health.

The right of citizens to maternity protection is exercised through:

1) medical examinations, dynamic observation and health improvement of women of reproductive age;

2) medical treatment of common diseases that directly affect the reproductive health of women and the health of the child when admitted to a hospital for the care of a sick child.

Footnote. Article 77 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 78. Children’s rights

1. In addition to the rights provided for in paragraph 1 of Article 77 of this Code, every child has the right to:

1) modern and effective medical services and means of treating diseases and health recovery;

2) education in the field of health protection;

3) preventive medical examinations and dynamic observation, treatment, drug provision, health improvement and vaccination;

4) the provision of medical services during the recovery period and organized recreation in the manner prescribed by the authorized body;

5) sanitary and hygienic education, training and work under conditions appropriate for his/her physiological characteristics and state of health, excluding the influence of adverse factors on him/her;

6) obtain medical documentation on the state of health on a free basis at the place of his/her registration when becoming a student and being employed;

7) obtain information on the state of health in an intelligible form;

8) obtain information in an intelligible form on a healthy lifestyle and proper nutrition, on the dangers of smoking, the use of psychoactive substances;

9) obtain information in an intelligible form on the protection of reproductive health;

10) palliative care.

2. Minors aged sixteen and over have the right to informed consent or refusal to preventive, consultative and diagnostic assistance, except for surgical interventions, artificial abortion, which are performed with the consent of their parents or legal representatives.

3. When treating children under five years of age in a hospital, as well as sick older children who, in doctors’ opinion, need additional care, the mother (father) or another person directly caring for the child is given the opportunity to stay with him/her in the medical facility and a sheet or certificate of temporary disability in accordance with the legislation of the Republic of Kazakhstan.

A nursing mother of a child up to one year of age is provided with free meals by a medical facility for the entire period of childcare.

4. When treating children under five years of age in outpatient and hospital-replacing conditions, as well as sick older children who, in doctors’ opinion, need additional care, the mother (father) or another person directly caring for the child is given the opportunity to stay with him/her and a sheet or certificate of temporary disability in accordance with the legislation of the Republic of Kazakhstan.

5. When receiving specialized medical assistance, medical rehabilitation, as well as palliative medical care in stationary conditions, school-age children have the right to continue education in the manner prescribed by the authorized body together with the authorized body for education.

Healthcare organizations providing medical assistance to children create conditions for their games, recreation and education.

6. Children with disabilities, infected with HIV have the right to receive free medical-pedagogical correctional support in educational institutions, healthcare organizations in accordance with the legislation of the Republic of Kazakhstan.

Children infected with HIV have the right to stay in children’s homes and other healthcare organizations and educational institutions.

Children born to mothers infected with HIV have the right to receive free adapted milk formulas in accordance with established nutritional standards.

6-1. Children with disabilities (children with disabilities) have the right to priority care in healthcare organizations.

7. The list of medical contraindications for placing children in a children’s home and educational institutions, organizations for orphans and children left without parental care is approved by the authorized body.

8. Orphans, children left without parental care, and children who are recipients of special social services, until they reach the age of three years inclusive, may be kept in state medical organizations in accordance with the procedure established by the authorized body.

Footnote. Article 78 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication); dated 20.04.2023 No. 226-VII (shall be enforced from 01.07.2023).

Article 79. Rights of citizens of the Republic of Kazakhstan and a family in the field of protection of reproductive rights

1. Citizens of the Republic of Kazakhstan have the right to:

1) free reproductive choice;

2) receive services for reproductive health and family planning;

3) get reliable and complete information on the state of their reproductive health;

4) infertility treatment, also with the use of modern assisted reproductive methods and technologies, which are permitted in the Republic of Kazakhstan;

5) prevent unwanted pregnancy;

6) safe motherhood;

7) the donation of germ cells, tissue of reproductive organs;

8) the use and free choice of contraception methods;

9) surgical sterilization;

10) artificial abortion;

11) protect their reproductive rights;

12) free decision-making regarding the number of children and the time of their birth within and out of wedlock, the intervals between births necessary to maintain the health of the mother and child;

13) store germ cells, tissue of reproductive organs, embryos in accordance with the procedure established by the legislation of the Republic of Kazakhstan.

2. When exercising their reproductive rights, citizens are obliged to observe the rights, freedoms and legal interests of other persons.

3. Given medical indications, citizens have the right to consultations on family planning, the presence of socially significant diseases and diseases that pose a danger to others, on the medical and psychological aspects of family and marriage relations, as well as to medical genetic and other consultations and examinations in medical facilities in order to prevent possible hereditary and congenital diseases in descendants.

4. The child’s father or another family member is granted the right, given the woman’s consent and taking into account the state of her health, to be present at the birth of the child, except for cases of operative delivery, provided that obstetrics organizations (individual delivery rooms) have appropriate conditions and the father or another family member has no infectious diseases. This right is exercised free of charge.

5. HIV-infected citizens of the Republic of Kazakhstan have the right to adopt children on an equal basis with other citizens of the Republic of Kazakhstan in accordance with the legislation of the Republic of Kazakhstan.

6. HIV-infected citizens of the Republic of Kazakhstan have the right to use assisted reproductive methods and technologies in accordance with the legislation of the Republic of Kazakhstan.

Article 80. Obligations of citizens of the Republic of Kazakhstan

Citizens of the Republic of Kazakhstan are obliged to:

1) take care of their health, bear joint responsibility for the preservation and strengthening of individual and public health;

2) pay contributions for compulsory social health insurance in accordance with the Law of the Republic of Kazakhstan “On Compulsory Social Health Insurance”;

3) take preventive medical examinations, screening tests;

4) follow the prescriptions of healthcare professionals related to individual and public health;

5) take part in the process of managing their own health, including in programs for managing chronic diseases, if any, be interested in getting information on the disease and methods of its treatment, possible risks and complications;

6) inform healthcare professionals on individual characteristics of their body;

7) observe precautions to protect their own health and the health of others, take examination and treatment at the request of public health entities, inform medical personnel on the presence of infectious and other diseases that pose a danger to others;

8) comply with the legislation of the Republic of Kazakhstan in the field of healthcare.

In case of evasion of examination and treatment, citizens of the Republic of Kazakhstan, sick with diseases that pose a danger to others, except for HIV infection, are subject to forcible examination and treatment in accordance with this Code and the laws of the Republic of Kazakhstan.

Article 81. Rights and obligations of pregnant women and mothers in the field of health protection

1. Motherhood in the Republic of Kazakhstan is protected and encouraged by the state.

2. Citizens have the right to support breastfeeding, including protection and promotion of breastfeeding, inter alia:

1) the protection of the rights of pregnant and nursing women is aimed at ensuring conditions for the preparation and implementation of breastfeeding (maternity leave, additional breaks from work to feed infants, part-time work, services on a priority basis in medical facilities, use of the services provided by parenting rooms, etc.);

2) informing the population on the benefits of exclusive breastfeeding for children under six months of age and on continuing breastfeeding with healthy complementary foods for up to two years or more.

3. Pregnant women have the right to:

1) health protection and assistance during pregnancy, during and after childbirth, including premature one, determined by the international live birth and stillbirth criteria, using methods permitted in the Republic of Kazakhstan;

2) medical assistance during pregnancy, during and after childbirth;

3) examination, treatment and medical intervention during pregnancy only with their consent or that of a legal representative, except for cases when delay in examination, treatment and medical intervention threatens the life of a woman and a child (fetus), when a decision to carry out examination, treatment and medical intervention is made by a doctor or a medical case conference;

4) observe a work schedule, maternity leave, unpaid leave to care for a child until the child reaches the age of three, and working conditions for pregnant women and nursing mothers in accordance with the labor legislation of the Republic of Kazakhstan;

5) qualified support provided to nursing mothers (parents), counseling by healthcare professionals trained in lactation, methods of exclusive breastfeeding and complementary feeding;

6) support for the practice of breastfeeding, which is implemented by child-friendly medical facilities;

7) time for medical examination and registration as pregnant within twelve weeks of gestation, which is granted by an employer together with protecting job, securing position and preserving average salary;

8) other guarantees and incentives in accordance with the laws of the Republic of Kazakhstan.

4. Pregnant women are obliged to:

1) within twelve weeks of gestation, register as pregnant at the place of registration for receiving medical assistance within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance;

2) follow the doctor’s recommendations during pregnancy, during and after childbirth.

5. If a woman with contraindications for pregnancy plans a pregnancy, she assumes full responsibility for all health risks to herself and the fetus during pregnancy and up to forty-two calendar days of childbirth.

Article 82. Obligations of individual entrepreneurs and legal entities for their employees’ health protection

1. In accordance with their activities, individual entrepreneurs and legal entities are obliged:

1) to take sanitary-antiepidemic and sanitary-preventive measures;

2) to comply with regulatory legal acts in the field of sanitary-epidemiological welfare of the population, as well as acts of officials exercising state control and supervision in the field of sanitary-epidemiological welfare of the population;

3) to ensure the safety and goof quality of works performed, services provided and products during their production, transportation, storage and sale to the population, disposal and destruction;

4) to perform production control;

5) to promptly inform the state body for the sanitary-epidemiological welfare of the population on emergencies, suspension of production, breakdowns in technological processes that pose a threat to the sanitary-epidemiological welfare of the population, in cases of mass and group infectious and parasitic, occupational diseases and poisoning;

6) to promptly inform the state body for the distribution of medicines and medical products on the identification of side effects of medicines and medical products;

7) to arrange hygienic training for employees belonging to the decreed population group;

8) to provide officials of the state body for the sanitary-epidemiological welfare of the population with the opportunity to take samples of products, raw materials, goods, production environment for laboratory research within their competence;

9) to bar from working persons without a document certifying their medical examination, hygienic training, and also those with infectious, parasitic diseases and carriers of pathogens of infectious, parasitic diseases, persons with contraindications to work in harmful and (or) hazardous working conditions identified by public health entities, except for those infected with HIV;

10) to prohibit the sale of goods, products, raw materials which are found to be inconsistent with regulatory legal acts in the field of sanitary-epidemiological welfare of the population, and also to make a decision on the possibility of their use or disposal;

11) to submit accounting and reporting documentation relating to the sanitary-epidemiological welfare of the population for inspection to the state body for the sanitary-epidemiological welfare of the population;

12) to suspend entrepreneurial and (or) other activities if they pose a threat to the life or health of the population;

13) to ensure unhindered access of officials exercising state control and supervision in the field of sanitary-epidemiological welfare of the population to facilities in order to check their compliance with regulatory legal acts in the field of sanitary-epidemiological welfare of the population;

14) at their own expense, to carry out disinfection, disinsection and deratization according to epidemiological indications and prescriptions, decisions of officials of the state body for the sanitary-epidemiological welfare of the population;

15) to pay deductions and (or) contributions for compulsory social health insurance in accordance with the Law of the Republic of Kazakhstan “On Compulsory Social Health Insurance”.

2. The employer shall create favorable conditions for health promotion and disease prevention among employees.

Article 83. Rights and obligations of kandasses, foreigners, stateless persons and other persons

1. Kandasses, refugees, as well as foreigners and stateless persons permanently residing in the Republic of Kazakhstan, have the right to receive a guaranteed volume of free medical care on an equal basis with citizens of the Republic of Kazakhstan.

2. Foreigners and stateless persons temporarily staying in the Republic of Kazakhstan, asylum seekers have the right to receive a guaranteed volume of free medical care for diseases that pose a danger to others, according to the list and in the amount determined by the authorized body unless otherwise provided for by laws of the Republic of Kazakhstan or international treaties ratified by the Republic of Kazakhstan.

Foreigners and stateless persons identified as victims of human trafficking in the territory of the Republic of Kazakhstan have the right to receive a guaranteed amount of free medical care according to the list and in the amount determined by the authorized body.

3. Kandasses, refugees and asylum seekers, foreigners and stateless persons staying in the Republic of Kazakhstan bear the same responsibilities in the field of healthcare as the citizens of the Republic of Kazakhstan.

Footnote. Article 83 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

Chapter 13. FEATURES OF THE PUBLIC HEALTH PROTECTION

Article 84. Prevention of diseases and formation of a healthy lifestyle

1. The purpose of disease prevention is to prevent the emergence or progression of diseases, as well as their consequences and complications.

2. Disease prevention can be primary, secondary and tertiary.

Primary prevention of diseases (mass and individual) is aimed at creating favorable conditions for life in order to prevent the emergence of diseases.

Secondary prevention of diseases is aimed at preventing the progression of diseases in the early stages and their consequences.

Tertiary prevention of diseases is aimed at controlling the already developed complications, damage to organs and tissues.

3. Preventive and health-improving measures are carried out in relation to all groups of the population throughout life and take into account gender, age, psychological and social aspects.

4. The formation of a healthy lifestyle includes regular exercise, promotion of a healthy lifestyle, healthy nutrition and disease prevention through information support, hygienic education and education of the population in promoting health and preventing diseases associated with a lifestyle.

Physical exercises in organizations are carried out on weekdays.

Standard rules for making physical exercises are developed and approved by the authorized body.

Article 85. Prophylactic immunization

1. Prophylactic immunization is the administration of immunobiologicals to the human body for immunoprophylaxis in order to create a specific immunity to infectious diseases.

2. Prophylactic immunization can be mandatory and voluntary.

3. There are such types of mandatory prophylactic immunization as:

1) planned prophylactic immunization;

2) prophylactic immunization given epidemiological indications.

4. Individuals permanently residing in the Republic of Kazakhstan are subject to mandatory prophylactic immunization against infectious and parasitic diseases.

5. The list of diseases requiring mandatory prophylactic immunization within the guaranteed volume of medical care, the procedure, timing of their implementation and population groups subject to prophylactic immunization are determined by the Government of the Republic of Kazakhstan.

6. Persons who have reached the age specified in the list of diseases requiring mandatory prophylactic immunization and not having medical contraindications are subject to planned prophylactic immunization.

7. Before the prophylactic immunization, a healthcare professional examines a person to be immunized. The healthcare professional provides him/her or his/her legal representative with complete and objective information on prophylactic immunization, possible adverse events and consequences of refusing it.

The list of medical contraindications for prophylactic immunization is approved by the authorized body.

8. Individuals without medical contraindications are subject to prophylactic immunization given epidemiological indications according to the list.

9. Prophylactic immunization not included in the list of diseases requiring mandatory prophylactic immunization is voluntary and is carried out on a paid basis.

10. The procedure for registering and investigating adverse events following immunization is established by the authorized body.

11. Children who have not received routine preventive vaccinations are admitted to preschool institutions only when the threshold level of herd immunity in the preschool institution is achieved.

Herd immunity is indirect protection of unvaccinated persons ensured by achieving the threshold level of coverage with routine preventive vaccinations of the population against vaccine-preventable infections.

The rules for admitting children without routine preventive vaccinations to preschool institutions and the threshold level of herd immunity are determined by the authorized body.

Article 86. Medical examination

1. A medical examination is carried out to ensure a timely medical check-up aimed at identifying and preventing the spread of diseases, including occupational diseases, poisoning, accidents, and also to ensure occupational safety and health protection of employees.

2. The types of medical examinations are mandatory and preventive.

3. Mandatory medical examinations are subdivided into preliminary, periodic, pre-shift (pre-trip), post-shift (post-trip) ones.

Preliminary mandatory medical examinations are carried out when admitting to work or study in order to ascertain the suitability for performing professional duties or study, and also to prevent general, occupational diseases and the spread of infectious and parasitic diseases.

Periodic mandatory medical examinations are carried out in order to ensure dynamic observation of the health status of workers, timely identify initial signs of diseases, and prevent general, occupational diseases and the spread of infectious and parasitic diseases.

Pre-shift (pre-trip) mandatory medical examinations are carried out in order to identify or confirm the presence or absence of a disease in an individual, to determine the state of health, as well as temporary disability, professional suitability for work in the oncoming shift (trip), including the influence of alcohol, drugs or other toxicants, and the residual effects of such intoxication.

Post-shift (post-trip) medical examinations are carried out at the end of a working day (shift, trip) in order to identify signs of the impact of harmful and (or) hazardous production factors of the working environment and the labor process on the health of workers, acute occupational disease or poisoning, signs of alcohol, drug or other toxicants.

4. The list of harmful and (or) hazardous production factors, professions and jobs, the performance of which requires preliminary mandatory medical examinations before the admission to work and periodic mandatory medical examinations, is approved by the authorized body.

5. Employers, at their own expense, arrange for timely pre-shift (pre-trip), post-shift (post-trip) mandatory medical examinations for employees engaged in heavy work, work in harmful and (or) dangerous working conditions, machines and mechanisms in accordance with the legislation of the Republic of Kazakhstan in the field of healthcare.

The decreed group of the population takes mandatory medical examinations at their own expense or at the expense of the employer by agreement of the parties.

6. Target groups of persons subject to mandatory medical examinations, as well as their procedure and frequency, the volume of laboratory and functional tests, medical contraindications are determined by the authorized body.

7. Employers create conditions for employees to take medical examinations and are also obliged, without hindrance, to grant them a paid leave to take them.

8. Employers do not admit to work persons who failed to take mandatory medical examinations and those recognized as unfit for work for health reasons. The results of mandatory medical examinations are entered into personal medical history sheets.

9. The procedure for issuing, recording and maintaining personal medical history sheets is determined by the state body for the sanitary-epidemiological welfare of the population.

10. Preventive medical examinations are carried out among the child population and include a set of medical and other measures aimed at preventing the emergence of diseases and their early diagnosis, followed by dynamic observation and rehabilitation.

11. The rules, volume and frequency of preventive medical examinations of target population groups, including children of preschool, school age, as well as students of technical and vocational, post-secondary and higher educational institutions, are developed and approved by the authorized body.

12. Timeliness, quality of conducting and taking preventive and mandatory medical examinations are controlled by the state body for the sanitary-epidemiological welfare of the population.

Article 87. Screening

1. Screening is carried out among target groups of the population in order to identify diseases in their early stages and prevent the development of diseases, risk factors that contribute to the emergence of diseases, to form and improve public health.

2. Target groups of persons subject to screening shall be screened in the manner, to the extent and as frequently as determined by the authorized body.

3. The screening results are entered into an electronic health passport by public health entities doing the screening.

4. Employers create conditions for persons subject to the screening to have it done within the framework of the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance, and also, without hindrance, grant a paid leave to employees for the screening during working hours in accordance with the labor legislation of the Republic of Kazakhstan.

5. The timeliness and quality of screening are controlled by the state body for medical services (assistance).

Article 88. Dynamic observation

1. Patients with chronic diseases are subject to dynamic observation within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance.

2. The list of chronic diseases subject to dynamic observation is approved by the authorized body.

3. The rules for providing medical services to persons with chronic diseases, the frequency and timing of observation, the mandatory minimum and frequency of diagnostic tests are approved by the authorized body.

Article 89. Temporary disability examination

1. Temporary disability examination is done in order to officially recognize the disability of an individual and his/her temporary release from work duties for the period of illness.

2. The procedure for the examination of temporary disability for work, as well as the issuance of a sheet or certificate of temporary disability for work, shall be established by the authorized body.

Article 90. First aid

1. First aid is a set of basic urgent measures to save a person’s life, prevent complications in emergency conditions, and also to reduce the threat to the health and life of an injured person in an emergency, which are taken at the scene by the victim himself/herself (self-help) or another nearby person (mutual assistance) before healthcare professionals arrive.

First aid can be provided by persons without medical education, including those appropriately trained, in the manner prescribed by the authorized body.

2. Certified trainers for teaching citizens of the Republic of Kazakhstan to acquire first aid skills are trained by public health entities that meet the requirements set by the authorized body.

3. The list of professions with an indication of the contingent of employees who are obliged to take first aid courses, as well as their frequency, are approved by the authorized body jointly with the concerned state bodies.

4. The rules for training citizens of the Republic of Kazakhstan in the first aid skills, as well as the list of emergency and urgent conditions for providing first aid, are developed and approved by the authorized body.

5. Training in the first aid skills is carried out using budgetary funds, employer’s funds or own funds of citizens of the Republic of Kazakhstan.

6. The first aid standard is developed and approved by the authorized body.

Article 91. Preschool and school medicine

1. The activities of preschool and school medicine are aimed at health protection and dynamic observation of the health status of pupils and schoolchildren.

2. Measures to protect the health of pupils and schoolchildren include:

1) preventive medical examinations right in preschool and educational institutions, also with the involvement of mobile teams of specialists;

2) recreational activities during the academic period and holidays;

3) introduction of health-saving technologies in preschool and secondary educational institutions aimed at preventing diseases, introduction and observance of the principles of rational nutrition, protection of reproductive health;

4) protection of mental health, prevention of suicidal behavior and addictions caused by the consumption of tobacco products, non-medical use of psychoactive substances, as well as pathological gambling;

5) referral of schoolchildren for an in-depth medical examination following the results of preventive examinations;

6) immunization according to the National Vaccination Schedule;

7) organization and conduct of training seminars, training courses and lectures on disease prevention, promotion and formation of a healthy lifestyle among schoolchildren, first aid;

8) involvement of parents and teachers in the protection of health of pupils and schoolchildren through educational and awareness-raising activities;

9) compliance with the requirements of sanitary rules;

10) provision of first aid in case of emergency conditions before the arrival of healthcare professionals providing emergency medical assistance.

3. Medical assistance to pupils and schoolchildren is arranged for by public health entities providing primary health services in the territory of location of preschool and secondary (primary, basic secondary, general secondary) educational institutions.

4. The organization of the activities of preschool and school medicine is carried out by local public health authorities.

Article 92. Features of providing reproductive and mental health services to minors aged 10-18 and young people

1. Healthcare entities provide minors aged 10-18 and young people with confidential comprehensive assistance, including medical, psychosocial and legal services.

2. Minors aged 10-18 and young people are accessed to services and means of protection of reproductive and mental health without a referral from primary healthcare specialists.

3. The rules for organizing medical assistance for the protection of the reproductive and mental health of minors aged 10-18 and young people are developed and approved by the authorized body.

Chapter 14. ACTIVITIES IN THE FIELD OF SANITARY-EPIDEMIOLOGICAL WELFARE OF THE POPULATION

Article 93. The system of the sanitary-epidemiological service

The unified system of the state sanitary-epidemiological service includes:

1) the state body for the sanitary-epidemiological welfare of the population and its territorial units;

2) structural units of other state bodies carrying out activities in the field of sanitary-epidemiological welfare of the population;

3) legal entities and individuals carrying out activities in the field of sanitary-epidemiological welfare of the population.

Article 94. State sanitary-epidemiological regulation

1. State sanitary-epidemiological regulation is the activity of the sanitary-epidemiological service, which includes:

1) the development of uniform requirements for the justification of documents of sanitary-epidemiological regulation and control over their development;

2) the development (processing), examination, approval and publication of documents of sanitary-epidemiological regulation;

3) the study, generalization of the practice of application, control over the application of documents of sanitary-epidemiological regulation;

4) the formation and maintenance of a unified data bank of documents of sanitary-epidemiological regulation;

5) the harmonization of documents of sanitary-epidemiological regulation with generally accepted international requirements.

2. The documents of the state system of sanitary-epidemiological regulation are sanitary rules, hygienic standards, technical regulations, unified sanitary-epidemiological and hygienic requirements for goods of the Eurasian Economic Union, instructions, methodological recommendations, guidelines, techniques, orders, rules and standards.

3. The procedure for the development and approval of documents of the state system of sanitary-epidemiological regulation is determined by the state body for the sanitary-epidemiological welfare of the population.

4. Regulatory legal acts in the field of sanitary-epidemiological welfare of the population include sanitary rules, hygienic standards, rules, technical regulations and uniform sanitary-epidemiological and hygienic requirements for goods of the Eurasian Economic Union.

5. When developing and approving regulatory legal acts concerning issues in the field of the sanitary-epidemiological welfare of the population, state bodies are obliged to have them approved by the state body for the sanitary-epidemiological welfare of the population.

6. Regulatory legal acts in the field of sanitary and epidemiological welfare of the population and documents of the state system of sanitary and epidemiological regulation, containing requirements for handling of pathogenic biological agents are developed and applied taking into account the requirements in the field of biological safety.

Footnote. Article 94 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 95. Sanitary-epidemiological requirements

1. Sanitary rules set sanitary-epidemiological requirements for facilities that are subject to state control and supervision in the field of sanitary-epidemiological welfare of the population and contain requirements for:

1) the choice of a land plot for the construction of a facility;

2) the design, construction of new facilities, reconstruction, re-equipment, redevelopment and expansion of existing facilities, repair and commissioning of facilities;

3) the maintenance and operation of industrial, public, residential and other premises, buildings, structures, equipment, vehicles;

4) water supply, sewerage, heat supply, lighting, ventilation, air conditioning of facilities;

5) the acceptance, storage, processing of raw materials;

6) the conditions of production, packaging, transportation, storage, sale, disposal of food products, disposal of tobacco products;

7) the conditions for the production, packaging, transportation, storage, sale, disposal and destruction of immunologic agents (immunobiologicals);

8) application and use of potentially dangerous chemical and biological substances (including toxic, radioactive, biological and chemical substances, poisons and toxic substances, biological and microbiological organisms and their toxins, biological agents and materials), their disposal (destruction), transportation, storage, burial and working conditions with them;

9) the conditions of handling sources of physical factors that affect a person;

10) the conditions for the industrial production of medicines;

11) industrial-technical products;

12) household-hygienic goods and technologies for their production, utilization and destruction;

13) the conditions of upbringing, training, living and industrial practice, physical development, work, rest, food, water supply and medical services for various groups of the population;

14) teaching-work load and the mode of training in educational institutions;

15) the conditions for sterilization and disinfection of medical products;

16) arranging for specialized (children’s, dietary therapeutic and dietary preventive), therapeutic and prophylactic, public catering of the population;

17) water sources (places of water intake for household and drinking purposes), household and drinking water supply, and places of cultural and household water use, and safety of water bodies;

18) the collection, use, application, neutralization, transportation, storage and disposal of production and consumption waste;

19) the organization and implementation of works and services, including the development, testing, manufacturing, production, storage, transportation, sale, use of disinfectants, disinsection and deratization agents, equipment, materials, maintenance and operation of objects of disinfection activities, as well as monitoring the effectiveness and safety of works and services;

20) the conditions of passenger transportation;

21) the liquidation, temporary closing-down, conversion of facilities;

22) the implementation of production control;

23) the conditions of labor, consumer services, medical support, specialized dietary therapeutic and dietary preventive nutrition;

24) hygienic education and training of the population;

25) the organization and conduct of sanitary-antiepidemic and sanitary-preventive measures, including the implementation of sanitary protection of the Republic of Kazakhstan, the introduction of restrictive measures, including quarantine, in relation to patients with infectious and parasitic diseases, medical examinations, preventive vaccinations of the population;

26) zones of sanitary protection and buffer zones, roadside clear zones;

27) optimal noise levels at workplaces, permissible noise levels in residential and public buildings and in the area of residential development;

28) the organization and conduct of the population’s immunization, the investigation of cases of adverse events following immunization;

29) the organization and implementation of disinfection, disinsection and deratization in natural foci of infectious diseases, as well as in foci of infectious diseases.

2. Hygienic standards set standards for maximum permissible concentrations of harmful (chemical, biological) substances, physical effects, permissible levels of radiation exposure, the observance of which ensures favorable living and safe-health conditions for humans.

3. Hygienic standards are set for:

1) microclimate, air exchange, workplace air, physical factors of industrial, residential and other premises, industrial areas;

2) radiation, chemical, microbiological, toxicological, parasitological safety of products (goods) and the environment;

3) atmospheric air in urban and rural settlements, in the premises of industrial facilities;

4) physical factors, maximum permissible emissions and maximum permissible discharges of harmful substances into the environment;

5) new types of products, technological equipment, processes.

Footnote. Article 95 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 95-1. Collections of pathogenic and industrial microorganisms

Collection, identification, study, registration, certification, storage (deposit) and maintenance of national and working collections of pathogenic and industrial microorganisms used in the field of sanitary and epidemiological welfare of the population are carried out taking into account the legislation of the Republic of Kazakhstan in the field of biological safety.

Footnote. Chapter 14 is supplemented by Article 95-1 in accordance with the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Chapter 15. PREVENTION OF INFECTIOUS AND NON-COMMUNICABLE DISEASES

Clause 1. Prevention of infectious diseases

Article 96. Hygienic training of the population

1. Hygienic training for the decreed population group is the training in the prevention of infectious and parasitic, occupational diseases, regulatory legal acts in the field of the sanitary-epidemiological welfare of the population (maintenance, operation and placement of facilities, personal and public hygiene) in accordance with the professions of students.

The list of the decreed population group subject to hygienic training is determined by the state body for the sanitary-epidemiological welfare of the population.

2. Hygienic training is paid for by the decreed persons independently or by their employers by agreement of the parties.

3. Control over the quality of hygienic training for the decreed population group is carried out by the bodies of the state sanitary-epidemiological service by way of:

1) monitoring notices of commencement and termination of business;

2) checking the compliance with the hygiene training procedure and program;

3) checking the knowledge of persons belonging to the decreed group during inspections, preventive control.

Article 97. Requirements for persons carrying out hygienic-training activities

1. Activities on hygienic training of decreed groups of the population are carried out by individuals or representatives of legal entities with higher education in sanitary-hygienic (medical-preventive) specialty.

2. Individuals and legal entities, before and after the termination of hygienic training activities, are obliged to notify the territorial unit of the state body for the sanitary-epidemiological welfare of the population in accordance with the procedure established by the Law of the Republic of Kazakhstan “On Permits and Notifications”.

3. Persons carrying out hygienic-training activities shall:

1) ensure high-quality training;

2) comply with regulatory legal acts in the field of sanitary-epidemiological welfare of the population;

3) conduct training on the basis of documents of state sanitary-epidemiological regulation in accordance with training programs corresponding to the professions of decreed population groups;

4) comply with the hygienic training procedure;

5) not allow joint hygienic training of various decreed population groups.

Article 98. Prevention of tuberculosis

1. Measures for the prevention of tuberculosis are carried out by:

1) conducting epidemiological surveillance of the prevalence of tuberculosis among the population;

2) specific prophylaxis, including vaccination according to the National Vaccination Schedule;

3) early identification of tuberculosis;

4) treating active tuberculosis and latent tuberculosis infection;

5) taking a set of infection control measures aimed at preventing the transmission of the tuberculosis pathogen through the ambient air in the habitable environment;

6) social prevention, i.e. improving the living conditions of the population and the quality of food; combating non-medical use of psychoactive substances, smoking; instilling in the population the skills of personal hygiene in everyday life; promotion of physical culture and sports;

7) informing the population through the mass media on the tuberculosis epidemic and preventive measures;

8) developing and disseminating information materials on the prevention of tuberculosis for various groups of the population, also through social networks and the media;

9) placing and implementing state social grants and state social orders through non-governmental organizations.

2. Measures for the tuberculosis prevention are taken in the manner prescribed by the authorized body.

Article 99. Prevention of HIV infection

1. Measures to prevent HIV infection are taken by:

1) conducting epidemiological monitoring of the prevalence of HIV infection among the population, including key population groups;

2) informing various groups of the population on HIV infection through information materials, social networks and the media;

3) integrating HIV prevention issues into the education system and workplaces;

4) providing key population groups with treatment and prophylactic services in trust points, friendly offices.

A friendly office is a specially organized point for the provision of preventive, therapeutic and diagnostic assistance in case of sexually transmitted infections to HIV-infected people and key population groups on a free basis following the principles of voluntariness and confidentiality;

5) placing and implementing state social grants and state social orders through non-governmental organizations;

6) ensuring the infectious safety of donation and transplantation, as well as when providing the population with services related to the violation of the integrity of the skin and mucous membranes;

7) preventing transmission of HIV infection from a mother to her fetus and child;

8) providing pre-exposure and post-exposure prophylaxis;

9) providing antiretroviral therapy to reduce the risk of HIV transmission from the time of its diagnosing.

2. Measures to prevent HIV infection are taken in the manner prescribed by the authorized body.

Article 100. Medical waste management

1. Medical waste is a type of production and consumption waste generated during the provision of medical services and medical procedures.

2. According to the level of hazard, medical waste is divided into 5 hazard classes:

1) class A - non-hazardous medical waste, similar to solid household waste;

2) class B - (epidemiologically) hazardous medical waste;

3) class C - extremely (epidemiologically) hazardous medical waste;

4) class D - toxicologically hazardous medical waste, the composition of which is close to industrial waste;

5) class E - radioactive medical waste.

Medical waste of classes B - E is hazardous.

3. Sanitary-epidemiological requirements for the collection, transportation, storage, neutralization, use of medical waste are determined by the sanitary rules approved by the state body for the sanitary-epidemiological welfare of the population.

4. In accordance with the environmental legislation of the Republic of Kazakhstan, waste owners provide the authorized body for environmental protection with information in the form of an annual report in the field of medical waste management (hereinafter referred to as the report) for entering it into the State cadaster of production and consumption waste.

5. Information on medical waste is provided on an annual basis as of January 1, on or before March 1 of a year following a reporting year, in electronic and (or) paper-based form.

6. Waste owners ensure the completeness, continuity and reliability of these reports.

7. The procedure for providing information on medical waste is determined by the state body for the sanitary-epidemiological welfare of the population.

Article 101. Requirements for persons engaged in the collection, transportation, storage, neutralization, burial and (or) use of medical waste

1. Activities on the collection, transportation, storage, neutralization, use of medical waste are carried out by individuals and legal entities.

2. Individuals and legal entities carrying out activities on the collection, transportation, storage, neutralization, disposal and use of medical waste, prior to the commencement of activities, shall obtain permits in the manner prescribed by the legislation of the Republic of Kazakhstan on permits and notifications.

3. Qualification requirements for individuals and legal entities engaged in the collection, transportation, storage, neutralization, burial and use of medical waste are established by the state body for the sanitary-epidemiological welfare of the population.

Article 102. Sanitary-antiepidemic, sanitary-preventive measures

1. In order to prevent the emergence and spread of infectious and parasitic diseases, poisoning of the population, it is necessary to take sanitary-antiepidemic, sanitary-preventive measures, including sanitary protection of the territory of the Republic of Kazakhstan, the introduction of restrictive measures, including quarantine, in relation to persons with infectious and parasitic diseases, for medical examinations, preventive vaccinations, hygienic training of persons belonging to the decreed group of the population, and persons employed in heavy work, work in harmful and (or) dangerous working conditions.

2. Sanitary-antiepidemic, sanitary-preventive measures shall be included in the documents of the State Planning System of the Republic of Kazakhstan under development.

3. Persons with infectious and parasitic diseases, as well as those with suspected infectious and parasitic diseases, bacteria carriers are subject to isolation and (or) treatment, and persons who were in contact with them - to medical supervision and, if necessary, isolation and (or) treatment.

4. Persons with chronic infectious and parasitic diseases (except for those with HIV infection), chronic bacteria carriers posing a danger to others are subject to temporary suspension from work in accordance with the labor legislation of the Republic of Kazakhstan.

Article 103. Sanitary protection of the territory of the Republic of Kazakhstan

1. Sanitary-quarantine control at checkpoints (sanitary-quarantine points) across the State Border of the Republic of Kazakhstan is conducted by territorial units of the state body for the sanitary-epidemiological welfare of the population.

2. It is not allowed to import dangerous cargo and goods, the import of which is prohibited, into the territory of the Republic of Kazakhstan, as well as cargo and goods, which, during the sanitary-quarantine supervision, were found as able to create a threat of the emergence and spread of infectious diseases or mass non-communicable diseases and poisoning in case of their import into the Republic of Kazakhstan.

3. Radiological control over cargo and goods, passengers at checkpoints across the State Border of the Republic of Kazakhstan is carried out by the state revenue authorities of the Republic of Kazakhstan.

Article 104. Conditions for introducing restrictive measures, including quarantine, in the event of a threat of epidemics, infectious diseases

1. In the event of a threat of import of infectious and parasitic diseases into the Republic of Kazakhstan and (or) their spread throughout the entire territory of the Republic of Kazakhstan, the Chief State Sanitary Doctor of the Republic of Kazakhstan introduces restrictive measures, including quarantine, at checkpoints at the State Border of the Republic of Kazakhstan, which coincides with the customs border of the Eurasian Economic Union, or throughout the territory of the Republic of Kazakhstan with special conditions for entrepreneurial and (or) other activities and life of the population.

2. In the event of a threat of the spread of infectious and parasitic diseases in corresponding administrative-territorial units (at individual facilities), the chief state sanitary doctors introduce restrictive measures, including quarantine, in corresponding administrative-territorial units (at individual facilities) with special conditions for entrepreneurial and (or) other activities and life of the population.

3. Restrictive measures, including quarantine, are introduced (canceled) by a resolution of the Chief State Sanitary Doctor of the Republic of Kazakhstan or the chief state sanitary doctor of a corresponding administrative-territorial unit (in the field of transport), as well as at departmental facilities of other state bodies by decision of the chief state sanitary doctor of structural units of the state body for the sanitary-epidemiological welfare of the population.

The decision of the chief state sanitary doctor is subject to publication (dissemination) in the media and to mandatory execution.

4. Operational management of activities of central and local executive bodies, individuals and legal entities in cases of imposition of restrictive measures, including quarantine, is assigned to the interdepartmental state commission for the prevention and elimination of emergency situations and territorial commissions for emergency situations.

5. The procedure for the implementation of restrictive measures, including quarantine, and the list of infectious diseases, the threat of the emergence and spread of which requires the introduction of restrictive measures, including quarantine, are established by the state body for the sanitary-epidemiological welfare of the population.

6. Restrictive measures, including quarantine, are introduced depending on territorial characteristics, contagiousness, transmission routes, mortality and other epidemically significant factors in the spread of infectious diseases in accordance with the criteria for determining the risks of importing infectious diseases from abroad into the territory of the Republic of Kazakhstan and (or) the occurrence of cases of infectious diseases identified by the authorized body.

6-1. In order to ensure compliance with restrictive measures, including quarantine, monitoring groups may be created by local executive bodies in the relevant administrative-territorial units.

Information about the established monitoring groups, composition and powers, as well as the algorithm of the monitoring group's actions shall be posted in the media and on the websites of local executive bodies.

The activities of such groups shall be carried out by monitoring the observance by individuals and legal entities of public order, sanitary and anti-epidemic, sanitary and preventive and restrictive measures, including quarantine, related to the prevention of the threat of the spread of infectious diseases.

Monitoring is an audit and shall not apply to other forms of state control and supervision.

To conduct monitoring, these groups shall carry out preliminary registration on the information resource in order to receive an act on the appointment of monitoring in electronic form, presented when visiting the facility.

Monitoring groups shall have the right to collect photo and video information indicating signs of violation of the decision of the Chief State Sanitary Doctor of the Republic of Kazakhstan and regulatory legal acts in the field of sanitary and epidemiological welfare of the population related to the prevention of the threat of the spread of infection, for its subsequent sending to a state body in the field of sanitary and epidemiological welfare of the population in the manner prescribed by the legislation of the Republic of Kazakhstan, without interfering in the work of business entities and without creating obstacles in the implementation of legitimate business activities.

The competence of monitoring groups shall not include the initiation of cases on administrative offenses.

If during the period of introduction of restrictive measures, including quarantine, as part of the monitoring group, a representative of a state body in the field of sanitary and epidemiological welfare of the population, in accordance with the procedure for creating monitoring groups and conducting monitoring, the monitoring group shall have the right to suppress violations of the conditions of restrictive measures, including quarantine, on the spot up to the suspension of the activities of business entities. In this case, the initiation of cases of administrative offenses shall be carried out directly by the representative of the state body in the field of sanitary and epidemiological welfare of the population.

Monitoring groups shall carry out their activities within the framework of regulatory legal acts in the field of sanitary and epidemiological welfare of the population and resolutions of the Chief Public Health Officer of the Republic of Kazakhstan related to the prevention of the threat of the spread of infection.

Based on the results of monitoring a business entity, in the event of violations of the requirements of the legislation of the Republic of Kazakhstan in the field of sanitary and epidemiological welfare of the population related to the prevention of the threat of the spread of infection, an official of the state body in the field of sanitary and epidemiological welfare of the population shall issue a resolution on conducting sanitary and anti-epidemic and sanitary and preventive measures. events.

The procedure for creating monitoring groups and conducting monitoring shall be determined by the state body in the field of sanitary and epidemiological welfare of the population.

When carrying out the activities of monitoring groups, business entities shall have the right to protect their rights and legitimate interests, including the inviolability of property, in accordance with the Entrepreneurial Code and the legislation of the Republic of Kazakhstan.

7. Restrictive measures, including quarantine, include:

1) restriction of entry into the territory of the Republic of Kazakhstan from abroad (exit from the territory of the Republic of Kazakhstan) and movement in certain regions (oblasts, cities of republican significance and the capital) using vehicles (by air, rail, road);

2) restriction of operation of facilities of entrepreneurial and (or) other activities;

3) restriction of the organization and holding of peaceful assemblies, entertainment, sports, religious and other mass events, as well as family rituals associated with birth, wedding, death;

4) restriction of production, import, export, use and sale of products intended for use and application by the population, as well as in entrepreneurial and (or) other activities, in the territory of the Republic of Kazakhstan;

5) carrying out non-contact thermometry measurement, laboratory examination and, if necessary, isolation of persons, arriving from countries with unfavorable infectious situation, at checkpoints at the State Border of the Republic of Kazakhstan;

6) referral of patients with infectious diseases for laboratory examination, isolation and hospitalization (or isolation at home), medical supervision, treatment;

7) referral of persons who are potential sources of the spread of infectious diseases, persons who have been in contact with infectious patients, as well as persons with suspected infectious disease, for laboratory and medical examination and isolation;

8) measures for personal and collective prevention of infectious diseases;

9) preventive and focal disinfection, disinsection and deratization measures in premises and vehicles, territories, foci of infectious diseases.

Footnote. Article 104 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced upon expiry of ten calendar days after the date of its first official publication).

Article 105. Registration and investigation of cases of infectious, parasitic diseases and (or) poisoning

1. All cases of infectious and parasitic diseases and (or) poisoning, adverse events following immunization are subject to registration by public health entities at the place of their identification, state registration and reporting by state bodies and organizations of the sanitary-epidemiological service.

2. Cases of infectious and parasitic diseases and (or) poisoning of the population are subject to investigation by specialists of the state body for the sanitary-epidemiological welfare of the population.

3. The registration and investigation, recording and reporting of cases of infectious, parasitic diseases and (or) poisoning, adverse events following immunization are carried out in the manner prescribed by the authorized body.

4. Cases of HIV infection among the population are investigated by specialists of public health entities carrying out activities in the field of HIV prevention in the manner prescribed by the authorized body.

5. Within seven calendar days of receipt of an emergency notification, the state body for the sanitary-epidemiological welfare of the population, structural units of other state bodies carrying out activities in the field of sanitary-epidemiological welfare of the population conduct an epidemiological investigation of cases of infectious and parasitic diseases and (or) poisoning of the population.

6. In the case of registration of quarantine and especially dangerous diseases in troops, units and departmental organizations, the timing of epidemiological investigations approved by the authorized body may be changed by decision of the chief state sanitary doctors of other state bodies operating in the field of sanitary-epidemiological welfare of the population, depending on the place of registration.

Article 106. Registration and investigation of cases of occupational diseases and (or) poisoning

1. All cases of occupational diseases and (or) poisoning, including suspicions of occupational diseases and (or) poisoning caused by exposure of an employee to harmful production factors in connection with the employee’s performance of his/her work (official) duties or other actions on his/her own initiative in the interests of the employer, are subject to registration by public health entities at the place of their identification in the manner prescribed by the authorized body.

2. Cases of occupational diseases and (or) poisoning are subject to registration with state healthcare organizations that provide specialized medical assistance in the field of occupational pathology and expertise, and to state registration and reporting by state bodies and organizations of the sanitary-epidemiological service.

3. Cases of occupational diseases and (or) poisoning caused by exposure of an employee to harmful production factors in connection with the employee’s performance of his/her work (official) duties or other actions on his/her own initiative in the interests of the employer are subject to investigation.

4. Immediately, within 24 hours, the employer notifies the state body for the sanitary-epidemiological welfare of the population about all cases of occupational diseases and (or) poisoning associated with the employee’s performance of his/her work (official) duties or other actions on his/her own initiative in the interests of the employer in accordance with the form established by the authorized state body for labor.

5. The employer is responsible for organizing the investigation of occupational diseases and (or) poisoning at work.

6. The employer ensures free access to officials of the state body for the sanitary-epidemiological welfare of the population for investigating cases of occupational diseases and (or) poisoning.

7. The organization of investigation of cases of occupational diseases and (or) poisoning, which occurred to seconded employees, is assigned to a legal entity to which the employee was seconded, with the participation of the employer’s representative.

8. To resolve issues requiring an expert opinion, specialists from research organizations and (or) healthcare organizations providing specialized medical assistance in the field of occupational pathology and expertise are involved in the work of the commission for investigating occupational diseases and (or) poisoning, at the expense of the employer.

9. The investigation of circumstances and causes of the emergence of a chronic occupational disease and (or) poisoning in persons who, at the time of investigation, have no contact with a harmful production factor that caused this occupational disease, including nonworkers, is carried out at the place of previous work with a harmful production factor, taking into account the responsibility of all employers in proportion to the length of service in harmful conditions with each employer.

10. The conditions for investigating occupational diseases and (or) poisoning associated with work at high-security facilities are determined with account of features of access thereto.

Article 107. Disinfection, disinsection and deratization

1. In order to prevent the emergence, spread of infectious and parasitic diseases, individuals and legal entities are obliged, at their own expense, on a regular basis in accordance with the documents of the state sanitary-epidemiological regulation, to take preventive measures, and also disinfection, disinsection and deratization measures given epidemiological indications.

2. In the event of epidemic emergencies, by decision of the local executive body of a region, a city of republican significance and the capital, upon a recommendation of the state body for the sanitary-epidemiological welfare of the population, it is necessary to take extraordinary mandatory disinfection, disinsection or deratization measures using budgetary funds.

3. Preventive measures of disinsection and deratization (except for disinsection and deratization in natural foci of infectious diseases, as well as in foci of infectious diseases) are carried out by local executive bodies of regions, cities of republican significance, the capital, district, cities of regional significance.

4. Focal disinfection, disinsection, deratization measures in foci of infectious and parasitic diseases of humans and natural foci of infectious and parasitic diseases are carried out by organizations of the sanitary-epidemiological service and medical facilities in order to prevent and (or) eliminate infectious and parasitic diseases.

Clause 2. Prevention of non-communicable diseases

Article 108. Prevention of non-communicable diseases, including occupational diseases, and injuries

1. The prevention of non-communicable diseases, including occupational ones, includes:

1) the prevention of behavioral risk factors for diseases and raising public awareness by:

promoting a healthy lifestyle and healthy diet;

informing the population through the mass media together with introducing training programs on disease prevention;

2) introduction of programs for the management of chronic non-communicable diseases;

3) the monitoring of risk factors for diseases of the registered population by primary healthcare specialists, monitoring of occupational diseases with temporary disability of workers - by specialists of state bodies carrying out activities in the field of sanitary-epidemiological welfare of the population;

4) minimization of the impact of work-related risk factors for diseases and control of health risks due to the impact of work-related harmful and (or) hazardous factors, taking into account their assessment by state bodies within their powers, other bodies and organizations, as well as individual entrepreneurs;

5) identification of persons with chronic non-communicable diseases, including occupational ones, by conducting screening, preventive medical examinations of the population, and motivating early presentation;

6) dynamic observation and timely rehabilitation of persons with chronic diseases, also occupational ones, including outpatient drug provision of certain categories of citizens of the Republic of Kazakhstan, medical rehabilitation;

7) temporary transfer to lighter work for health reasons for the period specified in the medical report in the manner prescribed by the authorized body.

2. Injuries and occupational diseases shall be prevented at the intersectoral level by state bodies within their powers, by individuals and legal entities.

3. An organization’s healthcare professional is obliged to:

1) have knowledge of occupational health, occupational diseases associated with professional activities and working conditions of employees;

2) analyze the incidence of temporary disability;

3) provide a medical facility, carrying out mandatory medical examinations, with the description of the professional activity and working conditions of employees subject to mandatory preliminary and periodic medical examinations.

Article 109. Prevention of addiction to psychoactive substances

1. The prevention of addiction to psychoactive substances includes:

1) the promotion of knowledge of the harm caused by psychoactive substances, and also of medical-social and legal aspects of their use;

2) the prohibition to promote narcotic drugs, psychotropic substances and their analogues, including information on the techniques, methods of development, manufacture and use, places of their acquisition, production and distribution;

3) the prohibition of advertising of narcotic drugs, psychotropic substances and their analogues included in the list of narcotic drugs, psychotropic substances and precursors subject to control in the Republic of Kazakhstan, except for specialized printed publications designed for healthcare professionals and pharmaceutical workers, including distribution for advertising purposes of samples of medicinal products containing narcotic drugs or psychotropic substances;

4) voluntary anonymous treatment of persons addicted to psychoactive substances;

5) voluntary medical-social rehabilitation of drug addicts.

2. The prevention of addiction to psychoactive substances is carried out by all individuals and legal entities within their rights.

Article 110. Prevention and control of consumption of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids, and alcohol

1. The prevention and control of consumption of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, heating tobacco systems, electronic delivery systems and e-liquids, as well as alcohol, are aimed at protecting public health from the consequences of their consumption and preventing the emergence of addiction, including that caused by new types of systems of nicotine delivery and tobacco consumption, heating tobacco systems, electronic delivery systems, hookah, introducing an age requirement for persons entitled to purchase tobacco products, forming public attitudes towards the consumption of tobacco products and alcohol as high risk factors for life and health, taking concerted action to prevent the spread of alcohol and tobacco consumption in accordance with international obligations.

2. It is prohibited to sell tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids:

1) to persons under the age of twenty-one;

2) by persons under the age of eighteen;

3) from open packs of tobacco products or to sell tobacco products by the piece;

4) without direct participation of a seller using vending machines, other electronic or mechanical devices;

5) in buildings and premises of healthcare organizations, educational institutions, health and fitness, sports and sports-technical facilities, stadiums;

6) without relevant documents confirming the products’ quality;

7) without means of identification applied to the pack of tobacco products;

8) if there are less than twenty cigarettes in a pack of tobacco products;

9) without information on a pack of tobacco products, package of a tobacco product on at least three harmful compounds - systemic poisons, carcinogenic and mutagenic substances, which shall be placed on a pack of tobacco products, package of a tobacco product;

10) without warnings about harm caused by the consumption of tobacco products and nicotine on a pack of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, heating tobacco systems;

11) without an inscription prohibiting the sale to persons under the age of twenty-one and persons under the age of eighteen on a pack of tobacco products, consumer package, including heated tobacco products, hookah tobacco, hookah mix, heating tobacco systems, electronic delivery systems and e-liquids;

12) which contain information directly or indirectly misleading the consumer, including such words as “low-tar”, “light”, “ultra-light”, “mild”, “extra”, “ultra” or others phrases, also in foreign languages, any terms, descriptions, signs, symbols or other designations that create a false impression about lesser harm of certain products and (or) methods of consumption in comparison with other products and (or) methods of consumption, and also evoking associations with foods (food additives), including fruits, berries, confectionery;

13) as part of sets with other goods;

14) from self-service shelves;

15) in the premises of trade organizations delling children’s goods;

16) with the display and open demonstration of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, heating tobacco systems, electronic delivery systems and e-liquids. In case of retail trade, information on tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids is brought to the attention of buyers by posting a list of products sold, the text of which is typed in same-size black letters on a white background, the size of not more than 40x30 centimeters per a sales place and compiled in alphabetical order, indicating the price of saleable tobacco products, without any graphic images and drawings. Tobacco products, including heated tobacco products, hookah tobacco, hookah mix, heating tobacco systems, electronic delivery systems and e-liquids can be presented to the buyer in a shopping facility at his/her request after reviewing the list of saleable tobacco products, electronic delivery systems and e-liquids;

17) in the premises of and inside (except for duty-free trade) railway stations, bus stations, airports, seaports, river ports, at underground stations intended for providing passenger transportation services, in the premises intended for providing housing and hotel services, services for temporary accommodation and (or) temporary residence, consumer services.

3. In places where tobacco products are sold, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids, the following inscription shall be placed in a conspicuous place: “The sale of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids is prohibited to persons under the age of twenty-one”, as well as a warning about the harm caused by smoking, which shall be approved by the authorized body.

4. Persons selling tobacco products, including products with heated tobacco, hookah tobacco, hookah mixture, tobacco heating systems, electronic consumption systems and liquids for them, in case of doubt that the buyer is twenty-one years old, shall be obliged:

1) require to present an identity document;

2) refuse to sell tobacco products, including products with heated tobacco, hookah tobacco, hookah mixture, tobacco heating systems, electronic consumption systems and liquids for them, in the event that an identity document has not been presented.

5. The consumption of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids, is prohibited:

1) inside and in the premises of educational institutions, and also in organizations for the recreation of minors;

2) in the premises of healthcare organizations;

3) in public catering facilities;

4) in cultural facilities, museums, libraries and lecture halls, cinemas, theaters, circuses, concert, viewing and exhibition halls, sports organizations and health-fitness organizations, in sports arenas and other facilities intended for public recreation;

5) in night clubs, discos;

6) on local and long-distance trains, on aircraft, sea and river vessels, as well as inside urban, suburban and intercity road public transport, in the underground, in public transport performing regular and irregular road transportation of passengers and luggage, taxis;

7) in the buildings of airports, railway, automobile and water stations, at public bus shelters;

8) in the buildings of state bodies and organizations;

9) in the premises that are workplaces and work areas;

10) in the entrances of houses;

11) inside and in the premises of gas stations;

12) in playgrounds;

13) in underpasses;

14) inside a motor vehicle with minors.

6. The provisions of subparagraphs 3) and 7) of paragraph 5 of this article shall not apply given specially equipped places for the consumption of tobacco products, including heated tobacco products, heating tobacco systems, electronic delivery systems and e-liquids.

7. Places allocated specifically for the consumption of tobacco products, including heated tobacco products, heating tobacco systems, electronic delivery systems and e-liquids, shall be equipped in accordance with the requirements established by the state body for the sanitary-epidemiological welfare of the population.

8. It is prohibited to import, manufacture, sell and distribute smoking tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, electronic delivery systems and e-liquids, with exceeded maximum permissible levels of nicotine and tar substances determined by the state body for the sanitary-epidemiological welfare of the population, and also tobacco products for which sanitary-epidemiological requirements have not been established.

9. The import, manufacture, sale and distribution of smokeless tobacco products are prohibited.

10. The manufacture, sale and distribution of imitation tobacco products are prohibited.

11. There shall be signs prohibiting the consumption of tobacco products, including heated tobacco products, heating tobacco systems, electronic delivery systems and e-liquids, indicating the amount of a fine, in places, and also at the entrance, where their consumption is prohibited.

12. A pack of a smoking tobacco product, package of a smoking tobacco product shall have a warning about harm caused by the consumption of tobacco products in accordance with the requirements approved by the Technical Regulations for tobacco products of the Eurasian Economic Union.

The consumer package of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, shall have a warning about harm caused by the consumption of tobacco and nicotine, which shall meet the following requirements:

1) it shall occupy at least sixty-five percent of each larger side of a pack of tobacco products, package of tobacco products, including heated tobacco products, hookah tobacco, hookah mix;

2) it may not be printed on clear wrap or any other outer wrapping material;

3) it shall be executed in the form of color drawings (pictograms, graphics) or photographic images, including text.

The text of the warning about the dangers of using tobacco products must comply with the requirements of the Law of the Republic of Kazakhstan “On languages in the Republic of Kazakhstan”.

Sketches of warnings about harm caused by the consumption of tobacco products and nicotine are approved by the authorized body.

A manufacturer, an importer shall put the sketches of warnings on a consumer package of tobacco products in accordance with the sketches within twelve months of their approval.

The sketches of warnings are put on the equal number of consumer packages of tobacco products, including heated tobacco products, hookah tobacco, hookah mix.

13. Annually, by February 1 of a year following a reporting period, a manufacturer, importer of tobacco products, including heated tobacco products, electronic delivery systems and e-liquids, shall submit reports on the results of laboratory tests on the maximum permissible nicotine content in all brands of tobacco and tobacco products, including heated tobacco products, electronic delivery systems and e-liquids, in the manner approved by the authorized body.

14. Research on the level of nicotine and other harmful compounds, carcinogenic and mutagenic substances in tobacco products, including heated tobacco products, hookah tobacco, hookah mix, electronic delivery systems and e-liquids, is carried out by the manufacturer, importer of tobacco products, including heated tobacco products, hookah tobacco, hookah mix, electronic delivery systems and e-liquids, at their own expense in laboratories accredited as required by the legislation of the Republic of Kazakhstan.

15. It is prohibited to sell by retail:

1) alcoholic beverages to persons under the age of twenty-one;

2) alcoholic beverages, except for sales in restaurants, bars and cafes:

between 23.00 and 08.00;

with a volume fraction of ethyl alcohol over thirty percent - between 21:00 and 12:00;

3) in other cases provided for by the laws of the Republic of Kazakhstan.

16. It shall be prohibited to sponsor and advertise tobacco, tobacco products, advertising of alcoholic products, products imitating alcoholic beverages.

Individuals and legal entities engaged in the import, manufacture, sale and distribution of tobacco are allowed to provide charitable assistance in the manner prescribed by the legislation of the Republic of Kazakhstan.

17. Minors are prohibited from using alcoholic beverages, tobacco and tobacco products, including heated tobacco products, hookah tobacco, hookah mix, tobacco heating systems, as well as electronic delivery systems and e-liquids.

Parents and other legal representatives of minors bear administrative responsibility for the consumption of alcoholic beverages by minors in accordance with the laws of the Republic of Kazakhstan.

18. When selling alcoholic products, persons engaged in the sale of alcoholic products, in case of doubt that the buyer has reached the age of twenty-one, shall be obliged:

1) require to present an identity document;

2) refuse to sell alcoholic products if an identity document has not been presented.

Footnote. Article 110 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication ): dated 29.12.2021 No. 94-VII (shall be enforced upon expiry of ten calendar days after the date of its first official publication); dated 31.12.2021 No. 100 (shall be enforced from 01.01.2022).

Article 111. Prevention of iron deficiency anemia

1. Iron deficiency anemia is a pathological process of the body caused by insufficient intake of iron in the body with food, absorption of iron in the body and an increase in iron loss in some chronic diseases of the gastrointestinal tract, genitourinary system and blood system, increased need for iron.

2. Measures for the iron deficiency prevention are carried out based on the principles of:

1) responsibility of state bodies, individuals and legal entities for ensuring and complying with the requirements for the production, import, export, sale of fortified foods and their movement at other stages of the distribution in the Republic of Kazakhstan;

2) prophylactic provision of target population groups with ferriferous medicines;

3) enrichment (fortification) of flour and other foods with ferriferous vitamins, minerals and other substances.

3. High-grade and first-grade wheat flour sold (distributed) in the Republic of Kazakhstan is subject to enrichment (fortification) with ferriferous vitamins, minerals and other substances.

The procedure for enrichment (fortification) and market distribution of foods subject to mandatory fortification is determined by the state body for the sanitary-epidemiological welfare of the population.

Article 112. Prevention of iodine deficiency disorders

1. Iodine deficiency disorders are a pathological condition of the body caused by dysfunction of the thyroid gland associated with insufficient intake of iodine in the body.

2. The prevention of iodine deficiency disorders is a system of measures to prevent iodine deficiency disorders aimed at:

1) the protection of public health;

2) carrying out coordinated measures for the prevention of iodine deficiency disorders in the Republic of Kazakhstan;

3) the development of production and sale of foods enriched with iodine compounds.

3. Measures for the prevention of iodine deficiency disorders are carried out based on the principles of responsibility of state bodies, individuals and legal entities for ensuring and complying with the requirements for the production, import, export, sale of iodized edible and fodder salt in the Republic of Kazakhstan.

4. The requirements for the production, distribution and safety of salt are as follows:

1) edible and fodder salt imported, produced and (or) sold in the Republic of Kazakhstan shall be iodized, except for salt intended for:

persons with contraindications to the use of iodized salt;

production of certain types of foods produced using non-iodized salt.

The procedure for the import, production and sale of non-iodized edible salt is determined by the state body for the sanitary-epidemiological welfare of the population;

2) the iodine level in salt, its quality, safety, iodization methods, the process of re-iodization in case of a decrease in the iodine level shall comply with regulatory legal acts in the field of sanitary-epidemiological welfare of the population;

3) the production, import, and also sale of non-iodized salt in the Republic of Kazakhstan is prohibited, except for the cases specified in items two and three of subparagraph 1) of paragraph 4 of this article;

4) the production, import, export and (or) sale of fake salt is prohibited.

5. The requirements for iodized edible salt are as follows:

1) iodized edible salt intended for sale in the Republic of Kazakhstan is subject to mandatory confirmation of conformity in accordance with the legislation of the Republic of Kazakhstan in the field of technical regulation;

2) it is not allowed to import and sell iodized edible salt without a certificate of conformity issued in accordance with the legislation of the Republic of Kazakhstan in the field of technical regulation.

6. The production of foods enriched with iodine compounds, as well as conditions for their storage, transportation and sale shall comply with the requirements established by the legislation of the Republic of Kazakhstan.

7. Individuals and legal entities engaged in the production and sale of foods enriched with iodine compounds shall guarantee their good quality and safety to consumers, compliance with regulatory legal acts in the field of sanitary-epidemiological welfare of the population.

Article 113. Public health and the environment

1. When developing strategic documents on state planning, it is necessary to assess risks to human health within strategic environmental examination.

2. In order to improve the state of the environment, the authorized body creates a system for monitoring the state of the environment, including indoors, and for preparing an updated assessment of risks of pollutants’ impact on public health.

3. State bodies and organizations of the sanitary and epidemiological service conduct sanitary and epidemiological monitoring in accordance with the procedure determined by the state body in the field of sanitary and epidemiological welfare of the population, taking into account the methodology of biological risk management and requirements for the assessment of biological risks.

The results of sanitary-epidemiological monitoring (the state of environmental objects) are entered into the Unified State System for Monitoring the Environment and Natural Resources.

4. Local representative bodies approve target indicators of environmental quality.

Target indicators of environmental quality are determined with account of environmental problems of a region and provide for indicators of the state of atmospheric air with the development of a set of measures to reduce pollution.

5. In order to raise public awareness, the authorized body develops and sends recommendations on the population’s actions, depending on the level of air pollution and other environmental factors, to local executive bodies.

Local executive bodies ensure the provision of the population with information on the state of atmospheric air.

6. Issues of public health and the environment are considered within the framework of cooperation of state bodies and public associations.

7. Local executive bodies ensure the creation of favorable conditions for public recreation.

In order to reduce the negative impact of noise on public health, the activities accompanied by increased noise, not related to an urgent need, preventing the normal rest and peace of mind of individuals, in and out of residential buildings, shall be carried out during the daytime and not exceed 8 hours a day.

8. Activities accompanied by increased noise may not be carried out in the premises of residential buildings and in areas of residential development between 22:00 and 09:00, in entertainment establishments - between 22:00 and 09:00 on weekdays, between 23:00 and 10:00 - on weekends and holidays.

The state body for the sanitary-epidemiological welfare of the population arranges for the sanitary-epidemiological monitoring of noise.

Local executive bodies ensure the development of noise maps in residential areas and their implementation in accordance with the results of sanitary-epidemiological monitoring.

9. In order to assess the epidemiological situation in an area and determine potential danger of the impact of water used for household and drinking needs by the population on public health, the state body for the sanitary-epidemiological welfare of the population arranges for the sanitary-epidemiological monitoring of water.

The use of water for household and drinking needs by the population from water supply sources located in an area that is in private ownership is allowed if the water safety indicators comply with the established hygienic standards.

Footnote. Article 113 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 114. Sanitary-epidemiological monitoring

1. Sanitary-epidemiological monitoring is a state system for monitoring the state of public health and the environment, their analysis, assessment and forecast, and also the determination of causal relationships between the state of public health and the impact of the environment.

2. The goals of sanitary-epidemiological monitoring are to obtain reliable information on the impact of the environment (chemical, physical, biological factors) on human health, to assess the effectiveness of measures taken to prevent the occurrence of poisoning and outbreaks of infectious, parasitic and occupational diseases, to predict their emergence.

3. Sanitary-epidemiological monitoring and assessment of effectiveness of the activities performed are carried out to identify their compliance with the requirements of the documents of the state system of sanitary-epidemiological regulation.

4. Sanitary-epidemiological monitoring is carried out in relation to facilities and products subject to sanitary-epidemiological control and supervision, environmental objects (soil, water, air) following the results of laboratory and instrumental studies (measurements), indicators of infectious, parasitic, non-infectious and occupational morbidity.

5. Sanitary-epidemiological monitoring is carried out by state bodies and organizations of the sanitary-epidemiological service in the manner and as frequently as determined by the state body for the sanitary-epidemiological welfare of the population.

6. Sanitary-epidemiological monitoring can be carried out with a visit to (for taking samples from environmental objects, measuring physical factors) and without visiting an object. The results of sanitary-epidemiological monitoring are not a ground for scheduling inspections, preventive control.

7. Sanitary-epidemiological monitoring is carried out in stages and includes:

1) the collection, processing, systematization of (digital, analytical) data on the state of public health and the human environment following the results of sanitary-epidemiological examinations of facilities subject to state sanitary-epidemiological control and supervision, using laboratory and instrumental research methods;

2) analysis and identification of causal relationships between the state of health and the human environment, the reasons and conditions for changes in the sanitary-epidemiological welfare of the population following the results of laboratory and instrumental studies of products and objects of sanitary-epidemiological control and supervision;

3) identification of environmental factors and selection of key indicators of health disorders to optimize laboratory control in the system of sanitary-epidemiological monitoring;

4) in case of detection of infectious and mass non-communicable diseases (poisoning), the establishment of the causes and conditions of their emergence and spread;

5) interdepartmental cooperation in sanitary-epidemiological monitoring in order to ensure the sanitary-epidemiological welfare of the population;

6) the assessment and forecast of changes in the state of public health due to changes in the human environment;

7) the determination of urgent and long-term measures to prevent and eliminate the impact of harmful factors on public health;

8) the creation of information and analytical systems, networks, software materials and databases of sanitary-epidemiological monitoring of a district, city, region and the republic and the storage of sanitary-epidemiological monitoring data.

8. The data of sanitary-epidemiological monitoring are used in the work of the bodies of the sanitary-epidemiological service, local executive and other state bodies.

9. Pursuant to the results of sanitary-epidemiological monitoring:

1) summaries, reports, recommendations, scientific forecasts, diagrams, tables are compiled, which describe the dynamics, direction and intensity of the development of changes;

2) managerial decisions are made in order to eliminate violations of regulatory legal acts in the field of sanitary-epidemiological welfare of the population in the Republic of Kazakhstan.

10. The results of sanitary-epidemiological monitoring are posted on the official website the state body for the sanitary-epidemiological welfare of the population and its territorial bodies at half-year end, at year end.

11. In cases of exceeded morbidity rates, deteriorated indicators of the state of controlled objects and environmental objects, the results of sanitary-epidemiological monitoring are submitted for the consideration of concerned state bodies to make managerial decisions.

SECTION 3. PROVISION OF MEDICAL ASSISTANCE

Chapter 16. GENERAL RULES FOR THE PROVISION OF MEDICAL ASSISTANCE

Article 115. Organization of medical assistance

1. Medical assistance is organized by the authorized body, central executive bodies and other central state bodies having military-medical (medical) units, local public health authorities of regions, cities of republican significance and the capital; healthcare entities provide medical assistance in the manner prescribed by this Code.

2. Healthcare entities providing medical assistance are obliged to:

1) provide timely and high-quality medical assistance;

2) use methods of prevention, diagnosis, treatment and medical rehabilitation with the greatest proven effectiveness and safety;

3) be prepared to work in an emergency situation, military conflict and in case of an act of terrorism;

4) take measures for the prophylaxis, prevention, diagnosis, treatment and medical rehabilitation of diseases that pose a danger to others, as well as occupational diseases;

5) provide individuals with free, prompt and reliable information on the forms and types of medical assistance;

6) comply with regulatory legal acts in the field of sanitary-epidemiological welfare of the population and hygienic standards;

7) interact with other healthcare entities and ensure consistency in their activities;

8) form a healthy lifestyle and healthy diet;

9) maintain medical source statements and submit reports in the forms and in the manner established by the authorized body, with account of the requirements of the Law of the Republic of Kazakhstan “On State Secrets” and the specific nature of their activities;

10) submit information (expedited report):

on cases of infectious diseases, poisoning, which pose a danger to others, - to the state body for the sanitary-epidemiological welfare of the population;

on cases of death of pregnant women, women in labor, parturient women within forty-two calendar days after childbirth, sudden death of patients during the provision of routine medical assistance (primary medical and specialized medical, including high-tech, assistance) - to the state body for providing medical services (assistance);

on the threat of emergence and (or) the emergence of medical-sanitary consequences of emergency situations - to the authorized body for civil protection;

on persons who complained about recent injuries, wounds, illegal abortion, domestic violence, cases of diseases that pose a danger to others - to the internal affairs bodies.

3. Healthcare entities provide medical assistance in accordance with the standards for the provision of medical assistance, the rules for the provision of medical assistance, as well as clinical protocols.

Article 116. Levels of providing medical assistance

The Republic of Kazakhstan has a three-tier system of providing medical assistance, which includes:

1) primary level - the level of medical assistance provided by primary healthcare specialists in outpatient, hospital-replacing conditions and at home;

2) secondary level - the level of medical assistance provided by specialized professionals who provide specialized medical assistance in outpatient, hospital-replacing and inpatient conditions, also pursuant to the referral from specialists providing medical assistance at the primary level;

3) tertiary level - the level of medical assistance provided by specialized professionals providing specialized medical assistance with the use of high-tech medical services in outpatient, hospital-replacing and inpatient conditions, also pursuant to the referral from specialists of the primary and secondary levels.

Article 117. Forms of medical assistance

Medical assistance is provided in:

1) the urgent form - medical assistance provided in case of sudden acute diseases and conditions, exacerbation of chronic diseases requiring urgent medical intervention to prevent significant harm to health and (or) eliminate the threat to life;

2) the emergency form - medical assistance provided in case of sudden acute diseases and conditions, exacerbation of chronic diseases that do not pose an obvious threat to the patient’s life;

3) the planned form - medical assistance provided in case of diseases and conditions not endangering the patient’s life, a delay in the provision of which for a certain time will not deteriorate the patient’s condition, as well as that provided during preventive measures.

Article 118. Conditions for the provision of medical assistance

1. Medical assistance is provided:

1) on an outpatient basis without round-the-clock medical supervision and treatment, including in the admission departments of round-the-clock hospitals;

2) in inpatient conditions with round-the-clock medical supervision, treatment, care, and also with the provision of a bed and meals, as well as in the event of day-case therapy and surgery with round-the-clock supervision during the first day after the start of treatment;

3) in hospital-replacing conditions that do not require round-the-clock medical supervision and treatment and provide for medical supervision and treatment during the day with the provision of a bed;

4) at home: when calling a healthcare professional, a mobile team, in case of active nursing by healthcare professionals, when organizing treatment at home (hospital at home);

5) in sanatoriums and health resorts;

6) outside a medical facility: at the place where the ambulance team is called, on ambulance vehicles and medical aviation during transportation, as well as on medical trains, mobile (field) medical complexes, field hospitals, en-route medical rescue points and when providing telemedicine services.

2. The route of providing medical assistance to patients at the primary, secondary and tertiary levels in the context of profiles is established by local public health authorities of regions, cities of republican significance and the capital in accordance with the rules and standards for the provision of medical assistance.

3. Healthcare organizations provide medical assistance based on the triage principle (medical or sanitary triage of patients) depending on the severity of their condition and sanitary-epidemiological risk.

Medical facilities observe the principles of infection control aimed at preventing the emergence and spread of infectious diseases there.

Article 119. Features of provision of medical assistance at the rural healthcare level

1. Services for health promotion, prevention, treatment and rehabilitation shall be available to the rural population at all levels of rural healthcare.

2. To provide access to primary medical assistance and specialized medical assistance at the level of rural healthcare, it is necessary to use mobile medical complexes, medical trains and means of providing telemedicine services.

3. When planning the volume of medical assistance for rural healthcare, it is necessary to take into account the geographical remoteness, population density, demographic indicators, gender and age composition and other criteria affecting the access to medical assistance.

4. Local public health authorities are responsible for ensuring access to medical assistance for the rural population at all levels of providing medical assistance.

Article 120. Types of medical assistance

The types of medical assistance are as follows:

1) emergency medical care;

2) paramedic assistance;

3) primary medical care;

4) specialized medical assistance, including high-tech one;

5) medical rehabilitation;

6) palliative care.

Article 121. Emergency medical care

1. Emergency medical care is a system for organizing medical assistance in an emergency and urgent form for acute diseases and conditions that threaten life, and also for preventing significant harm to health at the scene of an accident and (or) on-route to a medical facility.

2. Emergency medical care with the involvement of medical aviation is provided:

1) if it is impossible to provide medical assistance because a medical facility at the location of the patient lacks medical products and (or) specialists of required qualifications;

2) if it is necessary to deliver specialists of the secondary and tertiary levels of medical assistance to the destination;

3) for the transportation of a patient to medical facilities of the secondary and tertiary levels of medical assistance in case of impossibility and ineffectiveness of medical care at the location of the patient;

4) for the transportation of organs (parts of an organ) and (or) tissues (parts of tissue) for subsequent transplantation to a relevant medical facility.

3. Medical aviation can be used to:

1) deliver a very ill patient from foreign clinics to domestic ones;

2) deliver a patient in need of medical escort from medical facilities of the secondary and tertiary levels of medical assistance to medical facilities at the place of residence to continue treatment.

4. Rules for the provision of emergency medical care, also with the involvement of medical aviation, are developed and approved by the authorized body.

5. Local public health authorities of regions, cities of republican significance and the capital are responsible for ensuring the access to and timely provision of emergency medical care.

Article 122. Paramedic assistance

1. Pre–medical care - medical care provided by paramedical workers independently or as part of a multidisciplinary team, including health promotion, assessment of the patient's condition, making a pre-medical diagnosis, prescribing a plan for pre-medical interventions, performing pre-medical manipulations and procedures and caring for patients, persons with disabilities and dying people.

2. Paramedics provide medical assistance in accordance with the rules for the provision of paramedic assistance approved by the authorized body.

3. Local public health authorities of regions, cities of republican significance and the capital are responsible for ensuring the accessibility of paramedic assistance.

Footnote. Article 122 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 123. Primary medical care

1. Primary medical care is a place of the first access to medical care focused on the needs of the population, including prevention, diagnosis, treatment of diseases and conditions provided at the level of an individual, family and society, including:

1) diagnosis, treatment and management of the most common diseases;

2) preventive examinations of target population groups (children, adults);

3) early identification and monitoring of behavioral risk factors for diseases and training in the skills to reduce the identified risk factors;

4) immunization;

5) formation and promotion of a healthy lifestyle;

6) measures to protect reproductive health;

7) observation of pregnant women and new mothers in the postpartum period;

8) sanitary-antiepidemic and sanitary-preventive measures in the foci of infectious diseases.

2. Healthcare organizations providing primary medical care carry out their activities based on such principles as:

1) the family service principle;

2) territorial access to primary medical care;

3) free choice of a medical facility that can be accessed within their district in accordance with subparagraph 2) of paragraph 2 of this article;

4) the patient’s satisfaction with the quality of medical care;

5) equality and fair competition regardless of the form of ownership and departmental affiliation;

6) primary medical services covering prevention, diagnosis and treatment, which are available to all patients regardless of their location.

3. Primary medical care is provided by general practitioners (family doctors), district therapists, pediatricians, paramedics, obstetricians, advanced practice (general practice) nurses, district nurses, social workers, healthcare psychologists.

4. To receive primary medical care, individuals shall register with healthcare entities providing primary medical care.

The registration of an individual with a primary medical care facility is the basis for exercising the right to receive medical care and fulfilling the obligations of healthcare organizations to provide medical care within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance.

The rules for individuals’ registration with healthcare organizations providing primary medical care are developed and approved by the authorized body.

5. Primary medical care facilities set up emergency departments (points) for the provision of emergency care.

6. Local public health authorities of regions, cities of republican significance and the capital are responsible for ensuring the accessibility of primary medical care.

Article 124. Specialized medical assistance, including high-tech one

1. Specialized medical assistance is provided by specialized professionals for diseases requiring special methods of diagnosis, treatment, medical rehabilitation, including the use of telemedicine services.

2. Specialized medical assistance is provided in the form of consultative and diagnostic assistance on an outpatient basis, stationary and inpatient care at the secondary and tertiary levels of medical assistance.

3. High-tech medical assistance is part of specialized medical assistance provided by specialized professionals for diseases requiring the use of innovative and (or) unique methods of diagnosis and treatment with scientifically proven effectiveness and safety and technologies developed on the basis of the achievements of medical science and related branches of science and technology.

4. The procedure for determining types of high-tech medical assistance and their list, as well as the criteria for transferring types of high-tech medical assistance into the list of specialized medical services, are determined by the authorized body.

5. The rules for the provision of specialized medical assistance, including high-tech one, are developed and approved by the authorized body.

Article 125. Medical rehabilitation

1. Medical rehabilitation is provided to persons with congenital diseases, after acute conditions, surgical interventions, injuries, as well as their consequences, according to the list approved by the authorized body.

2. Medical rehabilitation for persons with congenital diseases, after acute conditions, surgical interventions and injuries is provided when treating the underlying disease in outpatient, inpatient, hospital-replacing conditions of medical facilities of primary, secondary and tertiary levels.

2-1. Medical rehabilitation to persons held in pre-trial detention centers and institutions of the penal (penitentiary) system, shall be provided after acute conditions, surgical interventions, injuries, as well as their consequences according to the list determined by the authorized body.

3. Medical rehabilitation of congenital diseases, the consequences of acute conditions, surgical interventions and injuries is provided with account of the rehabilitation potential in accordance with the medical part of the individual rehabilitation program of the patient in outpatient, inpatient, hospital-replacing conditions of medical facilities of primary, secondary and tertiary levels, as well as at home and in sanatorium-resort facilities in the manner prescribed by the authorized body.

4. A patient with a lack of rehabilitation potential is not provided with medical rehabilitation pursuant to the opinion of the multidisciplinary team.

5. Medical habilitation is a process of medical rehabilitation aimed at acquiring or compensating for the unformed functions and skills of children with disabilities and integrating them into society. Medical habilitation is carried out for children with congenital functional limitations until they reach the age of three years.

6. The procedure for the provision of medical rehabilitation is developed and approved by the authorized body.

Footnote. Article 125 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 126. Palliative medical care

1. Palliative care is a range of services aimed at improving the quality of life of patients with severe and incurable diseases (conditions), as well as their families and caregivers, including medical, special social services, spiritual support.

2. Palliative care is a range of medical services aimed at relieving pain and severe manifestations of a disease (condition) of a terminally ill patient in the absence of indications for radical treatment.

Palliative care is provided on the basis of a healthcare standard developed and approved by the authorized body.

Article 127. Nursing activities

1. Nursing activities include nursing care delivered by nurses and advanced practice nurses independently or as part of multidisciplinary teams.

A nurse is a specialist with technical and professional medical education in the field of nursing who provides nursing care independently or under the supervision of an advanced practice nurse or a physician.

An advanced practice nurse is a specialist with post-secondary or tertiary nursing education who performs advanced nursing functions in care.

2. Nursing care is provided in cases that do not require round-the-clock medical supervision, in specialized structural units (departments, wards, beds, offices) of healthcare organizations, independent specialized medical facilities (nursing hospitals) in inpatient, hospital-replacing conditions and at home, also using mobile teams.

3. Nurses and advanced practice nurses provide nursing care in accordance with the legislation of the Republic of Kazakhstan, the rules for the provision of nursing care, and also follow clinical nursing guidelines.

4. Clinical nursing guidelines are scientifically proven guidelines for best practice in a specific clinical area, which are developed and systematically updated by professional medical associations.

5. Advanced practice nurses have the right to provide independent professional nursing care, including nursing assessment of the patient’s (client’s) condition, making a nursing diagnosis, prescribing a nursing intervention plan and effectiveness monitoring, in accordance with clinical protocols and clinical nursing guidelines.

6. Rules for the provision of nursing care are developed and approved by the authorized body. The rights and obligations of nurses and advanced practice nurses providing nursing care are established in accordance with these rules.

7. Local public health authorities in regions, cities of republican significance and the capital are responsible for ensuring the accessibility of nursing care.

Article 128. Integrated model of providing medical assistance

1. An integrated model of medical assistance is a model of organizing the provision of a complex of medical and social services throughout a person’s life for the prevention, timely identification, treatment and reduction of the risk of developing complications of the disease in order to increase life expectancy.

2. An integrated model of providing medical assistance is implemented through a multidisciplinary approach in accordance with clinical protocols, standards and rules for the provision of medical assistance.

Article 129. Features of the provision of telemedicine services

1. Telemedicine services are provided for:

1) giving advice, including by specialists from research institutes, research centers, university hospitals, as well as foreign clinics;

2) expedient referral of a patient for an in-person consultation at higher levels of medical assistance;

3) receiving practical assistance from specialists of the secondary and tertiary levels by specialists of the primary level and rural healthcare;

4) evaluating the effectiveness of treatment and diagnostic measures, medical observation of the patient’s health status;

5) the clarification of the diagnosis, adjustment and determination of further tactics of patient management and prescription of therapy-diagnostic measures;

6) determining the possibility of transporting a patient to higher levels of medical assistance, including the feasibility of using medical aviation equipment;

7) organizing electronic consultations;

8) the provision of medical rehabilitation services.

2. An opinion of doctors providing telemedicine services on the health status and diagnosis of the patient is an official document and shall be entered in the patient’s electronic health passport using the electronic digital signature of the doctor, and in the cases provided for in subparagraph 8) of paragraph 1 of this article, using the electronic digital signature of a specialist who provided medical rehabilitation services.

3. Certified wearable medical devices are used to assess the physiological parameters and health status of a patient.

4. Telemedicine services are provided in compliance with the requirements established by the legislation of the Republic of Kazakhstan in the field of personal data protection and for medical confidentiality.

5. The organization, procedure for the provision and payment of telemedicine services are determined by the authorized body.

Article 130. Laboratory diagnostics

1. Laboratory diagnostics is a complex of laboratory studies of biomaterials of patients aimed at diagnosing a disease, monitoring the effectiveness of treatment and correcting treatment.

2. The standard for the organization of laboratory diagnostics is developed and approved by the authorized body.

3. External assessment of the quality of measurements of laboratory tests is controlled and carried out by reference laboratories in the manner prescribed by the authorized body.

4. The list of reference laboratories, regulations on their activities, as well as criteria and requirements for their selection, are approved by the authorized body.

5. Local public health authorities of regions, cities of republican significance and the capital are responsible for ensuring the accessibility of laboratory diagnostics.

Article 131. Pathoanatomical diagnosis

1. Pathoanatomical diagnosis is carried out in order to identify a diagnosis by analyzing the totality of changes in organs (fragments of organs), tissues and cells of patients, removed by surgery and (or) biopsy (operational biopsy material), as well as in tissues, organs and cells of a dead body during a postmortem examination.

2. Postmortem examination is carried out in order to determine the cause of death and clarify the diagnosis of the disease and to issue a document certifying the fact of death in the form approved by the authorized body.

3. Pathoanatomical diagnosis is based on the results of direct examination (macroscopic studies), studies using magnifying devices (microscopic studies), other technologies, as well as clinical and anatomical comparisons.

4. In the absence of suspicion of violent death, it is allowed to hand over a dead body without postmortem examination, except for cases of maternal, infant deaths or stillbirth.

In case of an unidentified direct cause of death, pathoanatomical diagnosis is carried out with the written consent of the spouse or a close relative or a legal representative.

5. At the request of the spouse, close relatives or legal representative of the deceased, the postmortem examination may be performed by an independent expert (experts) in the manner prescribed by the authorized body.

6. The state body for medical services (assistance) issues a pathologist’s opinion on the cause of death and the diagnosis of the disease to the spouse, close relatives or legal representatives, and in their absence, to other relatives, as well as at the request of law enforcement agencies and (or) the court in the cases provided for in subparagraph 3) of paragraph 4 of Article 273 of this Code.

7. The standard for the organization of pathoanatomical diagnosis is developed and approved by the authorized body.

8. A postmortem report can be appealed in court by the spouse, close relative or legal representative of the deceased in the manner prescribed by the legislation of the Republic of Kazakhstan.

9. Postmortem examination is carried out with respect for the body of the deceased and the maximum preservation of its external anatomical forms.

Article 132. Conventional medicine. Healing

1. Conventional medicine is a set of codified methods of prevention, diagnosis, treatment and rehabilitation, which are based on centuries-old traditions of traditional medicine and are approved for medical use.

2. Persons with medical education who have a certificate of a healthcare specialist and a license issued in accordance with the legislation of the Republic of Kazakhstan on permits and notifications are entitled to work in the field of conventional medicine.

3. Healing is a set of empirical information on healing methods, techniques, skills and their practical application in order to produce health effects.

4. It is prohibited to conduct healing sessions with the involvement of two or more persons, and also using the mass media.

5. A person who has caused harm to human health when applying healing methods is liable under the laws of the Republic of Kazakhstan.

Article 133. Assessment of health technologies

1. The objects of health technology assessment are health technologies offered for use within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance or through other sources not prohibited by the legislation of the Republic of Kazakhstan.

2. The procedure for assessing health technologies and their application are determined by the authorized body.

Article 134. Rights of patients

1. In addition to the rights specified in Chapter 12 of this Code, the patient has the right to:

1) respectful attitude in the process of prevention, diagnosis, treatment, respect for his/her cultural and personal values;

2) receive medical assistance in accordance with the priority determined solely on the basis of medical criteria, without the influence of any discriminatory factors;

3) select, replace a doctor or a medical facility providing medical assistance within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance, except for cases of emergency and urgent assistance;

4) be informed by a medical facility about audio and (or) video surveillance and recording;

5) be relieved of suffering to the extent enabled by the current level of medical technologies;

6) obtain information (data on possible risks and benefits, proposed and alternative methods of treatment, information on possible consequences of refusing treatment, information on the diagnosis, prognosis and treatment plan in an intelligible form, and also explanation of the reasons for discharging him/her home or transferring to another medical facility), and an independent opinion on the state of his/her health, and a consultation;

7) obtain information on his/her rights and obligations, the services provided, the cost of paid services and the amount of co-payment, the procedure for their provision with account of their accessibility for persons with visual and (or) hearing impairments; the prescribed medicinal product; healthcare professionals providing medical services to him/her;

8) refuse to participate in the educational process, and also to refuse third parties to be present at medical and diagnostic procedures;

9) other rights provided for by the laws of the Republic of Kazakhstan.

2. Information on the patient’s rights is placed on visual outreach boards of medical facilities.

3. Medical assistance is provided after obtaining the patient’s informed consent to receive medical assistance. The informed consent of the patient during invasive interventions is drawn up in the form approved by the authorized body.

4. The patient can choose a person who shall be informed about the state of his/her health. With account of the state of the patient’s health, information thereon can be hidden from the patient and communicated to the patient’s spouse, close relatives or legal representatives.

5. Patients’ rights are protected by state bodies, healthcare organizations, public associations within their competence.

Article 135. Obligations of patients

1. In addition to the obligations specified in Chapter 12 of this Code, the patient is obliged:

1) to take measures to preserve and strengthen his/her health;

2) to show respect and tact in communication with healthcare professionals;

3) to provide a physician with all the information necessary for the diagnosis and treatment of the disease; after giving consent to medical intervention, to strictly follow the prescriptions of healthcare professionals;

4) to comply with internal regulations and take good care of the property of a medical facility, to cooperate with medical personnel when receiving medical assistance;

5) to promptly inform healthcare professionals on changes in his/her state of health in the process of diagnosis and treatment, as well as in cases of diseases that pose a danger to others, or suspicion of them;

6) not to commit acts that violate the rights of other patients;

7) to fulfill other obligations provided for by the laws of the Republic of Kazakhstan.

2. The obligations of patients specified in subparagraphs 2), 3) and 5) of paragraph 1 of this article apply to parents or other persons who care for a sick child in a hospital.

Article 136. Right to refuse medical assistance

1. The patient or his/her legal representative has the right to refuse medical assistance, except for the cases specified in Article 137 of this Code.

2. If medical assistance is denied, a healthcare professional explains possible consequences to the patient or his/her legal representative in an intelligible form.

3. Refusal of medical assistance with an indication of possible consequences is entered in medical records, also in electronic format, and signed by the patient or his/her legal representative, as well as by a healthcare professional.

If the patient or his/her legal representative refuses to sign their denial of medical assistance, it is necessary to make an appropriate entry in medical records, also in electronic format, which is signed by the healthcare professional.

4. If legal representatives of a minor or an incapacitated person refuse medical assistance necessary to save their lives, a medical facility has the right to apply to the guardianship and custody body and (or) the court to protect their interests.

Article 137. Provision of medical assistance without the patient’s consent

1. The provision of medical assistance without the consent of the patient is allowed in relation to persons:

1) who are in a state of shock, in a comatose state, when they are unable to express their will;

2) with diseases that pose a danger to others;

3) with severe mental disorders (diseases);

4) with mental disorders (diseases) who committed a socially dangerous act.

2. Consent to the provision of medical assistance in relation to minors, except for the cases provided for by paragraph 2 of Article 78 of this Code, and consent for persons declared incapacitated by the court shall be given by their legal representatives.

3. The decision on the provision of medical assistance without consent in relation to the persons specified in paragraph 1 of this article shall be made by a case conference, and if it is impossible to gather required specialists - by a healthcare professional with subsequent notification of officials of a medical facility.

4. Medical assistance is provided without the consent of the patient until the grounds provided for in paragraph 1 of this article disappear.

Article 138. Requirements for the development of standards for the provision of medical assistance

1. Standard for the provision of medical assistance is a regulatory legal act establishing the requirements and rules for the processes of providing medical assistance in accordance with the legislation of the Republic of Kazakhstan in the field of healthcare.

2. The standard for providing medical assistance is developed for the profiles of diseases (services) and includes such requirements as:

1) general provisions;

2) the structure of facilities providing medical assistance;

3) the main tasks and areas of activities of facilities providing medical assistance;

4) the procedure for providing medical assistance in the context of levels, types, forms and conditions of its provision;

5) recommended staff;

6) recommended medical devices;

7) and others with account of the characteristics of the profile of the disease (service).

3. Standards for providing medical assistance are developed and approved by the authorized body.

Chapter 17. DEPARTMENTAL MEDICINE

Article 139. Military-medical (medical) support of military personnel, cosmonaut candidates, cosmonauts, employees of special state and law enforcement agencies, their family members, retired law enforcement employees, and also citizens dismissed from military service, service in special state agencies

1. Military-medical (medical) support is a set of measures, including the organization and provision of military-medical (medical) assistance, medical examinations, ensuring sanitary-epidemiological welfare, the supply of medicines and medical products, expertise in the field of healthcare, as well as scientific-methodological development and training in military medicine in the troops, units and departments of special state and law enforcement agencies in order to restore the combat capability and working capacity of personnel.

2. Military-medical (medical) support for military personnel, cosmonaut candidates, cosmonauts, employees of special state and law enforcement agencies, their family members, retired law enforcement employees, as well as citizens dismissed from military service, service in special state bodies, is carried out in accordance with the legislation of the Republic of Kazakhstan.

3. The procedure for organizing and conducting medical examinations, providing military-medical (medical) assistance, ensuring sanitary-epidemiological welfare, supplying medicines and medical products in the Armed Forces of the Republic of Kazakhstan, other troops and military formations is established with account of the specifics of military service.

When providing medical assistance in the Armed Forces of the Republic of Kazakhstan, it is allowed to use medicines registered in the Republic of Kazakhstan and not included in the medicines formulary of military-medical institutions (organizations), the list of which is approved by the state body for defense.

4. The persons specified in paragraph 2 of this article have the right to receive medical assistance within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance in other healthcare entities in accordance with the legislation of the Republic of Kazakhstan.

Article 140. Military-medical expertise

1. Military-medical expertise is a type of medical activity, which is a set of scientific, methodological, organizational and practical measures carried out in order to optimally staff and improve medical support in the Armed Forces of the Republic of Kazakhstan, other troops and military formations of the Republic of Kazakhstan, special state and law enforcement agencies and to address other issues provided for by the legislation of the Republic of Kazakhstan.

2. Military-medical expertise is carried out in the Armed Forces of the Republic of Kazakhstan, other troops and military formations, special state and law enforcement agencies to:

1) determine the category of fitness of citizens for military service or service in special state and law enforcement agencies, as well as for battle assembly, training sessions of special state agencies or for the purposes of recording for health reasons;

2) establish the causal relationship of diseases, injuries (wounds, traumas, contusions) (hereinafter referred to as injuries) and death of citizens of the Republic of Kazakhstan in connection with their military service (performance of duties), service in special state and law enforcement agencies and battle assembly, training sessions of special state agencies;

3) determine the severity of injuries that did not entail disability, which were received by military personnel or employees in the performance of duties of service, military service (official duties);

4) identify psychophysiological qualities of the personality of citizens of the Republic of Kazakhstan joining special state and law enforcement agencies, their employees, as well as those joining state aviation, aviation personnel.

3. To conduct military-medical expertise, it is necessary to set up in-service and non-staff (regular and temporary) military-medical commissions under the Armed Forces of the Republic of Kazakhstan, other troops and military formations of the Republic of Kazakhstan, special state agencies and internal affairs bodies.

For special state agencies, the military-medical expertise is carried out by the military-medical commission of the national security bodies and the State Security Service of the Republic of Kazakhstan.

With regard to law enforcement agencies and the state courier service of the Republic of Kazakhstan, the military-medical expertise is carried out by the military-medical commission of the internal affairs bodies of the Republic of Kazakhstan.

To determine the degree of citizens’ fitness for military service, regular medical commissions are set up in regions, cities of republican significance, the capital, towns and districts by decision of local executive bodies.

4. The procedure for conducting military-medical expertise, as well as the composition and powers of the military-medical expertise commission, are determined by the Rules for conducting military-medical expertise and the Regulations on the military-medical expertise commissions.

5. The category of citizens’ fitness for military service in the Armed Forces of the Republic of Kazakhstan, other troops and military formations of the Republic of Kazakhstan, service, military service in special state and law enforcement agencies, as well as state aviation, is determined in the course of a medical examination.

When conducting a medical examination, it is necessary to apply the requirements for the state of health of citizens willing to serve in the Armed Forces of the Republic of Kazakhstan, other troops and military formations of the Republic of Kazakhstan, in special state and law enforcement agencies, as well as in state aviation.

Article 141. Forensic medical, forensic psychiatric and forensic narcological examinations

1. The procedural order for scheduling and producing forensic medical, forensic psychiatric and forensic narcological examinations is established by the Criminal Procedure Code of the Republic of Kazakhstan, the Civil Procedure Code of the Republic of Kazakhstan, the Administrative Offences Code of the Republic of Kazakhstan.

2. The procedure for organizing these types of forensic examinations and conducting forensic expert examinations is established by the legislation of the Republic of Kazakhstan on forensic expert examinations.

Article 142. Provision of medical assistance to certain categories of civil servants and citizens of the Republic of Kazakhstan

1. Medical assistance to certain categories of civil servants and citizens of the Republic of Kazakhstan is provided in accordance with the list approved by the Administrative Department of the President of the Republic of Kazakhstan in consultation with the Executive Office of the President of the Republic of Kazakhstan.

2. Medical assistance to persons specified in paragraph 1 of this article shall be provided:

1) within the guaranteed volume of free medical care in accordance with this Code;

2) in the system of compulsory social health insurance in accordance with the Law

of the Republic of Kazakhstan “On Compulsory Social Health Insurance”;

3) using budgetary funds by types and in amounts determined by the Administrative Department of the President of the Republic of Kazakhstan.

3. Services for the provision of medical assistance in accordance with subparagraphs 1) and 2) of paragraph 2 of this article are paid for by the social health insurance fund.

4. The persons specified in paragraph 1 of this article have the right to receive medical assistance within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance in other healthcare entities.

Article 143. Provision of medical persons, who are persons detained, taken into custody, placed in special institutions, held in pre-trial detention centers and institutions of the penal (penitentiary) system

1. Medical care to persons, who are detained, taken into custody and placed in special institutions, shall be provided in accordance with the procedure, determined by the internal affairs bodies of the Republic of Kazakhstan in agreement with the authorized body.

2. Medical care to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, shall be provided in accordance with the procedure, determined by the authorized body.

3. The persons specified in paragraphs 1 and 2 of this article shall exercise the rights of citizens of the Republic of Kazakhstan when receiving medical care, specified in subparagraphs 1), 2), 4), 5), 6), 7), 8) and 9) of paragraph 1 of article 134 of this Code.

4. Foreigners and stateless persons with restricted liberty, as well as those serving sentences in detention centers, detainees, who are taken into custody and placed in special institutions, have the right to receive a guaranteed volume of free medical care in accordance with the list and in the amount determined by the authorized body unless otherwise provided for by the laws of the Republic of Kazakhstan and international treaties ratified by the Republic of Kazakhstan.

Footnote. Article 143 - as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022).

Article 144. Provision of medical assistance to athletes and coaches

1. Medical support and medical assistance to athletes and coaches are provided in accordance with the rules for providing medical support and medical assistance to athletes and coaches during sports events, the recovery period after intense physical exertion, athletes’ diseases and injuries, which are approved by the authorized body for physical culture and sports in consultation with the authorized body.

2. Athletes who failed to take a medical examination in accordance with the rules for medical examination of athletes for participation in sports competitions approved by the authorized body for physical culture and sports in consultation with the authorized body are not allowed to participate in sports competitions.

3. Sports medicine organizations belong to healthcare organizations.

Chapter 18. REGULATION OF INDIVIDUAL RELATIONS IN THE FIELD OF HEALTHCARE

Article 145. Procedure for surgical intervention, transfusion of blood, its components and the use of invasive diagnostic methods

1. Surgical intervention, transfusion of blood, its components and the use of invasive diagnostic methods are implemented with the informed consent of patients.

Surgical intervention, transfusion of blood and its components, invasive diagnostic methods for persons with mental, behavioral disorders (diseases), recognized as incompetent by the court, and minors are carried out with the informed consent of their legal representatives.

2. Consent may be withdrawn, except for those cases when healthcare professionals have already started surgical intervention for health reasons and its termination is impossible due to the threat to the life and health of the patient.

3. In cases where a delay in performing a surgical intervention, transfusion of blood and its components, invasive diagnostic methods threatens the patient’s life, and obtaining the consent of the patient or his/her legal representatives is impossible, the decision is taken by the attending physician or case conference who later inform the patient or his/her legal representatives on the measures taken.

Article 146. Assisted reproductive methods and technologies

1. Assisted reproductive methods and technologies are methods of treating infertility (artificial insemination, artificial fertilization and embryo transfer), in the application of which some or all stages of conception and early development of embryos are carried out outside the mother’s body (also using donor and (or) cryopreserved reproductive cells, tissues of reproductive organs and embryos, as well as surrogacy).

2. A woman and a man who are married have the right to use assisted reproductive methods and technologies with mutual informed consent to medical intervention.

3. A woman or a man who are not married have the right to use assisted reproductive methods and technologies given her (his) informed consent to medical intervention.

4. The procedure and conditions for applying assisted reproductive methods and technologies are determined by the authorized body.

5. When using assisted reproductive methods and technologies, it is not allowed to choose the sex of an unborn child, except for cases of possible inheritance of sex-related diseases.

6. The human embryo cannot be used for commercial, military or industrial purposes.

7. It is not allowed to export germ cells, human embryos from the Republic of Kazakhstan for commercial, military or industrial purposes.

Article 147. Cloning

Human cloning - the reproduction of genetically identical individuals - is prohibited in the Republic of Kazakhstan.

Article 148. Donation of germ cells, tissues of reproductive organs

1. Citizens of the Republic of Kazakhstan aged 18-35, physically and mentally healthy, who have undergone medical and genetic examination, have the right to be donors of germ cells, tissues of reproductive organs.

2. Donors have no right to information on further fate of their donor germ cells, tissues of reproductive organs.

3. The procedure and conditions for the donation of germ cells, tissues of reproductive organs are determined by the authorized body.

Article 149. Use of contraception

1. Citizens have the right to choose methods and means of contraception, including medical ones, as well as to refuse them.

2. Citizens are provided with medical assistance for the individual selection of acceptable methods and means of contraception, taking into account their health status, age and individual characteristics.

Article 150. Artificial abortion

1. A woman has the right to artificial abortion.

2. Artificial abortion at the request of a woman is performed at a gestational age of up to twelve weeks.

In order to prevent the artificial abortion, doctors are obliged to hold conversations aimed at clarifying the moral, ethical, psychological and negative physiological consequences, possible complications.

3. Artificial abortion for social reasons is performed at a gestational age of up to twenty-two weeks, and given medical indications and conditions that threaten the life of the pregnant woman and (or) the fetus (in the presence of monogenic genetic disorders, uncorrected congenital anomalies and fetal abnormalities incompatible with life) - regardless of the gestational age.

4. The performance of artificial abortion upon minors requires the consent of their parents or other legal representatives.

5. The performance of artificial abortion upon an adult recognized as legally incompetent, if she is incapable of expressing her will due to her condition, is possible by a court judgment taken at the request of her legal representative and with the participation of an adult recognized as legally incompetent.

6. At the request of a woman, medical facilities provide medical and social counseling before and after artificial abortion, including individual selection of methods and means of contraception.

7. The procedure for, the list of medical and social indications, as well as contraindications for artificial abortion are determined by the authorized body.

Article 151. Surgical sterilization

1. Surgical sterilization as a method of preventing unwanted pregnancy can be performed in relation to a patient who is at least thirty-five years old or has at least two children, and in the presence of medical indications and the consent of an adult citizen - regardless of the age and presence of children.

2. Surgical sterilization is performed only with the informed consent of the patient by healthcare entities licensed to carry out this activity, with mandatory prior notification of the irreversibility of this operation.

3. The procedure and conditions for carrying out surgical sterilization are determined by the authorized body.

Article 152. Chemical castration

1. Chemical castration is taking drugs by a patient that reduce sexual desire, which is performed in a medical facility on the basis of a court judgment.

2. The type of medicinal product used, the frequency of its administration within the period of validity of the compulsory medical measure established by the court, as well as the procedure for applying this measure shall be determined by the authorized body in agreement with the General Prosecutor’s Office.

Footnote. Article 152 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022).

Article 153. Determination of biological death, irreversible brain death. Conditions for the continuation, termination of artificial sustainment of functions of organs

1. Biological death is the cessation of life processes in a living organism with complete loss of vital functions.

2. Biological death is determined by a healthcare professional given the combination of such symptoms as:

1) cardiac arrest;

2) respiratory arrest;

3) loss of functions of the central nervous system.

3. Irreversible brain death is the cessation of brain functions due to the death of the brain substance disabling any artificial sustainment of functions of organs.

4. Irreversible brain death is ascertained by a case conference of a medical facility on the basis of a combination of symptoms of cessation of the functions of the central nervous system, as well as clinical tests and other diagnostic studies in the manner prescribed by the authorized body.

5. Artificial sustainment of functions of organs continue if a person, whose irreversible brain death was diagnosed, during his/her lifetime agreed to the donation of organs (part of an organ) and (or) tissues (part of tissue) for transplantation.

In the absence of a person’s living will, artificial sustainment of functions of organs can be continued in the case of the consent of the spouse, and in his (her) absence - the person’s close relative, to the retrieval of organs (part of an organ) and (or) tissues ( pieces of tissue) for transplantation.

6. It is allowed to stop artificial life support measures only in case of:

1) pronouncement of biological death;

2) irreversible brain death registered by a case conference, confirmed by necessary diagnostic and other studies in the manner prescribed by the authorized body, given written consent of the spouse, in his (her) absence - a close relative and (or) legal representative.

Article 154. Euthanasia

Euthanasia is prohibited in the Republic of Kazakhstan.

Article 155. Anatomical gift

1. Anatomical gift is voluntary donating by a capable person of his/her organs (parts of an organ) and (or) tissues (parts of tissue) both during life and after his/her death, which is documented as a duly executed contract or will of the person.

2. Information on the anatomical gift is not subject to disclosure.

3. In addition to bequeathed organs (parts of an organ) and (or) tissues (parts of tissue), an anatomical gift is also a dead body of an identified person, which is unclaimed for burial within twenty days of his/her death from a medical facility.

Unidentified dead bodies are not recognized as an anatomical gift.

4. The anatomical gift can be used for scientific, academic-research and educational purposes for biomedical studies.

5. The procedure and conditions for making and transferring the anatomical gift to healthcare organizations are determined by the authorized body.

Article 156. Sex change

1. Persons with gender identity disorders who have reached the age of twenty-one, are capable, except for persons with mental, behavioral disorders (diseases), have the right to change their sex.

2. The procedure for medical examination and sex reassignment for persons with gender identity disorders is determined by the authorized body.

Chapter 19. PROVISION OF MEDICAL ASSISTANCE IN CASE OF COMMON INFECTIOUS DISEASES

Clause 1. Provision of medical-social assistance to persons with TB disease

Article 157. Provision of medical assistance to persons with TB disease

1. The state guarantees persons with TB disease:

1) medical assistance and drug provision within the guaranteed volume of free medical care;

2) social and legal protection;

3) prevention of any forms of discrimination due to the nature of the disease;

4) the implementation of preventive measures to reduce the incidence of severe, acutely progressive TB forms among children.

2. Persons with active TB disease shall be subject to compulsory hospitalization, treatment and rehabilitation.

3. A person is recognized as having active TB disease on the basis of an opinion of a healthcare organization with account of the results of laboratory tests.

4. The procedure for conducting a medical examination to recognize a person as having active TB disease is determined by the authorized body.

5. A person recognized as having active TB disease may appeal against the decision of a healthcare organization in the manner prescribed by the laws of the Republic of Kazakhstan.

Article 158. Grounds and procedure for referring persons with active TB disease for compulsory treatment

1. Compulsory treatment of persons with TB disease includes treatment with anti-TB drugs and symptomatic treatment isolating patients in phthisiopulmonology organizations and is carried out within the framework of the guaranteed volume of free medical care.

2. The grounds for compulsory treatment of persons with TB disease are as follows:

1) refusal from treatment of a patient with active TB disease, which is entered in the patient’s medical records;

2) unauthorized leave and violation of the treatment regimen in the form of unreasonable skipping of seven daily doses of anti-TB drugs during a calendar month, which is fixed in the patient’s medical records.

3. Persons with TB disease who have undergone compulsory treatment, after being discharged from phthisiopulmonology organizations, shall register with a medical facility at their place of residence.

The rules for providing medical assistance to persons with TB disease referred for compulsory treatment are developed and approved by the authorized body.

4. At the request of healthcare organizations in accordance with the legislation of the Republic of Kazakhstan, a court shall take a judgment on compulsory treatment of persons with TB disease that evade treatment.

5. Persons with TB disease undergoing compulsory treatment enjoy all the rights of citizens of the Republic of Kazakhstan with restrictions related to the need to comply with the regime of stay in phthisiopulmonology organizations.

6. The job position of a person with TB disease who is referred for compulsory treatment is secured.

The time spent on compulsory treatment does not interrupt the length of service and is included in the total length of service.

7. Referral for compulsory treatment to a phthisiopulmonary organization does not entail a criminal record.

8. A person with TB disease referred for compulsory treatment, who lives in a dwelling of the state housing stock, shall retain dwelling for the entire period of being treated.

Article 159. Social and legal protection of persons with TB disease or those who recovered from it

1. Local executive bodies provide:

1) social support to persons with TB disease treated on an outpatient basis;

2) labor and household assistance to persons who recovered from TB disease.

2. Children with TB disease are allowed to study at school and other educational institutions on equal terms by decision of the central medical advisory commission of healthcare organizations providing phthisiopulmonary care.

3. The peculiarities of admission to, being in and dismissal from military service, service in special state and law enforcement agencies, courier service of persons with TB disease or who recovered from it are determined by the legislation of the Republic of Kazakhstan.

4. Persons disclosing information on persons who have fallen ill with and recovered from TB disease shall be liable under the laws of the Republic of Kazakhstan.

Clause 2. Provision of medical-social assistance to persons infected with HIV

Article 160. Provision of medical assistance to persons infected with HIV

1. The state guarantees persons infected with HIV:

1) accessible and good-quality confidential medical examination on a free basis, dynamic observation, provision of psychosocial, legal and medical advice;

2) medical assistance and drug provision within the guaranteed volume of free medical care;

3) implementation of preventive measures to reduce the risk of HIV transmission from a mother to her fetus and child;

4) social legal protection.

2. Citizens of the Republic of Kazakhstan, Candace, foreigners, stateless persons, refugees infected with HIV infection, permanently residing in the territory of the Republic of Kazakhstan, and children born to HIV-infected mothers with an unspecified diagnosis are subject to dynamic monitoring and provision of medicines within the guaranteed volume of free medical care.

3. Persons in need of pre-exposure and post-exposure prophylaxis of HIV infection are subject to medical observation and drug provision within the guaranteed volume of free medical care.

4. Persons infected with HIV, including foreigners and stateless persons with restricted liberty, serving a sentence in detention centers, detainees, who are taken into custody and placed in special institutions, have the right to receive a guaranteed volume of free medical care.

Article 161. Social and legal protection of people infected with HIV

1. Persons infected with HIV shall not be limited to training in educational institutions, stay in sanatorium-resort organizations and health-improving educational institutions.

2. Termination of an employment contract, a ban on conclusion of an employment contract, except for cases established by the labor legislation of the Republic of Kazakhstan, admission to educational organizations and social institutions, as well as infringement of the rights and legitimate interests of persons infected with HIV, as well as infringement of housing and other rights and interests of their close relatives.

3. It shall not be allowed for the employer to request the results of HIV testing, except for medical workers who have contact with blood, other biological fluids and biomaterials, subject to preliminary and periodic medical examinations.

4. If HIV infection is detected, employees with an established diagnosis of HIV infection shall be subject to transfer by the employer to another job, not related to the violation of the integrity of the skin or mucous membranes.

5. The specifics of admission, passage and dismissal from military service, service in special state and law enforcement agencies of persons infected with HIV shall be determined by the legislation of the Republic of Kazakhstan.

6. Persons who have become infected with HIV as a result of improper performance of their official duties by medical workers and workers in the field of consumer services have the right to compensation for harm caused to life or health, in accordance with the legislation of the Republic of Kazakhstan.

Article 162. HIV infection testing

1. Citizens of the Republic of Kazakhstan, kandasses, foreigners, stateless persons, refugees and asylum seekers permanently and temporarily residing in the territory of the Republic of Kazakhstan have the right to voluntary anonymous and (or) confidential medical testing and counseling on HIV infection within the guaranteed volume of free medical care in public health organizations carrying out activities in the field of HIV infection prevention, in the manner determined by the authorized authority.

2. Obligatory confidential medical testing for HIV infection within the guaranteed volume of free medical care shall be subject to:

1) donors and recipients of blood, its components, organs (parts of organ) and (or) tissues (parts of tissue), sex cells;

2) persons on the basis of requests from the prosecution, investigation and (or) court;

3) persons for clinical and epidemiological indications in the manner determined by the authorized authority;

4) persons whose liberty is limited, who are serving a sentence by a court verdict in places of deprivation of liberty, taken into custody and placed in special institutions.

Obligatory confidential medical testing for HIV infection shall be carried out in public health organizations operating in the field of HIV infection prevention, in the manner determined by the authorized authority.

3. Medical testing for HIV infection of minors shall be carried out with the consent of their legal representatives or, at their request, incapacitated persons - with the consent of their legal representatives.

4. Employees of foreign diplomatic missions, employees of foreign consular offices and other persons who enjoy privileges and immunities in the Republic of Kazakhstan shall be tested for HIV only with their consent. The authorized authority shall preliminarily agree on a proposal on the need for their testing with the Ministry of Foreign Affairs of the Republic of Kazakhstan.

5. Health care organizations that have identified the fact of HIV infection during a medical testing, notify the examinee in writing about the result obtained, inform about the need to observe precautions aimed at protecting their own health and the health of others, and also warn about administrative and criminal liability for avoiding treatment and infecting others.

Chapter 20. PROVIDING MEDICAL CARE FOR MAJOR NON-COMMUNICABLE DISEASES

Item 1. Provision of medical care in the field of mental health to persons with mental, behavioral disorders (diseases)

Article 163. The rights of persons with mental, behavioral disorders (diseases)

1. Persons with mental, behavioral disorders (diseases) have all the rights and freedoms of citizens provided by the Constitution of the Republic of Kazakhstan and this Code.

Restriction of exercise of the rights and freedoms of citizens associated with mental, behavioral disorders (diseases) shall be permissible only in cases provided by the laws of the Republic of Kazakhstan.

2. Persons with mental, behavioral disorders (diseases) in provision of medical care in the field of mental health have the right to:

1) receiving medical care in the field of mental health at the place of residence, as well as, if necessary, at the location;

2) refusal at any stage of treatment from the use of medical devices and methods, scientific research or educational process, from photography, video or filming;

3) invitation of a specialist involved in provision of medical care in the field of mental health (with the consent of the latter) to work in the medical commission;

4) receiving education according to the program of a general education school or a special school for children with intellectual disabilities, if the patient has not reached the age of eighteen;

5) conducting correspondence, receiving and sending parcels, postal packets, money, postal orders, using the telephone, receiving visitors, subscribing to periodicals;

6) possession of basic necessities and their acquisition, use of their own clothing;

7) a daily walk.

3. Persons with mental, behavioral disorders (diseases), in respect of whom compulsory medical measures shall be applied in psychiatric institutions of a specialized type with intensive supervision, have, in addition to the rights specified in Paragraphs 1 and 2 of this Article, the right to:

1) purchase of additional food;

2) receiving medical services in excess of the guaranteed volume of free medical care;

3) purchase of soft inventory, clothing, footwear;

4) use of long-distance telephone communication;

5) use of a cash control account.

The implementation of these rights shall be carried out at the expense of the person to whom they are granted.

Article 164. Protection of the rights and interests of persons with mental, behavioral disorders (diseases)

1. Persons with mental, behavioral disorders (diseases) in provision of medical care in the field of mental health have the right to invite a representative of their choice to protect their rights and legitimate interests. Registration of a representative office shall be carried out in the manner prescribed by the laws of the Republic of Kazakhstan.

2. The protection of the rights and legal interests of a minor or a person recognized by a court as incompetent shall be carried out by his legal representative.

3. Protection of the rights and legal interests of persons with mental, behavioral disorders (diseases) shall be carried out by their legal representatives.

4. A medical organization providing medical assistance in the field of mental health to persons with mental, behavioral disorders (diseases) shall provide the possibility of inviting a lawyer or legal representative, except for cases provided by Paragraph 5 of Article 166 of this Code.

Article 165. Organization of medical care in the field of mental health for persons with mental, behavioral disorders (diseases)

1. In order to organize medical care in the field of mental health to persons with mental, behavioral disorders (diseases), the state shall:

1) creates medical and production facilities and structural units for occupational therapy, training in new professions, as well as special production facilities, workshops or sites with facilitated working conditions for employment of persons with mental, behavioral disorders (diseases) in these organizations, including persons with disabilities;

2) ensure the organization and conduct of medical and social rehabilitation for persons with mental, behavioral disorders (diseases) at the place of residence, as well as, if necessary, at the location, at the request of the patient can be carried out anonymously.

2. Minors with mental, behavioral disorders (diseases), as well as persons recognized by the court as legally incompetent, medical and social rehabilitation shall be carried out with the consent of their legal representatives.

Footnote. Article 165 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 166. Psychiatric examination

1. Psychiatric examination shall be carried out in order to establish mental, behavioral disorders (diseases) in the examined person, to determine the need for medical care in the field of mental health, as well as to resolve issues of custody, determine temporary disability, expertise of professional suitability, including during military medical expertise.

2. Psychiatric examination, as well as preventive examinations shall be carried out by a psychiatrist:

1) with the written consent of the examined person or upon the written application from his legal representatives indicating the reason for examination;

2) in relation to a minor or a person recognized by a court as incompetent, with the written consent of his legal representative;

3) when carrying out a military medical examination in accordance with the legislation of the Republic of Kazakhstan.

The data of the psychiatric examination and the conclusions on state of mental health of the examined person shall be recorded in medical records, which also indicate the reasons for contacting a psychiatrist and medical recommendations.

3. In case of objection or lack of consent of the examined person or the legal representative of the minor, the examination shall be carried out by decision of the custody and guardianship authority, which can be appealed to the court.

4. The doctor conducting the psychiatric examination shall be obliged to introduce himself to the examined person and his legal representative as a psychiatrist, except for the cases provided by Subparagraph 1) of Paragraph 5 of this Article.

5. A psychiatric examination of a person may be carried out without his consent or without the consent of his legal representative in the case when the examined person commits actions that give grounds to assume that he has a serious mental disorder (disease), which causes:

1) his immediate danger to himself and others;

2) his helplessness, that is, the inability to independently meet basic life needs in the absence of proper care;

3) significant harm to his health due to the deterioration of his mental state, if the person is left without medical assistance in the field of mental health.

6. A psychiatric examination of a person may be carried out without the consent of his legal representative, if the person being examined is under dynamic supervision in the manner prescribed by Paragraph 2 of Article 176 of this Code.

7. Psychiatric examination and psychiatric examination of a person shall be carried out in accordance with the legislation of the Republic of Kazakhstan.

8. In the cases provided by Paragraph 5 of this Article, the decision on psychiatric examination shall be made by the commission of psychiatrists with notification of legal representative of person.

9. The decision on a psychiatric examination of a person without his consent or without the consent of his legal representative, except for cases provided by Paragraph 6 of this Article, shall be made by a psychiatrist upon an application containing information on existence of grounds for such examination listed in Paragraph 5 of this Article.

10. The application for a psychiatric examination must be written, contain detailed information justifying the need for such an examination, and data on refusal of person (or his legal representative) to go to a psychiatrist. A psychiatrist has the right to request additional information necessary for making a decision, having established that the application does not contain the circumstances provided by Paragraph 5 of this Article, or reasonably refuse in writing a psychiatric examination.

11. A minor or a person recognized by a court as incapable, placed in an organization providing medical care in the field of mental health to persons with mental, behavioral disorders (diseases), shall be subject to mandatory examination by the commission of psychiatrists in the manner prescribed by this Article.

12. During the first six months, a minor or a person declared legally incompetent by a court shall be subject to examination by the commission of psychiatrists at least once a month in order to resolve the issue of extending hospitalization. The decision to extend hospitalization for more than six months shall be made by a court decision on the basis of an appeal by the commission of psychiatrists in the manner prescribed by the legislation of the Republic of Kazakhstan in the field of healthcare.

13. If the commission of psychiatrists or the administration of an organization providing medical assistance in the field of mental health to persons with mental, behavioral disorders (diseases), abuses committed during hospitalization by legal representatives of a minor or a person declared incapable by a court, the administration of organization within twenty four hours from the moment of revealing the specified circumstances, notifies the prosecutor and the custody and guardianship authority at the place of residence of the ward.

Article 167. Provision of medical care to persons with mental, behavioral disorders (diseases)

1. The state guarantees:

1) emergency and routine medical care in the field of mental health within the guaranteed extent of free medical care;

2) psychiatric examination, determination of temporary disability;

3) social and household help and assistance in employment for persons with mental, behavioral disorders (diseases);

4) implementation of medical programs and measures aimed at ensuring equal opportunities for persons with special needs.

2. The diagnosis of a mental, behavioral disorder (disease) shall be established by a psychiatrist in accordance with the criteria of the international classification of diseases.

A primary health care doctor has the right to diagnose and treat borderline mental and behavioral disorders in the amount established by the authorized authority, with the patient's written consent. The conclusion of a doctor of primary health care shall not be a basis for restricting the rights and freedoms of a patient, as well as a psychiatric examination.

3. For the diagnosis and treatment of a person with a mental, behavioral disorder (disease), medical devices and methods shall be used, permitted by the legislation of the Republic of Kazakhstan in the field of healthcare.

4. Medicines and methods are used only for diagnostic and therapeutic purposes in accordance with the nature of painful disorders and are prohibited for use as punishment for a person.

5. The doctor, within forty-eight hours from the moment of the psychiatric examination, provides a person with a mental, behavioral disorder (disease), if he can correctly perceive the essence of the information presented, or his legal representative, written information about the nature of the mental, behavioral disorder (disease), goals and methods of treatment, as well as data on duration of the recommended treatment, possible pain, side effects, and expected results. The information provided shall be recorded in the medical records. In other cases, this information may be provided in accordance with Paragraph 4 of Article 273 of this Code.

6. Treatment of a person with a mental, behavioral disorder (disease) shall be carried out after obtaining his consent or his legal representative, except for the cases provided by Paragraph 7 of this Article.

7. Treatment can be carried out without the consent of a person with a mental, behavioral disorder (disease) or his legal representative only when applying compulsory medical measures on the grounds established by the laws of the Republic of Kazakhstan, as well as when compulsory hospitalization on the grounds provided by Paragraph 1 of Article 137 of this Code. In these cases, except for emergency hospitalization, treatment shall be carried out by the decision of the commission of psychiatrists. When a person is hospitalized without his consent, a decision on the procedure for treatment by the commission of psychiatrists must be ensured within forty-eight hours from the moment of his hospitalization.

8. A person with a mental, behavioral disorder (disease) or his legal representative has the right to refuse the proposed treatment or terminate it, except for the cases provided by Paragraph 7 of this Article.

9. The person who has refused treatment or his legal representative must be explained the possible consequences of termination of treatment. Refusal of treatment with indication of information about possible consequences shall be made out by an entry in the medical documentation signed by a person with a mental, behavioral disorder (disease) or his legal representative and a psychiatrist.

Article 168. Hospitalization in a hospital of an organization providing medical care in the field of mental health to persons with mental, behavioral disorders (diseases)

1. The grounds for hospitalization in a hospital shall be the presence of a person's mental, behavioral disorder (disease) and the decision of a psychiatrist on the need for examination or treatment in a hospital.

2. The hospitalization of a person in a hospital shall be carried out voluntarily at his request or with his written consent, except for the cases provided by Article 137 of this Code.

3. A minor shall be hospitalized in a hospital with the written consent of his legal representative.

4. In the event of an objection or the absence of a legal representative, hospitalization of a minor in a hospital shall be carried out by decision of the custody and guardianship authority, which can be appealed in court, with a written notification of the prosecutor within twenty-four hours from the date of the decision on hospitalization.

5. The consent of the person to hospitalization shall be formalized by an entry in the medical documentation signed by the person or his legal representative and the psychiatrist.

6. Compulsory hospitalization in a hospital shall be allowed on the basis of a court decision.

Compulsory hospitalization of a person in a hospital before a court makes a decision shall be allowed only in the cases provided by Subparagraphs 3) and 4) of Paragraph 1 of Article 137 of this Code.

For each case of involuntary hospitalization without a court decision, the administration of organization providing medical care in the field of mental health to persons with mental, behavioral disorder (disease), within forty-eight hours from the moment the person shall be placed in a hospital, sends a written notification to the prosecutor in accordance with the laws of the Republic of Kazakhstan, and also informs the spouse, close relatives and (or) legal representatives if there is information about them.

7. Stay of a person in a hospital forcibly continues only during the period of preservation of the grounds on which the hospitalization was carried out.

8. A person admitted to a hospital in a compulsory manner during the first six months shall be subject to examination by the commission of psychiatrists at least once a month in order to resolve the issue of extending hospitalization. The extension of hospitalization for more than six months shall be carried out by a court decision on the basis of an application by an organization providing medical assistance in the field of mental health to persons with mental, behavioral disorders (diseases), about the need to extend the period of compulsory hospitalization and treatment, to which the conclusion of the commission of psychiatrists shall be attached.

9. An extraordinary examination of a compulsorily hospitalized person may be carried out at the request of the patient himself or his legal representative.

A person hospitalized in a hospital on the grounds provided by Paragraph 1 of Article 137 of this Code shall be subject to compulsory examination within forty-eight hours from the moment of hospitalization by the commission of psychiatrists, which decides on the justification for hospitalization. In cases where hospitalization shall be recognized as unjustified and the hospitalized person does not express a desire to stay in the hospital, it shall be subject to immediate discharge.

10. In case of disagreement with compulsory hospitalization, a person with mental, behavioral disorder (disease) or his legal representative has the right to apply to the court in the manner prescribed by the laws of the Republic of Kazakhstan.

Article 169. Discharge from hospital of organization providing medical care in the field of mental health to persons with mental, behavioral disorders (diseases)

1. Discharge from the hospital shall be made after the person has recovered or his mental state has improved, when no further inpatient treatment shall be required, as well as upon completion of examination or expertise, which were the grounds for admission to the hospital.

2. Discharge of a person who is voluntarily in the hospital shall be made on his personal application, on application of his legal representative or by decision of his attending physician.

3. Discharge of a person admitted to a hospital forcibly shall be made upon the conclusion of the commission of psychiatrists, a court decision or a prosecutor's order.

4. Discharge of a person to whom, according to a court ruling, compulsory measures of a medical nature were applied, shall be made only by ruling of the court.

5. A person admitted to a hospital voluntarily may be denied discharge if the commission of psychiatrists of organization providing medical care in the field of mental health to persons with mental, behavioral disorder (disease) establishes the grounds for compulsory hospitalization provided by Paragraph 1 of Article 137 of this Code. In this case, the issues of his stay in the hospital, prolongation of hospitalization and discharge from the hospital shall be resolved in the manner prescribed by Paragraphs 7 - 9 of Article 168 of this Code and Paragraph 3 of this Article.

Article 170. Compulsory medical measures against a person with mental, behavioral disorders (diseases)

1. Compulsory medical measures shall be applied by a court decision against a person with a mental, behavioral disorder (disease) who has committed socially dangerous acts, on the grounds and in the manner established by the legislation of the Republic of Kazakhstan.

2. Compulsory medical measures shall be carried out in organizations providing medical care in the field of mental health to persons with mental, behavioral disorder (disease), in the form of:

1) compulsory observation and treatment by a psychiatrist on an outpatient basis;

2) compulsory treatment in a general psychiatric hospital;

3) compulsory treatment in a psychiatric hospital of a specialized type;

4) compulsory treatment in a psychiatric hospital of a specialized type with intensive supervision.

3. A person admitted to a hospital for application of compulsory medical measures shall be recognized as incapable of work for the whole period of stay in the hospital.

4. Rules for use of funds from individuals and legal entities, including pension payments and state social benefits, credited to the cash control account of a state psychiatric organization of a specialized type with intensive supervision, for use by persons with mental, behavioral disorders (diseases) who are on compulsory treatment shall be developed and approved by the authorized authority.

5. Accounting and reporting on use of funds of control account of cash of a state psychiatric organization of a specialized type with intensive supervision, as well as control over their use shall be carried out in accordance with the legislation of the Republic of Kazakhstan.

6. Protection of organization providing medical care in the field of mental health in the form of compulsory treatment of persons with mental, behavioral disorders (diseases) caused by use of psychoactive substances shall be assigned to the administration of this organization and shall be carried out in accordance with the legislation of the Republic of Kazakhstan in the field of security activities.

7. Protection of a state psychiatric organization of a specialized type with intensive supervision shall be carried out in accordance with the procedure determined by the Ministry of Internal Affairs of the Republic of Kazakhstan jointly with the authorized authority.

8. The equipment of a state psychiatric organization of a specialized type with intensive supervision with engineering and technical means of protection shall be carried out by the authorized authority in accordance with the procedure determined by the Ministry of Internal Affairs of the Republic of Kazakhstan jointly with the authorized authority.

Article 171. Compulsory measures of medical nature against a person with mental, behavioral disorders (diseases) associated with use of psychoactive substances

1. Compulsory medical measures shall be applied by a court decision in relation to a person with mental, behavioral disorders (diseases) associated with the use of psychoactive substances, who has committed a criminal offense, recognized in need of treatment, as well as against a person who has committed an administrative offense and evades voluntary treatment.

2. Referral for compulsory treatment in organizations providing medical care in the field of mental health to persons with mental, behavioral disorders (diseases) shall not entail a criminal record.

The time spent on compulsory treatment shall not interrupt the length of service and shall be included in the total length of service.

3. For a person sent for compulsory treatment, living in a dwelling from the state housing stock, housing shall be retained for the whole period of being on treatment.

4. A person with a mental, behavioral disorder (disease) associated with the use of psychoactive substances who being under compulsory treatment has the right to:

1) become familiar with the internal regulations of organization for compulsory treatment and other documents regulating the procedure for staying in this organization;

2) maintain correspondence, receive and send parcels, small parcels, money, postal orders, use the telephone, receive visitors, subscribe to periodicals;

3) receive food, material and household and medical services;

4) labor in accordance with the labor legislation of the Republic of Kazakhstan;

5) purchase, at the expense of the funds in personal account, food and basic necessities, as well as other things that shall not be prohibited for storage and use on the territory of organization for compulsory treatment;

6) have meetings with close relatives in the manner prescribed by the internal regulations;

7) conduct correspondence without restriction;

8) receive packages, send and receive parcels in the manner determined by the internal regulations;

9) receive money transfers, which are credited to his personal account;

10) for a daily walk;

11) file complaints against actions (inaction) of employees of organizations to the authorized authority, prosecutor's office, court in the manner established by the laws of the Republic of Kazakhstan.

5. A person with a mental, behavioral disorder (disease) associated with the use of psychoactive substances who is under compulsory treatment in an organization shall be obliged to:

1) comply with the established internal regulations;

2) fulfill the legal requirements of administration of organization for compulsory treatment and medical personnel;

3) take the prescribed treatment;

4) take care of property of organization;

5) maintain cleanliness and order in organization for compulsory treatment, as well as carry out cleaning on its territory no more than two hours a week;

6) maintain personal hygiene.

Article 172. Registration of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances for compulsory treatment

1. A person registered for compulsory treatment in connection with mental, behavioral disorder (disease) associated with use of psychoactive substances shall be notified of the date and place of medical examination by the organization providing medical assistance in the field of mental health.

The notice shall be sent by registered mail, telegram with acknowledgment of receipt.

2. A person duly notified by mental health care provider of the date and place of a medical examination (unless there are valid reasons) and evading a medical examination on the basis of a reasoned opinion of mental health care provider shall be subject to brought by the internal affairs authorities for compulsory examination.

3. The bringing shall be carried out by compulsory escorting the person evading medical examination to the place of compulsory examination for a period not exceeding three hours only on working days from nine to eighteen hours.

4. The following shall be recognized as valid reasons for a person's failure to appear for a medical examination: illness that makes it impossible for him to appear, death of close relatives, natural disasters, and other reasons that make it impossible to appear at the appointed time. The escorted person shall be obliged to notify the initiator of compulsory bringing about the existence of valid reasons preventing the appearance of the summons at the appointed time.

5. The conclusion on bringing shall be announced to the person subject to the bringing before its execution, which shall be certified by his signature on conclusion.

In case of refusal of the forwarded person to sign, a note shall be made in conclusion.

Article 173. Organization of compulsory treatment of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances

1. A person with mental, behavioral disorder (disease) associated with use of psychoactive substances who is under compulsory treatment in organization providing medical care in the field of mental health has all the rights and freedoms of citizens provided by the Constitution of the Republic of Kazakhstan.

2. Restrictions on exercise of the rights and freedoms of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances undergoing compulsory treatment in an organization providing medical care in the field of mental health shall be permissible only in cases provided by the laws of the Republic of Kazakhstan.

3. A person with mental, behavioral disorder (disease) associated with use of psychoactive substances, who is under compulsory treatment in an organization providing medical care in the field of mental health, shall be provided with work at his request, he shall be subject to the labor legislation of the Republic of Kazakhstan.

4. During the period of compulsory treatment in organization providing medical care in the field of mental health, the time of compulsory hospitalization for examination shall be counted.

5. The conditions of detention of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances for compulsory treatment in an organization providing medical assistance in the field of mental health shall be established by the internal regulations approved by the authorized authority.

6. A person with mental, behavioral disorder (disease) associated with use of psychoactive substances, who is under compulsory treatment in organization providing medical care in the field of mental health to persons with mental, behavioral disorders (diseases), violating the internal regulations of procedure or avoiding treatment, shall be placed in a special ward if his actions threaten the life and health of others or personally to him. Placement in a special ward shall be carried out by written order of the head of organization providing medical care in the field of mental health, for a period of up to ten days, with a notification from the prosecutor within twenty-four hours from the moment the person shall be placed. In the absence of the head at the workplace, the decision to be placed in a special ward shall be made by the senior employee of the organization providing mental health care, with subsequent informing the head, who determines by written order the terms of detention in the special ward.

7. Unauthorized leave of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances from organization providing medical care in the field of mental health, as well as failure to arrive at the organization by the established date, are evasion of treatment and entail liability in accordance with the laws Republic of Kazakhstan. His delivery for compulsory treatment shall be carried out by the internal affairs authorities of the Republic of Kazakhstan on the basis of a court order.

The period of unauthorized absence of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances in organization providing medical care in the field of mental health shall not be included in the treatment period.

8. For committing offenses and (or) causing material damage, a person with mental, behavioral disorder (disease) associated with use of psychoactive substances, who is under compulsory treatment in organization providing medical assistance in the field of mental health, shall be liable as established by the laws of the Republic of Kazakhstan.

Article 174. Discharge of a person with mental, behavioral disorder (disease) associated with use of psychoactive substances from organization providing medical care in the field of mental health

1. A person with mental, behavioral disorder (disease) associated with use of psychoactive substances, terminates compulsory treatment and shall be discharged from organization providing medical care in the field of mental health:

1) upon expiration of the period of compulsory treatment determined by the court;

2) in connection with the identification of concomitant serious diseases that impede the implementation of compulsory treatment, by a court order;

3) ahead of schedule in connection with a successful cure, but not earlier than six months, by court order.

2. If a person with mental, behavioral disorder (disease), associated with use of psychoactive substances, who is in organization providing medical care in the field of mental health, avoids treatment, the period of stay may be extended by a court decision on the basis of a request from the administration of organization providing medical care in the field of mental health based on medical opinion, but for no more than one year. In this case, the time spent in an organization providing medical care in the field of mental health should not exceed two years.

3. A person discharged from an organization providing medical care in the field of mental health shall be returned documents, money and things seized and stored in the organization's storage room.

4. The working conditions of persons with mental, behavioral disorder (disease) associated with use of psychoactive substances shall be determined by the labor legislation of the Republic of Kazakhstan.

5. The administration of organization providing medical care in the field of mental health shall notify the local executive authority at the place of residence about persons become free from the organization providing medical care in the field of mental health to provide assistance in the household and work arrangement and to the healthcare organization at the place of residence to ensure surveillance.

6. Persons who have undergone compulsory treatment, after being discharged from an organization providing medical assistance in the field of mental health, except for those discharged by a court order as recovered early, shall be obliged to register with an organization providing medical assistance in the field of mental health to persons with mental, behavioral disorders (diseases), at the place of residence and undergo supportive treatment in it in the manner determined by the authorized authority.

In case of evasion of registration and undergoing supportive treatment, the person may be forced to be brought by the internal affairs authority.

7. Labor and household arrangements of a person discharged from an organization providing medical care in the field of mental health shall be carried out at the place of residence and shall be assigned to local executive authorities.

Article 175. Safety measures in providing medical care in the field of mental health

1. Medical care in the field of mental health in inpatient conditions shall be carried out in the least restrictive conditions that ensure the safety of the hospitalized person and other persons, subject to medical personnel observing their rights and legitimate interests.

2. Measures of physical restraint and isolation during compulsory hospitalization and hospitalization shall be applied only in those cases, forms and for that period of time when, in the opinion of the psychiatrist, it is impossible to prevent the actions of the hospitalized person posing an immediate danger to him or others by other methods persons, and shall be carried out under the constant supervision of medical personnel. The forms and time of application of measures of physical restraint or isolation shall be recorded in medical records with notification of his legal representative.

3. Law enforcement officers shall be obliged to assist medical workers in the implementation of compulsory examination, compulsory hospitalization, to ensure safe conditions for access to the hospitalized person for the purpose of his examination, as well as in cases that threaten the life and health of others from the hospitalized person (person subject to hospitalization).

Article 176. Dynamic observation of persons with mental, behavioral disorders (diseases)

1. Dynamic observation of persons with mental, behavioral disorders (diseases) may be established regardless of the consent of the person with mental, behavioral disorder (disease) or his legal representative in the cases provided by Paragraph 2 of this Article, and involves monitoring the state of mental health of the person by regular examinations by a psychiatrist and providing him with the necessary medical and social assistance.

2. Dynamic observation can be established for a person suffering from a chronic or protracted disorder with severe, persistent, often exacerbated painful manifestations.

3. Rules of dynamic observation, as well as termination of dynamic observation of persons with mental, behavioral disorders (diseases) shall be developed and approved by the authorized authority.

4. When the mental state changes, a person with mental, behavioral disorders (diseases) may be examined without his consent or without the consent of his legal representative on the grounds and in the manner provided by Paragraph 5 of Article 166 of this Code. Dynamic observation of persons with mental, behavioral disorders (diseases) can be resumed in such cases by the decision of the commission of psychiatrists.

Item 2. Providing medical care for orphan diseases

Article 177. Providing medical care for orphan diseases

1. Orphan (rare) diseases include rare serious diseases that threaten human life or lead to disability, the frequency of which does not exceed the officially defined level.

2. Treatment of orphan diseases shall be carried out within the guaranteed capacity of free medical care.

3. The list of orphan diseases and medicines for their treatment (orphan) shall be approved by the authorized authority, taking into account the following criteria:

1) prevalence in the Republic of Kazakhstan;

2) the need for systematic treatment, for which there are medicines (curable patients) developed and registered on the territory of the Republic of Kazakhstan;

3) the need for systematic treatment with use of medicines that shall be developed and available in the world, but shall not be registered for use on the territory of the Republic of Kazakhstan;

4) the presence of diseases for treatment of which there are no developed medicines in the world;

5) the need to provide palliative care due to the lack of radical therapy (incurable patients).

4. The rules for formation of the list of orphan diseases and medicines for their treatment shall be developed and approved by the authorized authority.

Chapter 21. TEMPORARY ADAPTATION AND DETOXIFICATION CENTERS

Article 178. Temporary adaptation and detoxification centers

1. Temporary adaptation and detoxification centers shall be created by decision of local executive authorities.

2. The procedure for organizing the activities of temporary adaptation and detoxification centers and the internal regulations of temporary adaptation and detoxification center shall be determined by the authorized authority in agreement with the Ministry of Internal Affairs of the Republic of Kazakhstan.

Article 179. Grounds for placing persons in temporary adaptation and detoxification centers

The basis for placing persons in temporary adaptation and detoxification centers shall be the conclusion of a medical examination of the person being placed in a state of alcohol inebriation (intoxication), carried out by the staff of an organization providing medical care in the field of mental health.

Article 180. Reception and registration of persons placed in temporary adaptation and detoxification centers

1. The procedure for admitting and registering persons placed in temporary adaptation and detoxification centers, for conducting a personal examination, medical examination, as well as a list of things subject to seizure, shall be determined in accordance with the rules for organizing the activities of temporary adaptation and detoxification centers.

2. Close relatives at the place of residence shall be immediately notified of the placement in temporary adaptation and detoxification center of persons in a state of alcohol inebriation (intoxication).

When a foreigner is placed in a temporary adaptation and detoxification center, the medical personnel shall notify the General Prosecutor's Office of the Republic of Kazakhstan, the Ministry of Foreign Affairs of the Republic of Kazakhstan, the National Security Committee of the Republic of Kazakhstan and the Ministry of Internal Affairs of the Republic of Kazakhstan.

Article 181. Regimen of detention in temporary adaptation and detoxification centers

1. In temporary adaptation and detoxification centers, a regime shall be established that ensures the safety of detainees and excludes the possibility of their unauthorized leave. The conditions of detention, the requirements for the equipment of the premises shall be determined by the internal regulations of temporary adaptation and detoxification center.

2. Men placed in temporary adaptation and detoxification centers shall be placed separately from women.

3. Minors placed in temporary adaptation and detoxification centers shall be hospitalized in the specialized departments of the relevant medical organization with the consent of their legal representatives.

4. Persons with infectious and parasitic diseases may not be kept with other persons placed in temporary adaptation and detoxification centers.

Article 182. Rights and obligations of persons placed in temporary adaptation and detoxification centers

1. Persons placed in temporary adaptation and detoxification centers have the right:

1) receive information about their rights and obligations, the regime of detention;

2) personal safety while in temporary adaptation and detoxification center;

3) receive material and household and medical and sanitary services;

4) apply to the medical personnel of organization providing medical care in the field of mental health, as well as to the police, prosecutor's office, and the court on issues of violation of their rights and legal interests.

2. Persons placed in temporary adaptation and detoxification centers shall be obliged to comply with the internal regulations of the temporary adaptation and detoxification center, approved by the authorized authority in agreement with the Ministry of Internal Affairs of the Republic of Kazakhstan.

Article 183. Releasing persons placed in temporary adaptation and detoxification centers

1. Persons placed in temporary adaptation and detoxification centers shall be subject to immediate release in a planned manner upon achieving an improvement in their condition that does not require further observation and treatment in the center, within 24 hours from the date of admission.

2. The released persons shall be returned against receipt the documents, money and things confiscated from them for storage, except for things the storage of which is illegal.

3. In case of illegal storage by persons placed in temporary adaptation and detoxification centers, firearms or cold weapons, explosive, potent or poisonous substances, narcotic drugs, psychotropic substances and their precursors, decisions shall be made in accordance with the legislation of the Republic of Kazakhstan.

4. Upon discharge, the person shall be issued a certificate of his stay in temporary adaptation and detoxification center.

Chapter 22. NATIONAL PREVENTIVE MECHANISM

Footnote. In Chapter 22, the words "Commissioner for Human Rights", "Commissioner for Human Rights", "of Commissioner for Human Rights", "by Commissioner for Human Rights", "to Commissioner for Human Rights" are replaced, respectively, by the words "Commissioner for Human Rights in the Republic of Kazakhstan", "Commissioner for Human Rights in the Republic of Kazakhstan", "of Commissioner for Human Rights in the Republic of Kazakhstan", "by Commissioner for Human Rights in the Republic of Kazakhstan", "to Commissioner for Human Rights in the Republic of Kazakhstan" in accordance with the Law of the Republic of Kazakhstan dated 05.11.2022 No. 157-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 184. National preventive mechanism

1. The National preventive mechanism operates as a system for prevention of torture and other cruel, inhuman or degrading treatment or punishment, functioning through the activities of participants in the national preventive mechanism.

2. As part of their activities, the participants of the national preventive mechanism visit organizations for compulsory treatment (specialized anti-tuberculosis organizations, organizations providing medical care in the field of mental health, for use of compulsory medical measures (for compulsory treatment - a general psychiatric hospital, a specialized psychiatric hospital), a psychiatric hospital of a specialized type with intensive supervision) and other organizations determined by the laws of the Republic of Kazakhstan for visiting by these participants.

3. Participants of the national preventive mechanism shall be the Commissioner for Human Rights in the Republic of Kazakhstan, as well as members of public oversight commissions and public associations selected by the Coordination Council, carrying out activities to protect the rights and legal interests of citizens of the Republic of Kazakhstan, lawyers, social workers, doctors.

4. The Commissioner for Human Rights in the Republic of Kazakhstan coordinates the activities of the participants in the national preventive mechanism, takes measures in accordance with the legislation of the Republic of Kazakhstan to ensure the necessary potential and professional knowledge of the participants in the national preventive mechanism.

5. Reimbursement of expenses of participants of the national preventive mechanism for preventive visits shall be carried out from budget funds in the manner determined by the Government of the Republic of Kazakhstan.

Article 185. Coordination Council

1. In order to ensure effective coordination of the activities of the national preventive mechanism, a Coordination Council shall be established under the Commissioner for Human Rights in the Republic of Kazakhstan.

The members of the Coordination Council, except for the Ombudsman, shall be elected by the commission created by the Ombudsman from among the citizens of the Republic of Kazakhstan.

2. The Commissioner for Human Rights in the Republic of Kazakhstan approves:

1) regulations on the Coordination Council under the Commissioner for Human Rights in the Republic of Kazakhstan;

2) rules for selection of participants in the national preventive mechanism;

3) rules for formation of groups of members of the national preventive mechanism for preventive visits;

4) guidelines for preventive visits;

5) rules for preparation of the annual consolidated report on the results of preventive visits.

3. The Coordination Council works with the Subcommittee on Prevention of Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment of the United Nations Committee against Torture.

Article 186. Requirements for participants in the national preventive mechanism

1. Participants of the national preventive mechanism cannot be persons:

1) having an outstanding or unexpunged conviction in the manner prescribed by the law of the Republic of Kazakhstan;

2) suspects or accused of committing a criminal offense;

3) recognized by the court as incapable or partially incapacitated;

4) judges, lawyers, civil servants and military personnel, as well as employees of law enforcement and special state authorities;

5) registered with organization providing medical care in the field of mental health.

2. Participants of the national preventive mechanism also cannot be persons released from criminal liability on the basis of Paragraphs 3), 4), 9), 10) and 12) of part one of Article 35 or Article 36 of the Criminal Procedure Code of the Republic of Kazakhstan for committing an intentional crime; dismissed from the state or military service, from law enforcement and special state authorities, courts or excluded from the bar for negative reasons; deprived of a license to practice law.

Article 187. The rights of a participant in the national preventive mechanism

1. A participant in the national preventive mechanism has the right:

1) receive information on the number of persons held in organizations subject to preventive visits, the number of such organizations and their location;

2) have access to information regarding the treatment of persons held in organizations subject to preventive visits, as well as the conditions of their detention;

3) carry out preventive visits in the prescribed manner as part of the formed groups;

4) conduct interviews with persons detained in organizations subject to preventive visits and (or) their legal representatives without witnesses, personally or, if necessary, through an interpreter, as well as with any other person who, in the opinion of the participant of the national preventive mechanism, can provide relevant information;

5) freely select and visit organizations subject to preventive visits;

6) receive messages and complaints about the use of torture and other cruel, inhuman or degrading treatment or punishment.

2. A participant in the national preventive mechanism shall be independent in carrying out legal activities.

Article 188. Obligations of a participant in the national preventive mechanism

1. When exercising his powers, a participant of the national preventive mechanism shall be obliged to comply with the legislation of the Republic of Kazakhstan.

2. Interference of a participant of the national preventive mechanism in the activities of organizations subject to preventive visits shall not be allowed.

3. If there are circumstances that raise doubts about the impartiality of a participant in the national preventive mechanism, who is a member of the preventive visit group, he must refuse to participate in the preventive visit.

4. A participant in the national preventive mechanism shall be obliged to register received messages and complaints about the use of torture and other cruel, inhuman or degrading treatment or punishment in the manner determined by the Commissioner for Human Rights in the Republic of Kazakhstan.

Received messages and complaints shall be forwarded to the Commissioner for Human Rights in the Republic of Kazakhstan in the manner prescribed by the legislation of the Republic of Kazakhstan.

Information about received and transmitted messages and complaints shall be included in the report on the results of preventive visits.

5. A participant of the national preventive mechanism who has violated the provisions of this Code shall bear responsibility established by the laws of the Republic of Kazakhstan.

Article 189. Termination of powers of a participant of the national preventive mechanism

The powers of a participant in the national preventive mechanism shall be terminated when:

1) violation of the provisions of this Code;

2) a written statement of resignation;

3) his death or the entry into force of a court decision declaring him dead;

4) departure for permanent residence outside the Republic of Kazakhstan;

5) loss of citizenship of the Republic of Kazakhstan;

6) the entry into legal force of the judgment of the court;

7) the occurrence of other cases provided by the laws of the Republic of Kazakhstan.

Article 190. Types and periodic of preventive visits

1. Preventive visits to participants in the national preventive mechanism shall be divided into:

1) periodic preventive visits carried out on a regular basis at least once every four years;

2) intermediate preventive visits carried out in the period between periodic preventive visits in order to monitor the implementation of recommendations based on the results of the previous periodic preventive visit, as well as to prevent the persecution of persons with whom the participants of the national preventive mechanism had interviews by the administration of organization subject to the preventive visit;

3) special preventive visits carried out on the basis of received reports of torture and other cruel, inhuman or degrading treatment or punishment.

2. The Coordination Council determines the time frame and list of organizations subject to preventive visits within the allocated budgetary funds.

Article 191. Procedure for preventive visits

1. Preventive visits shall be conducted by groups formed by the Coordination Council from the participants of the national preventive mechanism, in the manner determined by the Government of the Republic of Kazakhstan in agreement with the Ombudsman.

2. When forming groups for preventive visits, none of the participants in the national preventive mechanism may be subjected to any discrimination on the basis of origin, social, official and property status, sex, race, nationality, language, attitude to religion, beliefs, place of residence or any other circumstances.

3. Ensuring the safety of the participants in the national preventive mechanism shall be the responsibility of the administration of organization subject to the preventive visit. In case of illegal actions of the participants of the national preventive mechanism, the head of the administration of organization subject to the preventive visit shall inform the Commissioner for Human Rights in the Republic of Kazakhstan in writing.

4. Based on the results of each preventive visit, on behalf of the group, a written report shall be drawn up in the form approved by the Coordination Council, which shall be signed by all members of the group that carried out the preventive visit. A member of the group with a dissenting opinion shall draw up it in writing and attach it to the report.

Article 192. Annual consolidated report of participants of the national preventive mechanism

1. The Coordination Council prepares an annual consolidated report of participants of the national preventive mechanism, taking into account their reports on the results of preventive visits.

2. The annual consolidated report of participants in the national preventive mechanism shall also include:

1) recommendations to authorized state authorities to improve the conditions for treatment of persons held in organizations subject to preventive visits and to prevent torture and other cruel, inhuman or degrading treatment or punishment;

2) proposals for improving the legislation of the Republic of Kazakhstan.

A financial report on preventive visits for the past year shall be attached to the annual consolidated report of participants in the national preventive mechanism.

3. The annual consolidated report of participants of the national preventive mechanism shall be sent for consideration to the authorized state authorities and posted on the Internet resource of the Ombudsman no later than one month from the date of its approval by the Coordination Council.

Article 193. Confidentiality

1. Participants of the national preventive mechanism shall not have the right to disclose information about the private life of a person that became known to them during preventive visits, without the consent of this person.

2. Disclosure by the participants of the national preventive mechanism of information about the private life of a person, which became known to them in the course of preventive visits, without the consent of this person shall entail responsibility established by the laws of the Republic of Kazakhstan.

Article 194. Interaction of authorized state authorities with participants in the national preventive mechanism

1. State authorities and their officials shall assist the participants of the national preventive mechanism in carrying out their legal activities.

No state authority or official has the right to restrict the rights and freedoms of citizens of the Republic of Kazakhstan for informing the participants of the national preventive mechanism about the use of torture and other cruel, inhuman or degrading treatment and punishment.

Officials who obstruct the legal activities of the participants of the national preventive mechanism shall bear responsibility established by the laws of the Republic of Kazakhstan.

2. The authorized state authorities, within three months from the date of receipt of the annual consolidated report of the participants of the national preventive mechanism, shall inform the Commissioner for Human Rights in the Republic of Kazakhstan in writing about the measures taken following the consideration of the reports received.

3. Based on the reports of the participants of the national preventive mechanism based on the results of preventive visits, the Commissioner for Human Rights in the Republic of Kazakhstan, in the manner prescribed by the legislation of the Republic of Kazakhstan, has the right to apply to authorized state authorities or officials with a petition to initiate disciplinary or administrative proceedings or a criminal case against an official who has violated rights and freedoms of a person and a citizen of the Republic of Kazakhstan.

Chapter 23. SCOPE OF MEDICAL CARE

Article 195. Scope of medical care

Medical care shall be provided in the following scope:

1) the minimum, which is a guaranteed amount of free medical care provided in accordance with Article 196 of this Code;

2) basic, which is medical care in the system of compulsory social health insurance, provided in accordance with the Law of the Republic of Kazakhstan "On compulsory social health insurance";

3) additional scope of medical care, including medical care:

within the framework of voluntary and (or) imputed medical insurance provided at the expense of contributions of individuals and legal entities;

provided through the provision of paid services and other sources not prohibited by the legislation of the Republic of Kazakhstan;

provided to military personnel, candidates for astronauts, cosmonauts, employees of special state and law enforcement agencies, members of their families, pensioners of law enforcement agencies, persons dismissed from military service, service in special state authorities, as well as certain categories of civil servants and citizens of the Republic of Kazakhstan in the military and medical (medical) institutions (organizations) at the expense of the funds provided by the legislation of the Republic of Kazakhstan;

provided to persons, held in pre-trial detention centers and institutions of the penal (penitentiary) system, at the expense of funds provided for by the legislation of the Republic of Kazakhstan;

provided to individuals at the expense of one-time pension payments in accordance with the legislation of the Republic of Kazakhstan.

The program of guarantees of medical care within the guaranteed volume of free medical care and medical care in the system of compulsory social health insurance is determined annually by the Government of the Republic of Kazakhstan for a three-year period.

Footnote. Article 195 as amended by the Law of the Republic of Kazakhstan dated 02.01.2021 No. 399-VI (shall be enforced from 01.01.2021); dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022); dated 19.04.2023 No. 223-VII (for the procedure of entry into force, see Article 3).

Article 196. Guaranteed scope of free medical care

1. The guaranteed volume of free medical care is provided to citizens of the Republic of Kazakhstan, Candas, refugees, foreigners and stateless persons permanently residing in the territory of the Republic of Kazakhstan at the expense of budgetary funds, includes preventive, diagnostic and curative medical services with the greatest proven effectiveness, as well as drug provision.

The list of the guaranteed scope of free medical care shall be approved by the Government of the Republic of Kazakhstan.

Foreigners and stateless persons temporarily staying in the Republic of Kazakhstan, asylum seekers have the right to receive a guaranteed scope of free medical care for diseases that pose a danger to others, according to the list and in the amount determined by the authorized authority, unless otherwise provided by the laws of the Republic Kazakhstan or international treaties ratified by the Republic of Kazakhstan.

2. Medical care included in the guaranteed scope of free medical care shall be provided on the basis of clinical protocols by medical workers admitted to clinical practice in the territory of the Republic of Kazakhstan.

3. The guaranteed scope of free medical care includes:

1) emergency medical care;

2) primary health care;

3) specialized medical care on an outpatient basis:

in provision of services for prevention and diagnosis of HIV infection and tuberculosis;

in case of injury, poisoning or other emergency conditions;

with socially significant diseases;

for chronic diseases subject to dynamic observation, according to the list determined by the authorized authority;

4) specialized medical care in hospital-replacing conditions:

with socially significant diseases;

for chronic diseases subject to dynamic observation, according to the list determined by the authorized body;

5) specialized medical care in stationary conditions:

when isolating persons who were in contact with a sick infectious or parasitic disease that poses a danger to others, as well as bacteria carriers, virus carriers and persons with suspected infectious or parasitic disease posing a danger to others, according to the list determined by the authorized authority;

in treatment of infectious, parasitic diseases and diseases that pose a danger to others, according to the list determined by the authorized authority;

in an emergency form for persons who are not consumers of services in the system of compulsory social health insurance, including carrying out medical and diagnostic measures in the admission department of a round-the-clock hospital until a diagnosis shall be established that does not require treatment in a round-the-clock hospital, according to the list determined by the authorized authority;

in a planned form according to the list of diseases determined by the authorized authority;

6) medical rehabilitation in treatment of the underlying disease, as well as medical rehabilitation of patients with tuberculosis;

7) palliative medical care according to the list of diseases determined by the authorized authority;

8) provision of blood products and blood components;

9) pathological diagnostics;

10) preparation of a posthumous donor for removal of organs (part of organ) and (or) tissues (part of tissue), removal, conservation, procurement, storage, transportation of organs (part of organ) and (or) tissues (part of tissue) for the purpose of organ transplantation (part of organ) and (or) tissues (parts of tissue).

4. Provision of medicines, medical devices, specialized medicinal products, immunobiological drugs within the guaranteed scope of free medical care shall be carried out:

1) in provision of ambulance, as well as specialized care, including high-tech medical services, in inpatient and inpatient substitution conditions in accordance with the medicinal formulations of healthcare organizations;

2) in provision of primary health care in accordance with the list of diseases against which preventive vaccinations shall be carried out;

3) in provision of primary health care and specialized care on an outpatient basis in accordance with the list of medicines and medical devices for free and (or) preferential provision of certain categories of citizens of the Republic of Kazakhstan with certain diseases (conditions).

5. When providing a guaranteed scope of free medical care, healthcare entities use medicines, medical devices and specialized medical products registered in the Republic of Kazakhstan. Medicines should be included in the Kazakhstan National Pharmaceutical Formulary.

It shall be allowed to use medicines and unregistered medical devices that are not registered in the Republic of Kazakhstan and are not included in the Kazakhstan National Medicinal Formulary to provide health care for a specific patient or to provide medical care to a limited contingent of patients with rare (orphan) diseases and (or) conditions in accordance with the procedure determined by the authorized body.

Footnote. Article 196 as amended by the Law of the Republic of Kazakhstan dated 03.01.2022 No. 101-VII (shall be enforced upon expiry of sixty calendar days from the date of its first official publication).

Article 197. Principles for formation of the guaranteed scope of free medical care

1. The guaranteed scope of free medical care shall be formed on the basis of the principles of universality, accessibility, evidence, realism and regulation.

2. The principle of universality implies universal and equal coverage of the minimum volume of medical care, regardless of the level of income and social status of the persons specified in Paragraph 1 of Article 196 of this Code.

3. The principle of accessibility lies in the possibility of receiving by the persons specified in Paragraph 1 of Article 196 of this Code the guaranteed scope of free medical care in the territory of the Republic of Kazakhstan.

4. The principle of evidence implies the availability of proven scientific and clinical data on effectiveness and safety of medical services, drugs and medical devices.

5. The principle of realism implies that the guaranteed scope of free medical care corresponds to the budget parameters.

6. The principle of regulation consists in state regulation of tariffs for medical services, prices for medicines and medical devices provided in provision of the guaranteed scope of free medical care.

Article 198. The goals of providing medical care within the guaranteed scope of free medical care

The goals of providing medical care within the guaranteed scope of free medical care shall be:

1) diagnosis and treatment of diseases;

2) control over complications of chronic diseases, damage to organs and tissues;

3) prevention of disease progression in the early stages and their consequences;

4) medical care during pregnancy and childbirth;

5) formation of the patient's skills to control their own health;

6) medical care for incurable patients in the terminal (final) stage of the disease.

Article 199. Minimum social standards in the field of healthcare

The guaranteed scope of free medical care, ensuring the availability of healthcare services to the population shall be the minimum social standards in the field of healthcare in accordance with the Law of the Republic of Kazakhstan “On minimum social standards and their guarantees”.

Article 200. Medical care in compulsory social health insurance system

1. The system of compulsory social health insurance provides:

1) specialized medical care on an outpatient basis, including:

preventive medical examinations in the manner and with the periodic established by the authorized authority, except for preventive examinations within the guaranteed scope of free medical care;

reception and consultation by specialized specialists of patients in the direction of doctors of primary health care;

dynamic observation by specialized specialists of persons with chronic diseases in the manner and with the periodic established by the authorized authority;

provision of emergency and planned dental care to certain categories of the population according to the list determined by the authorized authority;

diagnostic services, including laboratory diagnostics, according to the list determined by the authorized authority;

procedures and manipulations according to the list determined by the authorized authority;

2) specialized, including high-tech, medical care in hospital-substituting conditions (except for cases of treatment of diseases within the guaranteed scope of free medical care);

3) specialized, including high-tech, medical care in stationary conditions in a planned form (except for cases of treatment of diseases within the guaranteed scope of free medical care);

4) specialized inpatient care in an emergency form, including the conduct of medical and diagnostic measures in admission department of a round-the-clock hospital until a diagnosis shall be established that does not require treatment in a round-the-clock hospital (except for cases of treatment of diseases within the guaranteed scope of free medical care);

5) medical rehabilitation according to the list of diseases determined by the authorized authority;

6) postmortem diagnostics;

7) preparation of a posthumous donor for removal of organs (part of organ) and (or) tissues (part of tissue), removal, conservation, procurement, storage, transportation of organs (part of organ) and (or) tissues (part of tissue) for the purpose of organ transplantation (parts of organ) and (or) tissues (parts of tissue).

2. Provision of medicines, medical devices, specialized medicinal products, immunobiological preparations in provision of medical care in the system of compulsory social health insurance shall be carried out in provision of:

1) specialized, including high-tech, medical care in inpatient and inpatient-substituting conditions in accordance with the medicinal forms of healthcare organizations;

2) primary health care and specialized medical care on an outpatient basis in accordance with the list of medicines, medical devices approved by the authorized authority for certain categories of citizens with certain diseases (conditions).

3. When providing medical care in the system of compulsory social health insurance, healthcare subjects use medicines, medical products and immunobiological drugs registered in the Republic of Kazakhstan, included in the Kazakhstan national drug formulary.

Article 201. Medical care within voluntary health insurance

Voluntary medical insurance shall be a type of personal insurance that allows you to receive medical services included in the guaranteed scope of free medical care and (or) the scope of medical care in compulsory social health insurance system, as well as additional programs, the costs of which shall be compensated by the insurance organization.

The voluntary health insurance program includes a list of:

medical services under a voluntary insurance contract, which shall be paid by the insured, indicating the total insured amount or separate insurance amounts for each type of medical services provided;

health care organizations where the policyholder (insured) receives medical services.

The list of medical services shall be established by the insurance organization in agreement with the policyholder (insured).

Article 201-1. Medical care within the framework of imputed medical insurance

1. Imputed medical insurance is a type of medical insurance for foreigners temporarily staying in the Republic of Kazakhstan, in accordance with the Law of the Republic of Kazakhstan "On population migration" and international treaties ratified by the Republic of Kazakhstan, allowing to receive medical services on the terms defined by the standard imputed medical insurance contract approved by the authorized body in coordination with the authorized body for regulation, control and supervision of the financial market and financial organizations.

2. The object of imputed medical insurance is the property interest of the insured person associated with the need to receive medical services as a result of the occurrence of an insured event determined by the standard contract of imputed medical insurance.

3. The insured risk is the probability of deterioration of the health of the insured person, resulting in the need to apply to medical organizations.

4. An insured event in the case of imputed medical insurance is the deterioration of the health of the insured person and the associated receipt of medical care in a medical organization:

1) primary health care;

2) specialized medical care in inpatient conditions in an emergency form.

The minimum list of medical care in case of imputed medical insurance is determined by the authorized body.

5. The amount of the insurance sum under the imputed medical insurance contract is determined by the terms of the agreement of the parties and must be at least the amount determined in monthly calculation indices established by the law on the republican budget for the relevant financial year, in order to provide:

1) primary health care - at least fifty monthly calculation indices;

2) specialized medical care in inpatient conditions – at least one hundred monthly calculation indices.

6. Other conditions of imputed medical insurance are determined and established by the standard contract of imputed medical insurance.

Footnote. Chapter 23 is supplemented with Article 201-1 in accordance with the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 202. Medical care provided through the provision of paid services and other sources

1. Medical care provided on a paid basis (paid medical services) shall be provided by health care subjects in accordance with standards on a contractual basis.

2. The sources of formation of paid medical services shall be citizens 'own funds, voluntary medical insurance funds, employers' funds and other sources not prohibited by the legislation of the Republic of Kazakhstan.

3. Paid medical services are provided to persons, including those held in pre-trial detention centers and institutions of the penal (penitentiary) system, in:

1) provision of medical care at their initiative, including without sending specialists of the primary and secondary levels;

2) provision of medical care in excess of the guaranteed scope of free medical care and (or) in the system of compulsory social health insurance;

3) treatment with medicinal products not included in the medicinal form of the healthcare organization;

4) conducting medical research that is not included in the list of guaranteed scope of free medical care and (or) the list of medical care in the compulsory social health insurance system, and (or) without medical indications;

5) rehabilitation treatment and medical rehabilitation provided in sanatorium organizations in excess of the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance, with the exception of persons held in pre-trial detention centers and institutions of the penal (penitentiary) system;

6) medical genetic research without medical indications;

7) medical examination not provided by the guaranteed scope of free medical care and in excess of the scope of compulsory social health insurance;

8) provision of medical care under a contract, including voluntary medical insurance;

9) provision of medical care to foreigners and stateless persons, except for the cases provided by Paragraphs 1 and 2 of Article 83 of this Code.

4. Paid non-medical services to persons shall be provided with additional services (additional household and service services, including stay in superior wards; additional care not due to medical indications; additional food; equipping wards and offices with additional types of non-medical equipment: telephone, TV, office equipment, refrigerator; transport and other services).

5. The types of paid services and the price list for them shall be brought to the attention of the population through visual information, including on Internet resources, by healthcare entities.

6. When providing paid services, healthcare entities maintain primary accounting and reporting documentation in medical healthcare information systems in the forms approved by the authorized authority.

7. The healthcare organization shall be responsible for the timely and high-quality provision of paid medical services to persons from the moment they apply in the manner established by the legislation of the Republic of Kazakhstan.

8. The procedure for provision of paid services by healthcare subjects shall be determined by the authorized authority in accordance with this Code and the laws of the Republic of Kazakhstan.

9. It shall be prohibited to provide, on a paid basis, medical care provided within the guaranteed scope of free medical care and (or) in the system of compulsory social health insurance.

Footnote. Article 202 as amended by the law of the Republic of Kazakhstan dated 30.12.2021 No. 95-VII (shall be enforced from 01.07.2022).

Chapter 24. DONATION AND TRANSPLANTATION

Item 1. Blood donation of and its components

Article 203. Donation, collection of blood, its components and production of blood products

1. Blood donation and its components shall be the voluntary participation of donors in protecting the health of citizens through the implementation of the donated function.

2. Attraction of donors for implementation of the donor function shall be carried out free of charge or on a reimbursable basis.

Attraction of donors on a reimbursable basis shall be carried out in the absence of donors performing a donor function on a gratuitous basis.

3. The process of collecting blood and its components includes donation:

1) blood, which is the process of taking donated blood;

2) blood components, which is the process of taking individual blood components (plasma, cells).

4. In the process of collecting and processing blood, you get:

1) blood components, which are constituents of blood, secreted in the form of cells and cell-free media;

2) blood products, which are medicines produced during the processing of donated blood.

Article 204. Healthcare organizations and other organizations carrying out activities in the field of donation, preparation of blood, its components and production of blood products

1. Preparation, processing, storage and sale of blood, its components from allogeneic donors shall be carried out by state healthcare organizations that have an appropriate license.

2. The production of blood products shall be carried out by organizations that have the appropriate license.

3. Healthcare organizations and other organizations carrying out activities in the field of donation, preparation of blood, its components and preparations shall be responsible for their quality, and also sell blood and its components for the following purposes:

1) clinical use;

2) production of blood products;

3) use for the manufacture of reagents and (or) consumables for medical devices for diagnostics outside a living organism (in vitro) (including from blood components unsuitable for clinical use).

4. In the event of a state of emergency or martial law on the territory of the Republic of Kazakhstan, the organization of donation shall be carried out in accordance with the legislation of the Republic of Kazakhstan.

Article 205. Ensuring the safety and quality of donated blood, its components and preparations

1. The safety of donated blood, its components and preparations shall be ensured by compliance with the established requirements for medical examination of donors, safety and quality in the production of blood products for medical use, approved by the authorized authority.

The assessment of the quality of laboratory tests carried out in organizations operating in the field of blood services shall be carried out by the republican reference laboratory of the blood service.

2. It shall be prohibited to use and sell donated blood, its components, preparations without appropriate labeling.

3. Healthcare organizations and medical workers performing transfusion of donated blood, its components and preparations shall be obliged to ensure compliance with the relevant requirements for their safe use, as well as the procedure for provision of transfusion care.

Article 206. Rights and obligations of donors of blood and its components

1. A donor has the right to be an individual who has reached the age of eighteen, has passed an appropriate medical examination and has no contraindications, who has expressed a voluntary desire to donate blood and its components for medical purposes.

2. The donor has the right:

1) donate blood and its components free of charge;

2) donate blood and its components for a fee;

3) get acquainted with the results of medical examination;

4) be encouraged in accordance with this Code.

3. The donor shall be obliged to provide information known to him about all existing and previously transferred diseases, as well as about the use of narcotic drugs, psychotropic substances, their analogues and precursors.

Article 207. Donor medical examination

1. Before the donation of blood and its components, the donor undergoes a compulsory medical examination within the guaranteed scope of free medical care in the manner determined by the authorized authority.

2. Certificates of health status for implementation of the donor function shall be issued in the state healthcare organizations free of charge.

3. Medical examination of donors of blood and its components shall be carried out within the guaranteed scope of free medical care.

Article 208. Guarantees provided to the donor, the rights and obligations of employers and organizations for development of blood donation and its components

1. An employee during a medical examination and blood donation and (or) its components on working days shall be released from work with the preservation of the average wage.

2. A donor who donated blood and (or) its components on a gratuitous basis shall be provided with an additional day of rest with the preservation of the average wage, which can be added to the annual labor leave. These guarantees shall be valid for one year from the date of donation.

In case of a failed donation of blood and its components, an additional day of rest shall not be provided.

3. In the event that, by agreement with the employer, an employee who is a donor, on the days of donating blood and (or) its components, has begun work, he is given, at his request, another day of rest with the preservation of his average wage, or this day can be added to the annual labor leave.

4. It shall not be allowed to involve an employee who is a donor on the days of donating blood and (or) its components to work at night, overtime work, heavy work, work with harmful and (or) dangerous working conditions.

5. Military personnel, employees of law enforcement and special state authorities, as well as students (pupils) who are donors, on the days of donating blood and (or) its components shall be exempt from duty, watch and other forms of service and from the educational process.

6. Donors shall be encouraged in accordance with the legislation of the Republic of Kazakhstan.

7. A donor who donated blood and (or) its components on a gratuitous basis, to replenish the volume of his blood and energy expenditures of the body after donating blood and (or) its components at his choice, receives free food or its monetary equivalent in the amount established by the authorized authority.

In case of failed donation of blood and (or) its components, free food or its monetary equivalent to replenish the volume of one's own blood and energy expenditure of the authority after donating blood and (or) its components shall not be issued.

8. A donor of blood, its components, who donates blood and its components on a reimbursable basis, a healthcare organization that carries out activities in the field of procurement of blood and its components shall be paid.

9. The procedure, criteria and amount of payments to donors who donate blood and its components on a reimbursable basis shall be established by the authorized authority.

10. Employers and heads of organizations, in order to create conditions for development of donation, shall be obliged to:

1) provide assistance to local government healthcare authorities, state healthcare organizations in attracting citizens of the Republic of Kazakhstan to the ranks of donors;

2) provide the necessary premises free of charge and create conditions for taking blood and its components;

3) unimpeded to release the employee who is the donor from work on the day of examination and donation of blood and its components;

4) provide the employee who is a donor with the guarantees established by this Code.

11. Employers and heads of organizations have the right to further encourage donors.

Item 2. Transplantation of organs (part of organ) and (or) tissues (part of tissue)

Article 209. Transplantation of organs (part of organ) and (or) tissues (part of tissue) and conditions for their removal

1. Transplantation of organs (part of organ) and (or) tissues (part of tissue) shall be carried out from a donor to a recipient and consists of the following stages: removal, conservation, storage, transportation and transplantation of organs (part of an organ) and (or) tissues (part of tissue).

2. Removal, conservation, storage, transportation and transplantation of organs (part of organ) and (or) tissues (part of tissue) shall be carried out in state medical organizations, one hundred percent of the voting shares (stakes in the authorized capital) of which belong to the state, as well as in the medical organizations "Nazarbayev University" in the presence of a license to carry out medical activities for the provision of organ (part of an organ) and (or) tissue (part of tissue) transplantation services in accordance with profile of medical activity.

3. Removal of organs (part of an organ) and (or) tissues (part of tissue) for further transplantation to a person (potential recipient) shall be performed from a living person (intravital donor) or deceased (posthumous donor).

4. When transplanting organs (part of organ) and (or) tissues (part of tissue), it shall be prohibited:

1) forced removal of organs (part of an organ) and (or) tissues (part of tissue) from a person;

2) forcing a person to provide his organ (part of organ) and (or) tissues (part of tissue);

3) buying and selling organs (parts of an organ) and (or) tissues (parts of tissue) of a person;

4) removal of organs (part of organ) and (or) tissues (part of tissue) from an intravital donor or a posthumous donor who is a minor or incapacitated person;

5) removal of organs (part of organ) and (or) tissues (part of tissue) from a posthumous donor for transplantation to foreigners and stateless persons;

6) removal of organs (part of organ) and (or) tissues (part of tissue) from persons who, for health reasons, age or other reasons, could not provide data about their identity and whose identity was not established at the time of ascertaining death.

5. Removal of organs (part of organ) and (or) tissues (part of tissue) from an infected living donor or posthumous donor for transplantation to a recipient shall be prohibited.

The list of infectious diseases in which transplantation of organs (part of organ) and (or) tissues (part of tissue) from a donor is permitted shall be approved by the authorized authority.

6. To ensure the transplantation of organs (part of organ) and (or) tissues (part of tissue), a register shall be formed:

1) potential recipients of organs (part of organ) and (or) tissues (part of tissue);

2) recipients of organs (part of organ) and (or) tissues (part of tissue);

3) donors of organs (parts of organ) and (or) tissues (part of tissue);

4) citizens who have expressed the right to posthumous donation of organs (part of organ) and (or) tissues (part of tissue).

7. The procedure for formation and maintenance of the register shall be determined by the authorized authority.

8. Registration of the will of a citizen of the Republic of Kazakhstan on consent or refusal to remove organs (part of organ) and (or) tissues (part of tissue) from him after death for the purpose of transplantation in the register of citizens who have expressed the right to posthumous donation of organs (part of organ) and (or) tissue (part of tissue), can be produced by direct contact with a medical organization providing primary health care, or on the web portal of "electronic government".

Access to the register of citizens who have expressed the right to posthumous donation of organs (part of organ) and (or) tissues (parts of tissue) shall be possible only for authorized persons of the Coordination Center for Transplantation in the manner determined by the authorized authority.

Footnote. Article 209 as amended by the Law of the Republic of Kazakhstan dated 31.03.2021 No. 24-VII (shall be enforced upon expiration of ten calendar days after the date of its first official publication ).

Article 210. The procedure for transplantation of organs (part of organ) and (or) tissues (part of tissue) from an intravital donor

1. An intravital donor of an organ (part of organ) and (or) tissues (part of tissue) may be a person aged eighteen and older, capable, who is in genetic connection with the recipient and (or) has tissue compatibility with him, who has expressed a written notarially certified consent to the removal of an organ (part of organ) and (or) tissues (part of tissue) for further transplantation.

2. For transplantation, only one of the paired organs, a part of organ or tissue, the removal of which will not entail an irreversible health disorder, may be removed from a living donor.

3. An intravital donor must undergo a comprehensive medical examination in the manner prescribed by the authorized authority.

4. To establish a genetic link between a potential recipient and an intravital donor, an Ethics Commission shall be created. The composition and position of the Ethics Commission shall be approved by the authorized authority.

Article 211. Coordination and support of organ transplantation (part of organ) and (or) tissues (part of tissue)

1. Coordination Center for Transplantation - a healthcare organization dealing with the coordination and support of organ transplantation (part of organ) and (or) tissues (part of tissue), the regulation of which shall be approved by the authorized authority.

2. Determination of the immunological compatibility of tissues during transplantation shall be carried out in tissue typing laboratories (HLA-laboratories), functioning as a structural unit under state medical organizations that carry out activities in the field of donation, preparation of blood, its components and preparations.

The rules for determining the immunological compatibility of tissues during transplantation of organs (part of organ) and (or) tissues (parts of tissue) and the regulation on the activities of the HLA laboratory shall be developed and approved by the authorized authority.

Determination of the immunological compatibility of tissues during transplantation shall be carried out on the basis of a referral for research from an organization licensed to carry out medical activities for provision of services for organ transplantation (part of organ) and (or) tissues (part of tissue).

3. The activity of tissue banks shall be aimed at the formation of stocks of biological materials and their provision to healthcare organizations carrying out transplantation.

4. The procedure for carrying out the activities of the tissue bank shall be determined by the authorized authority.

Article 212. The procedure for transplantation of organs (part of organ) and (or) tissues (part of tissue) from a posthumous donor

1. A posthumous donor may be a person aged eighteen and older, who has been diagnosed with irreversible death of the brain, whose organs (parts of organ) and (or) tissue (parts of tissue) can be used for transplantation to a recipient.

2. The procedure for giving a person's lifetime expression of will to posthumous donation of organs (parts of organ) and (or) tissues (parts of tissue) and notifying a spouse or one of close relatives about this shall be determined by the authorized authority.

3. Removal of organs (part of organ) and (or) tissues (part of tissue) from a posthumous donor for transplantation shall not be allowed if the medical organization at the time of removal being informed that the person concerned during life or after his death other persons specified in part two of this Paragraph, declared their disagreement with the removal of his organs (part of organ) and (or) tissues (part of tissue).

In the absence of a person's lifetime expression of will, the spouse has the right to declare in writing his disagreement (consent) to removal of his organs (part of organ) and (or) tissues (parts of tissue) for transplantation, and in his (her) absence, one of close relatives.

4. Removal and conservation of visual organs from corpses for the purpose of transplantation shall be carried out in organizations carrying out the activities of pathological anatomy and forensic medical examination, in the manner determined by the authorized authority in agreement with the authorized authority in the field of forensic expertise.

5. The procedure and conditions for removal, conservation, storage, transportation and transplantation of organs (parts of organ) and (or) tissues (parts of tissue) shall be determined by the authorized authority.

6. Participation of persons carrying out the removal of organs (part of organ) and (or) tissues (part of tissue) for subsequent transplantation in the statement of irreversible death of the brain shall be prohibited.

7. This Article shall not apply to organs (parts of organ) and (or) tissues (parts of tissue) related to the process of human reproduction, including reproductive tissues (germ cells), as well as blood, its components, hematopoietic stem cells, cells of the human body and (or) animal for use in biomedical purposes.

Article 213. The rights of donor and recipient of organs (part of organ) and (or) tissues (part of tissue)

1. The donor has the right:

1) demand full information from healthcare organizations about possible complications for his health in connection with the forthcoming intervention to remove organs (part of organ) and (or) tissues (part of tissue);

2) undergo a medical examination in order to be included in the register of organ donors (organ parts) and (or) tissues (tissue parts) within the guaranteed scope of free medical care and (or) in the system of compulsory social health insurance;

3) receive treatment, including medication, in health care organizations in connection with the intervention performed to remove organs (part of organ) and (or) tissues (part of tissue) within the guaranteed scope of free medical care and (or) in the system of compulsory social medical insurance;

4) refuse before the start of the surgical intervention for transplantation.

2. The recipient has the right:

1) demand full information from the healthcare organization about possible complications for his health in connection with the upcoming intervention for transplantation of organs (part of organ) and (or) tissues (part of tissue);

2) undergo a medical examination to be included in the register of potential recipients of organs (parts of organ) and (or) tissues (parts of tissue) within the guaranteed scope of free medical care and (or) in the system of compulsory social health insurance.

3) to receive treatment, including medication, in a health care organization in connection with the intervention for removal and transplantation of donor organs (part of organ) and (or) tissues (part of tissue) within the guaranteed scope of free medical care;

4) refuse before the start of the surgical intervention for transplantation.

3. Medical and other employees of health care organizations shall be prohibited from disclosing information about the donor and (or) recipient.

Article 214. Obligations of employers and heads of organizations to create conditions for development of organ donation (part of organ) and (or) tissues (part of tissue)

1. Employers and heads of organizations, in order to create conditions that ensure the development of organ donation (part of organ) and (or) tissues (part of tissue), shall be obliged to free from work an employee who is a donor of organs (part of organ) and (or) tissues (part of tissue).

2. An employee who is a donor of organs (parts of organ) and (or) tissues (parts of tissue) shall be provided with a sheet of temporary disability in accordance with the legislation of the Republic of Kazakhstan, taking into account the time for travel to a medical organization where organs (parts of organ) and (or) tissues (parts of tissue) for the purpose of transplantation, and back to the place of residence while maintaining the average monthly wage.

3. Employers and leaders of organizations have the right to additionally encourage donors of organs (part of organ) and (or) tissue (part of tissue).

Article 215. Register of donors of hematopoietic stem cells (bone marrow)

1. Formation and maintenance of the register of donors of hematopoietic stem cells (bone marrow) in order to ensure the transplantation of hematopoietic stem cells shall be carried out in the manner determined by the authorized authority.

2. The procedure for searching and activating a donor of hematopoietic stem cells, including from international registries, and transporting hematopoietic stem cells to the recipient shall be determined by the authorized authority.

Article 216. Transplantation of artificial organs (part of organ) and (or) tissues (part of tissue)

1. Transplantation of artificial organs (part of organ) and (or) tissues (part of tissue) shall be carried out when:

1) organ failure;

2) the absence of donor organs (part of organ) and (or) tissues (part of tissue);

3) the absence of contraindications for transplantation of artificial organs and tissues.

2. The list of indications and contraindications for transplantation of artificial organs (parts of organ) and (or) tissues (parts of tissue) shall be developed and approved by the authorized authority.

3. Citizens of the Republic of Kazakhstan with artificial organs (parts of organ) and (or) tissues (parts of tissue), if necessary, shall be included in the register of potential recipients of organs (parts of organ) and (or) tissues (parts of tissue) in the manner determined by the authorized authority.

Item 3. Import, export of organs (parts of organ) and (or) tissues (parts of tissue) of a person, hematopoietic stem cells (bone marrow), blood and its components, samples of cells, biological fluids and human secretions

Article 217. Grounds for import, export of organs (parts of organ) and (or) tissues (parts of tissue) of a person, hematopoietic stem cells (bone marrow), donor lymphocytes, germ cells, embryos

1. The import of organs (part of organ) and (or) tissues (part of tissue) of a person, hematopoietic stem cells (bone marrow), donor lymphocytes into the territory of the Republic of Kazakhstan shall be carried out when:

1) the need for transplantation in healthcare organizations;

2) the need for diagnostic tests on the territory of the Republic of Kazakhstan;

3) conducting joint scientific research.

2. Removal of organs (part of organ) and (or) tissues (part of tissue) of a person, hematopoietic stem cells (bone marrow), donor lymphocytes from the territory of the Republic of Kazakhstan shall be carried out:

1) if it is necessary to provide medical care to a citizen of the Republic of Kazakhstan who is outside the Republic of Kazakhstan;

2) if necessary, diagnostic tests;

3) when conducting joint scientific research;

4) in cases provided by international treaties ratified by the Republic of Kazakhstan;

5) if necessary, transplantation of hematopoietic stem cells (bone marrow), donor lymphocytes from a donor living in the Republic of Kazakhstan, to a recipient living abroad and awaiting transplantation.

3. A license to import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (part of organ) and (or) tissues (part of tissue) of a person in the cases provided by Subparagraph 1) Paragraph 1 and Subparagraphs 1) and 4) of Paragraph 2 of this Article, issued by the authorized authority at the request of healthcare organizations operating in the specialty "transplantology", "hematology" in accordance with a license for medical activities, in cases of placement of organs (part of organ) and (or) tissues (part of tissue) of a person under customs procedures for export or release for domestic consumption.

4. Conclusion (permitting document) for import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (parts of organ) and (or) tissues (parts of tissue) of a person premises under the customs procedures for processing in the customs territory, processing outside the customs territory, processing for domestic consumption and in the case of placement under customs procedures for re-export and re-import in order to complete the customs procedures for processing in the customs territory, processing outside the customs territory and processing for domestic consumption shall be issued by the authorized authority.

5. Import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of hematopoietic stem cells (bone marrow), donor lymphocytes in the event of their movement for the purpose of unrelated transplantation shall be carried out on the basis of the conclusion (permitting document) issued by the authorized authority.

6. Import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of germ cells and embryos shall be carried out on the basis of an opinion (permit) issued by the authorized authority in the following cases:

1) the need for in vitro fertilization in health care organizations of the Republic of Kazakhstan;

2) the need for diagnostic tests;

3) conducting joint scientific research;

4) if necessary, in vitro fertilization to a citizen of the Republic of Kazakhstan who is outside the Republic of Kazakhstan;

5) if necessary, in vitro fertilization to close relatives and spouses of citizens of the Republic of Kazakhstan located outside the Republic of Kazakhstan;

6) if necessary, in vitro fertilization of a donor living in the territory of the Republic of Kazakhstan, a recipient living abroad;

7) provided by international treaties ratified by the Republic of Kazakhstan.

7. Import and export of organs (parts of organ) and (or) tissues (parts of tissue) of a person, germ cells and embryos, hematopoietic stem cells (bone marrow), donor lymphocytes by individuals shall not be allowed.

8. The procedure for biological safety research, preservation and transportation of tissues (parts of tissues) of a person and (or) organs (parts of organ) intended for import and export shall be determined by the authorized authority.

Article 218. Grounds for import, export of blood and its components, samples of human biological materials

1. The import of blood and its components, samples of human biological materials into the territory of the Republic of Kazakhstan shall be carried out at:

1) the need to provide medical care on the territory of the Republic of Kazakhstan;

2) the need for diagnostic tests on the territory of the Republic of Kazakhstan;

3) conducting joint scientific research;

4) the need to conduct laboratory studies using the HLA system to confirm the tissue compatibility of a donor living abroad and a recipient living in the Republic of Kazakhstan, as well as to carry out immunostimulation of the recipient as part of hematopoietic stem cell transplantation.

2. Export of blood and its components, samples of human biological materials from the territory of the Republic of Kazakhstan shall be carried out:

1) if it is necessary to provide medical care to a citizen of the Republic of Kazakhstan who is outside the Republic of Kazakhstan, as well as recipients living abroad;

2) if it is necessary to provide medical assistance to close relatives and spouses of citizens of the Republic of Kazakhstan located outside the Republic of Kazakhstan;

3) if necessary, diagnostic tests;

4) when conducting joint scientific research;

5) in cases provided by international treaties ratified by the Republic of Kazakhstan;

6) when sending blood components harvested in state healthcare organizations operating in the field of blood service of the Republic of Kazakhstan, abroad for production of plasma blood products at factories of a foreign manufacturer in order to provide the population of the Republic of Kazakhstan with blood products (contract fractionation);

7) if it is necessary to conduct laboratory studies using the HLA system in order to confirm the tissue compatibility of a donor living in the Republic of Kazakhstan and a recipient living abroad, as well as immunostimulation of the recipient within the hematopoietic stem cell transplantation;

8) when sending blood components and (or) samples of human biological materials abroad as raw materials used in the manufacture of reagents and (or) consumables for medical devices for diagnostics outside of a living organism (in vitro).

3. In addition to the cases provided by Paragraphs 1 and 2 of this Article, the import and export of blood and its components, samples of human biological materials may be carried out in the manner of exchange, carried out only in the absence of blood and its components with the necessary biological properties.

4. A license to import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of blood and its components in the cases provided by Subparagraph 1) of Paragraph 1 and Subparagraphs 1), 2) and 5 ) of Paragraph 2 of this Article, shall be issued by the authorized authority at the request of healthcare organizations carrying out activities in the specialty of "blood banking" in accordance with the license for medical activities, and in the cases provided by Subparagraph 6) of Paragraph 2 of this Article, issued by the authorized authority at the request of a legal entity in cases of placing blood and its components under customs procedures for export or release for domestic consumption.

5. Conclusion (permitting document) for import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of blood and its components in cases of their placement under the customs procedures of processing in the customs territory, processing outside the customs territory or processing for domestic consumption and in the case of placement under the customs procedures of re-export and re-import in order to complete the customs procedures for processing in the customs territory, processing outside the customs territory and processing for domestic consumption shall be issued by the authorized authority.

6. Import into the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan samples of human biological materials used for diagnostic and scientific purposes, intended for external quality control of research, including for reference research, or obtained in the course of biomedical research and (or) clinical trials shall be carried out on the basis of an opinion (permit) issued by the authorized authority.

7. Import and export of blood and its components, samples of human biological materials by individuals shall not be allowed, except for the cases provided by Subparagraph 4) of Paragraph 1 and Subparagraph 7) of Paragraph 2 of this Article.

Article 219. The procedure for import, export of organs (parts of organ) and (or) tissues (parts of tissue) of a person, blood and its components

1. Import into the territory of the Republic of Kazakhstan from states that are not members of the Eurasian Economic Union, and export from the territory of the Republic of Kazakhstan to these states of organs (parts of organ) and (or) tissues (parts of tissue) of a person, blood and its components by healthcare organizations specified in Paragraph 3 of Article 217 and Paragraph 4 of Article 218 of this Code, shall be carried out on the basis of a license issued in the manner prescribed by the Law of the Republic of Kazakhstan "On Permits and Notifications", or an opinion (permitting document).

2. The authorized authority, within three working days, makes a decision on issue or refusal to issue a license for import, export of human tissues (part of tissues), blood and its components, and for import, export of human organs (part of an organ) - within one work day.

3. Decision to issue or refuse to issue an opinion (permit) for import, export of organs (part of organ) and (or) tissues (part of tissue) of a person, blood and its components in cases of placement of organs and tissues of a person, blood and its components under the customs procedures for processing in the customs territory, processing outside the customs territory or processing for domestic consumption and in the case of placement under the customs procedures of re-export and re-import in order to complete the customs procedures for processing in the customs territory, processing outside the customs territory and processing for domestic use, the authorized authority shall accept within three working days.

SECTION 4. EDUCATIONAL AND SCIENTIFIC ACTIVITIES IN THE FIELD OF HEALTHCARE Chapter 25. EDUCATIONAL ACTIVITY IN THE FIELD OF HEALTHCARE

Article 220. Subjects of educational activity in the field of healthcare and conditions for its implementation

1. Educational activity in the field of healthcare shall be carried out in organizations of medical and pharmaceutical education, scientific organizations in the field of healthcare and other educational organizations that implement educational programs in the field of healthcare.

2. Education in the field of healthcare includes:

1) medical education programs implemented in medical specialties;

2) programs of pharmaceutical education implemented in pharmaceutical specialties;

3) training programs for public health professionals and other healthcare professionals.

Organizations of higher and (or) postgraduate education that implement educational programs in the field of healthcare, created in the organizational and legal form of a non-profit joint-stock company, have autonomy in all areas of activity in accordance with the legislation of the Republic of Kazakhstan and shall be guided by the principles of freedom of teaching, research and creativity.

3. Mandatory conditions for implementation of educational programs in the field of healthcare in medical specialties shall be:

1) the presence of a simulation room (center) in the structure of the organization of education in the field of healthcare;

2) in preparation of doctors - the implementation in the organization of higher and (or) postgraduate education programs of integrated and postgraduate medical education (residency, doctoral studies);

3) attracting mentors from among qualified medical workers during the training of students at clinical bases;

4) formation in organizations of higher and (or) postgraduate education of university hospitals and (or) integrated academic medical centers operating on the basis of agreements with scientific organizations in the field of healthcare and healthcare organizations.

4. The scientific and practical bases of educational organizations in the field of healthcare shall be clinical bases, clinics of educational organizations in the field of healthcare, university hospitals, residency bases.

The regulations on clinical base, the clinic of the organization of education in the field of healthcare, the university hospital, the residency base, the integrated academic medical center and the requirements for them shall be developed and approved by the authorized authority.

Clinical bases, clinics of educational organizations in the field of healthcare, university hospitals, residency bases shall be subject to the accreditation procedure established by Paragraph 2 of Article 25 of this Code in order to recognize the compliance of the provided medical services with the established requirements and standards in the field of healthcare, as well as the requirements for clinical bases, clinics of educational organizations in the field of healthcare, university hospitals, residency bases.

5. Scientific organizations and educational organizations in the field of healthcare within the achieving strategic goals of sustainable development have the right to conclude agreements with foreign higher educational institutions and medical organizations in the field of educational, scientific, clinical activities.

The procedure for implementing strategic partnership in the field of medical education and science shall be determined by the authorized authority.

6. Associations of educational organizations in the field of healthcare, accredited by the authorized authority for coordination of actions to ensure the quality of educational activity in the field of healthcare, have the right:

1) develop the state compulsory standards for levels of education in the field of healthcare, model curricula and programs, guidelines and recommendations aimed at ensuring the quality of educational activities in the field of healthcare;

2) represent the interests of subjects of educational activities in the field of healthcare in advisory and expert bodies, working groups formed by the authorized authority.

Article 221. Specifics of educational activity in the field of healthcare

1. The objectives of educational activity in the field of healthcare shall be to train professional scientific, pedagogical, medical and pharmaceutical personnel, public health specialists and other specialists for healthcare system and improve their qualifications.

2. State compulsory standards for levels of education in the field of healthcare shall be approved by the authorized authority and determine the set of general requirements for the scope of the academic load (number of credits) and competence of the graduate.

Organizations of higher and (or) postgraduate education independently develop educational programs in accordance with the requirements of state compulsory standards, as well as taking into account the requirements for the level of qualifications established by professional standards in the field of healthcare.

The list of educational programs shall be contained in the register of educational programs by levels of education in the field of healthcare. The maintenance of the register and the procedure for inclusion in the register of educational programs by levels of education in the field of healthcare shall be carried out in the manner determined by the authorized authority.

3. Training of medical personnel shall be carried out according to the programs of continuous integrated medical education. Upon completion of training under the programs of continuous integrated medical education, the graduate who has passed the final certification shall be awarded the degree "Master of Medicine". Upon completion of training in the internship, the graduate who has passed the assessment of professional preparedness shall be awarded the qualification "doctor".

An internship is a form of training for students in clinical specialties within the continuous integrated medical education, in which they undergo general medical practice under the supervision of a mentor, as a result of which they acquire knowledge in the field of general medicine and clinical experience.

4. For persons who have mastered educational programs of technical and vocational, post-secondary, higher, postgraduate and additional education, the basis for carrying out professional activities in the field of healthcare shall be a state-recognized education certificate, and for medical specialties also a certificate of a healthcare specialist, except for doctors-residents during their residency studies.

5. Postgraduate medical and pharmaceutical education includes residency, master's and doctoral studies.

Persons with a Master's degree shall be eligible to enroll in a non-clinical doctoral program.

Persons who have completed their residency training shall be eligible to enroll in a doctoral program of clinical profile.

In organizations of higher and (or) postgraduate medical education, programs of continuous postgraduate medical education may be implemented, including residency and doctoral programs of a clinical profile.

6. The acquisition of additional knowledge and skills by healthcare professionals shall be carried out through additional and non-formal education.

Additional education shall be carried out in educational and scientific organizations that implement educational programs of additional education and have passed institutional accreditation in accreditation authorities entered in the register of recognized accreditation authorities.

Additional education on disinfection, disinsection, deratization in the field of healthcare is carried out by educational and scientific organizations, professional self-regulating organizations implementing educational programs of additional education and having passed institutional accreditation in accreditation bodies included in the register of recognized accreditation bodies.

Additional education in medical specialties and non-formal education of medical workers shall be carried out by organizations of higher and (or) postgraduate education, national and scientific centers, research institutes, higher medical colleges on the basis of accredited clinical bases, clinics of educational organizations in the field of healthcare, university hospitals.

The procedure for additional and non-formal education of healthcare professionals, qualification requirements for organizations that implement educational programs of additional and non-formal education in the field of healthcare, as well as the rules for recognizing learning outcomes obtained by healthcare professionals through additional and non-formal education, shall be determined by the authorized authority.

7. Educational organizations in the field of healthcare determine the procedure for attestation of scientific and pedagogical personnel and the requirements for them. Certification of scientific and pedagogical personnel should be carried out at least once every five years. Educational organizations in the field of healthcare provide regular improvement of the pedagogical, research and professional competence of scientific and pedagogical personnel.

Scientific and pedagogical personnel of organizations of higher and (or) postgraduate medical education with one hundred percent participation of the state have the right to advanced training at the expense of budgetary funds.

Footnote. Article 221 as amended by the Law of the Republic of Kazakhstan dated 21.05.2022 No. 123-VII (shall be enforced six months after the date of its first official publication).

Article 222. Residency

1. The implementation of residency programs shall be carried out by organizations of higher and (or) postgraduate education in accredited clinics of educational organizations in the field of healthcare, university hospitals, as well as national and (or) scientific centers, research institutes accredited as residency bases. Residency programs shall be implemented in medical specialties, the list of which shall be approved by the authorized authority.

2. The organization of higher and (or) postgraduate education, national and (or) scientific centers, research institutes independently develop educational residency programs in accordance with the requirements of the State Compulsory Education Standard of the Republic of Kazakhstan, as well as in accordance with the requirements for qualification levels established professional standards in the field of healthcare.

The list of educational residency programs shall be contained in the register of educational programs by levels of education in the field of healthcare.

3. A person studying in residency in order to change professional qualifications, masters the program in accordance with independently developed organizations of higher and (or) postgraduate education abbreviated educational programs based on the State Compulsory Education Standard of the Republic of Kazakhstan and requirements for the level of qualifications of graduates, taking into account the recognition of previously achieved learning outcomes of formal education.

4. Training in residency shall be carried out on the basis of integration of theory and clinical practice, with involvement of resident doctors in personal participation in provision of medical services and responsibility for patient care activities under the supervision of a mentor. The training process provides an increasing degree of independent responsibility of the resident physician as skills, knowledge and experience shall be acquired.

The rules for placing a state order, admission for education and training of medical personnel in residency shall be approved by the authorized authority.

5. The legal basis for training a resident doctor and attracting him to the provision of services shall be:

1) on the basis of residency of an organization of higher and (or) postgraduate education - a training agreement concluded between the organization of higher and (or) postgraduate education, the residency base and a resident doctor;

2) in the national and (or) scientific centers, research institutes accredited as residency bases - a training agreement concluded between the national and (or) scientific center, research institute and a resident doctor.

The form of a model agreement on training under the residency program shall be approved by the authorized authority.

Training in residency provides for provision of a workplace for a resident doctor with equal responsibility of the residency base, the organization of higher and (or) postgraduate education, as well as the national and (or) scientific center, research institute.

During the period of study, the resident doctor shall be subject to the labor regulations, safety and labor protection requirements of the residency base of the organization of higher and (or) postgraduate education, national and (or) scientific center, research institute.

6. Mastering a professional residency curriculum shall be a prerequisite for admission to independent clinical practice of citizens who graduated from the program of continuous integrated medical education and received the qualification "doctor".

Article 223. Assessment of trainees, medical graduates and healthcare professionals

1. Assessment of knowledge and skills of students and professional preparedness of graduates of educational programs in the field of healthcare shall be based on:

1) requirements for the competencies of graduates of educational programs of the relevant specialty;

2) industry qualifications framework and professional standard.

2. Assessment of knowledge and skills of students in educational programs in the field of healthcare shall be carried out in accordance with the learning outcomes.

3. The assessment of professional preparedness of graduates of educational programs in the field of healthcare shall be carried out in accordance with the final results of training in the corresponding educational program.

The assessment of professional preparedness of graduates of educational programs in the field of healthcare shall be included in the structure of the final certification (state examination), final control. The positive results of the final certification (state exam), final control of graduates of educational programs in the field of healthcare give the right to receive a certificate of education and a certificate of a specialist in healthcare.

4. Assessment of professional preparedness of healthcare professionals shall be carried out in accordance with the requirements of the professional standard.

5. The assessment of knowledge and skills of students, the professional preparedness of graduates and healthcare professionals shall be carried out by an organization accredited by the authorized authority to assess the knowledge and skills of students and the professional preparedness of graduates of educational programs, healthcare professionals.

6. The rules for assessing the knowledge and skills of students, assessing the professional preparedness of graduates of educational programs in the field of healthcare, assessing the professional preparedness of specialists in the field of healthcare shall be determined by the authorized authority.

Article 224. Professional oath of a medical worker of the Republic of Kazakhstan

Graduates of educational organizations implementing educational programs of technical and professional, post-secondary, higher and continuous integrated medical education, take the professional oath of a medical worker of the Republic of Kazakhstan with the following content:

“Accepting the high title of a medical worker, in front of my teachers and colleagues, I solemnly swear to honestly and faithfully serve the great cause of protecting human health. In my work I swear to be guided only by the interests of my patients, whose health is the highest value. I vow with equal diligence and patience to provide medical care to everyone who needs it, regardless of age, gender, nationality, religion, social status and citizenship. I swear to keep the secret of a medical worker, never to use it for personal gain. I vow to constantly improve my knowledge and skills, to be demanding of myself and my students, never refuse disinterested help and seek advice from colleagues myself, if the patient's interests require it. I swear to protect and enhance the noble traditions of Kazakhstan medicine, to keep gratitude and respect for those who taught me the art of medicine”.

Chapter 26. HEALTHCARE SCIENTIFIC ACTIVITY

Article 225. Subjects of scientific activity

1. The subjects of scientific activity in the field of health care shall be individuals and legal entities carrying out biomedical research.

Scientific organizations in the field of healthcare include legal entities engaged in scientific, scientific and technical and innovative activities, as well as conducting research and development work in the field of healthcare.

The status of the scientific center and research institute shall be assigned to a healthcare organization by the authorized authority. The authorized authority decides on preservation of the status of the scientific center and research institute for a healthcare organization based on the results of assessing the effectiveness of scientific, scientific, technical and innovative activities.

The procedure for assigning and revising the status of a scientific organization in the field of healthcare, as well as the procedure for assessing the effectiveness of scientific, scientific, technical and innovative activities shall be determined by the authorized authority in agreement with the authorized authority in the field of science.

2. Subjects of scientific activity in the field of healthcare conduct biomedical research in compliance with the standards and requirements for conducting biomedical research adopted at the international level and in the Republic of Kazakhstan, bioethical norms.

Article 226. Management of scientific activity

1. The authorized authority coordinates and monitors the development of biomedical research.

2. The authorized authority organizes scientific and medical expertise:

1) projects of programs of applied scientific research;

2) results of completed scientific and medical programs;

3) scientific works nominated for state awards of the Republic of Kazakhstan;

4) scientific and medical developments planned for implementation in healthcare practice.

The procedure for conducting scientific and medical expertise shall be determined by the authorized authority.

Article 227. Biomedical Research

1. Biomedical research can be carried out on living people and experimental (laboratory) animals (subjects of research), biological samples of living and dead people and animals, as well as on the basis of the use of clinical and epidemiological data and other medical information.

Biomedical research includes basic and applied biomedical research. Applied biomedical research includes biomedical experiments, preclinical (non-clinical) research, clinical research, and public health research.

2. The creation of human embryos for biomedical research and human cloning shall be prohibited.

3. Biomedical research of human embryos or human fetuses, during or after which the human embryo or human embryo shall be destroyed, shall be prohibited.

4. Clinical trials shall be carried out subject to the receipt of positive results of biomedical experiments, preclinical (nonclinical) studies.

5. Applied biomedical research can be carried out only if the following requirements are met:

1) biomedical research shall be aimed at obtaining new scientific data and their introduction into practical healthcare;

2) protection of the interests of the research subject and the confidentiality of his medical information shall be ensured;

3) consent of the research subject or his legal representative has been obtained to participate in the research or to use his biological samples and medical information, including for filling out the biobank for scientific purposes;

4) interventional clinical trials of medicines, medical devices shall be carried out with the permission of the authorized authority.

6. For the following categories of persons, biomedical research shall be conducted only when it cannot be performed on other persons and there is scientific reason to expect that participation in such biomedical research will bring them direct benefits, outweighing the risks and inconveniences associated with biomedical research:

1) minors;

2) pregnant women;

3) incapacitated;

4) students in cases where participation in biomedical research shall be related to their studies;

5) retirees in need of outside help;

6) servicemen and employees of law enforcement and special state authorities;

7) personnel of medical organizations where biomedical research shall be carried out;

8) persons held in institutions of the penal system.

Interventional clinical trials on the categories of persons specified in Subparagraphs 1), 2), 3), 4) and 5) of Paragraph 6 of this Article shall be carried out only to study the therapeutic effect.

Interventional clinical trials on the categories of persons specified in Subparagraphs 6), 7) and 8) of Paragraph 6 of this Article shall be prohibited.

7. Upon receipt of written consent to participate in biomedical research, a volunteer or patient, legal representative of a minor, guardian of an incapacitated person must be provided with information:

1) on medical technology, pharmacological or medicinal product, nature and duration of medical research;

2) on degree of safety, risks and expected effectiveness of medical technology, pharmacological or medicinal product;

3) on actions in case of unforeseen effects of the use of medical technology, pharmacological or medicinal product on state of health;

4) on conditions of health insurance.

At the same time, before the start of research, a volunteer or patient, legal representative of a minor, guardian of an incapacitated person must be informed about the possibility of refusing biomedical research at any stage of the research.

8. Biomedical research shall be terminated at any stage:

1) at the request of a minor participating in research, his legal representative, guardian of an incapacitated person, patient or volunteer;

2) in the event of a threat to the life or health of a volunteer or patient, a minor, or an incapacitated person.

9. Mandatory conditions for conducting biomedical research shall be a positive conclusion of the Commission on Bioethics, and for interventional clinical research, also the execution of documents on life and health insurance of the research participant.

10. The rules for conducting biomedical research and the requirements for research centers shall be determined by the authorized authority.

11. The rules for application of new methods of diagnosis, treatment and medical rehabilitation shall be determined by the authorized authority.

Footnote. Article 227 as amended by the Law of the Republic of Kazakhstan dated 30.12.2021 No. 98-VII (shall be enforced upon expiry of sixty calendar days from the date of its first official publication).

Article 228. Bioethics Commission

1. The Bioethics Commission shall be an independent expert authority that conducts bioethical examination of documents related to the conduct of biomedical research, at the planning stage, during implementation and after completion in order to ensure the safety and protection of the rights of participants in biomedical research.

2. The Central Commission on Bioethics and local commissions on bioethics function in the Republic of Kazakhstan.

3. The Central Commission on Bioethics shall be created under the authorized authority to perform the following tasks:

1) analysis and informing specialists and the public on bioethics in the context of development of modern healthcare and the introduction of innovative medical technologies;

2) issuance of conclusions on conduct of interventional clinical trials of medicines, medical devices of foreign production, as well as interventional and non-interventional clinical trials of medicines, medical devices, conducted in two or more research centers located in the Republic of Kazakhstan;

3) implementation of bioethical monitoring over the course of biomedical research, for which the conclusion of the Central Commission on Bioethics and permission of the authorized authority were issued;

4) coordinating the activities of local bioethics commissions and assessing the compliance of their activities with the standards approved by the Central Bioethics Commission;

5) participation in development of documents on bioethics;

6) certification of local bioethics commissions.

4. Central and local commissions on bioethics shall be formed on an interdisciplinary basis and consist of representatives of the medical, humanitarian professions, public organizations and specialists in the field of law.

5. The composition and regulations on the Central Bioethics Commission shall be approved by the authorized authority.

6. Local commissions on bioethics shall be created at healthcare organizations to perform the following tasks:

1) issuance of conclusions on conducting biomedical research, except for the cases specified in Subparagraph 2) of Paragraph 3 of this Article;

2) implementation of bioethical monitoring of the progress of biomedical research, for which a conclusion was issued by this local commission on bioethics and permission of the authorized authority;

3) submission of an annual report to the Central Commission on Bioethics in the manner determined by it.

7. The composition and regulations on the local commission on bioethics shall be approved by the order of the first head of the healthcare organization, under which this commission shall be created, in agreement with the Central Commission on Bioethics.

8. Local commissions on bioethics have the right to issue conclusions on conducting biomedical research, subject to the availability of a certificate of compliance with the standards of activity of bioethics commissions issued by the Central Commission on Bioethics.

9. An appeal by an applicant who disagrees with the results of the bioethical examination shall be considered by a commission with the participation of the applicant himself and the involvement of independent experts.

10. The validity period of the certificate of conformity to the requirements of the activity of bioethical commissions and the procedure for its issuance shall be determined by the authorized authority.

Article 229. Biobanks

1. A biobank shall be created on the basis of a healthcare organization, an organization of higher and (or) postgraduate education and a scientific organization on the basis of a positive opinion of the Central Commission on Bioethics.

2. Biological materials stored in biobanks must be collected in accordance with the legislation of the Republic of Kazakhstan, bioethics standards in compliance with all requirements for sample preparation, transportation, laboratory processing and storage.

3. The procedure for creation and rules for the activities of biobanks shall be determined by the authorized authority.

SECTION 5. PHARMACEUTICAL ACTIVITY, CIRCULATION OF MEDICINES AND MEDICAL PRODUCTS

Chapter 27. PHARMACEUTICAL ACTIVITY

Article 230. Types of pharmaceutical activity

Pharmaceutical activity includes the following types:

1) production of medicines;

2) production of medical products;

3) manufacturing of medicinal products;

4) manufacturing of medical devices;

5) wholesale of medicines;

6) wholesale of medical products;

7) retail sale of medicines;

8) retail sale of medical products.

Article 231. Production of medicines and medical products

1. Production of medicines and medical products shall be a pharmaceutical activity, which includes the totality of all works required for the serial production of medicines and medical products associated with the acquisition of raw materials, materials, semi-finished products, equipment, components and a technological process, including the implementation of one of its stages, storage, sale of manufactured products, as well as all types of accompanying control.

2. Production of medicines in the territory of the Republic of Kazakhstan shall be carried out by entities in the field of circulation of medicines and medical products in accordance with the good manufacturing practice (GMP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union and on the basis of a license obtained in the manner prescribed by the legislation of the Republic of Kazakhstan.

Subjects in the field of circulation of medicines and medical products in production of medicines shall be required to comply with the requirements of good manufacturing practice (GMP).

3. Stability studies, determination of the shelf life and re-control of medical product shall be carried out by the manufacturer of the medical product in the manner determined by the authorized authority.

Stability studies, determination of the shelf life of medical products shall be conducted by the manufacturer of medical devices in accordance with international standards.

4. It shall be prohibited to manufacture medicines and medical products:

1) that have not passed state registration in the Republic of Kazakhstan, except for medicines and medical products intended for examination during their state registration, debugging and launching equipment and technological processes, preclinical (nonclinical) and clinical trials, contract production and production for export of medicinal means and medical products, as well as medicines of advanced therapy, produced for individual use using autologous biological materials of the patient or his donor, selected directly for him;

2) without a license for the right to manufacture medicines and medical products;

3) in violation of good manufacturing practices and rules for production of medical products.

5. Manufactured and imported medical products:

1) must not contain dyes and auxiliary substances prohibited for use in the Republic of Kazakhstan, the list of which shall be approved by the authorized authority;

2) must be subject to control in accordance with the regulatory document on the quality of medicines developed by the producer of medicines and agreed by the state expert organization for examination of medicines in the manner determined by the authorized authority;

3) must be made from a pharmaceutical substance (active pharmaceutical ingredient) produced under conditions not lower than the requirements of good manufacturing practice (GMP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union and declared during state registration, re-registration and amendments to the registration dossier of medicines.

Medicines produced in the territory of the Republic of Kazakhstan only for export shall not be subject to state registration and sale in the Republic of Kazakhstan.

6. Produced and imported medical products must be subject to control in accordance with the regulatory document of a medical product submitted by the producer of a medical device during the examination of a medical device for the purpose of state registration, re-registration and amendments to the registration dossier of a medical product.

Medical products produced in the territory of the Republic of Kazakhstan only for export shall not be subject to state registration and sale in the Republic of Kazakhstan.

7. The production and sale of patented medicines and medical products shall be carried out in accordance with the legislation of the Republic of Kazakhstan.

8. The production of medical products intended for diagnostics or treatment should ensure their safety, provide for their use in accordance with their functional purpose and exclude the approach of user errors when interpreting the results of diagnostics or treatment.

9. The producer of medical products shall ensure the presence in the staff of at least one authorized person of the producer who is responsible for fulfilling duties in accordance with the requirements of good producing practice (GMP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union.

Article 232. Production of medicines and medical products

Production of medicines and medical products shall be carried out by entities in the field of circulation of medicines and medical products that are licensed to manufacture medicines and medical products in the manner determined by the authorized authority. Produced medical products shall be subject to intra-pharmacy control in the manner determined by the authorized authority.

Article 233. Wholesale and retail trade of medicines and medical products

1. Wholesale of medicines and medical products shall be carried out by entities in the field of circulation of medicines and medical products that have received an appropriate license for wholesale in pharmacy warehouses or notified about the start of activities through a warehouse of medical products in the manner prescribed by the Law of the Republic of Kazakhstan "On permits and notifications".

2. Retail sale of medicines and medical products shall be carried out by entities in the field of circulation of medicines and medical products that have received an appropriate license for retail sale in pharmacies, pharmacies, mobile pharmacies or notified of the start of activities through optical stores and medical products in the manner prescribed the Law of the Republic of Kazakhstan "On Permits and Notifications".

3. Subjects in the field of circulation of medicines and medical products that carry out retail sale of medicines shall be obliged to comply with the requirements of Good Pharmacy Practice (GPP).

Entities in the field of circulation of medicines and medical devices engaged in the wholesale sale of medicines are obliged to comply with the requirements of good distribution practice (GDP).

Subjects in the field of circulation of medicines and medical products that have received a license or notified about the start of activities in the manner prescribed by the Law of the Republic of Kazakhstan "On permits and notifications" shall be allowed wholesale and retail sale of goods not related to medicines and medical products in accordance with the list approved by the authorized authority.

4. Wholesale and retail sales of medicines and medical products shall be prohibited:

1) those who have not passed state registration in the Republic of Kazakhstan;

2) the quality of which is not confirmed by a certificate of conformity in the manner established by the legislation of the Republic of Kazakhstan in the field of healthcare;

3) do not meet the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare;

4) expired;

5) by medical workers in healthcare organizations, with the exception of the retail sale of medicines and medical devices in rural settlements in the cases provided for in paragraph 6 of this article;

6) through warehouses for temporary storage of medicines and medical products.

4-1. The wholesale and retail sale of bulk products of medicines or medical products is prohibited, with the exception of the wholesale sale of bulk products of medicines or medical products used by entities in the field of circulation of medicines and medical products for the production of medicines.

5. OTC sales of medicinal products intended for dispensing with a doctor's prescription shall be prohibited. Prescriptions shall be issued in paper and (or) electronic form.

The shelf life of a paper prescription for a medical product shall be at least thirty calendar days, except for a prescription for a medical product containing narcotic drugs, psychotropic substances, precursors and poisonous substances, which shall be stored for one year, for a medicinal product dispensed within the guaranteed scope of free medical care and (or) compulsory social health insurance, the storage period of which shall be two years.

The rules for classifying medical products, taking into account the active substances in their composition, to the categories of medical products sold without a prescription and prescription, the rules for prescribing, recording and storing prescriptions shall be approved by the authorized authority.

6. In rural settlements where there are no pharmacies, the sale of medicines and medical products can be carried out by individuals and legal entities through pharmacy points in healthcare organizations providing primary health care, consultative and diagnostic assistance, and mobile pharmacy points. In the absence of pharmacy points, the retail sale of medicines and medical products can be carried out through healthcare organizations providing primary health care, consultative and diagnostic assistance. In the absence of specialists with pharmaceutical education for the retail sale of medicines and medical products, specialists with medical education who have been trained for their sale are allowed.

7. Medicines and medical products imported and produced in the territory of the Republic of Kazakhstan before the expiration of the registration certificate shall be used, circulated and operated in the territory of the Republic of Kazakhstan without restrictions.

Footnote. Article 233 as amended by the Laws of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication); dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication).

Chapter 28. CIRCULATION OF MEDICINES AND MEDICAL PRODUCTS

Article 234. System of the sphere of circulation of medicines and medical products

The unified system of the sphere of circulation of medicines and medical products includes:

1) the state authority in the field of circulation of medicines and medical products and its territorial divisions;

2) the state expert organization in the field of circulation of medicines and medical products and its territorial divisions;

3) subjects in the field of circulation of medicines and medical products.

Article 235. Development of medicines and medical products

1. Development of medicines includes the search and (or) creation of new active substances or their new combinations, the subsequent study of pharmacological properties, pharmaceutical development, preclinical (non-clinical) and clinical studies, as well as the development of technologies for the industrial production of medicines.

2. The development of medicines shall be carried out in compliance with the requirements of good pharmaceutical practices to ensure their safety and effectiveness.

3. Development of medical products includes the search and (or) creation of a technical solution, invention, design, construction and testing of prototypes, as well as the development of technologies for industrial production of medical products.

4. Development of medical products shall be carried out in compliance with the requirements of international standards to ensure their safety and effectiveness.

5. The rights of the developer of the medicines and medical product shall be protected by the legislation of the Republic of Kazakhstan.

Article 236. Preclinical (nonclinical) studies of medicines and studies (tests) evaluating the biological effect of medical products

1. The purpose of preclinical (nonclinical) studies of medicines shall be to obtain scientific evidence of their pharmacological activity and safety.

Studies (tests) evaluating the biological effect of medical products shall be carried out to determine the acceptability of any potential adverse biological response resulting from the contact of medical product materials with the human body.

2. The procedure for conducting preclinical (nonclinical) studies and requirements for preclinical bases for assessing the biological effect of medical products shall be determined by the authorized authority.

Preclinical (non-clinical) studies shall be carried out in accordance with good laboratory practice (GLP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union.

Assessment of materials and compliance of the conditions for conducting preclinical (nonclinical) studies with the requirements of good laboratory practice (GLP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union shall be carried out within the pharmaceutical inspection in the manner determined by the authorized authority.

Article 237. Technical tests of medical products

1. Technical tests of medical products shall be carried out in the form of tests and (or) evaluation and analysis of data to verify the quality and safety when used in accordance with the purpose provided by the documentation of the manufacturer of the medical product.

2. Technical tests of medical products shall be carried out in organizations accredited to conduct technical tests in the manner determined by the legislation of the Republic of Kazakhstan in the field of technical regulation.

3. The procedure for conducting technical tests shall be determined by the authorized authority.

Article 238. Clinical studies of medicines, medical products and clinical and laboratory tests of medical products for diagnostics outside a living organism (in vitro)

1. Clinical studies of medicines and medical products shall be carried out with the participation of a person as a subject to identify or confirm the clinical and (or) pharmacodynamic effects of the investigated pharmacological or medicines and (or) identify adverse reactions and (or) in order to study absorption, distribution, biotransformation and excretion of drugs, assessing the safety and (or) functional characteristics of medical products and (or) adverse events of a medical product to establish safety and efficacy.

Clinical and laboratory tests of medical products for diagnostics outside a living organism (in vitro) shall be carried out for analytical characteristics, clinical effectiveness (if applicable) to establish the compliance of a medical product for diagnostics outside a living organism (in vitro).

2. Clinical studies shall be carried out in accordance with the rules of good clinical practice (GCP) of the Republic of Kazakhstan and (or) the Eurasian Economic Union.

3. Accelerated examination of clinical studies (hereinafter referred to as the accelerated procedure) shall be carried out for medicines:

1) designed to prevent emergencies;

2) orphan drugs;

3) medicines of advanced therapy produced for individual use using autologous biological materials from the patient or his donor, selected directly for him.

4. When carrying out the accelerated procedure, the requirements for the safety, efficacy and quality of medicines shall not be reduced.

5. The applicant provides substantiated evidence of the need for and the possibility of carrying out an examination according to the accelerated procedure, confirmed by the authorized authority.

6. The procedure for conducting clinical studies of medicines and medical products, clinical and laboratory tests of medical products for diagnostics outside a living organism (in vitro) and requirements for clinical bases shall be determined by the authorized authority.

Article 239. Expertise of medicines and medical products

1. Expertise of medicines and medical products shall be a comprehensive assessment of safety, quality and efficacy, the benefit-risk ratio, the assessment of materials for clinical studies of medicines and medical products, the assessment of the optimal technical characteristics and clinical and technical justification of a medical product, carried out at the materials of the registration dossier, laboratory tests for compliance with regulated quality, pharmacovigilance data, monitoring the safety, quality and effectiveness of medical products, materials for evaluating clinical studies, materials for evaluating the optimal technical characteristics and clinical and technical justification of a medical product.

2. Expertise of medicines and medical products belongs to the state monopoly and shall be carried out by the state expert organization in the field of circulation of medicines and medical products.

Prices for goods (work, services) produced and (or) sold by a state monopoly entity shall be established by the authorized authority in agreement with the antimonopoly authority.

3. Requirements for the safety, quality and efficacy of pharmaceutical substances (active pharmaceutical ingredients), medicinal raw materials, medicinal plant raw materials, bulk products of medicines or medical products, original medicinal products, medicinal products of biological origin, biotechnological medicinal products, immunological medicinal products (immunobiological medicinal products), reproduced medicinal products (generics), homeopathic medicinal products, biosimilar medicinal products (biosimilars, biosimilar medicinal products, biosimilars) and medical products shall be presented during the expertise of medicines and medical products in the manner determined by the authorized authority.

4. The grounds for a negative conclusion of the expertise of medicines and medical products shall be:

1) failure to submit a complete set of registration dossier after the issuance of comments to the applicant during the expertise process within the time frame established in the manner determined by the authorized authority;

2) submission by the applicant of false information;

3) the ratio of the expected benefit to the possible risks associated with the use of the medicinal product shall not be favorable;

4) lower quality and safety indicators regulated by the State Pharmacopoeia of the Republic of Kazakhstan or pharmacopoeias recognized as valid in the territory of the Republic of Kazakhstan, or in comparison with previously registered analogues;

5) presence in the composition of the medicines of substances and materials prohibited for use in the Republic of Kazakhstan;

6) presence of preservatives in solid dosage forms;

7) obtaining negative results of one of the stages of examination and (or) negative opinions of experts from specialized organizations;

8) inconsistency of the actual production conditions and the quality assurance system with the conditions ensuring the declared safety, efficiency and quality, based on the results of the quality assurance system assessment;

9) the applicant's refusal to organize a visit to the enterprise (production site) in order to assess the quality assurance system in accordance with the requirements of the legislation of the Republic of Kazakhstan;

10) identification of irrational medicines combinations;

11) the applicant has not proven the clinical efficacy and safety of the medicinal product;

12) the quality of the medicinal product has not been confirmed;

13) a proven unfavorable benefit-risk ratio or a revealed lack of therapeutic efficacy, subject to the conditions of use of the medicinal product described in the approved general characteristics of the medicinal product in the post-registration period;

14) facts established according to pharmacovigilance data indicating an unfavorable benefit-risk ratio of medicines, including an excess of the frequency of reporting adverse reactions in comparison with the data specified in the approved general characteristics of the medicinal product;

15) inconsistency of the qualitative and quantitative composition of the drug with the declared one or repeated inconsistency of the quality of the medicinal product during the period of its circulation on the market with the declared one at the time of its registration;

16) failure of the holder of the marketing authorization to fulfill the obligations of pharmacovigilance;

17) the changes introduced have a negative impact on the benefit-risk ratio of medicinal product.

Article 240. State Pharmacopoeia of the Republic of Kazakhstan

1. The quality and safety of medicines and medical products on the pharmaceutical market of the Republic of Kazakhstan shall be established by the requirements of the State Pharmacopoeia of the Republic of Kazakhstan.

2. The State Pharmacopoeia of the Republic of Kazakhstan shall be harmonized with the requirements of the leading pharmacopoeias of the world and shall be subject to periodic updates due to changes in their standards and the peculiarities of development of pharmaceutical market of the Republic of Kazakhstan.

3. In the absence of relevant articles (monographs) in the State Pharmacopoeia of the Republic of Kazakhstan, the current editions of the world's leading pharmacopoeias, recognized by the authorized authority, shall be applied.

4. General articles of the State Pharmacopoeia of the Republic of Kazakhstan determine general requirements for:

1) quality of pharmaceutical substances (active pharmaceutical ingredients), medicines;

2) reagents, reference materials, methods and test procedures used to control their quality;

3) packaging materials and containers.

5. Private articles of the State Pharmacopoeia of the Republic of Kazakhstan define specific requirements for quality of pharmaceutical substances (active pharmaceutical ingredients), medicines.

6. The State Pharmacopoeia of the Republic of Kazakhstan shall be a mandatory requirement for individuals and legal entities engaged in production, manufacture, sale, storage, quality control, examination of medicines and medical products, during state registration, re-registration and amendments to the registration dossier.

7. The State Pharmacopoeia of the Republic of Kazakhstan shall be developed by the state expert organization in the field of circulation of medicines and medical products.

The procedure for development, registration, agreement, approval and introduction of amendments and additions to the State Pharmacopoeia of the Republic of Kazakhstan shall be determined by the authorized authority.

8. The State Pharmacopoeia of the Republic of Kazakhstan in terms of structure, design of monographs, numbering of sections and pharmacopoeial articles (monographs), symbols, representation of formulas must correspond to the leading pharmacopoeias of the world recognized by the authorized authority.

Article 241. Assessment of quality of medicines and medical products registered in the Republic of Kazakhstan

1. Assessment of quality of medicines and medical products registered in the Republic of Kazakhstan shall be carried out by determining the compliance of quality of medicines and medical products with the data of the registration dossier, regulatory documents on quality of medicines, on the basis of which they were registered in the Republic of Kazakhstan.

2. Assessment of quality of medicines and medical products registered in the Republic of Kazakhstan belongs to the state monopoly and shall be carried out by the state expert organization in the field of circulation of medicines and medical products.

Prices for goods (work, services) produced and (or) sold by a state monopoly entity shall be established by the authorized authority in agreement with the antimonopoly authority.

Article 242. Labeling of medicines and medical products

1. Medicines must be put into circulation with labeling applied to the packaging (primary and (or) secondary) in a well-readable font in Kazakh and Russian, and instructions for medical use (leaflet) in Kazakh and Russian.

Labeling texts and instructions for medical use (leaflet) must comply with the requirements of the Law of the Republic of Kazakhstan “On languages in the Republic of Kazakhstan”.

2. For medical workers on the Internet resources of the authorized authority and the state expert organization in the field of circulation of medicines and medical products, the general characteristics of the medicine, approved during state registration, shall be posted.

3. Medical products must be put into circulation with a label applied directly to medical devices and (or) packaging, and instructions for medical use or an operational document for a medical device in Kazakh and Russian.

Labeling texts, instructions for medical use or an operational document for a medical product must comply with the requirements of the Law of the Republic of Kazakhstan “On languages in the Republic of Kazakhstan”.

4. Rules for labeling medicines and medical products shall be approved by the authorized authority.

The procedure for preparation and execution of instructions for medical use of medicines and medical products, the general characteristics of medicine shall be determined by the authorized authority.

Footnote. Article 242 as amended by the law of the Republic of Kazakhstan dated 29.12.2021 No. 94-VII (shall be enforced upon expiry of ten calendar days after the date of its first official publication).

Article 243. Use of medicines of advanced therapy

1. Medicines of advanced therapy, according to the method of production and use, shall be divided into:

1) industrially produced (routine method) in a pharmaceutical production on a batch basis;

2) produced for individual use using autologous biological materials of the patient or his donor, selected directly for him.

2. The procedure for admission to the use, use and monitoring of effectiveness and safety of use of medicines of advanced therapy shall be determined by the authorized authority.

3. Medicines of advanced therapy shall be subject to clinical trials in accordance with the procedure established in Article 238 of this Code.

4. Medicines of advanced therapy, produced in an industrial environment, in respect of which positive results of clinical studies have been obtained, for admission to the market of medical services shall be subject to state registration in accordance with the procedure for State registration of a medicines or medical product established by Article 23 of this Code.

5. Medicines of advanced therapy, produced for individual use, in respect of which positive results of clinical studies have been obtained, shall be admitted to the market of medical services on the basis of conclusion of an expert organization in the field of circulation of medicines and medical products without the state registration procedure.

6. In exceptional cases, medicines of advanced therapy manufactured for individual use shall be used without conducting clinical trials as part of an exclusion from the standard procedure for marketing a medicinal product, provided:

1) presence of a positive conclusion of the local Commission on Bioethics;

2) scientific reason to expect that the use of medicines of advanced therapy will directly benefit the patient;

3) obtaining the informed consent of the patient or his legal representative for use of medicines of advanced therapy.

The doctor prescribing the medicines of advanced therapy ensures that the specified conditions shall met and, based on the results of use of the medicines of advanced therapy, as part of the exclusion from the standard procedure for marketing the medicines, submits a report to the state expert organization in the field of circulation of medicines and medical products and the Bioethics Commission.

7. The procedure for use of medicines of advanced therapy under exemption from the standard procedure for release of medicines on the market, as well as the list of medical organizations eligible for treatment under the Hospital exemption, shall be determined by the authorized authority.

Article 244. Pharmaceutical Inspectorate for Good Pharmaceutical Practices

1. Pharmaceutical Inspectorate for Good Pharmaceutical Practices - structural subdivisions of the state authority in the field of circulation of medicines and medical products, its territorial divisions and (or) an organization determined by the authorized authority that inspects compliance with good pharmaceutical practices for medicines and requirements for implementation, maintaining and evaluating the quality management system of medical products, depending on the potential risk of their use.

2. The state authority in the field of circulation of medicines and medical products coordinates the activities of the Pharmaceutical Inspectorate for Good Pharmaceutical Practices.

The state authority in the field of circulation of medicines and medical products and its territorial divisions issue or revoke certificates (opinions) for compliance with the requirements of good pharmaceutical practices.

3. Pharmaceutical inspection shall be carried out in the following cases:

1) on the basis of an application from entity in the field of circulation of medicines and medical products for obtaining a certificate (opinion) or renewal of its validity, as well as in accordance with good Pharmacovigilance Practice (GVP);

2) on the basis of an application by entity in the field of circulation of medicines and medical products, as well as for the purpose of licensing, registration, re-registration, examination of medicines or conducting investigations related to the safety, quality and efficacy of medicines in accordance with the pharmaceutical inspection program;

3) based on the results of a previously conducted pharmaceutical inspection in order to confirm the elimination of the identified inconsistencies;

4) for confirmation by entities that have received a certificate confirming the compliance of the facility with the requirements of Good Pharmaceutical Practices in the field of drug circulation (hereinafter referred to as the certificate), at least once every two years in accordance with the inspection schedule approved by the head of the state authority in the field of circulation of medicines and medical products;

5) according to Good Clinical Practice shall be carried out in the following cases:

revealing, during the examination of clinical reports related to the registration of a medicines, facts that cast doubt on the reliability of the information provided by the applicant in the registration dossier in relation to clinical studies (tests) of medicines;

before, during or after the completion of clinical studies of medicines, medical products of potential risk classes 3, 2b and implantable medical products;

inspection of the pharmacovigilance system of the marketing authorization holder in cases provided by the rules of good Pharmacovigilance Practice of the Republic of Kazakhstan and (or) the Eurasian Economic Union.

4. The validity period of the certificate of compliance of the object with the requirements:

1) Good Manufacturing Practice (GMP) - three years;

2) Good Distribution Practice (GDP), Good Laboratory Practice (GLP) - three years;

3) Good Pharmacy Practice (GPP) - the first two times for five years, upon subsequent confirmation - indefinitely.

5. Pharmacies shall be subject to pharmaceutical inspection for compliance with the requirements of Good Pharmacy Practice (GPP), pharmacy (distribution) warehouses - for compliance with the requirements of Good Distribution Practice (GDP), medicines production organizations - for compliance with the requirements of Good Manufacturing Practice (GMP), organizations, carrying out preclinical (non-clinical) studies - for compliance with the requirements of good laboratory practice (GLP), clinical studies carried out by healthcare organizations - for compliance with the requirements of good clinical practice (GCP), holders of drug registration certificates - for compliance with the requirements of good pharmacovigilance practice (GVP).

6. Pharmaceutical inspections shall be carried out in the manner determined by the authorized authority.

7. Within the pharmaceutical inspection, selection and examination, assessment of safety and quality of medicines may be carried out.

8. The conditions of storage and transportation of selected samples of medicinal products should not change the parameters by which the examination, safety and quality assessment of these samples of medicinal products will be carried out.

The pharmaceutical inspector for Good Pharmaceutical Practices ensures the safety of medicines samples and timely delivery to the place of examination, safety and quality assessment.

9. Inspections of medical products shall be carried out in accordance with the requirements for implementation, maintenance and assessment of the quality management system of medical products, depending on the potential risk of their use in the manner determined by the authorized authority.

10. During a state of emergency, in accordance with the Law of the Republic of Kazakhstan "On emergency state", pharmaceutical inspections for investigations related to the safety, quality and efficacy of medicines shall be carried out by decision of the state authority in the field of circulation of medicines and medical products.

Article 245. State regulation of prices for medicines and medical products

1. State regulation of prices shall be carried out for medicines registered and in circulation in the Republic of Kazakhstan for wholesale and retail sales, included in the list of medicines subject to price regulation, as well as for registered medicines and medical products within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance in the manner determined by the authorized body.

The list of medicines subject to price regulation for wholesale and retail sales shall be approved by the authorized body no more than once every six months no later than the tenth day of the third month of the six months in agreement with the antimonopoly authority.

2. The authorized body shall, no more than once every half a year, no later than the tenth day of the first month of the half year, approve, in agreement with the antimonopoly body, the manufacturer's maximum prices for the medicine trade name, the maximum prices for the medicine trade name for retail and wholesale sales, included in the list of medicines subject to price regulation.

3. The authorized body shall approve the maximum price for the trade name of a medicine or medical device within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance in agreement with the antimonopoly authority, the maximum price for the international generic name of a medicine or the technical characteristics of a medical product within the guaranteed volume of free medical care and (or) in the system of compulsory social health insurance.

4. The authorized authority on an ongoing basis keeps records and systematization of the information specified in Paragraphs 2 and 3 of this Article in electronic form in chronological order, taking into account the changes made and preserving previous versions and providing the possibility of open access to this information in electronic.

The information specified in Paragraphs 2 and 3 of this Article shall be stored for five years, starting from the year following the year of approval of the maximum prices for medicines.

5. The maximum retail price cannot be approved without observing the total wholesale and retail mark-up to the manufacturer's maximum price.

6. The authorized authority monitors and controls compliance with the marginal prices of medicines by trade names.

7. Wholesale and retail sale of medicines included in the list of medicines subject to price regulation shall not be allowed without a maximum price for medicines by trade names.

Footnote. Article as amended by the law of the Republic of Kazakhstan dated 03.01.2022 No. 101-VII (shall be enforced upon expiry of sixty calendar days from the date of its first official publication); dated 04.07.2022 No. 134-VII (shall be enforced sixty calendar days after the date of its first official publication).

Article 246. Procurement of medicines and medical products intended for provision of minimum, basic and additional scopes of medical care

1. Medicines intended to provide minimal, basic and additional volumes of medical care shall be purchased under international non-proprietary names, and in case of individual intolerance of the patient - under the trade names of medicines registered in the Republic of Kazakhstan, based on the conclusion of the medical advisory commission and the decision of the local representative authority of the region, cities of republican significance and the capital. In the case of the purchase of multicomponent medicine, its composition shall be indicated.

2. For the purpose of optimal and efficient spending of budgetary funds allocated for procurement of medicines and medical products within the guaranteed scope of free medical care, and compulsory social medical insurance funds, medicines and medical products shall be procured at prices not exceeding those established by the authorized authority, except for unregistered medicines and medical products imported into the territory of the Republic of Kazakhstan on the basis of an opinion (permitting document) issued by the authorized authority.

3. The procurement of medicines and medical products intended for provision of the guaranteed scope of free medical care and (or) medical care in the system of compulsory social health insurance shall be carried out in the manner and methods established by the Government of the Republic of Kazakhstan, including through the web portal for procurement of medicines and medical products, procurement of services from healthcare entities.

4. The preferential right to conclude contracts within the guaranteed scope of free medical care and (or) in the system of compulsory social health insurance have subjects in the field of circulation of medicines and medical products, including pharmacies with the right to manufacture medicines, having a certificate of conformity of the object requirements:

1) Good Manufacturing Practice (GMP), when purchasing drugs and concluding long-term contracts for supply of medicines;

2) Good Distribution Practice (GDP), when purchasing medicines, pharmaceutical services and concluding long-term contracts for storage and transportation of medicines and medical products;

3) Good Pharmacy Practice (GPP), in procurement of pharmaceutical services, services for registration and sale of medicines and medical products.

Footnote. Article 246 as amended by the Law of the Republic of Kazakhstan dated 03.01.2022 No. 101-VII (shall be enforced upon expiry of sixty calendar days from the date of its first official publication).

Article 247. National Distributor

The main scope of operation of the national distributor shall be:

1) selection of suppliers;

2) conclusion of agreements for delivery of pharmaceutical products and medical products, as well as for delivery and production of plasma-based blood preparations, including those industrial, within contractual fractionation;

3) conclusion of long-term agreements for delivery of pharmaceutical products and medical products, as well as for production and delivery of plasma-based blood preparations, including within contractual fractioning, as well as on production of plasma-based blood preparations (contractual fractioning) from producers, including from international producers;

4) provision of pharmaceutical products and medical products as per a list determined by the authorized body;

5) procurement of pharmaceutical products and medical products, plasma-based blood preparations, including within contractual fractioning, services on storage and transportation as per list determined by the authorized body, as well as services on production of plasma-based blood preparations (contractual fractioning) from producers, including from international producers;

6) procurement of pharmaceutical services;

7) procurement on accounting and sale of pharmaceutical products and medical products;

8) organization of procurement of medical products within statutory free medical assistance;

9) delivery, storage of pharmaceutical products and medical products of mobilization reserve, and issue thereof in order to replenish and cancel reservation in case of changed assortment stipulated by the laws of the Republic of Kazakhstan on civil protection.

Article 248. Principles for procurement of pharmaceutical products and medical products by the national distributor

The principles for procurement of pharmaceutical products and medical products are:

1) provision of potential suppliers with equal opportunities for participation in procurement procedure;

2) fair competition among potential suppliers;

3) publicity and transparency of procurement process;

4) support for national manufacturers.

Article 249. Powers of the national operator

The national operator:

1) administers establishment, development, support and system and technical maintenance of the web portal for procurement of pharmaceutical products and medical products, services from public healthcare entities;

2) administers management of projects on development of the web portal for procurement of pharmaceutical products and medical products, services from public healthcare entities;

3) provides public healthcare entities with services on the use of the web portal for procurement of pharmaceutical products and medical products, services from public healthcare entities;

4) provides advisory assistance to public healthcare entities on issues of operation of the web portal for procurement of pharmaceutical products and medical products, services from public healthcare entities;

5) maintains information security of storage of information resources of entities of the state procurement system, placed on the web portal for procurement of pharmaceutical products and medical products, services from public healthcare entities;

6) provides information content for the web portal for procurement of pharmaceutical products and medical products, services from public healthcare entities;

7) interacts with authorized entities on issues of integration of information systems of government bodies, government electronic information resources and maintenance of information security.

Article 250. Storage, transportation and elimination of pharmaceutical products and medical products

1. Pharmaceutical products and medical products shall be stored and transported in conditions ensuring maintenance of their safety, quality and efficiency in accordance with the regulations on storage and transportation of pharmaceutical products and medical products approved by the authorized body.

2. It is prohibited to extend shelf life of pharmaceutical products and medical products.

3. Entities in the field of circulation of pharmaceutical products and medical products, administering transportation and storage of pharmaceutical products, must meet the requirements of Good Distribution Practice (GDP) or Good Pharmacy Practice (GРP).

4. Pharmaceutical products and medical products, which are unfit for use, with expired shelf life, falsified pharmaceutical products or medical products and others not meeting the requirements of the laws of the Republic of Kazakhstan shall be considered unfit for sale and medical use, and shall be subject to elimination by entities in the field of circulation of pharmaceutical products and medical products, in the possession whereof they are, in accordance with the procedures determined by the authorized body.

Article 251. Procedures for importing of pharmaceutical products and medical products to the Republic of Kazakhstan

1. Import to the Republic of Kazakhstan of pharmaceutical products and medical products shall be in accordance with the procedures determined by the authorized body as per customs laws of the Republic of Kazakhstan and (or) international agreements and instruments in the field of customs regulation of Eurasian Economic Union.

It shall be allowed to import medicines registered in the Republic of Kazakhstan, using stickers with a well-readable font in Kazakh and Russian languages and medical products registered in the Republic of Kazakhstan, using stickers in Kazakh and Russian languages and with instructions for medical use (leaflet) or an instruction for medical use or an operational document for a medical product in the Kazakh and Russian languages for their sale below the approved limit wholesale and retail prices in the Republic of Kazakhstan in accordance with the procedure, determined by the authorized body.

The texts of stickers, instructions for medical use (leaflet), instructions for medical use or an operational document for a medical device must comply with the requirements of the Law of the Republic of Kazakhstan “On languages in the Republic of Kazakhstan”.

2. It is prohibited to import to the Republic of Kazakhstan pharmaceutical products and medical products, which have not passed state registration in the Republic of Kazakhstan, except for cases specified in paragraph 3 of this article and article 253 of this Code.

3. It is allowed to import to the Republic of Kazakhstan pharmaceutical products and medical products not registered in the Republic of Kazakhstan on the basis of a conclusion (authorization document) issued by the authorized body, when they are intended for:

1) conduction of clinical examination;

2) expert evaluation of pharmaceutical products and medical products at state registration, re-registration and introduction of amendments to registration dossiers;

3) state registration of pharmaceutical products and medical products;

4) delivery of emergency healthcare services for a certain patient or delivery of healthcare services to a limited contingent of patients with rare and (or) extra severe pathology with an opportunity of medical application and procurement;

5) holding of exhibitions without a right for further sale;

6) humanitarian aid (assistance), prevention and (or) elimination of emergency consequences;

7) adoption of innovative medical technology;

8) procurement by the national distributor of pharmaceutical products and medical products, supplied by international organizations, established by the United Nations General Assembly, and (or) re-categorized by the World Health Organization, except for pharmaceutical products and medical products within long-term agreements for delivery of pharmaceutical products and medical products;

9) use as a component included in the composition or structure of a medical product and not designed for independent use beyond the composition or structure of a medical product;

10) prevention and treatment of consequences of influence of radioactive, biological or chemical materials (vaccines, antidote).

4. It is prohibited to import to the Republic of Kazakhstan pharmaceutical products and medical products, which have not passed state registration, as humanitarian aid, except for separate cases to be defined by the authorized body.

5. Pharmaceutical products and medical products imported to the Republic of Kazakhstan, failing to meet the requirements of the laws of the Republic of Kazakhstan in the field of public health, are subject to confiscation and elimination.

Footnote. Article 251 as amended by the law of the Republic of Kazakhstan dated 29.12.2021 No. 94-VII (shall be enforced upon expiry of ten calendar days after the date of its first official publication).

Article 252. Persons allowed to import pharmaceutical products and medical products to the Republic of Kazakhstan

Pharmaceutical products and medical products to the Republic of Kazakhstan may be imported:

1) by entities in the field of circulation of pharmaceutical products and medical products, having license for production of pharmaceutical products and medical products;

2) entities in the field of circulation of pharmaceutical products and medical products, having license for wholesale trading of pharmaceutical products or those included in the register of entities of public health services, administering wholesale trading of medical products, upon notification of commencement of business;

3) research organizations, laboratories for development and state registration of pharmaceutical products and medical products in accordance with this Code;

4) international manufacturers of pharmaceutical products and medical products, their authorized representative offices (branches) or their authorized individuals or legal entities for conduction of expert evaluation at state registration, clinical examinations and (or) testing and for participation in exhibition of manufacturers of pharmaceutical products and medical products in the Republic of Kazakhstan;

5) public healthcare organizations for implementation of medical activities.

Article 253. Import of pharmaceutical products and medical products, as well as biological material for pre-clinical (non-clinical) and clinical examinations, reference materials of pharmaceutical substances (active pharmaceutical ingredients) and their admixtures to the Republic of Kazakhstan for personal use and other non-commercial purposes

1. Pharmaceutical products and medical products shall be imported to the Republic of Kazakhstan without permit from the authorized body, when they are intended for:

1) personal use by individuals;

2) treatment of passengers and members of transport crews, train crews and drivers of vehicles arriving to the customs area of Eurasian Economic Union;

3) treatment of participants of international cultural, sporting events and participants of international expeditions.

2. In cases provided for by paragraph 1 of this article, it is allowed to import to the Republic of Kazakhstan pharmaceutical products and medical products not registered in the Republic of Kazakhstan.

3. Biological material for pre-clinical (non-clinical) and clinical examinations, reference materials of pharmaceutical substances (active pharmaceutical ingredients) their admixtures shall be imported to the Republic of Kazakhstan without permit from the authorized body.

4. Biological material for pre-clinical (non-clinical) and clinical examinations, reference materials for pharmaceutical substances (active pharmaceutical ingredients) and their admixtures shall be imported to the Republic of Kazakhstan:

1) by manufacturers of pharmaceutical products and medical products;

2) international manufacturers of pharmaceutical products and medical products, their authorized representative offices (branches) or their authorized individuals and legal entities;

3) research organizations, laboratories in the field of public healthcare, education and science.

Article 254. Interaction of the authorized body and an authorized body in the field of customs affairs

1. In conveying across customs border of Eurasian Economic Union, which coincide with the State Border of the Republic of Kazakhstan, pharmaceutical products and medical products, an authorized body in the field of customs affairs shall receive details, confirmed by the authorized body, on state registration of each imported pharmaceutical product or medical product with indication of date and number of state registration, except for cases, provided for by subparagraphs 3 and 4 article 251 and article 253 of this Code.

2. An authorized body in the field of customs affairs shall present to the authorized body details on import to the Republic of Kazakhstan across the customs border of Eurasian Economic Union, which coincide with the State Border of the Republic of Kazakhstan, and on export from the Republic of Kazakhstan across the customs border of Eurasian Economic Union, which coincide with the State Border of the Republic of Kazakhstan, of pharmaceutical products and medical products.

Article 255. Procedures for import of pharmaceutical products and medical products, as well as biological material for pre-clinical (non-clinical) and clinical examinations, reference materials of pharmaceutical substances (active pharmaceutical ingredients) and their admixtures from the Republic of Kazakhstan

1. Export of pharmaceutical products and medical products from the Republic of Kazakhstan shall be in accordance with the procedures determined by the authorized body.

2. Pharmaceutical products and medical products may be exported from the Republic of Kazakhstan without approval of the authorized body:

1) for personal use by individuals, leaving the Republic of Kazakhstan, at the amount required for a treatment course;

2) as a part of first aid kit;

3) exhibits imported upon permit of the authorized body for holding of exhibitions;

4) medical products imported for conduction of pre-clinical (non-clinical) or clinical examinations;

5) as part of medical first-aid kits used by military personnel and employees of special state bodies, according to the list determined by state bodies in coordination with the authorized body.

3. Pharmaceutical products and medical products from the Republic of Kazakhstan as a part of facilities of medical and search-and-rescue organizations and units leaving the Republic of Kazakhstan to participate in emergency management, shall be exported in accordance with the procedures determined by the authorized body.

1) by manufacturers of pharmaceutical products and medical products;

2) international manufacturers of pharmaceutical products and medical products, their authorized representative offices (branches) or their authorized individuals and legal entities;

3) research organizations, laboratories in the field of public healthcare, education and science.

Footnote. Article 255 as amended by the Law of the Republic of Kazakhstan dated 19.04.2023 No. 223-VII (shall be enforced ten calendar days after the date of its first official publication).

Article 256. Installation, repair, technical and metrological maintenance of medical equipment

1. Installation, repair, technical and metrological maintenance of medical equipment shall be performed by individuals or legal entities having a right to perform such works in accordance with the laws of the Republic of Kazakhstan.

2. Level of safety of medical equipment after repair shall not be lower the level of safety established by technical certificate for medical products.

3. Organization of metrological support for measuring instruments of medical purpose, operated at healthcare organizations, shall be regulated in accordance with the laws of the Republic of Kazakhstan on measurement assurance.

4. Medical equipment, which is a measurement instrument, is subject to entering to the register of the state system for ensuring uniform measurement of the Republic of Kazakhstan and shall be approved for use in accordance with the laws of the Republic of Kazakhstan on measurement assurance.

List of medical equipment, which is a measurement instrument, shall be approved by the authorized body upon agreement with an authorized body exercising state control in the field of technical regulation and metrology.

Article 257. General requirements for efficiency, safety and quality of medical products

1. Medical products shall be designed and manufactured in such a manner that when using in conditions and for purposes corresponding to their use, defined by the manufacturer, and, where necessary, in consideration of know-how, experience, education and special training, clinical and physical state of a user, they would operate as per the use defined by the manufacturer, and would be safe for the user and third persons, provided that risk related to their use is acceptable in correlation with benefit for the user.

2. Medical products shall be designed, manufactured and packed in such a manner that their performance specifications and efficiency are not deteriorated during transportation and storage in accordance with instruction for use.

3. Medical products must be as efficient as it is provided for by the manufacturer, and be designed and manufactured in such a manner that under normal conditions of operation, they meet the purpose of use determined by the manufacturer.

4. Performance specifications and efficiency of a medical product shall not alter to the extent which poses a risk to life and health of users and third persons during operating life, determined by the manufacturer, provided that such medical product is exposed to impacts, which may arise under normal operational conditions, and technical maintenance is performed in accordance with instruction for use.

5. For each medical product, it is necessary to present information required for identification of such medical product and its manufacturer, country of origin, as well as information for user (professional or non-professional), relating to safety of such medical product, its functional properties and performance specifications. Such information shall be placed on medical product itself, on its package or in instruction for use.

Article 258. Classification of safety and re-classification of safety of medical products depending on the degree of potential risk of use

1. Medical products used in the Republic of Kazakhstan are divided into classes depending on the degree of potential risk of use and into types in accordance with the assortment of medical products of the Republic of Kazakhstan.

2. Rules for classification of medical products depending on the degree of potential risk of use are approved by the authorized body.

3. Class of medical products as per the degree of potential risk of use shall be approved upon state registration by the authorized body. Each medical product may only belong to one class.

4. Procedures for formation and maintenance of assortment of medical products of the Republic of Kazakhstan shall be defined by the authorized body.

5. The authorized body may enter amendments into classification based on detailed accounting of principles, occurrences, medical methods, underlying operation of medical products.

Article 259. Suspension, prohibition or withdrawal from circulation or restricted use of pharmaceutical products and medical products

1. The authorized body may suspend or prohibit the use, sale or production of pharmaceutical products and medical products, and take a decision to withdraw from circulation or to restrict use in the following cases:

1) non-compliance of pharmaceutical products and medical products with the requirements of the laws of the Republic of Kazakhstan in the field of public healthcare;

2) identification of adverse reactions of pharmaceutical products dangerous to human health, not specified in package leaflet, or increased frequency of identification of serious adverse reactions, specified in leaflet, or lower therapeutic efficacy (lack of therapeutic benefit), or available information on suspension and (or) its withdrawal from markets of other countries due to identification of adverse reactions with unfavourable "benefit-risk" relation;

3) identification of defects in design, operation, construction in the course of application of medical products, which affect safety of their application;

4) violation of approved process of production of pharmaceutical products and medical products, which affects safety, quality and efficiency of their application;

5) available data on harm to health of a patient or user due to application of pharmaceutical products and medical products;

6) receipt of data on inadequate scientific and technical level of production method and quality control, which lead to lower level of safety of application of pharmaceutical products and medical products;

7) application of the holder of a certificate of registration on suspension, on withdrawal of certificate of registration or withdrawal from circulation, or restriction of application of pharmaceutical products and medical products;

8) non-compliance of pharmaceutical products with the requirement of good pharmacy practices of the Republic of Kazakhstan and (or) Eurasian Economic Union, identified following pharmaceutical inspection;

9) non-performance of obligations on pharmacovigilance by a holder of certificate of registration for a pharmaceutical product or by a manufacturer of a medical product on monitoring of safety, quality and efficiency of medical products.

2. Rules for suspension, prohibition or withdrawal from circulation or restricted application of pharmaceutical products and medical products shall be approved by the authorized body.

Article 260. Falsified, counterfeit pharmaceutical products and medical products

1. It is prohibited to produce, import, store, use and sell falsified, counterfeit pharmaceutical products and medical products in the Republic of Kazakhstan.

2. Falsification of pharmaceutical products and medical products (presentation of false information on performance and (or) on source of origin) also includes accessories, parts and materials manufactured and designed for production of falsified products.

3. Prevention and fight against falsification of pharmaceutical products and medical products is administered by the authorized body in cooperation with concerned government bodies, organizations of manufacturers of pharmaceutical products and medical products, public healthcare entities and non-government organizations.

4. The authorized body implements international cooperation in the fight against falsified, counterfeit pharmaceutical products and medical products.

Article 261. Pharmacovigilance and monitoring of safety, quality and efficiency of medical products

1. The authorized body ensures operation of pharmacovigilance system and conducts monitoring of safety, quality and efficiency of medical products in the Republic of Kazakhstan.

2. State expert organization in the field of circulation of pharmaceutical products and medical products for the purposes of maintenance public health protection and improvement of safety of patients shall perform:

1) collection, analysis, assessment and verification of reports on adverse reactions of a pharmaceutical product, undesired events with a medical product received from entities of public healthcare and entities in the field of circulation of pharmaceutical products and medical products, consumers;

2) assessment of "benefit-risk" relation of pharmaceutical products and medical products on the basis of data of pharmacovigilance and monitoring of safety, quality and efficiency of medical products in the Republic of Kazakhstan, data, provided by holders of certificate of registration for pharmaceutical products, producers of medical products, data, received from other sources.

3. Procedures for conduction of pharmacovigilance and monitoring of safety, quality and efficiency of medical products shall be determined by the authorized body.

4. Pharmacovigilance and monitoring of safety, quality and efficiency of medical products shall be conducted by public healthcare entities, entities in the field of circulation of pharmaceutical products and medical products, as well as by holders of certificate of registration of pharmaceutical products and producers of medical products, organizations on service maintenance of medical products.

5. Public healthcare entities shall notify in written and in timely manner the authorized body of events of manifestation of adverse reactions, including those not specified in instruction for use of a pharmaceutical product, on patterns of interaction of a pharmaceutical product with other pharmaceutical products, on overdose, drug dependance, abuse, on absence or lower efficiency of a pharmaceutical product and on adverse events of medical products.

Holder of a certificate of registration of a pharmaceutical product and manufacturer of a medical product shall in full present to the authorized body data on safety of a pharmaceutical product, and in timely manner notify the authorized body of events of manifestation of adverse reactions and (or) adverse events in application of a pharmaceutical product or medical product.

6. The authorized body shall take into account data of pharmacovigilance and monitoring of safety, quality and efficiency of medical products in other countries when taking decision on suspension, prohibition or withdrawal from circulation, or restricted use of pharmaceutical products and medical products in the Republic of Kazakhstan.

Article 262. Information on pharmaceutical products and medical products

Information on pharmaceutical products and medical products approved for application and use in the Republic of Kazakhstan, on pharmaceutical products, which have not passed state registration, not meeting the requirements of the laws of the Republic of Kazakhstan in the field of public healthcare, on withdrawal of decision on state registration, as well as on pharmaceutical products, which are dispensed on prescription of a physician, shall be communicated in special print media designed for medical and pharmaceutical personnel.

Article 263. Kazakhstan National Drug Formulary

1. Kazakhstan National Drug Formulary is developed based on pharmacotheraupetic and (or) anatomicotheraupetic classification of pharmaceutical products.

2. For generation of Kazakhstan National Drug Formulary, State Register of Pharmaceutical Products and Medical Products shall be used.

3. Pharmaceutical products shall be entered into Kazakhstan National Drug Formulary under international non-proprietary name of a pharmaceutical product with specification of each trade name of such pharmaceutical product, registered in the Republic of Kazakhstan.

4. Rules for generation of Kazakhstan National Drug Formulary shall be developed and approved by the authorized body.

Article 264. Rational use of pharmaceutical products

1. Rational use of pharmaceutical products is intended for improvement of quality of medical care and outcomes of treatment through development of formulary system.

2. Formulary system ensures optimal utilization of safe, efficient, economically accessible pharmaceutical products. Operation of the formulary system shall be maintained in accordance with the procedures determined by the authorized body.

3. Public healthcare organizations shall ensure rational utilization of pharmaceutical products, training of clinical pharmacologists, clinical pharmacists and regular advance training of specialists in the field of public healthcare on rational use of pharmaceutical products.

Article 265. Ethics of promotion of pharmaceutical products and medical products

1. Ethics of promotion of pharmaceutical products and medical products is activities carried out in the course of promotion of safe, quality and efficient pharmaceutical products and medical products from a developer and (or) producer of a pharmaceutical product or medical product prior to its use by consumer based on fair competition and liability of all parties concerned.

2. Ethics of promotion of pharmaceutical products and medical products shall be implemented in accordance with the procedures determined by the authorized body.

3. For the purposes of rational utilization of pharmaceutical products and medical products, public healthcare entities, members of professional associations, entities in the field of circulation of pharmaceutical products and medical products must comply with the following terms of ethics of promotion of pharmaceutical products and medical products:

1) promotion of pharmaceutical products and medical products at the market must ensure completeness and accuracy of information presented regarding safe, quality and efficient pharmaceutical products and medical products;

2) patients, pharmaceutical and medical personnel must receive necessary and available information on pharmaceutical products and side effects;

3) promotion of pharmaceutical products and medical products at the market must be objective, comply with ethical standards and be implemented in accordance with the requirements of the laws of the Republic of Kazakhstan in the field of public healthcare.

4. In medical organizations and organizations of education in the field of public healthcare, it is prohibited to promote pharmaceutical products and medical products by representatives of manufacturers of pharmaceutical products and medical products and (or) distributors, except for daily doctors' conferences, research-to-practice conferences and (or) special workshops.

Daily doctors' conference is a routine meeting of a medical organization aimed to review results of a day, discuss and examine clinical events, and notify staff of new achievements in medical science and clinical practice.

SECTION 6. PERSONNEL POLICY IN THE FIELD OF PUBLIC HEALTHCARE

Chapter 29. HUMAN RESOURCES IN THE FIELD OF PUBLIC HEALTHCARE

Article 266. National system of accounting of human resources in the field of public healthcare

1. National system of accounting of human resources in the field of public healthcare (professional register) is a basis for registration, accounting, migration, outflow for the purposes of personal record-keeping, as well as continuous professional development of public healthcare personnel.

Procedures of accounting of human resources in the field of public healthcare (keeping of professional register) shall be defined by the authorized body.

2. On the basis of data of the professional register of public healthcare personnel, monitoring and forecasting of development of labour market and human resources, and planning of personnel training are implemented.

3. Persons, having certificates of specialist in the field of public healthcare are subject to mandatory registration in the National system of accounting of human resources in the field of public healthcare. Certificate of specialist in the field of public healthcare shall be valid in case of its registration in the National system of accounting of human resources in the field of public healthcare.

4. National coordinator on human resources in the field of public healthcare shall be defined by the authorized body.

Article 267. Special aspects of sectoral system of qualifications in the field of public healthcare

1. Sectoral system of qualifications in the field of public healthcare is a combination of mechanisms of legal and institutional regulation of demand for qualifications of public healthcare personnel on the part of the labour market and offer of qualifications on the part of the system of education in the field of public healthcare, including:

1) sectoral qualification framework in the field of public healthcare;

2) occupational standards in the field of public healthcare;

3) state compulsory standards of education in the field of public healthcare;

4) certification of specialists in the field of public healthcare;

5) system for continuous professional development of public healthcare personnel.

2. Occupational standards in the field of public healthcare shall be developed on medical and pharmaceutical specialties.

Article 268. Principles for implementation of personnel policy in the field of public healthcare

1. Implementation of personnel policy in the field of public healthcare is based on the following principles:

1) joint liability of the government and professional medical community, including professional medical associations, employers, medical and pharmaceutical personnel, for early and quality delivery of healthcare services;

2) regulation of human resources in the field of public healthcare for the purposes of satisfaction of real needs of the sector;

3) control and assistance in maintenance of training (preparation) of human resources in the field of public healthcare;

4) rational and efficient implementation of capacities of human resources in the field of public healthcare;

5) strengthening the status of administrative human resources in the field of public healthcare;

6) training of human resources in the field of public healthcare in consideration of current and further needs of the public healthcare system;

7) continuous improvement of programs of training of human resources in the field of public healthcare;

8) independent evaluation of expertise, competences, occupational training of human resources in the field of public healthcare;

9) development of professional medical associations;

10) social security for medical personnel;

11) availability of necessary human resources in the field of public healthcare;

12) generation of proper competences and skills of personnel;

13) continuous professional development (life-long learning);

14) improvement of productivity of human resources in the field of public healthcare;

15) social recognition.

2. Personnel policy in the field of public healthcare is formed:

1) at the republic level - by an authorized body, approving national policy of human resources management in the field of public healthcare;

2) at the regional level - by local public healthcare authorities of regions, cities of republican status and the capital city, approving regional policy of human resource management in the field of public healthcare;

3) at the level of public healthcare organizations - by public healthcare organizations, implementing corporate personnel policy.

3. Planning of training of medical and pharmaceutical personnel is implemented by the authorized body, central executive bodies and other central government bodies, having military-medical (medical) subdivisions, as well as local public healthcare authorities of regions, cities of republican status and the capital city within their competencies in consideration of needs of the sector.

Article 269. Continuous occupational development of public healthcare personnel

1. Continuous occupational development of medical and pharmaceutical personnel is designed for improvement of professional expertise and skills, acquisition of additional competences, considering needs of specialists, for the purposes of improvement of safety of medical services.

2. Outcomes of continuous occupational development of medical and pharmaceutical personnel shall be verified on the basis of accounting data of the professional register on additional and informal education, other activities on occupational development, level of competency, approved work experience.

3. Outcomes of continuous occupational development of medical and pharmaceutical personnel shall be verified in view of the requirements to the level of qualification, established by occupational standard and qualification criteria to professional duties of public healthcare personnel.

4. Professional medical associations shall participate in development of occupational standards and educational programs for additional and informal education.

Chapter 30. STATUS OF MEDICAL AND PHARMACEUTICAL PERSONNEL

Article 270. Status of medical and pharmaceutical workers and their rights

1. Medical and pharmaceutical personnel shall have a right for fundamental guarantees, provided for by the laws of the Republic of Kazakhstan and other regulatory legal acts, including for:

1) creation of proper conditions for personnel for performance of employment duties, including provision with necessary medical products in accordance with the procedures, established by the laws of the Republic of Kazakhstan;

2) advance training or change of professional qualification at the expense of employer or out of public funds, provided for such purposes by the laws of the Republic of Kazakhstan, when it is impossible to perform employment duties for medical reasons and in case of dismissal of personnel due to reduction in force or personnel, due to liquidation of an organization;

3) labour remuneration conforming to qualification level;

4) work motivation in accordance with level of qualification, specificity and complexity of work, scope and quality of labour, as well as with certain performance outcomes;

5) establishment of professional associations and participation therein;

6) insurance of professional liability of medical workers in case of harm to life and (or) health of a patient when providing medical care;

7) compensation for damage to life and health during performance of official duties, in accordance with the laws of the Republic of Kazakhstan;

8) engagement in private medical practice and pharmaceutical activities upon availability of authorization documents for medical and pharmaceutical activities;

9) unrestricted and free-of-charge use of communication means, owned by individuals and legal entities in case of transportation of a patient to the nearest medical organization to deliver urgent medical aid;

10) compensation for transportation expenses relating to transit.

2. Workers with technical and professional, post-secondary degree, higher, post-graduate medical degree, confirmed by a certificate of specialist in the field of public healthcare have a right to engage in medical activities.

3. Resident physicians within the period of their studies have a right to work at medical organizations in accordance with certificate of specialist in the field of public healthcare under the supervision of a mentor.

4. Persons, who earned medical degree abroad, shall be admitted to medical or pharmaceutical activities after recognition of documents of education, a positive result of the evaluation of professional qualifications at an organization, with issue of a certificate of specialist in the field of healthcare.

Evaluation of professional qualifications of persons, who earned medical degree abroad, shall be conducted in accordance with the rules for evaluation of professional qualification of graduates on programs of medical education.

5. Medical incident is an event relating to delivery of medical services in accordance with standards of an organization delivering medical services and using technology, equipment and tools, associated with deviation from proper functioning of an organism which may cause damage to life and health of a patient, or also lead to death of a patient, except for cases, provided for by administrative and criminal laws of the Republic of Kazakhstan.

Analysis of a medical incident shall be carried out through internal audit of a medical organization, as well as by local public healthcare authorities of regions, cities of republican status and the capital city, government bodies, exercising state control in the field of delivery of medical service (aid), public sanitary and epidemiological welfare, circulation of pharmaceutical materials and medical materials, the authorized body.

Footnote. Article 270 as amended by the Law of the Republic of Kazakhstan dated 08.01.2021 No. 410-VI (shall be enforced upon expiration of ten calendar days after the date of its first official publication); dated 03.01.2022 No. 101-VII (shall be enforced from 01.01.2023).

Article 271. Obligations of medical and pharmaceutical personnel

1. Medical and pharmaceutical personnel shall carry out activities in accordance with the laws of the Republic of Kazakhstan and, being guided by the principles of medical ethics and deontology, shall:

1) facilitate disease prevention, health promotion, promotion of healthy lifestyle among people of the Republic of Kazakhstan;

2) deliver medical services in accordance with own qualification, official and job duties;

3) refer, where necessary, for advice to specialists of other profile or higher qualification;

4) keep secret of medical worker, not disclose details on diseases, intimate and family life of a patient;

5) improve own professional level on a continuous basis;

6) be registered in the National system of accounting of human resources in the field of public healthcare;

7) in medication, prescribe pharmaceutical materials within own competence where there are respective medical indications under international non-proprietary name, except for cases of idiosyncrasy of a patient.

2. Medical and pharmaceutical personnel, heads of medical organizations shall not have a right to:

1) participate in advertising of pharmaceutical materials and medical materials;

2) recommend certain facilities of retail trade of pharmaceutical products and medical products to patients for the purposes of self-interest in receiving remuneration for own services;

3) promote pharmaceutical products and medical products with participation of representatives of manufacturers of pharmaceutical products and medical products and (or) distributors, except for daily doctors' conferences, research-to-practice conferences and (or) special workshops.

Article 272. Social guarantees Social protection for medical and pharmaceutical personnel

1. Medical personnel of state medical organizations, working in rural areas and in settlements, cities of district status, the following forms of social assistance shall be provided for:

1) mandatory provision of housing upon decision of local executive bodies, including service housing, in accordance with the laws of the Republic of Kazakhstan;

2) mandatory allowance payment in accordance with procedures established by a local executive body;

3) provision of social support on compensation for utility expenses and other benefits upon decision of local executive bodies;

4) other measures.

2. Medical and pharmaceutical personnel of state medical organizations have a priority right after vulnerable social groups to receive forms of social assistance, additional benefits and incentive payments at the expense of local budgets.

3. Local executive bodies in order to promote prestige of medical personnel and to maintain improvement of its personal and professional growth shall assign status "Best in Profession" with provision of incentive payments at the expense of local budgets.

4. Interference in professional activities of medical and pharmaceutical personnel on the part of government bodies and officials, as well as citizens of the Republic of Kazakhstan is prohibited, except for cases provided for by this Code.

5. In carrying out professional activities by a medical or pharmaceutical worker, the following is not allowed:

1) involvement in types of works not related to professional duties, except for cases, provided for by the laws of the Republic of Kazakhstan;

2) demand of reports or information, not provided for by the laws of the Republic of Kazakhstan;

3) imposition of obligations on procurement of goods (works) and services, not provided for by the laws of the Republic of Kazakhstan.

Article 273. Secrecy of medical worker

1. Personal medical data, information on event of seeking medical advice, state of health of a person, diagnosis of his disease and other details, obtained during examination and (or) treatment constitute secrecy of medical worker.

2. It is not allowed to disclose details constituting secrecy of medical worker, by persons, to whom they become known during training, performance of professional duties, official and other obligations, except for cases specified in paragraphs 3 and 4 of this article.

3. With informed consent of a patient or his legal representative, it is allowed to convey information, constituting secrecy of medical worker, for conduction of research activities, use of such information in educational process.

4. Provision of information, constituting secrecy of medical worker, without consent of a person is allowed in following cases:

1) for the purposes of examination and treatment of a person, incapable due to his state to express own will, in case of absence of a legal representative;

2) under the threat of disease distribution, constituting a danger to the public, including in donation of blood, its components, transplantation of organs (part of an organ) and (or) tissues (part of tissue);

3) upon request from bodies of inquiry and preliminary investigation, prosecutor, attorney and (or) court due to conduction of investigation or judicial proceedings;

4) in delivery of medical services to a minor child or incompetent person to notify his legal representative;

5) if there are grounds to suppose that damage to health of a citizen of the Republic of Kazakhstan is caused as a result of unlawful acts;

6) in case of disclosure of mental deviations and propensity towards sexual violence of a person;

7) in exercising state control of quality of delivery of medical services (aid), monitoring of contractual obligations on quality and scope of medical services;

8) when conducting inspections by the prosecutor's office in accordance with the procedure established by the Constitutional Law of the Republic of Kazakhstan "On the Prosecutor's Office";

9) upon request of special state bodies for the purposes of solution of tasks of counterintelligence activities.

5. The following shall not be considered as disclosure of secrecy of medical worker:

1) transmission for storage of a backup copy of electronic information resource to an integrated platform for standby storage of electronic information resources in accordance with the procedures and within the terms, established by an authorized body in the field of maintenance of information security, except for cases, when such electronic information resources contain information, related to intelligence, counterintelligence activities and guard activities on maintenance of safety of protected persons and facilities, transmission whereof is implemented in accordance with the laws of the Republic of Kazakhstan on state secrets;

2) exchange of information using information and communication technology for the purposes of delivery of medical services and to maintenance of operation of law enforcement and special state bodies.

6. It is not allowed to connect electronic information resources containing personal medical data of individuals to telecommunications networks linking them with other databases without the consent of individuals when using personal medical data related to their private life, except in cases related to blood donation and its components, organs (parts of an organ) and (or) tissues (parts of tissue), as well as requests from law enforcement and special state bodies to provide information in the form of an electronic document constituting a medical secret, about the registered persons suffering from or who have had tuberculosis, with mental and behavioral disorders (diseases) associated with the use of psychoactive substances.

7. Cases, when data on health of a patient become available due to reasons beyond the control of a medical worker, shall not be considered as violation of secrecy of medical worker.

Footnote. Article 273 as amended by the Law of the Republic of Kazakhstan dated 05.11.2022 No. 157-VII (shall be enforced ten calendar days after the date of its first official publication); dated 23.12.2023 No. 51-VIII (effective ten calendar days after the date of its first official publication).

Article 274. Code of honour of medical and pharmaceutical personnel of the Republic of Kazakhstan

1. Code of Honour of medical and pharmaceutical personnel of the Republic of Kazakhstan (hereinafter referred to as Code of Honour) establishes moral and ethical liability of medical and pharmaceutical workers of the Republic of Kazakhstan for their activities before the public.

2. Code of Honour shall be developed and approved by the authorized body.

SECTION 7. FINAL PROVISIONS

Article 275. Liability for violation of the laws of the Republic of Kazakhstan in the field of public healthcare

Violation of the laws of the Republic of Kazakhstan in the field of public healthcare creates liability, established by the laws of the Republic of Kazakhstan.

Article 276. Procedures for enforcement of this Code

1. This Code shall enter into force upon expiration of ten calendar days after its first official publication, except for:

1) article 39, subparagraph 1) paragraph 10 article 55, which shall enter into force on January 1, 2021;

2) part two paragraph 2 article 231 and part two paragraph 3 article 233, which shall enter into force for organizations producing pharmaceutical products, pharmacy depots on January 1, 2021;

3) paragraph 7 article 240, which shall enter into force on June 1, 2021;

4) subparagraph 16) paragraph 2 article 110, subparagraphs 2), 3) paragraph 1, subparagraphs 2), 3) paragraph 4, paragraphs 7 and 8 article 27, which shall enter into force on July 1, 2021;

5) subparagraph 2) paragraph 10 article 55, which shall enter into force on January 1, 2022;

6) part one paragraph 3 article 233, which shall enter into force for chemist’s shops on January 1, 2023;

      7) Excluded by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).
      2. Excluded by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).
      3. Excluded by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication)..

4. Suspend prior to enforcement of subparagraph 1) paragraph 22 article 1 of the Law of the Republic of Kazakhstan dated May 13, 2020 “On introduction of amendments and additions to some legal acts of the Republic of Kazakhstan on issues of regulation of migration processes” the force of title of article 83 in title list of content, title, paragraphs 1 and 3 article 83, paragraph 2 article 160, paragraph 1 article 162 and part one paragraph 1 article 196 of this Code, by establishing that within the period of suspension, such norms shall be in force as follows:

1) title of article 83 in list of content:

“Article 83. Rights and obligations of oralmans (repatriates), foreigners, persons without citizenship and other persons”;

2) title of article, subparagraphs 1 and 3 article 83:

“Article 83. Rights and obligations of oralmans (repatriates), foreigners, persons without citizenships and other persons

1. Oralmans (repatriates), refugees, as well as foreigners and persons without citizenship, permanently residing in the Republic of Kazakhstan, have a right to receive statutory free medical assistance on an equal basis with citizens of the Republic of Kazakhstan”;

“3. Oralmans (repatriates), refugees and persons, seeking refuge, foreigners and persons without citizenship, residing in the Republic of Kazakhstan, bear the same obligations in the field of public healthcare as citizens of the Republic of Kazakhstan;

3) paragraph 2 article 160:

“2. HIV-infected citizens of the Republic of Kazakhstan, oralmans (repatriates), foreigners, persons without citizenship, refugees, permanently residing in the Republic of Kazakhstan, and children born of HIV-infected mothers with unidentified diagnosis, shall be subject to case follow-up and provision with pharmaceutical products within statutory free medical assistance”;

4) paragraph 1 article 162:

“1. Citizens of the Republic of Kazakhstan, oralmans (repatriates), foreigners, persons without citizenship, refugees and persons, seeking refuge, permanently or temporarily residing in the Republic of Kazakhstan, have a right for voluntary anonymous and (or) private medical examination and advice on issues of HIV-infection within statutory free medical assistance in state organizations of public healthcare, carrying out activities in the field of HIV prevention, in accordance with the procedures, determined by the authorized body”;

5) part one paragraph 1 article 196:

“1. Statutory free medical assistance shall be provided to citizens of the Republic of Kazakhstan, oralmans (repatriates), refugees, foreigners and persons without citizenship, permanently residing in the Republic of Kazakhstan, at the expense of budgetary funds, includes prophylactic, diagnostic and therapeutic medical services, having best proven efficiency, as well as pharmacological support”.

5. The following shall be deemed to have lost force:

1) Code of the Republic of Kazakhstan dated September 18, 2009 “On People’s Health and Healthcare System” (Bulletin of the Parliament of the Republic of Kazakhstan, 2009, No. 20-21, article 89; 2010, No. 5, article 23; No. 7, article 32; No. 15, article 71; No. 24, articles 149, 152; 2011, No. 1, articles 2, 3; No. 2, article 21; No. 11, article 102; No. 12, article 111; No. 17, article 136; No. 21, article 161; 2012, No. 1, article 5; No. 3, article 26; No. 4, article 32; No. 8, article 64; No. 12, article 83; No. 14, articles 92, 95; No. 15, article 97; No. 21-22, article 124; 2013, No. 1, article 3; No. 5-6, article 30; No. 7, article 36; No. 9, article 51; No. 12, article 57; No. 13, article 62; No. 14, articles 72, 75; No. 16, article 83; 2014, No. 1, article 4; No. 7, article 37; No. 10, article 52; No. 11, article 65; No. 14, articles 84, 86; No. 16, article 90; No. 19-I, 19-II, article 96; No. 21, article 122; No. 23, article 143; 2015, No. 1, article 2; No. 7, article 33; No. 10, article 50; No. 19-II, article 102; No. 20-IV, article 113; No. 20-VII, article 115; No. 22-I, article 143; No. 22-V, article 156; No. 23-II, article 170; 2016, No. 6, article 45; No. 8-II, articles 67, 70; No. 23, article 119; 2017, No. 1-2, article 3; No. 4, article 7; No. 9, article 22; No. 13, article 45; No. 22-III, article 109; No. 23-III, article 111; No. 24, article 115; 2018, No. 10, article 32; No. 14, article 42; No. 15, article 47; No. 19, article 62; No. 23, article 91; No. 24, articles 93, 94; 2019, No. 7, article 36; No. 8, article 46; No. 21-22, article 90; No. 23, article 106; Law of the Republic of Kazakhstan dated May 4, 2020 “On introduction of amendments and additions to some legal acts of the Republic of Kazakhstan on issues of labour”, published in newspapers “Yegemen Qazaqstan” and “Kazakhstanskaya Pravda” on May 5, 2020; Law of the Republic of Kazakhstan dated May 13, 2020 “On introduction of amendments and additions to some legal acts of the Republic of Kazakhstan on issues of regulation of migration processes”, published in newspapers “Yegemen Qazaqstan” and “Kazakhstanskaya Pravda” on May 14, 2020; Law of the Republic of Kazakhstan dated May 25, 2020 “On introduction of amendments and additions to some legal acts of the Republic of Kazakhstan on issues of mobilization preparation and mobilization”, published in newspapers “Yegemen Qazaqstan” and “Kazakhstanskaya Pravda” on May 26, 2020);

2) Law of the Republic of Kazakhstan dated April 7, 1995 “On compulsory treatment of patients with alcohol, drug and inhalant dependence” (Bulletin of the Supreme Soviet of the Republic of Kazakhstan, 1995, No. 3-4, article 32; Bulletin of the Parliament of the Republic of Kazakhstan, 2004, No. 23, article 142; 2010, No. 24, article 152; 2012, No. 8, article 64; 2013, No. 13, article 62; 2014, No. 19-I, 19-II, article 96; 2018, No. 24, article 93);

3) Law of the Republic of Kazakhstan dated October 14, 2003 “On Prevention of Iodine Deficiency Disorders” (Bulletin of the Parliament of the Republic of Kazakhstan, 2003, No. 19-20, article 149; 2006, No. 1, article 5; 2007, No. 4, article 95; 2011, No. 11, article 102; 2012, No. 14, article 92; 2013, No. 14, article 75; 2014, No. 1, article 4; No. 23, article 143; 2018, No. 24, article 93).

Footnote. Article 276 as amended by the Law of the Republic of Kazakhstan dated 27.06.2022 No. 129-VII (shall be enforced ten calendar days after the date of its first official publication).

The President of the Republic of Kazakhstan

K. TOKAYEV

Примечание ИЗПИ!
Для удобства пользования ИЗПИ создано Содержание

СОДЕРЖАНИЕ

      Сноска. Оглавление исключено Законом РК от 24.06.2021 № 52-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      Примечание ИЗПИ!
Порядок введения в действие настоящего Кодекса см. ст. 276.
      Сноска. По всему тексту слова "профилактического контроля и надзора" предусмотрено заменить словами "профилактического контроля" в соответствии с Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

РАЗДЕЛ 1. ОБЩИЕ ПОЛОЖЕНИЯ

Глава 1. ОСНОВНЫЕ ПОЛОЖЕНИЯ

Статья 1. Основные понятия, используемые в настоящем Кодексе

1. В настоящем Кодексе используются следующие основные понятия:

1) среда обитания человека (далее – среда обитания) – совокупность природных, антропогенных и социальных факторов среды (природной и искусственной), определяющих условия жизнедеятельности человека;

2) ВИЧ-инфекция – хроническое инфекционное заболевание, вызванное вирусом иммунодефицита человека, характеризующееся специфическим поражением иммунной системы и приводящее к медленному ее разрушению до формирования синдрома приобретенного иммунодефицита;

3) сертифицированный тренер по первой помощи – лицо, прошедшее дополнительную подготовку по первой помощи и базовой сердечно-легочной реанимации;

4) анонимное обследование – добровольное медицинское обследование лица без идентификации личности;

5) медицина катастроф – область медицины, направленная на предупреждение и ликвидацию медико-санитарных последствий чрезвычайных ситуаций социального, природного и техногенного характера (далее – чрезвычайные ситуации), включающая предупреждение и лечение заболеваний населения, санитарно-противоэпидемические и санитарно-профилактические мероприятия, сохранение и восстановление здоровья участников ликвидации чрезвычайных ситуаций, а также медицинскую помощь сотрудникам аварийно-спасательных служб;

6) фонд социального медицинского страхования – некоммерческая организация, производящая аккумулирование отчислений и взносов, а также осуществляющая закуп и оплату услуг субъектов здравоохранения, оказывающих медицинскую помощь в объемах и на условиях, которые предусмотрены договором закупа медицинских услуг, и иные функции, определенные законами Республики Казахстан;

7) военная медицина – область медицины и здравоохранения, представляющая собой систему научных знаний (комплекс научно-практических дисциплин) и практической деятельности военно-медицинской службы, имеющая своей целью всестороннее медицинское обеспечение войск, подразделений и ведомств специальных государственных и правоохранительных органов в мирное и военное время;

8) военно-медицинская служба – совокупность военно-медицинских (медицинских) подразделений, в которых законами Республики Казахстан предусмотрены воинская служба или особый вид государственной службы, предназначенные для военно-медицинского (медицинского) обеспечения деятельности этих органов;

9) военно-медицинские (медицинские) подразделения – структурные подразделения центральных исполнительных органов и иных центральных государственных органов и их территориальных подразделений, а также военно-медицинские (медицинские) учреждения (организации), иные подразделения, осуществляющие военно-медицинское (медицинское) обеспечение;

10) обогащение (фортификация) – введение витаминов, минералов и других веществ в пищевую продукцию в процессе ее производства или переработки с целью повышения пищевой и биологической ценности, а также профилактики заболеваний, обусловленных их дефицитом у человека;

11) ребенок (дети) – лицо, не достигшее восемнадцатилетнего возраста (совершеннолетия);

12) профильный специалист – медицинский работник с высшим медицинским образованием, имеющий сертификат в области здравоохранения;

13) установленная (окончательная) санитарно-защитная зона – территория санитарно-защитной зоны, определяемая на основании результатов годичного цикла натурных исследований и измерений для подтверждения расчетной (предварительной) санитарно-защитной зоны;

14) перечень лекарственных средств и медицинских изделий для бесплатного и (или) льготного амбулаторного обеспечения отдельных категорий граждан Республики Казахстан с определенными заболеваниями (состояниями) – перечень лекарственных средств, медицинских изделий и специализированных лечебных продуктов, закупаемых за счет бюджетных средств и (или) активов фонда социального медицинского страхования в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования при оказании первичной медико-санитарной и специализированной медицинской помощи в амбулаторных условиях, включающий наименования и характеристики лекарственных средств, медицинских изделий и специализированных лечебных продуктов в разрезе отдельных категорий граждан Республики Казахстан с определенными заболеваниями (состояниями);

15) биоаналогичный лекарственный препарат (биоаналог, биоподобный лекарственный препарат, биосимиляр) – биологический лекарственный препарат, который содержит версию действующего вещества зарегистрированного биологического оригинального лекарственного препарата или референтного лекарственного препарата и по которому продемонстрировано сходство (подобие) на основе сравнительных исследований по показателям качества, биологической активности, безопасности и эффективности;

16) биобанк – специализированное хранилище биологических материалов для научных и медицинских целей;

17) биологически активные вещества – вещества натурального происхождения или их синтетические аналоги, нормализующие патологически измененные функции организма у животных и человека;

18) биологический лекарственный препарат – лекарственный препарат, действующее вещество которого произведено или выделено из биологического источника и для описания свойств и контроля качества которого необходимо сочетание биологических и физико-химических методов анализа с оценкой производственного процесса и методов его контроля;

19) лекарственные препараты биологического происхождения – препараты, содержащие биологические вещества (гормоны, цитокины, факторы свертывания крови, инсулины, моноклональные антитела, ферменты, колониестимулирующие факторы, препараты, созданные на базе клеток тканей, и прочие, полученные с помощью биотехнологических методов);

20) биомедицинское исследование – исследование, целью которого является получение научными методами новых знаний о жизни, здоровье человека, заболеваниях, их диагностике, лечении или профилактике, а также генетических и экологических факторах, связанных с процессами жизни, болезнями и здоровьем;

21) биотехнологический лекарственный препарат – лекарственный препарат, произведенный при помощи биотехнологических процессов и применения методов с использованием технологии рекомбинантной дезоксирибонуклеиновой кислоты, контролируемой экспрессии генов, кодирующих выработку биологически активных белков, гибридомных технологий, моноклональных антител или других биотехнологических процессов;

22) биоэтика – междисциплинарное научное направление, объединяющее биомедицинские и гуманитарные науки с целью анализа моральных, социальных, правовых аспектов применения новейших достижений наук о жизни;

23) родоразрешение – естественное или искусственное (инструментальное, ручным способом, медикаментозное) завершение родового акта;

24) предельная цена на торговое наименование лекарственного средства для розничной реализации – цена на торговое наименование лекарственного средства, включенного в перечень лекарственных средств, подлежащих ценовому регулированию, выше которой не может осуществляться его розничная реализация;

25) оригинальный лекарственный препарат – лекарственный препарат с новым действующим веществом, который был первым зарегистрирован и размещен на мировом фармацевтическом рынке на основании досье, содержащего результаты полных доклинических (неклинических) и клинических исследований, подтверждающих его безопасность, качество и эффективность;

26) сооплата – оплата разницы в стоимости лекарственных средств, медицинских изделий и установленной предельной цене их возмещения в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования на амбулаторном уровне, осуществляемая в добровольном порядке;

27) единый дистрибьютор – юридическое лицо, осуществляющее деятельность в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования в соответствии со статьей 247 настоящего Кодекса;

28) вакцины – лекарственные препараты для специфической профилактики инфекционных заболеваний, оказывающие профилактический эффект через иммунную систему;

29) гемопоэтические стволовые клетки – кроветворные клетки костного мозга человека, обладающие полипотентностью и находящиеся в процессе жизни в костном мозге, периферической крови и пуповинной крови;

30) регистр доноров гемопоэтических стволовых клеток (костного мозга) – перечень лиц, согласных на безвозмездное донорство гемопоэтических стволовых клеток (костного мозга) и типированных по системе-НLА;

31) генетически модифицированные объекты – сырье и продукты растительного и (или) животного происхождения, полученные с использованием методов генной инженерии, в том числе генетически модифицированные источники, организмы;

32) гомеопатический лекарственный препарат – лекарственный препарат, произведенный по гомеопатической технологии с использованием гомеопатического сырья в соответствии с требованиями фармакопей Республики Казахстан и (или) Евразийского экономического союза или в случае их отсутствия в соответствии с требованиями гомеопатических фармакопей;

33) лекарственное средство – средство, представляющее собой или содержащее вещество либо комбинацию веществ, вступающее в контакт с организмом человека, предназначенное для лечения, профилактики заболеваний человека или восстановления, коррекции или изменения его физиологических функций посредством фармакологического, иммунологического либо метаболического воздействия, или для диагностики заболеваний и состояния человека;

34) предельная цена на лекарственное средство – цена, выше которой не может быть осуществлена реализация лекарственного средства;

35) обращение лекарственных средств – деятельность, включающая процессы разработки, доклинических (неклинических) исследований, испытаний, клинических исследований, экспертизы, регистрации, фармаконадзора, контроля качества, производства, изготовления, хранения, транспортировки, ввоза и вывоза, отпуска, реализации, передачи, применения, уничтожения лекарственных средств;

36) надлежащие фармацевтические практики в сфере обращения лекарственных средств (далее – надлежащие фармацевтические практики) – стандарты в области здравоохранения, распространяющиеся на все этапы жизненного цикла лекарственных средств: надлежащая лабораторная практика (GLP), надлежащая клиническая практика (GCP), надлежащая производственная практика (GMP), надлежащая дистрибьюторская практика (GDP), надлежащая аптечная практика (GPP), надлежащая практика фармаконадзора (GVP) и другие надлежащие фармацевтические практики;

37) производитель лекарственных средств – организация, осуществляющая деятельность по производству лекарственных средств и имеющая лицензию на производство лекарственных средств;

38) реестр уполномоченных лиц производителей лекарственных средств – электронный информационный ресурс уполномоченного органа, содержащий сведения об уполномоченных лицах производителей лекарственных средств;

39) уполномоченное лицо производителя лекарственных средств – лицо, отвечающее за обеспечение и контроль качества лекарственных средств, произведенных производителем в соответствии с законодательством Республики Казахстан в области здравоохранения, и вошедшее в реестр уполномоченных лиц производителей лекарственных средств;

40) рациональное использование лекарственных средств – медикаментозное лечение, соответствующее клиническим показаниям, в дозах, отвечающих индивидуальным потребностям пациента, в течение достаточного периода времени и при наименьших затратах;

41) долгосрочный договор поставки лекарственных средств и медицинских изделий – гражданско-правовой договор, заключаемый единым дистрибьютором сроком до десяти лет с правом продления до трех лет с расположенным на территории Республики Казахстан производителем лекарственных средств или медицинских изделий либо с заказчиком контрактного производства оригинальных запатентованных лекарственных средств, а также c заказчиками контрактного производства медицинских изделий на поставку лекарственных средств или медицинских изделий либо с субъектом в сфере обращения лекарственных средств и медицинских изделий, имеющим намерение создать производство или модернизировать действующее производство лекарственных средств и медицинских изделий, расположенным на территории Республики Казахстан, в порядке, установленном законодательством Республики Казахстан;

42) розничная реализация лекарственных средств и медицинских изделий – фармацевтическая деятельность, связанная с приобретением (кроме ввоза), хранением, распределением, реализацией (кроме вывоза) конечному потребителю, уничтожением лекарственных средств и медицинских изделий;

43) контрактное производство лекарственных средств и медицинских изделий (далее – контрактное производство) – производство лекарственных средств и медицинских изделий на контрактной основе на производственных мощностях производителей лекарственных средств и медицинских изделий, расположенных на территории Республики Казахстан, которые обеспечивают полное соблюдение требований надлежащей производственной практики (GMP) для лекарственных средств и международного стандарта системы управления качеством (ISO 13485) для производителей медицинских изделий;

44) веб-портал закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения – информационная система, предоставляющая единую точку доступа к электронным услугам закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

45) единый оператор в сфере закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения (далее – единый оператор) – юридическое лицо, определяемое уполномоченным органом по согласованию с уполномоченным органом в сфере государственных закупок;

46) оптовая реализация лекарственных средств и медицинских изделий – фармацевтическая деятельность, связанная с закупом (приобретением), хранением, ввозом (импортом), вывозом (экспортом), реализацией (за исключением реализации населению) без ограничения объемов, транспортировкой и уничтожением лекарственных средств и медицинских изделий;

47) государственный орган в сфере обращения лекарственных средств и медицинских изделий – государственный орган, осуществляющий руководство в сфере обращения лекарственных средств и медицинских изделий, контроль за обращением лекарственных средств и медицинских изделий;

48) государственная экспертная организация в сфере обращения лекарственных средств и медицинских изделий – субъект государственной монополии, осуществляющий производственно-хозяйственную деятельность в области здравоохранения по обеспечению безопасности, эффективности и качества лекарственных средств и медицинских изделий;

49) объекты в сфере обращения лекарственных средств и медицинских изделий – аптека, в том числе осуществляющая реализацию через Интернет, аптечный пункт в организациях здравоохранения и передвижной аптечный пункт для сельских населенных пунктов, аптечный (дистрибьюторский) склад, склад временного хранения лекарственных средств, медицинских изделий, магазин оптики, магазин медицинских изделий, склад медицинских изделий, организации по производству лекарственных средств и медицинских изделий;

50) субъекты в сфере обращения лекарственных средств и медицинских изделий – физические или юридические лица, осуществляющие фармацевтическую деятельность;

51) Государственный реестр лекарственных средств и медицинских изделий – электронный информационный ресурс, содержащий сведения о зарегистрированных и разрешенных к медицинскому применению в Республике Казахстан лекарственных средствах и медицинских изделиях;

52) долгосрочный договор по хранению и транспортировке лекарственных средств и медицинских изделий – гражданско-правовой договор оказания услуг, заключаемый единым дистрибьютором с субъектом в сфере обращения лекарственных средств и медицинских изделий – резидентом Республики Казахстан, соответствующим требованиям надлежащей дистрибьюторской практики (GDP);

53) государственная перерегистрация лекарственного средства или медицинского изделия – процедура продления срока действия государственной регистрации лекарственного средства или медицинского изделия с выдачей бессрочного документа, удостоверяющего государственную регистрацию (далее – регистрационное удостоверение), под прежним регистрационным номером и внесением соответствующей записи в Государственный реестр лекарственных средств и медицинских изделий;

54) государственная регистрация лекарственного средства или медицинского изделия – процедура получения разрешения к обращению лекарственных средств или медицинских изделий на территории Республики Казахстан и внесения лекарственного средства или медицинского изделия на определенный срок в Государственный реестр лекарственных средств и медицинских изделий;

55) срок годности лекарственного средства – дата, после истечения которой лекарственное средство не подлежит применению;

56) упаковка лекарственного средства – средство или комплекс средств, обеспечивающих процесс обращения лекарственных средств путем их защиты от повреждений и потерь, а также предохраняющих окружающую среду от загрязнений;

57) балк-продукт лекарственного средства или медицинского изделия – дозированный готовый лекарственный препарат или готовое медицинское изделие, прошедшие все стадии технологического процесса, за исключением окончательной упаковки;

58) внесение изменений в регистрационное досье лекарственного средства или медицинского изделия – процедура, осуществляемая на основании экспертизы изменений, вносимых в регистрационное досье в течение срока действия регистрационного удостоверения;

59) качество лекарственного средства – совокупность свойств и характеристик фармацевтической субстанции (активной фармацевтической субстанции) и лекарственного препарата, обеспечивающая их соответствие целевому назначению;

60) нормативный документ по качеству лекарственного средства – документ, устанавливающий требования к контролю качества лекарственного средства в пострегистрационный период на основании проведенной экспертизы лекарственного средства при его регистрации и содержащий спецификацию, описание аналитических методик и испытаний лекарственного средства или ссылки на такие испытания, а также соответствующие критерии приемлемости для показателей качества;

61) торговое наименование лекарственного средства – название, под которым регистрируется лекарственное средство;

62) международное непатентованное наименование лекарственного средства – название лекарственного средства, рекомендованное Всемирной организацией здравоохранения;

63) качество лекарственного обеспечения – уровень соответствия требованиям стандартов в области здравоохранения, регулирующих производство, ввоз, хранение, своевременную поставку лекарственных средств и фармаконадзор;

64) лекарственная форма – состояние лекарственного препарата, соответствующее способам его введения, применения и обеспечивающее достижение необходимого лечебного эффекта;

65) лекарственное растительное сырье – свежие или высушенные растения, водоросли, грибы или лишайники либо их части, цельные или измельченные, используемые для производства лекарственных средств;

66) лекарственный препарат – лекарственное средство в виде лекарственной формы;

67) изготовление лекарственных препаратов – фармацевтическая деятельность, связанная с изготовлением лекарственных препаратов в аптеках, приобретением фармацевтических субстанций (активных фармацевтических субстанций) для фармацевтического применения, хранением, контролем качества, оформлением и реализацией изготовленных лекарственных препаратов;

68) безопасность лекарственного препарата – отсутствие недопустимого риска при применении лекарственного препарата, связанного с возможностью нанесения вреда жизни, здоровью человека и окружающей среде;

69) эффективность лекарственного препарата – совокупность характеристик лекарственного препарата, обеспечивающих достижение профилактического, диагностического или лечебного эффекта либо восстановление, коррекцию или модификацию физиологической функции;

70) лекарственное сырье – вещества растительного, минерального, животного происхождения или продукты химической промышленности, используемые для производства и изготовления лекарственных средств;

71) дезинсекция – комплекс профилактических и истребительных мероприятий по уничтожению насекомых и членистоногих в целях защиты от них человека, животных, помещений и территории;

72) дезинфекция – комплекс специальных мероприятий, направленных на уничтожение возбудителей инфекционных и паразитарных заболеваний во внешней среде;

73) здоровье – состояние полного физического, духовного (психического) и социального благополучия, а не только отсутствие болезней и физических дефектов;

74) здравоохранение – система мер политического, экономического, правового, социального, культурного, медицинского характера, направленных на предупреждение и лечение болезней, поддержание общественной гигиены и санитарии, сохранение и укрепление физического и психического здоровья каждого человека, поддержание его активной долголетней жизни, предоставление ему медицинской помощи в случае утраты здоровья;

75) система здравоохранения – совокупность государственных органов и субъектов здравоохранения, деятельность которых направлена на обеспечение прав граждан Республики Казахстан на охрану здоровья;

76) региональный перспективный план развития инфраструктуры здравоохранения – долгосрочный план развития инфраструктуры региона, отражающий информацию по существующей сети организаций здравоохранения, планируемой реструктуризации (открытию, объединению, закрытию, перепрофилированию), а также информацию о потребности в новых объектах здравоохранения и планировании инвестиций;

77) аттестация научно-педагогических кадров организаций образования в области здравоохранения – процедура определения уровня педагогической и профессиональной компетентности научно-педагогических кадров организаций образования в области здравоохранения;

78) организация образования в области здравоохранения – организация образования, реализующая образовательные программы по направлениям подготовки "Здравоохранение" и (или) "Междисциплинарные программы, связанные со здравоохранением и социальным обеспечением (медицина)";

79) клиника организации образования в области здравоохранения – структурное подразделение организации образования или организация здравоохранения, на базе которой реализуются образовательные программы технического и профессионального, послесреднего, высшего, послевузовского и дополнительного медицинского образования на основе современных достижений науки и практики;

80) научная организация в области здравоохранения – национальный центр, научный центр или научно-исследовательский институт, осуществляющие научную, научно-техническую и инновационную деятельность в области здравоохранения, а также медицинскую, фармацевтическую и (или) образовательную деятельность;

81) профессиональный стандарт в области здравоохранения – стандарт, определяющий требования к уровню квалификации, содержанию, качеству и условиям труда специалистов в области здравоохранения;

82) сертификация специалиста в области здравоохранения – процедура определения соответствия квалификации физического лица квалификационным требованиям, установленным отраслевой рамкой квалификаций и профессиональными стандартами в области здравоохранения, а также определение готовности к профессиональной деятельности в области здравоохранения, включая готовность к клинической или фармацевтической практике, или деятельности в сфере санитарно-эпидемиологического благополучия населения;

83) сертификат специалиста в области здравоохранения – документ установленного образца, подтверждающий квалификацию физического лица и его готовность к профессиональной деятельности в области здравоохранения, включая готовность к клинической или фармацевтической практике, или деятельности в сфере санитарно-эпидемиологического благополучия населения;

84) менеджер в области здравоохранения – первый руководитель, осуществляющий управление государственной медицинской организацией;

85) сертификат менеджера в области здравоохранения – документ установленного образца на занятие деятельностью по управлению государственной медицинской организацией;

86) экспертиза в области здравоохранения – совокупность организационных, аналитических и практических мероприятий, направленных на определение эффективности и качества средств, методов, технологий, образовательных и научных программ, услуг в различных сферах деятельности здравоохранения, а также определение временной нетрудоспособности, профессиональной пригодности по состоянию здоровья в соответствии с законодательством Республики Казахстан;

87) стандарт в области здравоохранения (далее – стандарт) – нормативный правовой акт, устанавливающий правила, общие принципы и характеристики для обеспечения стандартизации в области здравоохранения в сфере медицинской, фармацевтической деятельности, образовательной и научной деятельности в области здравоохранения, цифрового здравоохранения;

88) стандартизация в области здравоохранения (далее – стандартизация) – деятельность, направленная на достижение оптимальной степени упорядочения характеристик процессов, технологий и услуг здравоохранения путем разработки, внедрения и обеспечения соблюдения стандартов, требований, норм, инструкций, правил;

89) уполномоченный орган в области здравоохранения (далее – уполномоченный орган) – центральный исполнительный орган, осуществляющий руководство и межотраслевую координацию в области охраны здоровья граждан Республики Казахстан, медицинской и фармацевтической науки, медицинского и фармацевтического образования, санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий, качества оказания медицинских услуг (помощи);

90) национальный оператор в области здравоохранения –юридическое лицо, осуществляющее деятельность в области здравоохранения, в том числе по развитию инфраструктуры здравоохранения;

91) оценка технологий здравоохранения – комплексная оценка сравнительной доказанной клинической и клинико-экономической (фармакоэкономической) эффективности и безопасности технологий здравоохранения, а также экономических, социальных и этических последствий их применения, проводимая для принятия решений в области здравоохранения;

92) технология здравоохранения – применение знаний и навыков, которые используются для укрепления здоровья, профилактики, диагностики, лечения болезни, реабилитации пациентов и оказания паллиативной медицинской помощи, включая вакцины, лекарственные препараты и медицинские изделия, процедуры, манипуляции, операции, скрининговые, профилактические программы, в том числе информационные системы;

93) организация здравоохранения – юридическое лицо, осуществляющее деятельность в области здравоохранения;

94) лекарственный формуляр организации здравоохранения – перечень лекарственных средств для оказания медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования, сформированный на основе Казахстанского национального лекарственного формуляра и утвержденный руководителем организации здравоохранения в порядке, определяемом уполномоченным органом;

95) солидарная ответственность за здоровье – разделение ответственности между участниками общества: государством, работодателем и самим гражданином за сохранение и укрепление индивидуального и общественного здоровья, снижение рисков возникновения заболевания;

96) дератизация – комплекс профилактических и истребительных мероприятий, направленных на уничтожение или снижение числа грызунов;

97) детоксикация – комплекс медицинских мероприятий, направленных на выведение из организма человека токсических веществ эндогенного или экзогенного происхождения;

98) диагностика – комплекс медицинских услуг, направленных на установление факта наличия или отсутствия заболевания;

99) динамическое наблюдение – систематическое наблюдение за состоянием здоровья пациента, а также оказание необходимой медицинской помощи по результатам данного наблюдения;

100) донор – человек, труп человека, животное, от которых производятся забор донорской крови, ее компонентов, иного донорского материала (в том числе сперма, яйцеклетки, ткани репродуктивных органов, половых клеток, эмбрионов), а также изъятие органов (части органа) и (или) тканей (части ткани) для трансплантации к реципиенту;

101) донорская организация – организация здравоохранения, в которой осуществляется изъятие и консервация органов (части органа) и (или) тканей (части ткани) от трупов с целью трансплантации;

102) донорская функция – добровольное прохождение донором медицинского обследования и выполнение аллогенной донации крови и ее компонентов;

103) лечение – комплекс медицинских услуг, направленных на устранение, приостановление и (или) облегчение течения заболевания, а также предупреждение его прогрессирования;

104) лечащий врач – врач, оказывающий медицинскую помощь пациенту в период его наблюдения и лечения в медицинской организации;

105) добровольное лечение – лечение, осуществляемое с согласия пациента или его законного представителя;

106) расчетная (предварительная) санитарно-защитная зона – территория санитарно-защитной зоны, определяемая на основании проекта с расчетами рассеивания загрязнения атмосферного воздуха, физического (шум, вибрация, неионизирующие излучения) и (или) радиационного воздействия на здоровье человека;

107) нежелательная реакция – непреднамеренная, неблагоприятная реакция организма, связанная с применением лекарственного (исследуемого) препарата и предполагающая наличие возможной взаимосвязи с применением данного лекарственного (исследуемого) препарата;

108) фальсифицированные лекарственные средства и медицинские изделия – лекарственные средства, медицинские изделия, противоправно и преднамеренно снабженные недостоверной информацией об их составе или комплектации и (или) производителе, а также о поставках, включая записи и документы, затрагивающие использованные каналы поставки;

109) личная медицинская книжка – персональный документ, в который заносятся результаты обязательных медицинских осмотров с отметкой о допуске к работе;

110) высокотехнологичная медицинская услуга – услуга, оказываемая профильными специалистами при заболеваниях, требующих использования инновационных, ресурсоемких и (или) уникальных методов диагностики и лечения;

111) искусственное прерывание беременности – прерывание беременности до сроков жизнеспособности плода с использованием медикаментозных или хирургических методов, проводимое медицинскими работниками, имеющими высшее медицинское образование соответствующего профиля;

112) передвижные медицинские комплексы – мобильные клиники (кабинеты) на базе автомобильного транспорта, оснащенные необходимым медицинским оборудованием, которые используются для обеспечения доступности и расширения перечня оказываемых медицинских услуг населению сельской местности и отдаленных населенных пунктов либо в интересах обороны и национальной безопасности;

113) инфекции, передаваемые половым путем, – инфекционные заболевания, наиболее частым путем заражения которых является половой контакт;

114) лицо с расстройствами половой идентификации – лицо, стремящееся жить и быть принятым в качестве лица противоположного пола;

115) иммунологический лекарственный препарат (иммунобиологический лекарственный препарат) – лекарственный препарат, предназначенный для формирования активного или пассивного иммунитета или диагностики наличия иммунитета, или диагностики (выработки) специфического приобретенного изменения иммунологического ответа на аллергизирующие вещества;

116) система проведения иммунологического типирования (далее – система-НLА) – система антигенов, расположенная на лейкоцитах человека и определяющая тканевую совместимость донора и реципиента при трансплантации органов (части органа) и (или) тканей (части ткани);

117) инвазивные методы – методы диагностики и лечения, осуществляемые путем проникновения во внутреннюю среду организма человека;

118) инновационные медицинские технологии – совокупность методов и средств научной и научно-технической деятельности, внедрение которых в области медицины (биомедицины), фармации и цифровизации здравоохранения является социально значимым и (или) экономически эффективным;

119) интегрированный академический медицинский центр – объединение организации высшего и (или) послевузовского медицинского образования с научными организациями в области здравоохранения и организациями здравоохранения с целью совместного использования ресурсов для улучшения качества медицинских услуг путем интеграции образования, исследований и клинической практики;

120) неинтервенционное клиническое исследование – исследование, которое проводится после проведения государственной регистрации лекарственного средства или медицинского изделия и назначается в рамках медицинской практики;

121) интервенционное исследование – исследование с участием человека в качестве субъекта исследования, при котором врач-исследователь на основании протокола интервенционного клинического исследования, соответствующего порядку проведения клинических исследований, назначает субъекту исследования специальное вмешательство;

122) эпидемиологический надзор за неинфекционными заболеваниями – деятельность государственных органов и организаций санитарно-эпидемиологической службы по мониторингу факторов риска от воздействия объектов окружающей среды, влияющих на здоровье населения, в том числе производственных факторов, профессиональных заболеваний с временной утратой трудоспособности, минимизации и контролю за внедрением программ управления хроническими неинфекционными заболеваниями;

123) инфекционные и паразитарные заболевания – заболевания человека, возникновение и распространение которых обусловлены воздействием на него биологических факторов среды обитания и возможностью передачи болезни от заболевшего человека, животного к здоровому человеку;

124) йододефицитное заболевание – патологический процесс организма, обусловленный нарушением функции щитовидной железы, связанный с недостаточным поступлением и усвоением йода в организме;

125) профессиональное заболевание – острое или хроническое заболевание, вызванное воздействием на работника вредных производственных факторов в связи с выполнением им своих трудовых (служебных) обязанностей;

126) биологический материал доклинических (неклинических) и клинических исследований – образцы биологических жидкостей, тканей, секретов и продуктов жизнедеятельности человека и животных, биопсийный материал, гистологические срезы, мазки, соскобы, смывы, полученные при проведении доклинических (неклинических) и клинических исследований и предназначенные для лабораторных исследований;

127) доклиническое (неклиническое) исследование – химическое, физическое, биологическое, микробиологическое, фармакологическое, токсикологическое и другое экспериментальное исследование или серия исследований по изучению исследуемого вещества (лекарственного средства) путем применения научных методов оценки в целях изучения специфического действия и (или) получения доказательств безопасности для здоровья человека;

128) клиническая база – организация здравоохранения, которая используется организацией образования для подготовки и повышения квалификации кадров в области здравоохранения по договору о совместной деятельности;

129) клиническое исследование – исследование с участием человека в качестве субъекта, проводимое для выявления или подтверждения безопасности и эффективности средств, методов и технологий профилактики, диагностики и лечения заболеваний;

130) клиническое сестринское руководство – документ, содержащий научно доказанные рекомендации для сестринского персонала по уходу за пациентами, предполагающий использование профилактических, диагностических, лечебных и реабилитационных мероприятий в ведении пациентов;

131) клинический фармаколог – специалист с высшим медицинским образованием по профилям "лечебное дело", "педиатрия", "общая медицина", освоивший программу резидентуры или переподготовки по клинической фармакологии и имеющий сертификат специалиста в области здравоохранения;

132) клинический протокол – научно доказанные рекомендации по профилактике, диагностике, лечению, медицинской реабилитации и паллиативной медицинской помощи при определенном заболевании или состоянии пациента;

133) консилиум – исследование лица в целях установления диагноза, определения тактики лечения и прогноза заболевания с участием не менее трех врачей;

134) контрацепция – методы и средства предупреждения нежелательной беременности;

135) предельная цена на торговое наименование лекарственного средства для оптовой реализации – цена на торговое наименование лекарственного средства, включенного в перечень лекарственных средств, подлежащих ценовому регулированию, выше которой не может осуществляться его оптовая реализация;

136) Казахстанский национальный лекарственный формуляр – перечень лекарственных средств с доказанной клинической безопасностью и эффективностью, а также орфанных (редких) лекарственных препаратов, являющийся обязательной основой для разработки лекарственных формуляров медицинских организаций и формирования списков закупа лекарственных средств в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

137) номенклатура медицинских изделий Республики Казахстан – систематизированный номенклатурный классификатор видов медицинских изделий, гармонизированный с глобальной номенклатурой медицинских изделий (GMDN) и применяемый в Республике Казахстан;

138) Государственная фармакопея Республики Казахстан – свод минимальных требований к безопасности и качеству лекарственных средств и медицинских изделий;

139) реестр фармацевтических инспекторов Республики Казахстан – электронный информационный ресурс уполномоченного органа, содержащий сведения о фармацевтических инспекторах Республики Казахстан;

140) воспроизведенный лекарственный препарат (генерик) – лекарственный препарат, который имеет такой же количественный и качественный состав действующих веществ и ту же лекарственную форму, что и оригинальный лекарственный препарат, и биоэквивалентность которого оригинальному лекарственному препарату подтверждается соответствующими исследованиями биодоступности. Различные соли, эфиры, изомеры, смеси изомеров, комплексы или производные действующего вещества признаются одним и тем же действующим веществом, если их безопасность и эффективность существенно не отличаются. Различные лекарственные формы для приема внутрь с немедленным высвобождением веществ признаются в рамках исследований биодоступности одной и той же лекарственной формой;

141) аллогенная донация крови и ее компонентов – донация крови и ее компонентов для применения в медицинских целях от одного человека к другому;

142) доконтактная профилактика – антиретровирусная терапия, применяемая к неинфицированным людям для предотвращения заражения ВИЧ-инфекцией;

143) постконтактная профилактика – антиретровирусная терапия, применяемая с целью снижения риска заражения ВИЧ-инфекцией после возможного инфицирования;

144) общественное здоровье – комплексная характеристика психического, физического и социального благополучия населения, отражающая усилия общества по ведению гражданами Республики Казахстан здорового образа жизни, включая здоровое питание, по профилактике заболеваний и травм, а также по предотвращению влияния неблагоприятных факторов среды обитания;

145) исследование в области общественного здоровья – исследование, проводимое на основе сбора и обобщения клинико-эпидемиологических данных и иной медицинской информации для выявления основных факторов, влияющих на здоровье и определяющих развитие системы здравоохранения, разработки методов направленного влияния и управления этими факторами;

146) неблагоприятное событие – любая неисправность и (или) ухудшение характеристик или нарушение функционирования медицинского изделия, или недостаточность либо некорректность сопроводительной информации (документации) на медицинское изделие, побочные действия или нежелательная реакция, не указанные в инструкции по применению или руководстве по эксплуатации, которые прямо или косвенно привели или могли привести к смерти или серьезному ухудшению состояния здоровья пользователей или третьих лиц;

147) прикладное биомедицинское исследование – биомедицинское исследование, направленное на достижение конкретных целей в сфере диагностики, лечения или профилактики заболеваний, обеспечения здоровья населения;

148) кальян – прибор, используемый для вдыхания аэрозоля, пара или дыма, возникающих от тления и (или) нагревания табака, а также продуктов, не содержащих табачного листа, и в котором аэрозоль, пар или дым проходят через сосуд с жидкостью;

149) табак для кальяна – вид курительного табачного изделия, предназначенного для курения с использованием кальяна и состоящего из смеси резаного или рваного сырья с добавлением или без добавления нетабачного сырья и иных ингредиентов;

150) кальянная смесь – изделие, изготовленное без использования табачного листа в качестве сырьевого материала, приготовленное таким образом, чтобы использовать для потребления с использованием кальяна;

151) вспомогательное вещество – вещество, за исключением фармацевтических субстанций (активных фармацевтических субстанций), входящее в состав лекарственного препарата для придания ему необходимых свойств;

152) конфиденциальное медицинское обследование – обследование, основанное на соблюдении тайны медицинского работника и сохранении информации о личности обследуемого лица;

153) принудительное лечение – лечение больного, осуществляемое на основании решения суда;

154) медицинский работник – физическое лицо, имеющее профессиональное медицинское образование и осуществляющее медицинскую деятельность;

155) медицинская авиация – предоставление скорой медицинской помощи в экстренной форме населению с привлечением воздушного транспорта;

156) медицинская информация – информация о пациентах и заболеваниях, возникающая в процессе оказания медицинской помощи и отраженная в медицинских документах и медицинских информационных системах, а также информация по вопросам здравоохранения;

157) медицинское вмешательство – прямое или опосредованное воздействие и (или) иная манипуляция, выполняемые медицинским работником при оказании медицинской помощи пациентам с целью предупреждения, профилактики, диагностики, лечения, реабилитации, исследования и направленные на восстановление или улучшение здоровья;

158) медико-социальная помощь – это медицинская и социально-психологическая помощь, оказываемая лицам с социально значимыми заболеваниями, перечень которых определяется уполномоченным органом;

159) медико-социальная реабилитация – комплекс мер по восстановлению здоровья больных и лиц с инвалидностью с использованием медицинских, социальных и профессионально-трудовых мероприятий для приобщения к работе, включения в семейную и общественную жизнь;

160) медико-биологический эксперимент – исследование, основанное на воспроизведении (моделировании) структурно-функционального комплекса изучаемого состояния или болезни в упрощенной форме на экспериментальных (лабораторных) животных для выяснения причин, условий и механизмов возникновения состояния или развития заболевания, разработки методов лечения и профилактики;

161) медицинские изделия – изделия медицинского назначения и медицинская техника;

162) расходный материал к медицинским изделиям – изделия и материалы, расходуемые при использовании медицинских изделий, обеспечивающие проведение манипуляций в соответствии с функциональным назначением медицинского изделия, эксплуатационными характеристиками, руководством по сервисному обслуживанию производителя;

163) обращение медицинских изделий – проектирование, разработка, создание опытных образцов, проведение технических испытаний, исследований (испытаний) оценки биологического действия медицинских изделий, клинических исследований, экспертизы безопасности, качества и эффективности медицинских изделий, регистрация, производство (изготовление), хранение, транспортировка, реализация, монтаж, наладка, применение (эксплуатация), техническое обслуживание, ремонт и утилизация медицинских изделий;

164) исследования (испытания) оценки биологического действия медицинских изделий – исследования (испытания), проводимые с целью определения соответствия медицинских изделий общим требованиям безопасности и эффективности медицинских изделий, требованиям к их маркировке и эксплуатационной документации на них;

165) глобальная номенклатура медицинских изделий (GMDN) – систематизированный номенклатурный классификатор видов медицинских изделий, применяемый в целях идентификации медицинских изделий;

166) вид медицинских изделий – группа медицинских изделий, имеющих аналогичное назначение, схожие технологии применения, конструктивные признаки и общее цифровое обозначение в номенклатуре медицинских изделий Республики Казахстан;

167) мониторинг безопасности, качества и эффективности медицинских изделий – сбор, регистрация, анализ информации о неблагоприятных событиях;

168) производитель медицинского изделия – субъект в сфере обращения лекарственных средств и медицинских изделий, ответственный за разработку и изготовление медицинского изделия, делающий его доступным для использования от своего имени независимо от того, разработано и (или) изготовлено этим лицом или от его имени другим лицом (лицами), и несущий ответственность за его безопасность, качество и эффективность;

169) комплектующее медицинского изделия – часть медицинского изделия, не являющаяся самостоятельным медицинским изделием, в том числе блоки, части, элементы изделия, материалы, запасные части, предусмотренные производителем для использования в соответствии с функциональным назначением, эксплуатационными характеристиками, руководством производителя по сервисному обслуживанию;

170) безопасность медицинского изделия – отсутствие недопустимого риска при использовании медицинского изделия, связанного с причинением вреда жизни, здоровью человека, а также окружающей среде;

171) качество медицинского изделия – степень соответствия совокупности свойств и характеристик медицинского изделия целям его предназначенного использования;

172) торговое наименование медицинского изделия – название, под которым регистрируется медицинское изделие;

173) эффективность медицинского изделия – совокупность свойств и характеристик медицинского изделия, обеспечивающих достижение целей предназначения, установленных производителем медицинского изделия и подтвержденных практикой его использования;

174) медицинское образование – система подготовки и повышения квалификации медицинских работников, а также совокупность знаний и навыков, необходимых для медицинского работника, полученных в ходе обучения по программам подготовки повышения квалификации по медицинским специальностям, подтвержденных официальным документом об окончании обучения;

175) оценка знаний и навыков обучающихся по программам медицинского образования – оценка качества освоения обучающимися образовательных программ и сформированности знаний, умений и навыков в соответствии с этапом обучения;

176) оценка профессиональной подготовленности выпускников программ медицинского образования – процедура оценки знаний и навыков, проводимая в целях определения соответствия квалификации выпускника программы медицинского образования требованиям профессионального стандарта в области здравоохранения;

177) стратегическое партнерство в сфере медицинского образования и науки – форма среднесрочного или долгосрочного сотрудничества между научными организациями и организациями образования в области здравоохранения, и зарубежными организациями высшего и (или) послевузовского образования, и медицинскими организациями в сфере медицинского образования и науки для внедрения и адаптации международных стандартов образования, науки и клинической практики на основе договора;

178) организация медицинского образования – организация образования, реализующая образовательные программы по направлениям подготовки "Здравоохранение";

179) медицинская помощь – комплекс медицинских услуг, направленных на сохранение и восстановление здоровья населения, включая лекарственное обеспечение;

180) качество медицинской помощи – уровень соответствия оказываемой медицинской помощи стандартам оказания медицинской помощи;

181) медицинские услуги – действия субъектов здравоохранения, имеющие профилактическую, диагностическую, лечебную, реабилитационную и паллиативную направленность по отношению к конкретному человеку;

Примечание ИЗПИ!
Подпункт 182) предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

182) независимая экспертиза качества медицинских услуг (помощи) – процедура, проводимая независимыми экспертами в рамках внутренней и внешней экспертиз в целях вынесения заключения об уровне качества оказываемых медицинских услуг (помощи), предоставляемых субъектами здравоохранения, с использованием индикаторов, отражающих показатель эффективности, полноты и соответствия оказываемых медицинских услуг (помощи) стандартам;

183) медицинское освидетельствование – обследование физического лица с целью установления или подтверждения факта наличия или отсутствия у него заболевания, определения состояния здоровья;

184) медицинская деятельность – профессиональная деятельность физических лиц, получивших техническое и профессиональное, послесреднее, высшее и (или) послевузовское медицинское образование, а также юридических лиц, направленная на охрану здоровья населения Республики Казахстан;

185) государственный орган в сфере оказания медицинских услуг (помощи) – государственный орган, осуществляющий руководство в сфере оказания медицинских услуг (помощи), контроль за качеством медицинских услуг (помощи);

186) изделия медицинского назначения – материалы, изделия, растворы, реагенты, комплекты, наборы, используемые для оказания медицинской помощи в соответствии с функциональным назначением и инструкцией производителя;

187) медицинская реабилитация – комплекс медицинских услуг, направленных на сохранение, частичное или полное восстановление нарушенных и (или) утраченных функций организма пациента;

188) медицинские поезда – мобильные клиники на железнодорожном транспорте, оснащенные необходимым медицинским оборудованием, используемые для обеспечения доступности и расширения перечня оказываемых медицинских услуг населению, проживающему возле железнодорожных станций (путей) и на близрасположенных к ним территориях;

189) медицинская техника – аппараты, приборы, оборудование, комплексы, системы, применяемые отдельно или в сочетании между собой для оказания медицинской помощи в соответствии с функциональным назначением и эксплуатационными характеристиками, установленными производителем;

190) медицинская организация – организация здравоохранения, основной деятельностью которой является оказание медицинской помощи;

191) сестринский уход – комплекс медицинских услуг, оказываемых медицинскими сестрами и медицинскими сестрами расширенной практики лицам всех возрастов, групп и сообществ, больным или здоровым, включающий в себя пропаганду здоровья, профилактику болезней и уход за больными, лицами с инвалидностью и умирающими людьми;

192) дошкольная и школьная медицина – область медицины, включающая организацию оказания медицинской помощи детям дошкольного и школьного возраста, направленная на охрану и укрепление здоровья и профилактику заболеваний;

193) государственный фармацевтический инспектор – должностное лицо государственного органа, осуществляющее государственный контроль в сфере обращения лекарственных средств и медицинских изделий;

194) мультидисциплинарная группа – группа различных специалистов, формируемая в зависимости от характера нарушения функций и структур организма пациента, тяжести его клинического состояния;

195) никотин – алкалоид, содержащийся в табачных листьях и табачном дыме;

196) лекарственные средства передовой терапии – лекарственные средства, получаемые биотехнологическим или биоинженерным путем, которые предлагают новые возможности для лечения заболеваний и травм, включая средства для генной терапии, соматической клеточной терапии, тканевой инженерии;

197) реабилитационный потенциал – клинически обоснованная вероятность перспективы частичного или полного восстановления нарушенных и (или) утраченных функций организма пациента в определенный отрезок времени;

198) семейный врач – врач, прошедший специальную многопрофильную подготовку по оказанию первичной медико-санитарной помощи членам семьи и имеющий сертификат специалиста в области здравоохранения;

199) очаговая дезинфекция – дезинфекция, проводимая в очагах в целях профилактики и (или) ликвидации инфекционных и паразитарных заболеваний;

Примечание ИЗПИ!
В подпункт 200) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

200) предельная цена производителя – цена на торговое наименование лекарственного средства, предоставляемая производителем, являющаяся базовой ценой для расчета предельных оптовой и розничной цен на торговое наименование лекарственного средства, включенного в перечень лекарственных средств, подлежащих ценовому регулированию, в соответствии с Правилами регулирования цен на лекарственные средства, а также на медицинские изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

201) производственная площадка – территориально обособленный комплекс производителя лекарственных средств, медицинских изделий, предназначенный для выполнения всего процесса производства лекарственных средств, медицинских изделий или его определенных стадий;

202) производственный контроль – комплекс мероприятий, в том числе лабораторных исследований и испытаний производимой продукции, работ и услуг, выполняемых индивидуальным предпринимателем или юридическим лицом, направленных на обеспечение безопасности и (или) безвредности для человека и среды обитания;

203) свидетельство о государственной регистрации продукции – документ, подтверждающий безопасность продукции (товаров), удостоверяющий соответствие продукции (товаров) техническим регламентам и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям Евразийского экономического союза и выдаваемый государственным органом в сфере санитарно-эпидемиологического благополучия населения по единой форме;

204) мониторинг безопасности продукции – система мероприятий, направленных на выявление, предупреждение и пресечение ввоза, производства, применения и реализации продукции, не соответствующей требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

205) запатентованные лекарственные средства – лекарственные средства, получившие правовую охрану в соответствии с законодательством Республики Казахстан в области интеллектуальной собственности;

206) пациент – физическое лицо, являющееся (являвшееся) потребителем медицинских услуг независимо от наличия или отсутствия у него заболевания или состояния, требующего оказания медицинской помощи;

207) профилактика – комплекс медицинских и немедицинских мероприятий, направленных на предупреждение возникновения заболеваний, прогрессирования на ранних стадиях болезней и контролирование уже развившихся осложнений, повреждений органов и тканей;

208) психоактивные вещества – вещества синтетического или природного происхождения (алкоголь, наркотические средства, психотропные вещества, их аналоги, другие одурманивающие вещества), которые при однократном приеме оказывают воздействие на психические и физические функции, поведение человека, а при длительном употреблении вызывают психическую и физическую зависимость;

209) психическое здоровье – состояние благополучия, при котором каждый человек может реализовать свой собственный потенциал, справляться с обычными жизненными стрессами, продуктивно и плодотворно работать, а также вносить вклад в жизнь своего сообщества;

210) медицинская помощь в области психического здоровья – профилактика, диагностика, лечение, медико-социальная помощь и медико-социальная реабилитация лиц с психическими, поведенческими расстройствами (заболеваниями);

211) психические, поведенческие расстройства (заболевания) – группа заболеваний согласно международной классификации болезней, характеризующихся нарушением психической деятельности;

212) психологическая помощь – комплекс мероприятий, направленных на:

содействие человеку в предупреждении, разрешении психологических проблем, преодолении трудных жизненных и кризисных ситуаций и их последствий, способствующих поддержанию психического и соматического здоровья, оптимизации психического развития, адаптации и повышению качества жизни, в том числе путем активизации собственных возможностей человека;

информирование людей о причинах психологических проблем, способах их предупреждения и разрешения;

развитие личности, ее самосовершенствование и самореализацию;

213) психологическая проблема – состояние душевного дискомфорта человека, вызванное неудовлетворенностью собой, своей деятельностью, межличностными отношениями, обстановкой в семье и (или) другими проблемами личной жизни;

214) радиофармацевтический лекарственный препарат – лекарственный препарат, содержащий в готовом для применения состоянии один или несколько радионуклидов (радиоактивных изотопов) в качестве действующего вещества или в составе действующего вещества;

215) врач-резидент – врач, обучающийся в рамках образовательной программы резидентуры и работающий в медицинской организации под надзором наставника;

216) резидентура – уровень послевузовского медицинского образования, целью которого является приобретение или изменение профессиональной квалификации врача по соответствующей специальности для допуска к самостоятельной клинической практике;

217) база резидентуры – клиника организации образования в области здравоохранения, университетская больница, национальный центр, научный центр или научно-исследовательский институт, аккредитованные как медицинская организация, на базе которой реализуются программы резидентуры в порядке, установленном уполномоченным органом;

218) репродуктивное здоровье – здоровье человека, отражающее его способность к воспроизводству полноценного потомства;

219) антиретровирусная терапия – метод лечения ВИЧ-инфекции путем применения коротких и длительных курсов приема антиретровирусных препаратов с целью восстановления иммунной системы, снижения риска развития тяжелых угрожаемых жизни заболеваний, уменьшения числа осложнений и продления жизни зараженных ВИЧ-инфекцией;

220) референс-лаборатория – лаборатория организации здравоохранения, осуществляющая организационно-методическую работу по внедрению системы внешней оценки качества и проведение исследований в диагностически сложных и экспертных случаях в определенной области лабораторной диагностики;

221) референтный лекарственный препарат – лекарственный препарат, который используется в качестве препарата сравнения и является эталоном, по которому определяются (нормируются) свойства лекарственного препарата;

222) реципиент – пациент, которому проведено переливание донорской крови или выделенных из нее компонентов и (или) препаратов, введение мужского или женского донорского материала (спермы, яйцеклетки, эмбрионов) либо трансплантация органов (части органа) и (или) тканей (части ткани) от донора, а также искусственных органов (части органов);

223) санаторно-курортное лечение – вид медицинской реабилитации, проводимой в условиях временного пребывания лиц в санаторно-курортной организации;

224) санаторно-курортные организации – организации, предоставляющие санаторно-курортные услуги по оздоровлению и восстановлению здоровья человека с применением медицинских и иных услуг, природных лечебных факторов, расположенные на курортах или в лечебно-оздоровительных местностях: санаторий (для взрослых, взрослых и детей, детей), студенческий санаторий-профилакторий, детский реабилитационно-оздоровительный центр;

225) санитарно-карантинный контроль – вид государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения в отношении лиц, транспортных средств и подконтрольной государственному санитарно-эпидемиологическому контролю и надзору продукции (товаров) в пунктах пропуска через таможенную границу Евразийского экономического союза, на межгосударственных передаточных железнодорожных станциях или стыковых станциях в целях предотвращения ввоза потенциально опасной для здоровья человека продукции (товаров), завоза, возникновения и распространения инфекционных и массовых неинфекционных заболеваний (отравлений);

226) санитарно-защитная зона – территория, отделяющая зоны специального назначения, а также промышленные организации и другие производственные, коммунальные и складские объекты в населенном пункте от близлежащих селитебных территорий, зданий и сооружений жилищно-гражданского назначения в целях ослабления воздействия на них неблагоприятных факторов;

227) санитарно-профилактические мероприятия – организационные, административные, инженерно-технические, медико-санитарные, профилактические и иные меры, направленные на оценку риска, вредного воздействия на человека факторов среды обитания, устранение или уменьшение такого риска, предотвращение возникновения и распространения инфекционных и массовых неинфекционных болезней (отравлений) и их ликвидацию;

228) санитарно-эпидемиологический аудит – альтернативная форма контроля эпидемически значимых объектов, подлежащих государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, на предмет выявления и оценки санитарно-эпидемиологических рисков и разработки рекомендаций по приведению указанных объектов в соответствие с требованиями нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

229) санитарно-эпидемиологическая ситуация – состояние здоровья населения и среды обитания на определенной территории в определенное время;

230) санитарно-эпидемиологическое заключение – документ, удостоверяющий соответствие нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения объектов государственного санитарно-эпидемиологического контроля и надзора;

231) санитарно-противоэпидемические мероприятия – меры, принимаемые в целях локализации и ликвидации возникших очагов инфекционных, паразитарных заболеваний, отравлений среди населения;

232) пункт доверия – специально организованный пункт, где предоставляются профилактические услуги ключевым группам населения на бесплатной основе по принципу анонимности, добровольности и конфиденциальности;

233) симуляционный кабинет (центр) – структурное подразделение организации образования в области здравоохранения, на базе которого осуществляются отработка и сдача практических навыков обучающимися в условиях имитации клинической практики в безопасной среде обучения с применением симуляционных технологий: манекенов, тренажеров, компьютерного моделирования, технологий виртуальной реальности и специально подготовленных актеров, обученных изображать пациентов;

234) скрининговые исследования – комплекс медицинского обследования населения, не имеющего клинических симптомов и жалоб, с целью выявления и предупреждения развития различных заболеваний на ранней стадии, а также факторов риска их возникновения;

235) спортивная медицина – область медицины, отвечающая за медико-биологическое обеспечение подготовки спортсменов и включающая в себя врачебный и функциональный контроль в спорте, в том числе допуск спортсменов к занятию спортом высших достижений, функциональную и медицинскую реабилитацию спортсменов, повышение спортивной работоспособности, терапию соматических заболеваний спортсменов, спортивную травматологию, медицинскую помощь в неотложной форме в спорте и гигиену спорта;

236) стандартный образец – идентифицированное однородное вещество или смесь веществ, предназначенные для использования в химических, физических и биологических исследованиях, в которых его (ее) свойства сравниваются со свойствами исследуемого лекарственного средства, и обладающие достаточной для соответствующего применения степенью чистоты;

236-1) стратегически важные лекарственные средства и медицинские изделия – лекарственные средства и медицинские изделия, предназначенные для медицинского применения в условиях:

военных действий и ликвидации их последствий;

возникновения, предупреждения и ликвидации последствий чрезвычайных ситуаций;

угрозы возникновения, распространения новых особо опасных инфекционных заболеваний и ликвидации их последствий;

профилактики, диагностики, лечения заболеваний и поражений, полученных в результате воздействия неблагоприятных химических, биологических, радиационных факторов, а также ликвидации их последствий;

отсутствия или угрозы отсутствия лекарственных средств или медицинских изделий на рынках государств – членов Евразийского экономического союза в условиях введения ограничительных экономических мер в отношении хотя бы одного из государств-членов;

237) костный мозг – ткань, осуществляющая кроветворение, расположенная во внутренней части костей и включающая гемопоэтические стволовые клетки, строму и другие компоненты микроокружения;

238) биологически активные добавки к пище – природные и (или) идентичные природным биологически активные вещества, а также пробиотические микроорганизмы, предназначенные для употребления одновременно с пищей или введения в состав пищевой продукции;

239) стажировка – форма неформального образования, направленная на формирование и закрепление на практике профессиональных знаний, умений и навыков, полученных в результате теоретической подготовки, а также изучение специфики работы, передового опыта для дальнейшей профессиональной деятельности;

240) наставник – медицинский работник со стажем не менее пяти лет, назначаемый руководителем медицинской организации или организации медицинского образования для оказания практической помощи в профессиональной адаптации обучающихся по программам медицинского образования и молодых специалистов, осуществляющий деятельность на основе триединства образования, науки и практики;

241) риск-ориентированный подход – форма осуществления контроля качества лекарственных средств и медицинских изделий путем ежегодного отбора с рынка, в том числе в медицинских организациях;

242) оценка риска – обоснование вероятности проникновения и распространения возбудителей или переносчиков инфекционных и паразитарных заболеваний, а также негативного воздействия факторов среды обитания на состояние здоровья населения и связанных с этим потенциальных медико-биологических и экономических последствий;

243) независимый эксперт – физическое лицо, соответствующее требованиям, определяемым уполномоченным органом, и состоящее в реестре независимых экспертов;

244) гарантированный объем бесплатной медицинской помощи – объем медицинской помощи, предоставляемой за счет бюджетных средств;

Примечание ИЗПИ!
В подпункт 245) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

245) предельная цена на торговое наименование лекарственного средства или медицинского изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования – цена на торговое наименование лекарственного средства или медицинского изделия, зарегистрированного в Республике Казахстан, выше которой не может быть произведен закуп в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

Примечание ИЗПИ!
В подпункт 246) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

246) предельная цена на международное непатентованное наименование лекарственного средства или техническую характеристику медицинского изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования – цена на международное непатентованное наименование лекарственного средства или техническую характеристику медицинского изделия, зарегистрированного в Республике Казахстан, выше которой не может быть произведен закуп в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

247) табак – растение рода Nicotiana семейства пасленовых видов Nicotiana Tabacum и Nicotiana Rustica, используемое для производства табачных изделий;

248) табачные изделия – продукты, полностью или частично изготовленные из табачного листа и (или) других частей табачного растения в качестве сырья, приготовленного таким образом, чтобы использовать для курения, сосания, жевания, нюханья или иных способов потребления, в том числе с помощью системы для нагрева табака или любого иного прибора;

249) потребление табачных изделий – процесс потребления табачного изделия, кальянной смеси и табака для кальяна, в том числе с использованием кальяна, систем для нагрева табака и любых других систем потребления, вызывающих зависимость организма человека от никотина, отрицательно влияющий на его здоровье, а также на здоровье лиц, не потребляющих табачные изделия, и загрязняющий окружающую среду;

250) ингредиент табачного изделия – вещество (за исключением табачного листа и других частей табака), используемое при производстве табачного изделия и присутствующее в готовом табачном изделии, в том числе в измененной форме;

251) упаковка табачного изделия – единица групповой потребительской тары, содержащая определенное количество пачек табачного изделия;

252) пачка табачного изделия – единица потребительской тары, изготовленная из картона или бумаги или иного материала, содержащая определенное количество табачного изделия;

253) потребительская упаковка табачного изделия – упаковка, предназначенная для продажи или первичной упаковки табачных изделий, реализуемых конечному потребителю;

254) спонсорство табака – любой вид вклада в любое событие, мероприятие или отдельное лицо с целью, результатом или вероятным результатом стимулирования продажи табачного изделия или употребления табака прямо или косвенно, за исключением платежей и взносов, предусмотренных законодательством Республики Казахстан;

255) система для нагрева табака – устройство, используемое для нагревания табака с образованием аэрозоля, содержащего никотин;

256) табачная продукция – табачное изделие, упакованное в потребительскую упаковку;

257) фармацевтический инспектор по надлежащим фармацевтическим практикам – лицо, уполномоченное на осуществление функций по проведению фармацевтической инспекции по надлежащим фармацевтическим практикам и включенное в реестр фармацевтических инспекторов Республики Казахстан;

258) фармацевтическая инспекция по надлежащим фармацевтическим практикам (далее – фармацевтическая инспекция) – оценка объекта в сфере обращения лекарственных средств с целью определения его соответствия требованиям надлежащих фармацевтических практик Республики Казахстан и (или) Евразийского экономического союза;

259) трансплантация – пересадка органов (части органа) и (или) тканей (части ткани) на другое место в организме или в другой организм;

260) заразная форма туберкулеза – форма туберкулеза, представляющая опасность для окружающих в связи с выделением больным во внешнюю среду бактерий туберкулеза;

261) электронные системы потребления – электронные системы доставки никотина и электронные системы доставки продуктов, не являющихся никотином, – устройства (в том числе электронные сигареты), которые с помощью электронных технологий (аккумулятора) нагревают жидкость (в картриджах, резервуарах и других контейнерах) с содержанием никотина или без него, другие химические вещества, ароматизаторы с образованием аэрозоля, вдыхаемого пользователем;

262) выпускник – лицо, освоившее образовательную программу медицинского и (или) фармацевтического образования, иную образовательную программу в области здравоохранения;

263) ткань – совокупность клеток и межклеточного вещества, имеющих одинаковые строение, функции и происхождение;

264) тканевая совместимость – сходство тканей донора и потенциального реципиента по специфическим антигенам системы-HLA, определяющее совместимость донора и реципиента при трансплантации органов (части органа) и (или) тканей (части ткани);

265) медицинские изделия для диагностики вне живого организма (in vitro) – любые инструменты, аппараты, приборы, оборудование, материалы, реагенты, калибраторы, контрольные материалы и прочие изделия, применяемые в медицинских целях отдельно или в сочетании между собой, а также вместе с принадлежностями, необходимыми для применения указанных изделий по назначению, включая специальное программное обеспечение, и предназначенные производителем медицинского изделия для применения при исследованиях вне живого организма (in vitro) образцов биологических материалов человека для получения информации относительно физиологического или патологического состояния, врожденной патологии, предрасположенности к определенному клиническому состоянию или болезни, совместимости тканей с потенциальным реципиентом, прогнозирования реакций на терапевтические воздействия, выбора терапевтических средств и (или) контроля лечения;

266) временная адаптация – процесс по выведению человека из состояния опьянения и адаптации его к условиям среды обитания;

267) центр временной адаптации и детоксикации – центр, предназначенный для оказания специализированной медицинской помощи лицам, находящимся в состоянии алкогольного опьянения (интоксикации), и являющийся структурным подразделением организации, оказывающей медицинскую помощь в области психического здоровья;

268) отравление – заболевание (состояние), возникающее при остром (одномоментном) или хроническом (длительном) воздействии на человека химических, биологических и иных факторов среды обитания;

269) университетская больница – многопрофильное лечебно-профилактическое структурное подразделение организации высшего и послевузовского образования или многопрофильная лечебно-профилактическая организация, на базе которой реализуются образовательные программы высшего, послевузовского и дополнительного медицинского образования на основе современных достижений науки и практики;

270) фармаконадзор – вид деятельности, направленный на выявление, анализ, оценку и предотвращение нежелательных последствий применения лекарственных препаратов;

271) система фармаконадзора – система, организуемая держателями регистрационных удостоверений лекарственных препаратов и уполномоченным органом для выполнения задач и обязанностей по фармаконадзору, предназначенная для контроля безопасности лекарственных препаратов, своевременного выявления всех изменений в оценке соотношения "польза-риск" лекарственных препаратов, разработки и внедрения мер по обеспечению применения лекарственных препаратов при превышении пользы над риском;

272) фармацевтические работники – физические лица, имеющие фармацевтическое образование и осуществляющие фармацевтическую деятельность;

273) фармацевтическое образование – система подготовки и повышения квалификации фармацевтических работников, а также совокупность знаний и навыков, необходимых для фармацевтического работника, полученных в ходе обучения по программам подготовки и повышения квалификации по фармацевтическим специальностям, подтвержденных официальным документом об окончании обучения;

274) фармацевтическая услуга – деятельность субъектов в сфере обращения лекарственных средств и медицинских изделий, связанная с амбулаторным лекарственным обеспечением населения, включая закуп, транспортировку, хранение, учет и реализацию лекарственных средств и медицинских изделий, в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

275) фармацевтическая деятельность – деятельность, осуществляемая в области здравоохранения по производству и (или) изготовлению, и (или) оптовой и (или) розничной реализации лекарственных средств и медицинских изделий, связанная с закупом (приобретением), хранением, ввозом, вывозом, транспортировкой, контролем качества, оформлением, распределением, использованием и уничтожением лекарственных средств и медицинских изделий, а также обеспечением их безопасности, качества и эффективности;

276) сертификат на фармацевтический продукт (CPP) – документ, выдаваемый уполномоченным органом для регистрации отечественных лекарственных средств за рубежом и их экспорта;

277) фармацевтическая субстанция (активная фармацевтическая субстанция) – лекарственное средство, предназначенное для производства и изготовления лекарственных препаратов;

278) формулярная система – система периодической оценки и отбора лекарственных средств для лекарственных формуляров, поддержания лекарственных формуляров и предоставления информации в виде соответствующего руководства и перечня, направленная на рациональное использование лекарственных средств;

279) информированное согласие – процедура письменного добровольного подтверждения лицом своего согласия на получение медицинской помощи и (или) участие в конкретном исследовании после получения информации обо всех значимых для принятия им решения аспектах медицинской помощи и (или) исследования. Информированное письменное согласие оформляется по форме, утвержденной уполномоченным органом;

280) декретированная группа населения – лица, работающие в сфере обслуживания населения и представляющие наибольшую опасность для заражения окружающих людей инфекционными и паразитарными заболеваниями;

281) ключевые группы населения – группы населения, которые подвергаются повышенному риску заражения ВИЧ-инфекцией в силу особенностей образа жизни;

282) продукция, представляющая опасность для жизни и здоровья населения, – состояние продукции, свидетельствующее о наличии риска, связанного с вредным воздействием на здоровье человека при ее применении или употреблении, признанной не соответствующей требованиям безопасности, установленным техническими регламентами, гигиеническими нормативами; продукция, не имеющая документов производителя (поставщика), подтверждающих ее прослеживаемость, безопасность; маркировка которой не соответствует требованиям нормативных правовых актов; с неустановленным или истекшим сроком годности; фальсифицированная продукция;

283) санитарно-эпидемиологическое благополучие населения – состояние здоровья населения, среды обитания, при котором отсутствует вредное воздействие на человека факторов среды обитания и обеспечиваются благоприятные условия его жизнедеятельности;

284) деятельность в сфере санитарно-эпидемиологического благополучия населения – деятельность государственных органов и организаций в сфере санитарно-эпидемиологического благополучия населения, направленная на охрану здоровья граждан Республики Казахстан, включающая в себя государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, санитарно-эпидемиологический мониторинг, санитарно-эпидемиологическое нормирование, государственную регистрацию продукции, санитарно-эпидемиологическую экспертизу, гигиеническое обучение, санитарно-эпидемиологический аудит, проведение дезинфекции, дезинсекции и дератизации, оценку степени рисков в сфере санитарно-эпидемиологического благополучия населения;

285) государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения – деятельность государственных органов в сфере санитарно-эпидемиологического благополучия населения, направленная на предупреждение, выявление, пресечение и устранение нарушений нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, а также контроль и надзор за их соблюдением в целях охраны здоровья, среды обитания населения и безопасности продукции, процессов, услуг;

286) государственный орган в сфере санитарно-эпидемиологического благополучия населения – государственный орган, реализующий государственную политику в сфере санитарно-эпидемиологического благополучия населения, контроль и надзор за соблюдением требований, установленных нормативными правовыми актами в сфере санитарно-эпидемиологического благополучия населения и иными законодательными актами Республики Казахстан;

287) хирургическая стерилизация – метод контрацепции с применением медицинского вмешательства, в результате которого женщина или мужчина утрачивает репродуктивную способность;

288) живорождение и мертворождение плода – состояния новорожденного ребенка (плода), определяемые по соответствующим международным критериям Всемирной организации здравоохранения живорождения и мертворождения плода;

289) некурительные табачные (никотин-содержащие) изделия – продукты, содержащие никотин, полностью или частично изготовленные из табачного листа и (или) других частей табачного растения в качестве сырья и их синтетических аналогов, приготовленных таким образом, чтобы использовать для сосания, жевания, нюханья;

290) ограничительные мероприятия, в том числе карантин, – меры, направленные на предотвращение распространения инфекционных и паразитарных заболеваний и предусматривающие особый режим предпринимательской и (или) иной деятельности;

291) потенциально опасные химические и биологические вещества –вещества, которые при определенных условиях и в определенных концентрациях могут оказать вредное влияние на здоровье человека или будущего поколения, применение и использование которых регламентируются нормативными правовыми актами в сфере санитарно-эпидемиологического благополучия населения;

292) потенциальный реципиент – пациент, который нуждается в трансплантации тканей (части ткани) и (или) органов (части органа);

293) фундаментальное биомедицинское исследование – биомедицинское исследование, проводимое с целью расширения базовых знаний и понимания физических, химических и функциональных механизмов жизненных процессов и заболеваний;

294) эвтаназия – удовлетворение просьбы об ускорении смерти неизлечимого больного какими-либо действиями или средствами, в том числе введением лекарственных или иных средств, а также прекращением искусственных мер по поддержанию его жизни в случаях неблагоприятного исхода заболевания;

295) эпидемия – массовое распространение инфекционного заболевания, существенно превышающее обычно регистрируемый уровень заболеваемости;

296) эпидемически значимые объекты – объекты, производимая продукция и (или) деятельность которых при нарушении требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения могут привести к возникновению пищевых отравлений и (или) инфекционных, паразитарных заболеваний среди населения и (или) нанести вред здоровью населения от физических факторов, промышленных и радиоактивных загрязнений;

297) ядерная медицина – область медицины, в которой с целью профилактики, диагностики и лечения различных заболеваний органов и систем человека, включая онкологические заболевания, применяются радиоактивные элементы и ионизирующее излучение.

2. Понятия "психическое заболевание", "психическое расстройство", применяемые в других отраслях законодательства Республики Казахстан, равнозначны понятию "психическое, поведенческое расстройство (заболевание)", если иное не предусмотрено настоящим Кодексом.

3. Содержание иных терминов определяется отдельными статьями настоящего Кодекса.

Сноска. Статья 1 с изменениями, внесенными законами РК от 30.12.2021 № 98-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 03.01.2022 № 101-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 2. Законодательство Республики Казахстан в области здравоохранения

1. Законодательство Республики Казахстан в области здравоохранения основывается на Конституции Республики Казахстан и состоит из настоящего Кодекса и иных нормативных правовых актов Республики Казахстан.

2. Если международным договором, ратифицированным Республикой Казахстан, установлены иные правила, чем те, которые содержатся в настоящем Кодексе, то применяются правила международного договора.

Статья 3. Отношения, регулируемые настоящим Кодексом

1. Настоящий Кодекс регулирует общественные отношения в области здравоохранения в целях реализации конституционного права граждан Республики Казахстан на охрану здоровья.

2. На правоотношения, урегулированные законодательством Республики Казахстан в области здравоохранения, не распространяется действие законодательства Республики Казахстан о государственных закупках в части закупа:

1) услуг у субъектов здравоохранения по оказанию медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования, за исключением случаев, когда такой закуп осуществляется медицинскими подразделениями специальных государственных органов;

2) лекарственных средств и медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи для лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования, за исключением случаев, когда такой закуп осуществляется медицинскими подразделениями специальных государственных органов;

3) услуг по хранению и транспортировке лекарственных средств и медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи для лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования;

4) товаров и услуг для осуществления экспертизы при государственной регистрации, перерегистрации и внесении изменений в регистрационное досье лекарственных средств, медицинских изделий и оценке их безопасности и качества;

5) фармацевтических услуг;

6) услуг по учету и реализации лекарственных средств и медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования.

3. Требования по медицинскому освидетельствованию, медицинскому осмотру в сфере гражданской авиации, предъявляемые к авиационному персоналу, а также категории лиц, подлежащих обязательному медицинскому освидетельствованию и медицинскому осмотру, устанавливаются законодательством Республики Казахстан об использовании воздушного пространства Республики Казахстан и деятельности авиации.

Сноска. Статья 3 с изменениями, внесенными Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022).

Статья 4. Цель и задача законодательства Республики Казахстан в области здравоохранения

1. Целью законодательства Республики Казахстан в области здравоохранения является обеспечение реализации гражданами права на охрану здоровья, включая доступную и качественную медицинскую помощь для сохранения и укрепления здоровья населения Республики Казахстан.

2. Задачей законодательства Республики Казахстан в области здравоохранения является создание правовых условий, направленных на улучшение здоровья граждан Республики Казахстан.

Статья 5. Принципы законодательства Республики Казахстан в области здравоохранения

Правовое регулирование отношений в области здравоохранения основывается на принципах:

1) обеспечения равенства прав граждан Республики Казахстан на получение безопасной, эффективной и качественной медицинской помощи;

2) солидарной ответственности государства, работодателей и лиц за сохранение и укрепление индивидуального и общественного здоровья;

3) охраны материнства и детства;

4) обеспечения гарантированного объема бесплатной медицинской помощи;

5) отнесения здоровья населения, безопасности, качества и эффективности лекарственных средств к факторам обеспечения национальной безопасности;

6) обеспечения доступности безопасных, качественных и эффективных лекарственных средств, медицинских изделий и их рационального использования;

7) социальной ориентированности здравоохранения, направленной на удовлетворение потребностей, нужд населения и улучшение качества жизни;

8) содействия в формировании здорового образа жизни и здорового питания;

9) приоритетности профилактической направленности в деятельности системы здравоохранения;

10) доступности медицинской помощи;

11) постоянного повышения качества медицинской помощи;

12) участия общественных объединений в обеспечении прав граждан Республики Казахстан на охрану здоровья;

13) обеспечения санитарно-эпидемиологического благополучия населения;

14) преемственности деятельности субъектов здравоохранения при оказании медицинской помощи;

15) обеспечения непрерывности и преемственности образовательной деятельности в области здравоохранения с использованием современных технологий обучения;

16) государственной поддержки отечественной медицинской и фармацевтической науки, внедрения передовых достижений науки и техники в области профилактики, диагностики, лечения и медицинской реабилитации, инновационных разработок новых лекарственных средств и технологий, а также мирового опыта в области здравоохранения;

17) поощрения добровольного безвозмездного донорства;

18) государственной поддержки отечественных разработок и развития конкурентоспособной медицинской и фармацевтической промышленности;

19) расширения возможностей общества в вопросах охраны здоровья;

20) охвата мероприятиями по охране и укреплению здоровья всех категорий и групп населения.

Глава 2. ГОСУДАРСТВЕННОЕ РЕГУЛИРОВАНИЕ И УПРАВЛЕНИЕ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 6. Компетенция Правительства Республики Казахстан

Правительство Республики Казахстан:

1) разрабатывает основные направления государственной политики в области здравоохранения;

      2) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      3) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      4) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      5) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      6) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      7) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      8) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      9) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      Сноска. Статья 6 с изменениями, внесенными законами РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 7. Компетенция уполномоченного органа

Уполномоченный орган:

1) реализует государственную политику в области здравоохранения;

1-1) формирует и реализует государственную политику в области здравоохранения;

2) организует формирование здорового образа жизни и здорового питания;

3) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

4) внедряет новые методы профилактики, диагностики, лечения заболеваний и состояний медицинской реабилитации, а также контроля за ними;

5) осуществляет мониторинг в области здравоохранения;

6) формирует перечень гарантированного объема бесплатной медицинской помощи;

7) формирует перечень медицинской помощи в системе обязательного социального медицинского страхования;

7-1) определяет порядок, виды и объем медицинской помощи населению при чрезвычайных ситуациях, введении режима чрезвычайного положения;

8) осуществляет международное сотрудничество в области здравоохранения, в том числе по вопросам образовательной и научной деятельности в области здравоохранения;

9) реализует международные проекты в области здравоохранения;

9-1) определяет национального оператора в области здравоохранения, его функции и полномочия;

9-2) определяет единого дистрибьютора;

10) осуществляет межотраслевую координацию деятельности по внедрению и реализации международных медико-санитарных правил;

10-1) разрабатывает и утверждает перечень заболеваний, являющихся основанием для освобождения от прохождения дактилоскопической регистрации, по согласованию с Министерством внутренних дел Республики Казахстан;

11) разрабатывает и утверждает правила определения случаев (событий) медицинского инцидента, их учета и анализа;

12) признает действующими на территории Республики Казахстан требования ведущих фармакопей мира;

13) осуществляет государственное регулирование цен на лекарственные средства;

Примечание ИЗПИ!
В подпункт 14) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

14) осуществляет государственное регулирование цен на медицинские изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

15) определяет перечень лекарственных средств и медицинских изделий, закупаемых у единого дистрибьютора;

15-1) определяет порядок организации и проведения закупа лекарственных средств, медицинских изделий и специализированных лечебных продуктов в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи для лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования, фармацевтических услуг;

15-2) определяет порядок закупа услуг по хранению и транспортировке лекарственных средств и медицинских изделий, услуг по учету и реализации лекарственных средств и медицинских изделий единым дистрибьютором в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи для лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования;

16) определяет приоритетные направления биомедицинских исследований;

17) обеспечивает развитие медицинской и фармацевтической науки, медицинского и фармацевтического образования и координирует научную и образовательную деятельность в области здравоохранения;

18) размещает государственный образовательный заказ на подготовку и повышение квалификации кадров в области здравоохранения;

19) проводит аттестацию на профессиональную компетентность лиц, указанных в пункте 3 статьи 26 настоящего Кодекса;

20) участвует в разработке перечня профессий, работ и специальностей, занятых на работах с вредными условиями труда, в пользу которых агентами по уплате обязательных профессиональных пенсионных взносов за счет собственных средств осуществляются обязательные профессиональные пенсионные взносы;

21) формирует единый перспективный план развития инфраструктуры здравоохранения;

22) согласовывает региональные перспективные планы развития инфраструктуры здравоохранения;

23) осуществляет координацию и методическое руководство местных исполнительных органов в области здравоохранения;

24) исключен Законом РК от 30.12.2022 № 177-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования);

25) координирует деятельность субъектов здравоохранения;

26) осуществляет мероприятия по оснащению государственных организаций здравоохранения;

27) осуществляет координацию и мониторинг деятельности по вопросам корпоративного управления в государственных юридических лицах в области здравоохранения;

28) определяет единую методологию для организаций, имеющих право на проведение оценки риска и установление порядка проведения оценки риска;

29) разрабатывает и утверждает стратегию цифровизации здравоохранения;

30) создает и обеспечивает функционирование электронных информационных ресурсов и информационных систем, информационно-коммуникационных сетей в области здравоохранения, организацию доступа к ним физических и юридических лиц в соответствии с законодательством Республики Казахстан в сфере информатизации;

31) разрабатывает и утверждает в пределах своей компетенции нормативные правовые акты и формы учетной и отчетной документации в области здравоохранения;

32) разрабатывает и утверждает стандарты в области здравоохранения;

33) разрабатывает и утверждает инструкции, алгоритмы и регламенты в области здравоохранения;

34) разрабатывает и утверждает правила применения технических средств контроля, приборов наблюдения и фиксации, фото-, видеоаппаратуры, применяемых в медицинских организациях в целях обеспечения защиты прав пациентов и медицинских работников;

35) разрабатывает и утверждает правила присвоения почетных званий в области здравоохранения;

36) разрабатывает и утверждает правила отраслевой системы поощрения;

37) разрабатывает и утверждает типовую систему оплаты труда работников государственных предприятий на праве хозяйственного ведения в области здравоохранения;

38) определяет порядок проведения аттестации на профессиональную компетентность специалистов в области здравоохранения;

39) разрабатывает и утверждает минимальные нормативы обеспеченности регионов медицинскими работниками;

40) разрабатывает и утверждает положение о национальном координаторе по кадровым ресурсам здравоохранения;

41) разрабатывает и утверждает правила подтверждения результатов непрерывного профессионального развития работников здравоохранения;

42) разрабатывает и утверждает номенклатуру специальностей и специализаций в области здравоохранения, номенклатуру и квалификационные характеристики должностей работников здравоохранения;

43) разрабатывает и утверждает перечень лекарственных средств и медицинских изделий, закупаемых единым дистрибьютором в рамках долгосрочных договоров поставки лекарственных средств и медицинских изделий;

44) разрабатывает и утверждает правила проведения оценки качества лекарственных средств и медицинских изделий, зарегистрированных в Республике Казахстан;

45) разрабатывает и утверждает правила формирования реестра субъектов здравоохранения, осуществляющих оптовую и розничную реализацию медицинских изделий, в уведомительном порядке;

46) разрабатывает и утверждает Казахстанский национальный лекарственный формуляр;

47) разрабатывает и утверждает правила формирования Казахстанского национального лекарственного формуляра, перечень лекарственных средств и медицинских изделий для бесплатного и (или) льготного амбулаторного обеспечения отдельных категорий граждан Республики Казахстан с определенными заболеваниями (состояниями), а также правила разработки лекарственных формуляров организаций здравоохранения;

48) разрабатывает и утверждает правила проведения оценки рационального использования лекарственных средств;

49) разрабатывает и утверждает правила обеспечения лекарственными средствами и медицинскими изделиями в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования;

50) разрабатывает и утверждает правила формирования перечня закупа лекарственных средств и медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

51) разрабатывает и утверждает правила регулирования цен на лекарственные средства, а также на медицинские изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

52) разрабатывает и утверждает правила осуществления сервисного обслуживания медицинских изделий в Республике Казахстан;

53) разрабатывает и утверждает методику осуществления экспертной оценки оптимальных технических характеристик и клинико-технического обоснования медицинских изделий;

54) разрабатывает и утверждает правила взаимодействия по контрактному фракционированию;

55) разрабатывает и утверждает состав аптечки для оказания первой помощи;

56) разрабатывает и утверждает правила закупа товаров и услуг для осуществления экспертизы при государственной регистрации лекарственных средств и медицинских изделий и оценке их безопасности и качества;

57) разрабатывает и утверждает перечень лекарственных средств и медицинских изделий, необходимых для оказания экстренной и неотложной медицинской помощи в организациях здравоохранения;

58) разрабатывает и утверждает положение о национальном координаторе по международным медико-санитарным правилам;

59) разрабатывает и утверждает типовую форму договора по предоставлению платных медицинских услуг (помощи);

59-1) разрабатывает и утверждает правила организации оказания медицинской помощи лицам, больным туберкулезом, содержащимся в учреждениях уголовно-исполнительной (пенитенциарной) системы, по согласованию с Министерством внутренних дел Республики Казахстан;

59-2) разрабатывает и утверждает правила проведения медицинского освидетельствования осужденных, представляемых к освобождению от отбывания наказания в связи с болезнью, и определяет перечень заболеваний, являющихся основанием освобождения от отбывания наказания, по согласованию с Министерством внутренних дел Республики Казахстан;

59-3) определяет порядок закупа и оплаты услуг субъектов здравоохранения по оказанию медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств;

59-4) разрабатывает и утверждает типовые штаты и штатные нормативы медицинских организаций, оказывающих медицинскую помощь лицам, содержащимся в следственных изоляторах и в учреждениях уголовно-исполнительной (пенитенциарной) системы;

59-5) разрабатывает и утверждает правила и методику формирования тарифов на медицинские услуги, предоставляемые в рамках дополнительного объема медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств;

59-6) разрабатывает и утверждает минимальные нормативы оснащения медицинской техникой и изделиями медицинского назначения медицинских организаций, оказывающих медицинскую помощь лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы;

60) разрабатывает и утверждает правила направления граждан Республики Казахстан на лечение за рубеж и (или) привлечения зарубежных специалистов для проведения лечения в отечественных медицинских организациях в рамках гарантированного объема бесплатной медицинской помощи;

60-1) разрабатывает и утверждает правила использования единовременных пенсионных выплат на лечение;

61) разрабатывает и утверждает методику формирования (расчета) показателей в области здравоохранения;

62) разрабатывает и утверждает правила закупа услуг у субъектов здравоохранения по оказанию медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

63) разрабатывает и утверждает правила планирования объемов медицинских услуг в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

64) разрабатывает и утверждает правила и методику формирования тарифов на медицинские услуги, оказываемые в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

65) разрабатывает и утверждает тарифы на медицинские услуги, предоставляемые в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

66) разрабатывает и утверждает правила ведения учета потребителей медицинских услуг и предоставления права на получение медицинской помощи в системе обязательного социального медицинского страхования;

67) разрабатывает и утверждает правила ведения учета субъектов здравоохранения, оказывающих медицинскую помощь в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

68) разрабатывает и утверждает государственный норматив сети организаций здравоохранения;

69) разрабатывает и утверждает правила формирования, согласования и утверждения единого перспективного плана развития инфраструктуры здравоохранения;

70) разрабатывает и утверждает номенклатуру организаций здравоохранения и положения об их деятельности;

71) разрабатывает и утверждает минимальные стандарты оснащения организаций здравоохранения медицинскими изделиями;

72) разрабатывает и утверждает профессиональные стандарты в области здравоохранения;

73) разрабатывает и утверждает правила проведения медицинских осмотров лиц, претендующих на получение права управления транспортными средствами;

74) разрабатывает и утверждает правила проведения медицинского освидетельствования для установления факта употребления психоактивного вещества и состояния опьянения;

75) разрабатывает и утверждает правила забора, хранения и использования крови и тканей лиц, подвергшихся воздействию ионизирующего излучения;

76) разрабатывает и утверждает перечень заболеваний, связанных с воздействием ионизирующего излучения, и правила установления причинной связи;

77) разрабатывает и утверждает перечень медицинских противопоказаний, имеющихся у лиц с психическими, поведенческими расстройствами (заболеваниями), связанными с употреблением психоактивных веществ, в отношении которых не применяется направление в организацию, оказывающую медицинскую помощь в области психического здоровья;

78) разрабатывает и утверждает правила разработки и пересмотра клинических протоколов;

79) разрабатывает и утверждает методику внедрения и оценку эффективности внедрения клинических протоколов в практическое здравоохранение;

80) разрабатывает и утверждает квалификационные требования, предъявляемые к медицинской и фармацевтической деятельности;

81) разрабатывает и утверждает правила оказания медицинской помощи посредством передвижных медицинских комплексов и медицинских поездов;

82) разрабатывает и утверждает правила оказания медицинской помощи согласно видам, установленным статьей 120 настоящего Кодекса;

83) разрабатывает и утверждает правила оказания сурдологической помощи населению Республики Казахстан;

84) разрабатывает и утверждает номенклатуру, правила заготовки, переработки, контроля качества, хранения, реализации крови, ее компонентов, а также правила переливания крови, ее компонентов;

85) разрабатывает и утверждает правила и условия изъятия, заготовки, хранения, консервации, транспортировки, трансплантации органов (части органа) и (или) тканей (части ткани) от донора к реципиенту;

86) разрабатывает и утверждает правила подключения электронных информационных ресурсов, содержащих персональные медицинские данные, к сетям телекоммуникаций, связывающим их с другими базами данных в области здравоохранения, по согласованию с уполномоченным органом в сфере обеспечения информационной безопасности;

87) разрабатывает и утверждает стандарты, системы классификации, справочники и номенклатуры в области цифрового здравоохранения;

88) разрабатывает и утверждает минимальные требования к медицинским информационным системам в области здравоохранения;

89) разрабатывает и утверждает требования к электронным информационным ресурсам для дистанционных медицинских услуг;

90) разрабатывает и утверждает инструкции по кодированию заболеваемости и смертности, инструкции по использованию международных классификаторов;

91) утверждает методику формирования стоимости обучения по программам образования в области здравоохранения по согласованию с уполномоченным органом в области образования;

92) определяет порядок и методику формирования потребности в лекарственных средствах и медицинских изделиях в рамках гарантированного объема бесплатной медицинской помощи, дополнительного объема медицинской помощи лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств и (или) в системе обязательного социального медицинского страхования;

93) разрабатывает и утверждает правила осуществления сооплаты;

94) разрабатывает и утверждает правила формирования предельных цен и наценки на лекарственные средства и (или) медицинские изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

95) формирует и утверждает предельные цены и наценки на лекарственные средства и (или) медицинские изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

96) разрабатывает и утверждает предельные цены на торговое наименование лекарственного средства для розничной и оптовой реализации;

97) осуществляет деятельность по формированию, мониторингу реализации и оценке результатов государственного социального заказа в области охраны здоровья граждан для неправительственных организаций, в том числе для ключевых групп населения;

98) определяет перечень профессиональных заболеваний;

99) разрабатывает и утверждает правила проведения мониторинга исполнения условий договора закупа медицинских услуг у субъектов здравоохранения в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

100) разрабатывает и утверждает правила поощрения работников субъектов здравоохранения, оказывающих медицинские услуги в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

101) участвует в формировании и реализации государственной политики в сфере медицинской и фармацевтической промышленности;

101-1) определяет случаи ввоза на территорию Республики Казахстан в качестве гуманитарной помощи лекарственных средств и медицинских изделий, не прошедших государственную регистрацию в Республике Казахстан;

101-2) утверждает перечень сильнодействующих веществ, оказывающих вредное воздействие на жизнь и здоровье человека;

102) разрабатывает и утверждает правила организации оказания медицинской помощи на период введенного чрезвычайного положения в соответствии с Законом Республики Казахстан "О чрезвычайном положении";

103) разрабатывает и утверждает стандарты питания в организациях здравоохранения и образования;

104) разрабатывает и утверждает правила проведения конфиденциального аудита в медицинских организациях;

104-1) разрабатывает и утверждает положение о деятельности врачебно-консультативной комиссии;

104-1) определяет перечень стратегически важных лекарственных средств и медицинских изделий;

105) осуществляет иные функции, предусмотренные настоящим Кодексом, иными законами Республики Казахстан, актами Президента Республики Казахстан и Правительства Республики Казахстан.

Сноска. Статья 7 с изменениями, внесенными законами РК от 02.01.2021 № 399-VI (порядок введения в действие см. ст.2); от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 30.12.2022 № 177-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 04.07.2023 № 15-VIII (вводится в действие по истечении шестидесяти календарных дней со дня его первого официального опубликования); от 23.12.2023 № 50-VIII (вводится в действие с 01.01.2024).

Статья 8. Компетенция государственного органа в сфере оказания медицинских услуг (помощи)

Государственный орган в сфере оказания медицинских услуг (помощи):

1) реализует государственную политику в сфере оказания медицинских услуг (помощи);

2) разрабатывает и утверждает в пределах своей компетенции правовые акты и формы учетной и отчетной документации в сфере оказания медицинских услуг (помощи);

3) осуществляет государственный контроль в сфере оказания медицинских услуг (помощи);

4) рассматривает дела об административных правонарушениях в соответствии с Кодексом Республики Казахстан об административных правонарушениях;

5) осуществляет лицензирование медицинской деятельности, за исключением судебно-медицинской, судебно-наркологической, судебно-психиатрической экспертиз, в соответствии с Законом Республики Казахстан "О разрешениях и уведомлениях";

6) координирует деятельность организаций здравоохранения по вопросам контроля в сфере оказания медицинских услуг (помощи);

7) организует проведение аттестации на профессиональную компетентность специалистов в области здравоохранения;

8) взаимодействует с общественными объединениями по вопросам государственного контроля в сфере оказания медицинских услуг (помощи);

9) разрабатывает и утверждает правила аккредитации в области здравоохранения;

10) разрабатывает и утверждает правила, сроки проведения постаккредитационного мониторинга и отзыва свидетельства об аккредитации в области здравоохранения;

Примечание ИЗПИ!
Подпункт 11) предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

11) разрабатывает и утверждает правила оплаты независимой экспертизы качества медицинских услуг (помощи), проводимой аккредитованными субъектами здравоохранения;

12) осуществляет выдачу лицензии на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов;

13) определяет порядок выдачи заключений (разрешительных документов) на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства образцов биологических материалов человека, гемопоэтических стволовых клеток, костного мозга, донорских лимфоцитов в целях проведения неродственной трансплантации, половых клеток и эмбрионов;

14) осуществляет выдачу заключений (разрешительных документов) на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов, образцов биологических материалов человека, гемопоэтических стволовых клеток, костного мозга, донорских лимфоцитов в целях проведения неродственной трансплантации, половых клеток и эмбрионов;

Примечание ИЗПИ!
Подпункт 15) предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

15) разрабатывает и утверждает правила привлечения независимых экспертов при проведении экспертизы качества медицинских услуг (помощи);

Примечание ИЗПИ!
В подпункт 16) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

16) разрабатывает и утверждает требования к субъектам здравоохранения на оказание услуг по проведению независимой экспертизы качества медицинских услуг (помощи);

17) разрабатывает и утверждает правила предоставления информации (экстренного извещения) о случаях наступления смерти беременных, рожениц, а также в случае смерти родильниц в течение сорока двух календарных дней после родов, внезапной смерти пациентов при оказании им плановой медицинской помощи (первичной медико-санитарной и специализированной помощи, в том числе высокотехнологичных медицинских услуг);

18) разрабатывает и утверждает правила ведения реестра независимых экспертов, а также основания включения в единый реестр независимых экспертов и исключения из него;

19) формирует государственный социальный заказ, проводит мониторинг его реализации и оценку результатов по удовлетворенности граждан уровнем и качеством оказываемой медицинской помощи в соответствии с законодательством Республики Казахстан о государственном социальном заказе, государственном заказе на реализацию стратегического партнерства, грантах и премиях для неправительственных организаций в Республике Казахстан;

20) осуществляет мониторинг за соблюдением местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы государственного норматива сети организаций здравоохранения;

21) осуществляет государственный контроль при обжаловании субъектами здравоохранения результатов мониторинга договорных обязательств по качеству и объему медицинских услуг, проводимого фондом социального медицинского страхования;

22) разрабатывает и утверждает правила организации деятельности единого медицинского информационного call-центра и регламент его деятельности;

Примечание ИЗПИ!
Статью 8 предусмотрено дополнить подпунктом 22-1) в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

23) осуществляет иные функции, предусмотренные настоящим Кодексом, иными законами Республики Казахстан, актами Президента Республики Казахстан и Правительства Республики Казахстан.

Сноска. Статья 8 с изменением, внесенным Законом РК от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 9. Компетенция государственного органа в сфере санитарно-эпидемиологического благополучия населения

Государственный орган в сфере санитарно-эпидемиологического благополучия населения:

1) реализует государственную политику в сфере санитарно-эпидемиологического благополучия населения;

2) разрабатывает и утверждает в пределах своей компетенции правовые акты и формы учетной и отчетной документации в сфере санитарно-эпидемиологического благополучия населения;

3) разрабатывает и утверждает правила экспертизы установления связи профессионального заболевания с выполнением трудовых (служебных) обязанностей;

4) осуществляет санитарно-эпидемиологический мониторинг;

5) осуществляет государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения;

Примечание ИЗПИ!
Статью 9 предусмотрено дополнить подпунктами 5-1), 5-2), 5-3) и 5-4) в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

6) координирует деятельность организаций здравоохранения, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения;

7) обеспечивает ведомственное статистическое наблюдение в сфере санитарно-эпидемиологического благополучия населения;

8) создает и обеспечивает функционирование электронных информационных ресурсов и информационных систем, информационно-коммуникационных сетей в сфере санитарно-эпидемиологического благополучия населения, организацию доступа к ним физических и юридических лиц в соответствии с законодательством Республики Казахстан об информатизации;

9) исключен Законом РК от 30.12.2022 № 177-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования);

10) определяет порядок проведения санитарно-эпидемиологической экспертизы;

11) определяет порядок ведения реестра потенциально опасных химических, биологических веществ, запрещенных к применению в Республике Казахстан;

12) определяет класс опасности отходов по степени их воздействия на человека и окружающую среду (по степени токсичности);

13) разрабатывает и утверждает правила предоставления информации по медицинским отходам;

14) разрабатывает и утверждает правила предоставления в государственный орган в сфере санитарно-эпидемиологического благополучия населения информации (экстренного извещения) о случаях инфекционных заболеваний, отравлений;

15) реализует совместные международные проекты в сфере санитарно-эпидемиологического благополучия населения;

16) организует гигиеническое обучение населения;

17) организует и осуществляет в пределах своей компетенции санитарно-противоэпидемические и санитарно-профилактические мероприятия при пищевых отравлениях, инфекционных, паразитарных, профессиональных заболеваниях;

18) выдает санитарно-эпидемиологические заключения о соответствии объекта государственного санитарно-эпидемиологического контроля и надзора, проектов нормативной документации по предельно допустимым выбросам и предельно допустимым сбросам вредных веществ и физических факторов в окружающую среду, зонам санитарной охраны и санитарно-защитным зонам, на новые виды сырья и продукции нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения;

Примечание ИЗПИ!
Статью 9 предусмотрено дополнить подпунктом 18-1) в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

19) осуществляет эпидемиологический контроль за инфекционными и паразитарными заболеваниями, за устойчивостью возбудителей инфекционных болезней к противомикробным препаратам, проведением профилактических прививок населению;

20) рассматривает дела об административных правонарушениях в соответствии с Кодексом Республики Казахстан об административных правонарушениях;

21) определяет территории (ее части), свободные от заболеваний или с низким уровнем распространенности заболеваний;

22) создает в пунктах пропуска через Государственную границу Республики Казахстан, совпадающую с таможенной границей Евразийского экономического союза, санитарно-карантинные пункты;

23) разрабатывает и утверждает перечень эпидемически значимых объектов;

24) осуществляет контроль за соблюдением требований, установленных техническими регламентами;

Примечание ИЗПИ!
Статью 9 предусмотрено дополнить подпунктом 24-1) в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

25) разрабатывает и утверждает правила гигиенического обучения лиц декретированной группы населения;

26) определяет порядок присвоения учетных номеров объектам производства пищевой продукции, подлежащим государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, и ведения их реестра;

27) осуществляет прием уведомлений о начале или прекращении осуществления деятельности, указанной подпунктах 1), 2) и 3) пункта 1 статьи 24 настоящего Кодекса, в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях", а также ведет государственный электронный реестр разрешений и уведомлений;

28) определяет порядок государственной регистрации продукции, определяемой нормативными правовыми актами Евразийского экономического союза;

29) разрабатывает и утверждает правила ведения реестра продукции, не соответствующей требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

30) разрабатывает и утверждает правила взаимодействия государственных органов при проведении санитарно-противоэпидемических и санитарно-профилактических мероприятий;

31) осуществляет радиационный контроль за соблюдением санитарно-эпидемиологических требований к обеспечению радиационной безопасности населения;

32) осуществляет государственный контроль и надзор за продукцией, подлежащей государственному санитарно-эпидемиологическому контролю и надзору, в том числе за пищевой продукцией;

33) разрабатывает и утверждает перечень отдельных видов пищевой продукции, подлежащей государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, в производстве которой используется нейодированная соль;

34) осуществляет государственное регулирование в области профилактики йододефицитных заболеваний;

35) отбирает пробы продукции в соответствии с требованиями нормативных документов;

36) взаимодействует с общественными объединениями в области профилактики неинфекционных заболеваний, связанных с микронутриентной недостаточностью, в том числе йододефицитных и железодефицитных заболеваний;

37) осуществляет регулирование порядка сбора, хранения, транспортировки и утилизации медицинских отходов;

38) осуществляет контроль за обращением медицинских отходов;

39) осуществляет эпидемиологический надзор за неинфекционными заболеваниями;

40) разрабатывает и утверждает перечень медицинских противопоказаний для заключения трудового договора на тяжелые работы, работы с вредными и (или) опасными условиями труда, на подземные работы, а также для допуска к работе лица, относящегося к декретированной группе населения;

40-1) разрабатывает и утверждает квалификационные требования к лицензируемому виду деятельности на оказание услуг по дезинфекции, дезинсекции, дератизации в области здравоохранения;

40-2) осуществляет выдачу лицензии на оказание услуг по дезинфекции, дезинсекции, дератизации в области здравоохранения в соответствии с Законом Республики Казахстан "О разрешениях и уведомлениях";

40-3) разрабатывает и утверждает правила формирования, ведения и содержания рабочих коллекций патогенных и промышленных микроорганизмов, используемых в сфере санитарно-эпидемиологического благополучия населения;

40-4) разрабатывает и утверждает правила выдачи, возобновления действия, переоформления, прекращения действия разрешений на обращение с патогенными биологическими агентами и приложений к ним;

40-5) разрабатывает и утверждает квалификационные требования, предъявляемые к осуществлению обращения с патогенными биологическими агентами;

41) осуществляет иные функции, предусмотренные настоящим Кодексом, иными законами Республики Казахстан, актами Президента Республики Казахстан и Правительства Республики Казахстан.

Сноска. Статья 9 с изменениями, внесенными законами РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования); от 30.12.2022 № 177-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 10. Компетенция государственного органа в сфере обращения лекарственных средств и медицинских изделий

Государственный орган в сфере обращения лекарственных средств и медицинских изделий:

1) реализует государственную политику в сфере обращения лекарственных средств и медицинских изделий;

Примечание ИЗПИ!
В подпункт 2) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

2) осуществляет государственный контроль и надзор в сфере обращения лекарственных средств, медицинских изделий, а также за оборотом наркотических средств, психотропных веществ и прекурсоров в области здравоохранения;

3) разрабатывает и утверждает в пределах своей компетенции правовые акты и формы учетной и отчетной документации в сфере обращения лекарственных средств и медицинских изделий;

5) осуществляет лицензирование видов фармацевтической деятельности, указанных в подпунктах 1), 2), 3), 4), 5) и 7) статьи 230 настоящего Кодекса, а также видов деятельности, связанных с оборотом наркотических средств, психотропных веществ и прекурсоров в области здравоохранения;

6) координирует деятельность организаций здравоохранения в сфере обращения лекарственных средств и медицинских изделий;

7) осуществляет государственную регистрацию, перерегистрацию и внесение изменений в регистрационное досье, отзыв решения о государственной регистрации лекарственных средств и медицинских изделий, ведет Государственный реестр лекарственных средств и медицинских изделий;

8) согласовывает ввоз (вывоз) зарегистрированных и не зарегистрированных в Республике Казахстан лекарственных средств и медицинских изделий;

9) разрабатывает и утверждает стандарты надлежащих фармацевтических практик;

10) осуществляет прием уведомлений о начале или прекращении осуществления деятельности, указанной в подпунктах 4), 5) и 6) пункта 1 статьи 24 настоящего Кодекса, в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях", а также ведет государственный электронный реестр разрешений и уведомлений;

11) выдает сертификат на фармацевтический продукт (СРР);

12) выдает разрешение на проведение интервенционного клинического исследования лекарственного средства, медицинского изделия;

13) принимает решения о приостановлении медицинского применения лекарственного средства, медицинского изделия путем приостановления действия регистрационного удостоверения лекарственного средства, медицинского изделия, а также запрете медицинского применения и об изъятии из обращения или приостановлении медицинского применения серии (партии) лекарственных средств и медицинских изделий;

14) проводит аккредитацию испытательных лабораторий, осуществляющих монопольную деятельность по экспертизе и оценке безопасности и качества лекарственных средств и медицинских изделий;

15) разрабатывает и утверждает правила оптовой и розничной реализации лекарственных средств и медицинских изделий;

16) разрабатывает и утверждает проверочные листы, критерии оценки степени риска и полугодовые графики проведения проверок в регулируемой сфере в соответствии с Предпринимательским кодексом Республики Казахстан;

17) разрабатывает и утверждает правила проведения инспектирования в сфере обращения лекарственных средств и медицинских изделий;

18) осуществляет фармацевтические инспекции;

19) разрабатывает и утверждает правила формирования фармацевтического инспектората, ведения реестра фармацевтических инспекторов Республики Казахстан;

20) разрабатывает и утверждает правила отбора с рынка, в том числе в медицинских организациях, лекарственных средств и медицинских изделий, подлежащих контролю качества с учетом риск-ориентированного подхода;

21) участвует в определении порядка маркировки товаров и порядке осуществления контроля за оборотом товаров, подлежащих маркировке;

22) осуществляет иные функции, предусмотренные настоящим Кодексом, иными законами Республики Казахстан, актами Президента Республики Казахстан и Правительства Республики Казахстан.

Статья 11. Компетенция центральных исполнительных органов и иных центральных государственных органов, имеющих военно-медицинские (медицинские), судебно-медицинские, судебно-наркологические, судебно-психиатрические подразделения

1. Центральные исполнительные органы и иные центральные государственные органы, имеющие военно-медицинские (медицинские), судебно-медицинские, судебно-наркологические, судебно-психиатрические подразделения, в пределах своей компетенции:

1) реализуют государственную политику в области здравоохранения;

2) обеспечивают повышение квалификации работников военно-медицинских (медицинских) подразделений в соответствии с правилами, утвержденными уполномоченным органом;

3) осуществляют руководство деятельностью военно-медицинских (медицинских), судебно-медицинских, судебно-наркологических, судебно-психиатрических подразделений;

4) разрабатывают и утверждают правила военно-медицинского (медицинского) обеспечения;

5) назначают на должности и освобождают от должностей руководителей военно-медицинских (медицинских), судебно-медицинских, судебно-наркологических, судебно-психиатрических подразделений;

6) обеспечивают создание и функционирование ведомственных электронных информационных ресурсов и информационных систем, информационно-коммуникационных сетей в области здравоохранения;

7) разрабатывают и утверждают структуру военно-медицинских (медицинских) подразделений, положения об их деятельности, если иное не предусмотрено законами Республики Казахстан;

8) разрабатывают и утверждают типовые штаты и штатные нормативы военно-медицинских (медицинских), судебно-медицинских, судебно-наркологических, судебно-психиатрических подразделений, если иное не предусмотрено законами Республики Казахстан;

9) устанавливают (отменяют) ограничительные мероприятия, в том числе карантин, на территории войск, подразделений и ведомственных организаций с одновременным уведомлением государственного органа в сфере санитарно-эпидемиологического благополучия населения и его территориального подразделения;

10) разрабатывают и утверждают правила проведения военно-врачебной экспертизы и положение о комиссиях военно-врачебной экспертизы по согласованию с уполномоченным органом;

11) разрабатывают и утверждают требования, предъявляемые к состоянию здоровья лиц для прохождения службы в Вооруженных Силах, других войсках и воинских формированиях Республики Казахстан, государственной авиации, специальных государственных и правоохранительных органах, по согласованию с уполномоченным органом;

12) устанавливают порядок и периодичность проведения медицинских осмотров соответствующего контингента в военно-медицинских (медицинских) подразделениях (организациях);

13) разрабатывают и утверждают формы ведомственной военно-медицинской (медицинской) статистической отчетности;

14) осуществляют иные функции, предусмотренные законами Республики Казахстан, актами Президента Республики Казахстан и Правительства Республики Казахстан.

2. Министерство обороны Республики Казахстан разрабатывает и утверждает требования, предъявляемые к состоянию здоровья лиц для прохождения службы:

1) в Вооруженных Силах, других войсках и воинских формированиях Республики Казахстан;

2) в государственной авиации Республики Казахстан.

3. Министерство внутренних дел Республики Казахстан:

1) разрабатывает и утверждает правила проведения военно-врачебной экспертизы в правоохранительных органах и государственной фельдъегерской службе Республики Казахстан и положение о комиссиях военно-врачебной экспертизы в органах внутренних дел по согласованию с уполномоченным органом;

2) разрабатывает и утверждает требования, предъявляемые к состоянию здоровья лиц для прохождения службы в правоохранительных органах и государственной фельдъегерской службе Республики Казахстан, по согласованию с правоохранительными органами Республики Казахстан.

4. Комитет национальной безопасности Республики Казахстан разрабатывает и утверждает требования, предъявляемые к состоянию здоровья лиц для прохождения службы в органах национальной безопасности Республики Казахстан.

5. Управление делами Президента Республики Казахстан разрабатывает и утверждает:

1) правила оказания медицинской помощи, в том числе медицинской реабилитации, в подведомственных организациях;

2) правила направления медицинских специалистов подведомственных организаций на обучение, повышение квалификации за рубеж;

3) правила проведения образовательных мероприятий, привлечения зарубежных консультантов;

4) иные нормативные правовые акты в соответствии с законодательством Республики Казахстан.

Статья 12. Компетенция местных представительных и исполнительных органов областей, городов республиканского значения и столицы

1. Местные представительные органы областей, городов республиканского значения и столицы:

1) определяют систему мер социальной поддержки медицинских и фармацевтических работников, направленных для работы в сельской местности и поселках, городах районного и областного значения, а также порядок и размер оказания им социальной поддержки за счет бюджетных средств;

2) утверждают местные бюджеты здравоохранения и медицинского образования и отчеты об их исполнении;

3) принимают решение о предоставлении бесплатного или льготного проезда гражданам Республики Казахстан за пределы населенного пункта постоянного проживания для получения высокотехнологичных медицинских услуг в рамках гарантированного объема бесплатной медицинской помощи и (или) медицинской помощи в системе обязательного социального медицинского страхования;

4) принимают меры по обеспечению транспортом в случае разъездного характера оказания медицинской помощи населению в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования или возмещению транспортных расходов при выезде для оказания медицинской помощи в сельской местности;

5) принимают решение о дополнительном предоставлении гарантированного объема бесплатной медицинской помощи, в том числе лекарственных средств, специализированных лечебных продуктов, медицинских изделий, отдельным категориям граждан Республики Казахстан при амбулаторном лечении бесплатно и (или) на льготных условиях;

6) утверждают мероприятия, направленные на развитие и функционирование организаций здравоохранения, в том числе организаций, оказывающих медицинскую помощь лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы;

7) определяют меры по кадровому обеспечению государственных организаций здравоохранения в расчете на численность населения в соответствующих административно-территориальных единицах;

8) принимают решение о предоставлении дополнительного поощрения донорам;

9) принимают решение о дополнительном кадровом и материально-техническом обеспечении государственных организаций здравоохранения сверх утвержденного уполномоченным органом минимального норматива обеспеченности региона медицинскими работниками для обеспечения населения медицинской помощью;

10) осуществляют планирование кадрового обеспечения региона медицинскими работниками и размещают заказ на подготовку медицинских работников в организациях медицинского образования;

11) осуществляют мониторинг предоставления мер социальной поддержки, а также отработки и удержания молодых специалистов, прибывших из организаций медицинского образования;

12) содействуют формированию здорового образа жизни и здорового питания;

13) утверждают расходы на проведение мероприятий по профилактике йододефицитных заболеваний в составе местных бюджетов;

14) заслушивают информацию руководителей местных исполнительных органов областей, городов республиканского значения и столицы, организаций здравоохранения о состоянии работы по профилактике йододефицитных заболеваний;

15) осуществляют иные полномочия по обеспечению прав и законных интересов граждан Республики Казахстан в соответствии с законодательством Республики Казахстан.

2. Местные исполнительные органы областей, городов республиканского значения и столицы:

1) реализуют государственную политику в области здравоохранения на территории соответствующей административно-территориальной единицы;

2) обеспечивают реализацию прав лиц на получение гарантированного объема бесплатной медицинской помощи;

3) осуществляют контроль за содержанием лиц, находящихся в центрах временной адаптации и детоксикации;

4) обеспечивают деятельность организаций здравоохранения, являющихся коммунальными юридическими лицами;

5) организуют комплекс мероприятий по стимулированию здорового образа жизни;

6) обеспечивают эффективное планирование и использование ресурсов здравоохранения;

6-1) создают медицинские реабилитационные центры (отделения) для детей с ограниченными возможностями в городах республиканского и областного значения, столице, а также районных центрах, в том числе и на объектах существующей инфраструктуры субъектов здравоохранения данных населенных пунктов, с целью оказания реабилитационных услуг в соответствии со стандартом организации оказания медицинской реабилитации, правилами оказания медицинской помощи;

7) принимают меры по повышению качества медицинских услуг;

8) обеспечивают доступ населения к информации по вопросам здравоохранения;

9) обеспечивают реализацию мер по развитию добровольного безвозмездного донорства крови и ее компонентов;

10) оплачивают проезд внутри страны по перечню, определяемому местными представительными органами областей, городов республиканского значения и столицы, отдельным категориям граждан Республики Казахстан, выезжающим за пределы населенного пункта постоянного проживания для получения высокотехнологичных медицинских услуг в рамках гарантированного объема бесплатной медицинской помощи и (или) медицинской помощи в системе обязательного социального медицинского страхования;

11) создают местные органы государственного управления здравоохранением;

12) назначают на должность и освобождают от должности руководителей местных органов государственного управления здравоохранением областей, городов республиканского значения и столицы по согласованию с уполномоченным органом;

13) организуют контроль за кадровым обеспечением государственных организаций здравоохранения;

14) принимают меры по кадровому обеспечению государственных организаций здравоохранения, включая меры социальной поддержки и удержания молодых специалистов;

15) принимают меры по строительству и развитию сети организаций здравоохранения, их финансовому и материально-техническому обеспечению, в том числе по развитию государственной сети аптек и созданию аптечных складов;

16) координируют деятельность субъектов здравоохранения в пределах соответствующей административно-территориальной единицы;

17) обеспечивают оказание бесплатной медицинской помощи лекарственными средствами и медицинскими изделиями при чрезвычайных ситуациях, введении режима чрезвычайного положения;

18) осуществляют межрегиональное сотрудничество в области здравоохранения;

19) обеспечивают подготовку и повышение квалификации кадров в области здравоохранения;

20) осуществляют мероприятия, необходимые для укрепления здоровья, профилактики заболеваний, формирования здорового образа жизни и здорового питания;

21) организуют оказание населению медицинской помощи, в том числе профилактику и лечение социально значимых заболеваний и заболеваний, представляющих опасность для окружающих, включая лекарственное обеспечение в рамках гарантированного объема бесплатной медицинской помощи;

21-1) организуют оказание лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, медицинской помощи, в том числе профилактику и лечение социально значимых заболеваний и заболеваний, представляющих опасность для окружающих, включая лекарственное обеспечение;

21-2) организуют в сельских населенных пунктах, где отсутствуют аптеки, обеспечение лекарственными средствами и медицинскими изделиями;

22) обеспечивают направление детей с ограниченными возможностями на психолого-медико-педагогические консультации с согласия родителей или иных законных представителей;

23) в пределах своей компетенции осуществляют государственный контроль в области здравоохранения;

25) содействуют исполнению решения суда о направлении граждан Республики Казахстан, больных туберкулезом, на принудительное лечение;

26) организуют и проводят профилактическую дезинсекцию и дератизацию с оценкой их эффективности (за исключением дезинсекции и дератизации на территории природных очагов инфекционных и паразитарных заболеваний, а также в очагах инфекционных и паразитарных заболеваний);

27) проводят обучение специалистов с медицинским образованием для осуществления реализации лекарственных средств и медицинских изделий в сельских населенных пунктах через аптечные пункты в организациях здравоохранения, оказывающих первичную медико-санитарную, специализированную медицинскую помощь в амбулаторных условиях, и передвижные аптечные пункты в случае отсутствия специалиста с фармацевтическим образованием;

28) обеспечивают реализацию мер по развитию добровольного безвозмездного донорства органов (части органа) и (или) тканей (части ткани);

29) разрабатывают и утверждают региональный перспективный план развития инфраструктуры здравоохранения по согласованию с уполномоченным органом;

30) создают медицинские комиссии для проведения медицинского освидетельствования граждан Республики Казахстан в интересах воинской службы и обеспечивают их деятельность;

31) организуют обеспечение дошкольных организаций, организаций образования, здравоохранения и социальной защиты населения йодированной пищевой солью и другими обогащенными соединениями йода пищевыми продуктами;

32) осуществляют деятельность по формированию, мониторингу реализации и оценке результатов государственного социального заказа в области охраны здоровья граждан для неправительственных организаций, в том числе для ключевых групп населения;

33) размещают государственный социальный заказ по предоставлению паллиативной помощи, за исключением паллиативной медицинской помощи;

34) присваивают номинации "лучший по профессии";

35) обеспечивают создание условий для размещения интернов и врачей-резидентов в организациях здравоохранения соответствующей административно-территориальной единицы, включая предоставление места проживания и оказания медицинской помощи интернам и врачам-резидентам (в случае если организация здравоохранения расположена в другом населенном пункте с организацией высшего и (или) послевузовского образования);

36) организуют безопасную утилизацию медицинских отходов;

37) осуществляют развитие сети организаций здравоохранения и исполнение региональных перспективных планов развития инфраструктуры здравоохранения;

38) обеспечивают реализацию государственных программ развития системы здравоохранения, а также исполнение мероприятий в области здравоохранения и решений Национального координационного совета по охране здоровья при Правительстве Республики Казахстан;

39) обеспечивают создание и функционирование региональных электронных информационных ресурсов и информационных систем, информационно-коммуникационных сетей в области здравоохранения;

40) осуществляют в интересах местного государственного управления иные полномочия, возлагаемые на местные исполнительные органы законодательством Республики Казахстан.

Сноска. Статья 12 с изменениями, внесенными законами РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 03.05.2022 № 118-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 30.12.2022 № 177-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 13. Компетенция местных органов государственного управления здравоохранением областей, городов республиканского значения и столицы

Местные органы государственного управления здравоохранением областей, городов республиканского значения и столицы в пределах своей компетенции:

1) реализуют государственную политику в области здравоохранения;

2) обеспечивают исполнение законодательства Республики Казахстан в области здравоохранения;

3) обеспечивают реализацию прав лиц на получение гарантированного объема бесплатной медицинской помощи;

4) организуют и осуществляют мониторинг и контроль за деятельностью субъектов здравоохранения, за исключением организаций здравоохранения, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения;

5) осуществляют закуп фармацевтических услуг;

6) осуществляют закуп и хранение лекарственных средств, профилактических (иммунобиологических, диагностических, дезинфицирующих) препаратов, медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

7) организуют закуп медицинских изделий, санитарного транспорта, а также услуг на проведение капитального ремонта государственных организаций здравоохранения;

8) организуют обеспечение региона кадрами в области здравоохранения;

9) обеспечивают содержание и эксплуатацию государственных медицинских организаций в соответствии с требованиями нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

10) предоставляют клинические базы в коммунальных юридических лицах в области здравоохранения для организаций образования в области здравоохранения;

11) организуют оказание бесплатной медицинской помощи, обеспечение лекарственными средствами и медицинскими изделиями при чрезвычайных ситуациях;

12) организуют и координируют деятельность по подготовке и повышению квалификации кадров в области здравоохранения;

13) организуют гигиеническое обучение, пропаганду и формирование здорового образа жизни и здорового питания;

14) информируют население о распространении социально значимых заболеваний и заболеваний, представляющих опасность для окружающих;

14-1) осуществляют совместно с молодежными ресурсными центрами информационно-разъяснительную, консультативную работу с молодежью по вопросам охраны репродуктивного здоровья и планирования семьи, опасности игромании (лудомании);

15) взаимодействуют с международными и неправительственными общественными объединениями по вопросам охраны здоровья граждан Республики Казахстан;

16) осуществляют ведомственные статистические наблюдения в области здравоохранения в пределах соответствующей административно-территориальной единицы с соблюдением требований статистической методологии;

17) разрабатывают и утверждают персональный состав медицинских комиссий, создаваемых для проведения медицинского освидетельствования граждан Республики Казахстан в интересах воинской службы, и организовывают их деятельность;

18) представляют уполномоченному органу ежеквартальный отчет по выполнению государственных программ развития системы здравоохранения, а также по основным количественным и качественным показателям здравоохранения;

19) вносят уполномоченному органу предложения по улучшению деятельности системы здравоохранения в пределах соответствующей административно-территориальной единицы, в том числе по развитию первичной медико-санитарной помощи, охране материнства и детства и реализации программы по социально значимым заболеваниям;

20) организуют кадровое обеспечение руководителей государственных организаций здравоохранения по согласованию с уполномоченным органом;

21) организуют и проводят профилактические прививки населению;

21-1) образуют специальную медицинскую комиссию для проведения медицинского освидетельствования осужденных по перечню заболеваний, являющихся основанием для освобождения от отбывания наказания;

21-2) обеспечивают оказание медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы;

21-3) разрабатывают и утверждают тарифы на медицинские услуги, предоставляемые в рамках дополнительного объема медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет бюджетных средств;

21-4) организуют проведение профилактических прививок населению;

21-5) осуществляют координацию и мониторинг деятельности по вопросам корпоративного управления в государственных юридических лицах в области здравоохранения на соответствующих административно-территориальных единицах, за исключением организаций, подведомственных уполномоченному органу;

21-6) осуществляют деятельность по формированию, мониторингу реализации и оценке результатов государственного социального заказа в области охраны здоровья граждан для неправительственных организаций, в том числе для ключевых групп населения, за исключением организаций, подведомственных уполномоченному органу;

22) осуществляют в интересах местного государственного управления иные полномочия, возлагаемые на местные органы государственного управления здравоохранением областей, городов республиканского значения и столицы законодательством Республики Казахстан.

Сноска. Статья 13 с изменениями, внесенными законами РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 26.12.2022 № 168-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 14. Полномочия национального оператора в области здравоохранения

Национальный оператор в области здравоохранения реализует инвестиционные проекты и проекты государственно-частного партнерства в области здравоохранения.

Статья 15. Объединенная комиссия по качеству медицинских услуг

1. Объединенная комиссия по качеству медицинских услуг создается с целью выработки рекомендаций по совершенствованию стандартизации, клинических протоколов, стандартов системы контроля качества и доступности услуг в области здравоохранения, а также аккредитации субъектов согласно статье 25 настоящего Кодекса.

2. Объединенная комиссия по качеству медицинских услуг формируется из представителей государственных органов, неправительственных организаций, государственных и негосударственных организаций здравоохранения.

3. Порядок формирования объединенной комиссии по качеству медицинских услуг и положение о ее деятельности определяются уполномоченным органом.

Статья 16. Межведомственное взаимодействие государственных органов и общественных объединений в области здравоохранения

1. Межведомственное взаимодействие государственных органов, общественных объединений и других заинтересованных юридических лиц нацелено на снижение факторов риска возникновения инфекционных и неинфекционных заболеваний, осуществление мероприятий при чрезвычайных ситуациях.

2. Для обеспечения взаимодействия государственных органов, общественных объединений и других заинтересованных юридических лиц при Правительстве Республике Казахстан создается консультативно-совещательный орган Национальный координационный совет по охране здоровья.

Основной задачей Национального координационного совета по охране здоровья является выработка предложений по обеспечению выполнения мероприятий, предусмотренных стратегическими и программными документами по вопросам охраны здоровья граждан на территории Республики Казахстан, по совершенствованию государственной политики, законодательства Республики Казахстан в области здравоохранения, а также по определению основных направлений в области здравоохранения.

Национальный координационный совет по охране здоровья создается Премьер-Министром Республики Казахстан.

3. Местными исполнительными органами создаются региональные координационные советы, возглавляемые акимами соответствующих административно-территориальных единиц.

Состав региональных координационных советов утверждается местными представительными органами соответствующей административно-территориальной единицы.

Региональные координационные советы на обязательной и регулярной основе отчитываются о проведенной работе перед Национальным координационным советом по охране здоровья.

4. Уполномоченный орган осуществляет межведомственную координацию мероприятий по вопросам охраны здоровья граждан Республики Казахстан и ведения национального учета кадровых ресурсов здравоохранения.

5. Государственные органы взаимодействуют и реализуют функции, направленные на охрану здоровья населения Республики Казахстан, в пределах компетенции, установленной законодательством Республики Казахстан.

6. Охрана общественного здоровья осуществляется с привлечением органов местного самоуправления, неправительственных организаций и ассоциаций через реализацию социальных проектов и грантов за счет бюджетных средств, а также дополнительных источников финансирования, не запрещенных законодательством Республики Казахстан.

7. Общественные объединения по защите прав граждан в сфере охраны здоровья не вправе осуществлять рекламу конкретных торговых наименований лекарственных средств, биологически активных добавок к пище, медицинских изделий, специализированных продуктов лечебного питания и заменителей грудного молока.

8. Общественные объединения и другие некоммерческие организации могут заниматься вопросами профилактики социально значимых заболеваний, заболеваний, представляющих опасность для окружающих, а также пропагандой и формированием здорового образа жизни.

9. Государственные органы, имеющие ведомственные медицинские службы, обеспечивают представление ведомственной отчетности по деятельности подведомственных организаций (подразделений) здравоохранения и состоянию здоровья прикрепленного контингента в местные органы государственного управления здравоохранением, за исключением случаев, предусмотренных законами Республики Казахстан.

Глава 3. РАЗРЕШЕНИЯ И УВЕДОМЛЕНИЯ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Параграф 1. Лицензирование в области здравоохранения

Статья 17. Лицензирование деятельности в области здравоохранения

1. В области здравоохранения осуществляется лицензирование следующих видов деятельности:

1) медицинская деятельность;

2) фармацевтическая деятельность;

3) деятельность, связанная с оборотом наркотических средств, психотропных веществ и прекурсоров в области здравоохранения;

4) ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов.

5) оказание услуг по дезинфекции, дезинсекции, дератизации в области здравоохранения.

2. Порядок и условия выдачи и переоформления лицензии и (или) приложения к лицензии и дубликата лицензии и (или) приложения к лицензии, осуществления разрешительного контроля, приостановления, возобновления и прекращения действия лицензии и (или) приложений к лицензии на занятие медицинской или фармацевтической деятельностью устанавливаются законами Республики Казахстан "О разрешениях и уведомлениях" и "О наркотических средствах, психотропных веществах, их аналогах и прекурсорах и мерах противодействия их незаконному обороту и злоупотреблению ими".

3. Порядок и условия выдачи и переоформления лицензии и дубликата лицензии, осуществления разрешительного контроля, приостановления, возобновления и прекращения действия лицензии на оказание услуг по дезинфекции, дезинсекции, дератизации в области здравоохранения устанавливаются Законом Республики Казахстан "О разрешениях и уведомлениях".

Сноска. Статья 17 с изменениями, внесенными Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 18. Лицензирование ввоза на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоза с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов

1. Ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани)человека, крови и ее компонентов в случае помещения их под таможенную процедуру экспорта или выпуска для внутреннего потребления осуществляются на основании лицензии, выдаваемой в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях".

2. Уполномоченный орган в течение трех рабочих дней принимает решение о выдаче или отказе в выдаче лицензии на ввоз, вывоз тканей (части ткани) человека, крови и ее компонентов, а на ввоз, вывоз органов (части органа) человека – в течение одного рабочего дня.

Параграф 2. Разрешительная процедура и уведомительный порядок в области здравоохранения

Статья 19. Разрешения в области здравоохранения

1. Разрешительными документами в области здравоохранения являются:

1) санитарно-эпидемиологическое заключение о соответствии объекта высокой эпидемической значимости нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения;

2) разрешение на обращение с патогенными биологическими агентами и приложение к нему;

3) свидетельство о государственной регистрации продукции;

4) регистрационное удостоверение на лекарственное средство и медицинское изделие;

5) разрешение на проведение интервенционного клинического исследования лекарственного средства, медицинского изделия;

6) сертификат специалиста в области здравоохранения.

2. Сроки действия разрешительных документов в области здравоохранения устанавливаются Законом Республики Казахстан "О разрешениях и уведомлениях".

3. В случае невыполнения предписания об устранении нарушений требований законодательства Республики Казахстан в области здравоохранения должностные лица, выдавшие разрешительный документ, приостанавливают его действие по основаниям и в порядке, которые предусмотрены настоящим Кодексом и законами Республики Казахстан.

4. В случае непредставления заявления об устранении нарушений владельцем разрешительного документа до истечения срока приостановления разрешительного документа в области здравоохранения должностные лица, выдавшие разрешительный документ, в течение десяти рабочих дней с момента истечения указанного срока инициируют лишение (отзыв) разрешительного документа в судебном порядке.

5. Переоформление разрешительных документов допускается без проведения дополнительных или повторных исследований (испытаний), за исключением подпунктов 4) и 5) пункта 1 настоящей статьи, в следующих случаях:

1) выявления в документе ошибок (опечаток);

2) перерегистрации индивидуального предпринимателя – заявителя, изменения его наименования или юридического адреса;

3) изменения наименования и (или) места нахождения юридического лица – заявителя, изготовителя продукции;

4) изменения адреса места нахождения объекта без его физического перемещения.

Сноска. Статья 19 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 20. Выдача санитарно-эпидемиологического заключения

Примечание ИЗПИ!
В абзац первый статьи 20 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Санитарно-эпидемиологическое заключение выдается государственным органом в сфере санитарно-эпидемиологического благополучия населения или структурным подразделением иных государственных органов, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения, на основании результатов профилактического контроля и (или) санитарно-эпидемиологической экспертизы на:

1) объекты промышленного и гражданского назначения;

2) проекты нормативной документации по предельно допустимым выбросам и предельно допустимым сбросам вредных веществ и физических факторов в окружающую среду, зонам санитарной охраны;

3) проекты по установлению расчетных (предварительных) и установленных (окончательных) санитарно-защитных зон;

4) сырье и продукцию;

5) материалы по химической, биологической, токсикологической, радиологической нагрузке на почву, водоемы и атмосферный воздух.

Статья 21. Выдача разрешения на обращение с патогенными биологическими агентами и приложения к нему

Сноска. Заголовок статьи 21 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

1. Государственным органом в сфере санитарно-эпидемиологического благополучия населения выдается разрешение на обращение с патогенными биологическими агентами и приложение к нему микробиологическим лабораториям независимо от форм собственности на основании заключения комиссии по контролю за соблюдением требований в области биологической безопасности (режимной комиссии).

2. Положение о комиссии по контролю за соблюдением требований в области биологической безопасности (режимная комиссия) и ее состав утверждаются государственным органом в сфере санитарно-эпидемиологического благополучия населения.

3. На проведение научно-исследовательских, экспериментальных, производственных, полевых и диагностических работ с патогенными биологическими агентами при соблюдении мер лабораторного сдерживания, включающих инженерные, операционные и технические требования (уровень биологической безопасности лаборатории), выдается разрешение на обращение с патогенными биологическими агентами и приложение к нему в зависимости от группы риска используемых в работе патогенных биологических агентов.

На каждый объект (стационарный или мобильный), на котором будет осуществляться деятельность по обращению с патогенными биологическими агентами, выдается разрешение на обращение с патогенными биологическими агентами и приложение к нему с учетом группы патогенности и степени опасности с указанием наименований патогенных биологических агентов.

4. Основанием для выдачи разрешения на обращение с патогенными биологическими агентами и приложения к нему является соответствие деятельности субъекта, осуществляющего обращение с патогенными биологическими агентами, квалификационным требованиям, предъявляемым к данной деятельности.

5. Основаниями для отказа в выдаче разрешения на обращение с патогенными биологическими агентами и приложения к нему являются:

1) непредставление либо представление недостоверных документов и сведений, необходимых для получения разрешения на обращение с патогенными биологическими агентами и приложения к нему;

2) отсутствие санитарно-эпидемиологического заключения на объект высокой эпидемической значимости;

3) отрицательное заключение комиссии по контролю за соблюдением требований в области биологической безопасности (режимной комиссии) на основании несоответствия квалификационным требованиям, предъявляемым к осуществлению обращения с патогенными биологическими агентами.

6. Основаниями для лишения разрешения на обращение с патогенными биологическими агентами и приложения к нему являются:

1) неустранение в установленный срок нарушения, явившегося основанием для приостановления действия разрешения на обращение с патогенными биологическими агентами и приложения к нему;

2) повторное выявление в течение последних двенадцати календарных месяцев нарушения, оказывающего опасное воздействие на состояние здоровья людей, животных, растения и окружающую среду, которое послужило основанием для приостановления действия разрешения на обращение с патогенными биологическими агентами и приложения к нему;

3) иные случаи, предусмотренные законами Республики Казахстан.

Лишение либо приостановление действия разрешения на обращение с патогенными биологическими агентами и приложения к нему осуществляется в соответствии с Кодексом Республики Казахстан об административных правонарушениях.

7. Основаниями для прекращения действия разрешения на обращение с патогенными биологическими агентами и приложения к нему являются:

1) лишение разрешения на обращение с патогенными биологическими агентами и приложения к нему;

2) отмена разрешительного порядка;

3) прекращение деятельности, ликвидация юридического лица;

4) добровольное обращение заявителя о прекращении действия разрешения на обращение с патогенными биологическими агентами и приложения к нему;

5) иные случаи, предусмотренные законами Республики Казахстан.

С момента прекращения действия разрешения на обращение с патогенными биологическими агентами и приложения к нему не допускается осуществление деятельности по обращению с патогенными биологическими агентами.

Сноска. Статья 21 с изменениями, внесенными Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 22. Выдача свидетельства о государственной регистрации продукции

1. Государственной регистрации продукции подлежит продукция, определяемая решениями Евразийского экономического союза, в порядке, определяемом государственным органом в сфере санитарно-эпидемиологического благополучия населения.

2. Государственная регистрация продукции проводится на основании:

1) экспертной оценки влияния на население и среду обитания;

2) санитарно-эпидемиологической экспертизы на предмет соответствия требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

3) разработки специальных мер, в том числе условий утилизации и уничтожения веществ и отдельных видов продукции, по предотвращению их вредного воздействия на население и среду обитания.

3. На основании положительных результатов санитарно-эпидемиологической экспертизы представленной документации и результатов лабораторных исследований (испытаний) продукции производится государственная регистрация продукции с выдачей свидетельства о государственной регистрации продукции в части ее соответствия техническим регламентам и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям к товарам и техническому регламенту Евразийского экономического союза.

4. В выдаче свидетельства о государственной регистрации продукции отказывается в следующих случаях:

1) несоответствия продукции техническим регламентам и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям к товарам и техническому регламенту Евразийского экономического союза;

2) представления документов и (или) сведений, содержащих недостоверную информацию;

3) отсутствия прав, предусмотренных решением Евразийского экономического союза или законодательством Республики Казахстан, на осуществление государственной регистрации, а также оснований оформления и выдачи свидетельства о государственной регистрации продукции;

4) невозможности установления требований безопасности в отношении продукции и условий ее изготовления и оборота, а также отсутствия методик определения и измерения в продукции и среде обитания опасных факторов такой продукции;

5) наличия обоснованной информации, полученной в рамках присоединения государства-члена к международным конвенциям и договорам, о случаях вредного воздействия продукции на здоровье человека и среду обитания при изготовлении, обороте и употреблении (использовании) продукции.

5. Расходы, связанные с проведением санитарно-эпидемиологической экспертизы и научного обоснования продукции, подлежащей государственной регистрации, несут заявители.

6. Помимо общих оснований, предусмотренных Кодексом Республики Казахстан об административных правонарушениях и Законом Республики Казахстан "О разрешениях и уведомлениях", действие свидетельства о государственной регистрации продукции приостанавливается с указанием срока исполнения для устранения причин несоответствия в случаях:

1) установления факта несоответствия продукции техническим регламентам и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям к товарам Евразийского экономического союза, не связанного с нарушениями условий транспортирования, хранения и реализации подконтрольной продукции;

2) принятия Евразийской экономической комиссией изменений показателей безопасности подконтрольной продукции, основанных на результатах развития современного уровня научных знаний;

3) поступления информации от уполномоченных органов государств-членов Евразийского экономического союза, осуществляющих и (или) координирующих работы по техническому регулированию, санитарным, ветеринарным и фитосанитарным мерам, международных организаций или государств, не являющихся членами Евразийского экономического союза, о выявленном несоответствии продукции техническим регламентам и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям, а также о том, что продукция представляет опасность для жизни и здоровья человека.

7. Информация о приостановлении, лишении (отзыве), возобновлении или прекращении действия свидетельства о государственной регистрации продукции в связи с его несоответствием техническим регламентам и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям к товарам Евразийского экономического союза немедленно направляется руководителям (их заместителям) уполномоченных органов государств-членов Евразийского экономического союза и вносится в Единый реестр свидетельств о государственной регистрации продукции.

8. Помимо общих оснований, предусмотренных Законом Республики Казахстан "О разрешениях и уведомлениях", свидетельство о государственной регистрации продукции подлежит переоформлению без проведения дополнительных или повторных исследований (испытаний) в следующих случаях:

1) изменения юридического адреса изготовителя продукции либо заявителя;

2) издания нового нормативного правового акта Евразийского экономического союза, устанавливающего требования к продукции, принятие которого не влечет за собой внесение изменений в показатели гигиенической безопасности, состав продукции.

9. Единый реестр свидетельств о государственной регистрации продукции подлежит размещению на интернет-ресурсе государственного органа в сфере санитарно-эпидемиологического благополучия населения.

Статья 23. Выдача регистрационного удостоверения на лекарственное средство или медицинское изделие

1. Государственной регистрации подлежат произведенные в Республике Казахстан, а также ввозимые на ее территорию лекарственные средства и медицинские изделия, включая:

1) лекарственные средства под торговыми наименованиями с указанием лекарственной формы, дозировки, фасовки с каждой производственной площадки;

2) медицинские изделия под торговыми наименованиями с каждой производственной площадки;

3) расходные материалы к медицинским изделиям, кроме специально предназначенных производителем медицинского изделия для использования с медицинскими изделиями, способными функционировать только с данными расходными материалами;

4) медицинские изделия, входящие в состав специализированного транспортного средства для оказания медицинской помощи;

5) исключен Законом РК от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

6) лекарственные средства передовой терапии, произведенные в промышленных условиях;

7) медицинские изделия для диагностики вне живого организма (in vitro).

1-1. Государственная регистрация стратегически важных лекарственных средств и медицинских изделий осуществляется в порядке, определяемом уполномоченным органом.

2. Государственной регистрации не подлежат:

1) лекарственные препараты, изготовленные в аптеках;

2) фармацевтические субстанции (активные фармацевтические субстанции), произведенные в условиях надлежащей производственной практики;

3) фармакопейное лекарственное растительное сырье, в том числе в составе сборов и потребительской упаковке;

4) медицинские изделия, изготовленные по индивидуальным заказам пациентов исключительно для личного пользования, к которым предъявляются специальные требования в соответствии с назначением, выданным медицинским работником;

5) лекарственные средства и медицинские изделия, производимые в Республике Казахстан только для экспорта;

6) выставочные образцы лекарственных средств и медицинских изделий для проведения выставок без права их дальнейшей реализации;

7) образцы лекарственных средств и медицинских изделий, поступающие для проведения доклинических (неклинических) и клинических исследований и (или) испытаний;

8) лабораторные приборы, не используемые для диагностики заболеваний;

9) комплектующие, входящие в состав медицинских изделий и не используемые в качестве самостоятельного изделия или устройства;

10) радиофармацевтические лекарственные препараты, изготовленные непосредственно в организациях здравоохранения на месте их применения;

11) образцы лекарственных средств и медицинских изделий для проведения экспертизы при государственной регистрации;

12) лекарственные средства передовой терапии, произведенные для индивидуального применения с использованием аутологичных биологических материалов пациента или его донора, подобранного непосредственного для него;

13) балк-продукты лекарственных средств или медицинских изделий.

3. Государственная регистрация, перерегистрация лекарственного средства или медицинского изделия, внесение изменений в регистрационное досье лекарственного средства или медицинского изделия осуществляются государственным органом в сфере обращения лекарственных средств и медицинских изделий в порядке, определяемом уполномоченным органом.

4. Обязательным условием государственной регистрации, перерегистрации и внесения изменений в регистрационное досье лекарственного средства или медицинского изделия является проведение экспертизы лекарственного средства или медицинского изделия, осуществляемой в порядке, определяемом уполномоченным органом.

5. В экспертную организацию представляется регистрационное досье, содержащее документы, перечень которых определяется уполномоченным органом, а также образцы лекарственного средства или медицинского изделия, стандартные образцы фармацевтических субстанций (активных фармацевтических субстанций) и их примесей в количествах, достаточных для трехкратного анализа, специфические реагенты и расходные материалы, в исключительных случаях и на условии возврата.

6. Расходы, связанные с проведением экспертизы лекарственного средства или медицинского изделия при их государственной регистрации, перерегистрации и внесении изменений в регистрационное досье, несут заявители.

7. Государственная регистрация, перерегистрация, внесение изменений в регистрационное досье лекарственного средства или медицинского изделия осуществляются на основании заявления и положительного заключения экспертной организации о безопасности, качестве и эффективности лекарственного средства или медицинского изделия, выданного по результатам проведенной экспертизы.

8. Заявление о государственной регистрации и перерегистрации, внесении изменений в регистрационное досье лекарственного средства или медицинского изделия подается разработчиком или производителем лекарственного средства или медицинского изделия, или их доверенным лицом.

За государственную регистрацию, перерегистрацию и выдачу дубликата регистрационного удостоверения лекарственного средства или медицинского изделия взимается сбор в порядке, определяемом налоговым законодательством Республики Казахстан.

9. Учет и систематизация документов, представленных заявителем при государственной регистрации, перерегистрации и внесении изменений в регистрационное досье лекарственного средства или медицинского изделия, осуществляются в порядке, определяемом уполномоченным органом.

10. По решению уполномоченного органа лекарственное средство или медицинское изделие может быть зарегистрировано по ускоренной процедуре проведения экспертизы.

Порядок ускоренной процедуры проведения экспертизы лекарственного средства или медицинского изделия определяется уполномоченным органом.

11. Заявителю отказывается в государственной регистрации и перерегистрации и внесении изменений в регистрационное досье лекарственного средства или медицинского изделия в случаях отрицательного заключения по результатам экспертизы лекарственных средств и медицинских изделий и непредставления полного пакета документов, установленных в порядке, определяемом уполномоченным органом.

12. По результатам государственной регистрации и перерегистрации лекарственного средства или медицинского изделия выдается регистрационное удостоверение по форме, установленной уполномоченным органом.

В течение срока действия регистрационного удостоверения держатель регистрационного удостоверения лекарственного средства или производитель медицинского изделия несет ответственность за безопасность, качество и эффективность зарегистрированных лекарственных средств или медицинских изделий, которые должны соответствовать регистрационному досье, представленному на экспертизу лекарственных средств или медицинских изделий для целей государственной регистрации, перерегистрации, внесения изменений в регистрационное досье лекарственного средства или медицинского изделия.

13. Решение о государственной регистрации лекарственного средства или медицинского изделия может быть отозвано в порядке, определяемом уполномоченным органом.

14. Лекарственные средства и медицинские изделия, предназначенные для обращения на таможенной территории Евразийского экономического союза, подлежат регистрации по единым правилам в соответствии с нормативными правовыми актами Евразийского экономического союза.

Для регистрации отечественных лекарственных средств за рубежом уполномоченным органом выдается сертификат на фармацевтический продукт (СРР) в порядке, определенном уполномоченным органом.

15. Государственной экспертной организацией в сфере обращения лекарственных средств и медицинских изделий и государственным органом в сфере обращения лекарственных средств и медицинских изделий не допускаются без согласия заявителя разглашение и использование в коммерческих целях предоставленной для государственной регистрации лекарственного средства конфиденциальной информации, содержащейся в заявлении о государственной регистрации, материалах экспертизы лекарственного средства, а также регистрационном досье лекарственного средства, содержащего новые химические вещества, в течение шести лет со дня государственной регистрации лекарственного средства.

16. Предусмотренные в пункте 15 настоящей статьи положения, не допускающие разглашения и использования в коммерческих целях конфиденциальной информации, не распространяются на:

1) физических или юридических лиц, которым была выдана принудительная лицензия на использование лекарственного средства в соответствии с Патентным законом Республики Казахстан;

2) использование, производство, импорт, экспорт или распространение лекарственного средства в некоммерческих целях.

17. На основании решения суда допускаются без согласия заявителя разглашение и использование информации, указанной в пункте 15 настоящей статьи, при наличии одного из следующих случаев:

1) если поставки лекарственного средства недостаточны для удовлетворения потребностей населения в течение двенадцати месяцев со дня регистрации в Республике Казахстан;

2) выявления действий, нарушающих требования законодательства Республики Казахстан в области защиты конкуренции.

Сноска. Статья 23 с изменениями, внесенными Законом РК от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 24. Уведомления в области здравоохранения

1. Следующие виды деятельности в области здравоохранения осуществляются по уведомлению:

1) гигиеническое обучение декретированных групп населения;

2) деятельность (эксплуатация) объекта незначительной эпидемической значимости;

3) проведение санитарно-эпидемиологического аудита;

4) оптовая реализация медицинских изделий;

5) розничная реализация медицинских изделий;

6) проведение неинтервенционных клинических исследований.

2. Уведомление о начале или прекращении осуществления деятельности, указанной в настоящей статье, подается в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях".

Глава 4. АККРЕДИТАЦИЯ, АТТЕСТАЦИЯ И СЕРТИФИКАЦИЯ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 25. Аккредитация в области здравоохранения

1. Аккредитации в области здравоохранения, осуществляемой государственным органом в сфере оказания медицинских услуг (помощи), подлежат:

1) субъекты здравоохранения, осуществляющие аккредитацию медицинских организаций в целях признания соответствия оказываемых медицинских услуг установленным требованиям и стандартам в области здравоохранения;

2) организации, осуществляющие оценку знаний и навыков обучающихся, выпускников профессиональной подготовленности и специалистов в области здравоохранения;

3) субъекты здравоохранения, осуществляющие независимую экспертизу в области здравоохранения;

4) юридические лица, осуществляющие подтверждение подготовленности к управленческой деятельности по сертификации менеджеров здравоохранения;

5) исключен Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

6) профессиональные медицинские ассоциации и общественные объединения, осуществляющие деятельность в области здравоохранения.

2. Аккредитации в области здравоохранения, осуществляемой субъектами здравоохранения, аккредитованными государственным органом в сфере оказания медицинских услуг (помощи), подлежат медицинские организации на основе внешней комплексной оценки на соответствие деятельности стандартам аккредитации.

3. Аккредитации в области здравоохранения, осуществляемой профессиональными ассоциациями в сфере санитарно-эпидемиологического благополучия населения, аккредитованными государственным органом в сфере санитарно-эпидемиологического благополучия населения, подлежат физические и юридические лица по проведению санитарно-эпидемиологического аудита.

4. Аккредитация в области здравоохранения осуществляется на добровольной основе.

5. Аккредитация медицинских организаций проводится за счет средств медицинской организации и является инструментом материального и нематериального стимулирования медицинских организаций.

Аккредитация медицинских организаций проводится на основе внешней комплексной оценки на соответствие стандартам аккредитации, утверждаемым уполномоченным органом, и учитывается при размещении объемов медицинских услуг на оказание гарантированного объема бесплатной медицинской помощи и (или) медицинской помощи в системе обязательного социального медицинского страхования, при выделении государственного заказа на подготовку и повышение квалификации кадров в области здравоохранения по клиническим специальностям в высших колледжах и организациях высшего и (или) послевузовского медицинского образования.

6. Аккредитация испытательных лабораторий, осуществляющих монопольную деятельность по экспертизе и оценке безопасности и качества лекарственных средств и медицинских изделий, проводится в порядке, определяемом уполномоченным органом.

7. Постаккредитационному мониторингу подлежат лица, указанные в пунктах 1, 2 и 3 настоящей статьи, прошедшие аккредитацию в области здравоохранения.

Сноска. Статья 25 с изменением, внесенным Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 26. Аттестация на профессиональную компетентность специалистов в области здравоохранения

1. Аттестацией на профессиональную компетентность специалистов в области здравоохранения является периодически осуществляемая процедура определения уровня профессиональной компетентности.

2. В целях объективного и компетентного осуществления аттестации уполномоченным органом, местными исполнительными органами, а также государственным органом в сфере санитарно-эпидемиологического благополучия населения создаются аттестационные комиссии.

3. Уполномоченный орган проводит аттестацию руководителей местных органов государственного управления здравоохранением областей, городов республиканского значения и столицы и их заместителей, руководителей организаций, подведомственных уполномоченному органу, их заместителей.

4. Местные органы государственного управления здравоохранением областей, городов республиканского значения и столицы проводят аттестацию руководителей подведомственных им организаций здравоохранения.

5. Государственным органом в сфере санитарно-эпидемиологического благополучия населения проводится аттестация руководителей организаций здравоохранения, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения.

6. Аттестуемые лица проходят аттестацию каждые три года, но не ранее одного года со дня занятия соответствующей должности.

Статья 27. Сертификация специалиста и менеджера в области здравоохранения

1. Сертификация специалиста в области здравоохранения проводится:

1) государственным органом в сфере оказания медицинских услуг (помощи) в отношении медицинских работников;

2) государственным органом в сфере обращения лекарственных средств и медицинских изделий в отношении фармацевтических работников;

3) государственным органом в сфере санитарно-эпидемиологического благополучия населения в отношении специалистов санитарно-эпидемиологической службы.

Перечень специальностей и специализаций, подлежащих сертификации специалистов в области здравоохранения, определяется уполномоченным органом.

2. Сертификат специалиста в области здравоохранения подлежит подтверждению действия каждые пять лет.

3. Лица, имеющие сертификат специалиста в области здравоохранения, при перерыве стажа работы по специальности более трех лет допускаются к работе по соответствующей специальности после повышения квалификации, стажировки и оценки профессиональной подготовленности в организации, аккредитованной уполномоченным органом.

4. Запрещается без наличия соответствующего сертификата специалиста в области здравоохранения:

1) занятие клинической практикой, за исключением врачей-резидентов, которые допускаются к клинической практике (работе с пациентами) под надзором наставника и иностранных специалистов, имеющих признанные документы об образовании;

2) занятие фармацевтической практикой;

3) осуществление деятельности в сфере санитарно-эпидемиологического благополучия населения.

5. Иностранные специалисты допускаются для осуществления профессиональной медицинской деятельности в "Назарбаев Университет" или его медицинские организации, в медицинские организации Управления делами Президента Республики Казахстан, а также с целью обучения в организации высшего и (или) послевузовского образования, национальные и научные центры, научно-исследовательские институты и высшие медицинские колледжи, реализующие образовательные учебные программы дополнительного образования и прошедшие институциональную аккредитацию в аккредитационных органах, внесенных в реестр признанных аккредитационных органов, на базе аккредитованных университетских больниц, клиник организаций образования в области здравоохранения и базе резидентуры в порядке, определяемом уполномоченным органом.

6. Правила проведения сертификации специалиста в области здравоохранения, подтверждения действия сертификата специалиста в области здравоохранения, включая иностранных специалистов, а также условия допуска к сертификации специалиста в области здравоохранения лица, получившего медицинское образование за пределами Республики Казахстан, разрабатываются и утверждаются уполномоченным органом.

7. Сертификация менеджеров в области здравоохранения проводится государственным органом в сфере оказания медицинских услуг (помощи) и действует вне зависимости от осуществления управленческой деятельности.

8. Сертификат менеджера в области здравоохранения подлежит подтверждению действия каждые пять лет.

Подтверждение сертификата менеджера в области здравоохранения проводится государственным органом в сфере оказания медицинских услуг (помощи).

9. Правила проведения сертификации менеджера в области здравоохранения, подтверждения действия сертификата менеджера в области здравоохранения разрабатываются и утверждаются уполномоченным органом.

10. Приостановление действия или лишение (отзыв) сертификата специалиста в области здравоохранения осуществляется в соответствии с законами Республики Казахстан.

Сноска. Статья 27 с изменением, внесенным Законом РК от 08.01.2021 № 410-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Глава 5. ГОСУДАРСТВЕННЫЙ КОНТРОЛЬ И НАДЗОР В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 28. Общие положения о государственном контроле и надзоре в области здравоохранения

1. Реализацией государственной политики по государственному контролю и надзору в области здравоохранения признается комплекс мер, направленных на проверку соблюдения и исполнения требований законодательства Республики Казахстан, а также на предупреждение, выявление, пресечение и устранение правонарушений в области здравоохранения.

2. Государственный контроль и надзор осуществляются в сферах:

1) оказания медицинских услуг (помощи);

2) санитарно-эпидемиологического благополучия населения;

3) обращения лекарственных средств и медицинских изделий.

Примечание ИЗПИ!
Пункт 3 предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

3. Государственный надзор в области здравоохранения осуществляется в соответствии с настоящим Кодексом и Предпринимательским кодексом Республики Казахстан.

Государственный контроль в области здравоохранения осуществляется в форме проверки и профилактического контроля.

Проверка и профилактический контроль с посещением субъекта (объекта) контроля и надзора осуществляются в соответствии с Предпринимательским кодексом Республики Казахстан.

Профилактический контроль без посещения субъекта (объекта) контроля и надзора осуществляются в соответствии с настоящим Кодексом и Предпринимательским кодексом Республики Казахстан.

Сноска. Статья 28 с изменениями, внесенными Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

Статья 29. Порядок рассмотрения жалобы апелляционной комиссией

1. Акты о результатах проверки и предписание об устранении выявленных нарушений, вынесенные должностными лицами, осуществляющими государственный контроль в сферах оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий, могут быть обжалованы в вышестоящий орган.

2. Жалоба на акт о результатах проверки и предписание об устранении выявленных нарушений подается на имя руководителя вышестоящего государственного органа.

3. Для рассмотрения жалобы на акт о результатах проверки и предписание об устранении выявленных нарушений вышестоящий государственный орган создает апелляционную комиссию, в состав которой входят представители государственных органов в сферах оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий и неправительственных организаций Республики Казахстан.

Регламенты, положения и составы апелляционных комиссий определяются соответственно государственными органами в сферах оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий.

4. Жалоба на акт о результатах проверки и предписание об устранении выявленных нарушений государственных органов в сферах оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий рассматривается апелляционной комиссией в пределах обжалуемых вопросов.

5. Жалоба на акт о результатах проверки и предписание об устранении выявленных нарушений подается в течение десяти рабочих дней после подписания акта о результатах проверки.

6. Решение апелляционной комиссии носит рекомендательный характер и выносится на имя руководителя вышестоящего государственного органа. По результатам решения апелляционной комиссии руководитель вправе принять решение о признании акта о результатах проверки, заключения профилактического контроля с посещением субъекта (объекта) контроля и надзора и предписания об устранении нарушений законности недействительными и их отмене в соответствии со статьей 156 Предпринимательского кодекса Республики Казахстан.

7. Апелляционная комиссия ежегодно проводит обобщение результатов рассмотрения жалоб на акты о результатах проверки и предписания об устранении нарушений и вырабатывает рекомендации по совершенствованию законодательства Республики Казахстан.

8. В случае неудовлетворения вышестоящим органом жалобы акт о результатах проверки и предписание об устранении нарушений законности могут быть обжалованы в суд.

9. Сведения, составляющие коммерческую и иную охраняемую законом тайну, а также конфиденциальная информация предоставляются членам апелляционных комиссий при рассмотрении жалобы на акт о результатах проверки и предписание об устранении нарушений законности в соответствии с правилами, разрабатываемыми и утверждаемыми соответственно государственными органами в сферах оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий, без получения письменного разрешения лица, подавшего жалобу.

Параграф 1. Государственный контроль в сфере оказания медицинских услуг (помощи)

Статья 30. Государственный контроль в сфере оказания медицинских услуг (помощи)

1. Государственный контроль в сфере оказания медицинских услуг (помощи) направлен на предупреждение, выявление, пресечение и устранение нарушений законодательства Республики Казахстан в области здравоохранения субъектами здравоохранения.

2. Субъектами государственного контроля в сфере оказания медицинских услуг (помощи) являются физические и юридические лица, оказывающие медицинские услуги (помощь).

Примечание ИЗПИ!
Часть первая пункта 3 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

3. Объекты государственного контроля в сфере оказания медицинских услуг (помощи) делятся на две группы:

1) объекты высокой значимости;

2) объекты незначительной значимости.

Примечание ИЗПИ!
В часть вторую пункта 3 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Перечень объектов высокой и незначительной значимости, подлежащих государственному контролю в сфере оказания медицинских услуг (помощи), утверждается государственным органом в сфере оказания медицинских услуг (помощи) по согласованию с уполномоченным органом по предпринимательству.

Примечание ИЗПИ!
Пункт 4 предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

4. В отношении объектов государственного контроля в сфере оказания медицинских услуг (помощи) контроль осуществляется в форме проверки и профилактического контроля в соответствии с Предпринимательским кодексом Республики Казахстан.

5. Исключен Законом РК от 21.05.2022 № 123-VII (вводится в действие с 01.01.2023).
Сноска. Статья 30 с изменениями, внесенными Законом РК от 21.05.2022 № 123-VII (вводится в действие с 01.01.2023).

Статья 31. Должностные лица, осуществляющие государственный контроль в сфере оказания медицинских услуг (помощи)

1. Должностными лицами, осуществляющими государственный контроль в сфере оказания медицинских услуг (помощи), являются:

1) Главный государственный медицинский инспектор Республики Казахстан и (или) его заместитель;

2) главные государственные медицинские инспекторы соответствующих административно-территориальных единиц и их заместители, определяемые руководителем государственного органа в сфере оказания медицинских услуг (помощи);

3) специалисты государственного органа в сфере оказания медицинских услуг (помощи).

2. Вышестоящий главный государственный медицинский инспектор в соответствующей сфере вправе до вынесения решения по заявлению (жалобе) физических и (или) юридических лиц на действия (бездействие) нижестоящих должностных лиц приостановить исполнение, отменить либо отозвать принимаемые ими акты.

Статья 32. Права должностных лиц при осуществлении государственного контроля в сфере оказания медицинских услуг (помощи)

1. Должностные лица, осуществляющие государственный контроль в сфере оказания медицинских услуг (помощи), помимо прав, предусмотренных пунктом 1 статьи 154 Предпринимательского кодекса Республики Казахстан, имеют право:

Примечание ИЗПИ!
В подпункт 1) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

1) привлекать независимых экспертов в области здравоохранения к осуществлению государственного контроля в сфере оказания медицинских услуг (помощи);

2) запрашивать и получать от субъекта здравоохранения необходимую информацию по вопросам оказания медицинской помощи населению;

3) делать копии документов, необходимых для проведения контроля в сфере оказания медицинских услуг (помощи), и получать соответствующие данные (электронные паспорта здоровья, электронные карты и детальные отчеты о внесенных изменениях в них) из медицинской информационной системы субъекта здравоохранения;

Примечание ИЗПИ!
В подпункт 4) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

4) инициировать создание комиссии с привлечением независимых экспертов в области здравоохранения.

2. Должностным лицам, осуществляющим государственный контроль в форме профилактического контроля, проверки и расследования, запрещается предъявлять требования и обращаться с просьбами, не относящимися к предмету профилактического контроля, проверки или расследования.

3. Для принятия решения по результатам государственного контроля в сфере оказания медицинских услуг (помощи) в зависимости от установленных нарушений законодательства Республики Казахстан в области здравоохранения должностными лицами, осуществляющими государственный контроль в сфере оказания медицинских услуг (помощи), издаются следующие акты:

1) акт о результатах проверки субъекта здравоохранения – документ, выдаваемый должностным лицом, осуществляющим государственный контроль в сфере оказания медицинских услуг (помощи), по результатам проверки, профилактического контроля субъекта (объекта) на его соответствие требованиям нормативных правовых актов в сфере оказания медицинских услуг (помощи);

2) предписание об устранении нарушений требований нормативных правовых актов в сфере оказания медицинских услуг (помощи);

3) постановления главных государственных медицинских инспекторов о:

приостановлении исполнения или об отмене либо отзыве актов, принятых нижестоящими должностными лицами;

временном отстранении от работы медицинских работников;

приостановлении деятельности или отдельных видов деятельности индивидуального предпринимателя или юридического лица в соответствии с законами Республики Казахстан.

4. Главный государственный медицинский инспектор Республики Казахстан и (или) его заместитель на основании результата проверки вправе выносить предписание руководителю местного органа государственного управления здравоохранением области, городов республиканского значения и столицы.

Сноска. Статья 32 с изменениями, внесенными Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

Статья 33. Особый порядок проведения проверок при осуществлении государственного контроля в сфере оказания медицинских услуг (помощи)

Сноска. Статью 33 исключена Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

Статья 34. Профилактический контроль в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля

Примечание ИЗПИ!
В пункт 1 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

1. Профилактический контроль в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля проводится в виде камерального контроля путем анализа и сопоставления данных из информационных систем, а также других сведений о деятельности субъекта (объекта) контроля.

2. Целями профилактического контроля без посещения субъекта (объекта) контроля являются своевременные выявление, пресечение и недопущение нарушений, предоставление субъектам (объектам) здравоохранения права самостоятельного устранения нарушений, выявленных государственным органом в сфере оказания медицинских услуг (помощи) по результатам профилактического контроля без посещения субъекта (объекта) контроля, и снижение административной нагрузки на них.

3. Профилактический контроль в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля проводится не чаще одного раза в квартал.

4. В случае выявления нарушений по результатам профилактического контроля в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля оформляется рекомендация об устранении выявленных нарушений. Форма рекомендации об устранении выявленных нарушений устанавливается государственном органом в сфере оказания медицинских услуг (помощи).

5. Рекомендация об устранении выявленных нарушений в ходе профилактического контроля в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля направляется субъекту (объекту) контроля в срок не позднее семи рабочих дней со дня выявления нарушений одним из следующих способов:

1) по почте заказным письмом с уведомлением;

2) вручается его представителю и (или) должностному лицу субъекта (объекта) контроля под роспись;

3) электронным способом в личный кабинет пользователя на веб-портале "электронного правительства".

6. Исполнением рекомендации субъектом (объектом) контроля признается надлежащее устранение выявленных нарушений, указанных в рекомендации об устранении выявленных нарушений в ходе профилактического контроля в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля, в течение тридцати рабочих дней со дня, следующего за днем ее вручения (получения).

7. Субъект (объект) контроля в случае несогласия с нарушениями, указанными в рекомендации, вправе направить в государственный орган в сфере оказания медицинских услуг (помощи) возражение в течение пяти рабочих дней со дня, следующего за днем вручения (получения) рекомендации.

8. Неисполнение в установленный срок рекомендации об устранении выявленных нарушений в ходе профилактического контроля в сфере оказания медицинских услуг (помощи) без посещения субъекта (объекта) контроля является основанием для отбора субъекта (объекта) контроля для профилактического контроля в сфере оказания медицинских услуг (помощи) с посещением субъекта (объекта) контроля.

Результаты профилактического контроля без посещения субъекта (объекта) контроля подлежат учету государственным органом в сфере оказания медицинских услуг (помощи) и его территориальными подразделениями в специальном журнале регистрации профилактического контроля без посещения субъекта (объекта) контроля, который должен быть пронумерован, прошнурован и скреплен печатью государственного органа в сфере оказания медицинских услуг (помощи) или его территориального подразделения.

Примечание ИЗПИ!
Главу 5 предусмотрено дополнить статьей 34-1 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 35. Экспертиза качества медицинских услуг (помощи)

1. Экспертиза качества медицинских услуг (помощи) – совокупность организационных, аналитических и практических мероприятий, осуществляемых для вынесения заключения по уровню качества медицинских услуг, предоставляемых физическими и юридическими лицами, с использованием индикаторов, отражающих показатель эффективности, полноты и соответствия медицинских услуг стандартам.

2. Экспертиза качества медицинских услуг (помощи) подразделяется на внутреннюю и внешнюю.

3. Для проведения внутренней экспертизы в медицинской организации создается служба поддержки пациента и внутренней экспертизы.

Службой поддержки пациента и внутренней экспертизы проводятся текущий анализ организации оказания медицинской помощи, клинической деятельности медицинской организации, выявление фактов нарушения порядка оказания медицинской помощи и стандартов, медицинского инцидента, а также рассмотрение в срок, не превышающий пяти календарных дней, обращений пациентов.

По результатам экспертизы руководителю медицинской организации вносятся предложения по устранению выявленных причин и условий снижения качества оказываемых медицинских услуг.

4. Внешняя экспертиза качества медицинских услуг (помощи) проводится:

1) государственным органом в сфере оказания медицинских услуг (помощи), в том числе с привлечением независимых экспертов в области здравоохранения;

2) фондом социального медицинского страхования в рамках мониторинга исполнения договорных обязательств по качеству и объему медицинских услуг.

В случае несогласия субъекта здравоохранения с результатами мониторинга договорных обязательств по качеству и объему медицинских услуг результаты мониторинга могут быть обжалованы в государственный орган в сфере оказания медицинских услуг (помощи);

2-1) органами местного государственного управления здравоохранением в отношении медицинских организаций, оказывающих медицинскую помощь лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы.

Примечание ИЗПИ!
В подпункт 3) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

3) независимыми экспертами в области здравоохранения при привлечении их физическими или юридическими лицами на договорной основе;

4) ведомством Управления делами Президента Республики Казахстан в отношении подведомственных организаций.

По результатам внешней экспертизы качества медицинских услуг (помощи), проведенной государственным органом в сфере оказания медицинских услуг (помощи) и фондом социального медицинского страхования, государственный орган в сфере оказания медицинских услуг (помощи) проводит анализ для выработки предложений по совершенствованию оказания медицинских услуг (помощи).

5. Порядок организации и проведения внутренней и внешней экспертиз качества медицинских услуг (помощи) устанавливается уполномоченным органом.

Сноска. Статья 35 с изменением, внесенным Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022).

Параграф 2. Государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения

Статья 36. Государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения

1. Государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения направлены на предупреждение, выявление, пресечение и устранение нарушений законодательства Республики Казахстан в области здравоохранения, в том числе нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, субъектами контроля и надзора.

2. Субъектами (объектами) государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения являются физические и юридические лица, здания, сооружения, продукция, подлежащая государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, оборудование, транспортные средства, почва, вода, воздух и иные объекты, деятельность, использование, употребление, применение и эксплуатация которых могут нанести вред состоянию здоровья человека и среде обитания.

3. Объекты государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения (эпидемически значимые объекты) делятся на две группы:

1) объекты высокой эпидемической значимости;

2) объекты незначительной эпидемической значимости.

Перечень продукции и эпидемически значимых объектов, подлежащих государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, утверждается государственным органом в сфере санитарно-эпидемиологического благополучия населения по согласованию с уполномоченным органом по предпринимательству.

4. В отношении субъектов (объектов) государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения контроль и надзор осуществляются в форме проверки, профилактического контроля, расследования и надзора в соответствии с Предпринимательским кодексом Республики Казахстан.

4-1. В отношении потенциально опасных биологических объектов, на которых осуществляется обращение с патогенными биологическими агентами I и (или) II групп патогенности, с высокой эпидемической значимостью контроль и надзор в сфере санитарно-эпидемиологического благополучия населения осуществляются с учетом особенностей, предусмотренных законодательством Республики Казахстан в области биологической безопасности.

      Примечание ИЗПИ!
      Статью 36 предусмотрено дополнить пунктами 4-2 и 4-3 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).
      5. Исключен Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).
      Сноска. Статья 36 с изменениями, внесенными законами РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования); от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

Статья 37. Должностные лица, осуществляющие государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения

1. Должностными лицами, осуществляющими государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, являются:

1) Главный государственный санитарный врач Республики Казахстан и (или) его заместитель;

2) главные государственные санитарные врачи соответствующих административно-территориальных единиц (на транспорте), их заместители, определяемые руководителем государственного органа в сфере санитарно-эпидемиологического благополучия населения;

3) специалисты государственного органа в сфере санитарно-эпидемиологического благополучия населения;

4) главные государственные санитарные врачи и их заместители, руководители и специалисты структурных подразделений Министерства обороны Республики Казахстан, органов национальной безопасности и внутренних дел, ведомства Управления делами Президента Республики Казахстан, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения.

2. Вышестоящий главный государственный санитарный врач на соответствующей территории вправе до вынесения решения по заявлению (жалобе) физических и (или) юридических лиц на действия (бездействие) нижестоящих должностных лиц приостановить исполнение, отменить либо отозвать принимаемые ими акты.

Примечание ИЗПИ!
Статья 38 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 38. Права должностных лиц при осуществлении государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения

1. Должностные лица, осуществляющие государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, помимо прав, предусмотренных пунктом 1 статьи 154 Предпринимательского кодекса Республики Казахстан и иными законами Республики Казахстан, имеют право:

1) запрещать ввоз, применение и реализацию на территории Республики Казахстан продукции, предназначенной для использования и применения населением, а также в предпринимательской и (или) иной деятельности, при:

несоответствии требованиям технических регламентов и (или) единым санитарно-эпидемиологическим и гигиеническим требованиям Евразийского экономического союза;

отсутствии свидетельства о государственной регистрации продукции;

выявлении фальсифицированной продукции;

неустановленном сроке годности и (или) хранения, истекшем сроке годности и (или) хранения;

обнаружении насекомых, грызунов и следов их пребывания в самой продукции;

создании угрозы возникновения и распространения инфекционных заболеваний или массовых неинфекционных заболеваний и отравлений, в том числе признании ее опасной для здоровья человека и среды обитания по результатам санитарно-эпидемиологической экспертизы;

2) запрещать производство продукции, предназначенной для использования, применения населением, а также в предпринимательской и (или) иной деятельности, при:

несоответствии объектов и технологии производства нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения;

отсутствии санитарно-эпидемиологического заключения на объект высокой эпидемической значимости;

отсутствии уведомления по деятельности (эксплуатации) объекта незначительной значимости;

отсутствии необходимых для соблюдения технологического процесса производства продукции производственного и технологического оборудования, аппаратуры, инвентаря;

отсутствии государственной регистрации на впервые внедряемые в производство и ранее не использовавшиеся вещества и изготовляемые на их основе материалы и препараты;

использовании запрещенных пищевых добавок, ингредиентов и сырья;

создании угрозы возникновения и распространения инфекционных заболеваний или массовых неинфекционных заболеваний и отравлений;

3) выносить постановления о временном отстранении от работы лиц, относящихся к декретированным группам населения, являющихся источником инфекционных и паразитарных заболеваний, а также своевременно не прошедших обязательные медицинские осмотры, до получения результата лабораторного исследования и заключения специалиста, подтверждающих полную санацию и прохождение обязательного медицинского осмотра;

4) устанавливать ограничительные мероприятия, в том числе карантин, на соответствующих административно-территориальных единицах (на отдельных объектах);

5) направлять лиц, являющихся потенциальными источниками распространения инфекционных и паразитарных заболеваний, а также находившихся в контакте с инфекционными больными, на медицинское обследование с отстранением их от работы до получения результатов лабораторного обследования, подтверждающего полную санацию;

6) по показаниям направлять на госпитализацию лиц, являющихся источниками инфекционных и паразитарных заболеваний;

7) требовать проведение обязательной вакцинации населения, профилактической и очаговой дезинфекции, дезинсекции и дератизации в помещениях и на транспортных средствах, территориях, в очагах инфекционных и паразитарных заболеваний;

8) приостанавливать до устранения нарушений нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, гигиенических нормативов и (или) технических регламентов отдельные виды работ, деятельность (эксплуатацию) объектов, подлежащих государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, в соответствии с законодательством Республики Казахстан об административных правонарушениях;

9) запрещать производство, применение и реализацию новых видов сырья, продукции, химических веществ, технологического оборудования, механизмов, процессов, инструментария в случае признания их опасными для жизни и здоровья людей;

10) для проведения санитарно-эпидемиологической экспертизы запрашивать материалы, необходимые для изучения оценки влияния объекта экспертизы на окружающую среду и здоровье населения, а также снимать пробы и производить отбор образцов продукции в количествах, достаточных и не превышающих необходимых объемов для ее проведения, без компенсации стоимости этой продукции, за исключением отбора, производимого в рамках мониторинга безопасности продукции;

11) предъявлять требования о приведении правовых актов, затрагивающих вопросы санитарно-эпидемиологического благополучия населения, в соответствие с нормативными правовыми актами в сфере санитарно-эпидемиологического благополучия населения;

12) осуществлять радиационный контроль в сфере санитарно-эпидемиологического благополучия населения на территории Республики Казахстан;

13) устанавливать санитарно-защитные зоны: предварительные (расчетные) для действующих объектов, установленные (окончательные) размеры, и изменять их размеры;

14) обращаться в суд при невыполнении или ненадлежащем выполнении физическими или юридическими лицами актов должностных лиц, осуществляющих государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения;

15) привлекать специалистов организаций здравоохранения к осуществлению санитарно-противоэпидемических и санитарно-профилактических мероприятий при инфекционных и паразитарных заболеваниях, отравлениях населения в соответствии с правилами привлечения специалистов, утвержденными государственным органом в сфере санитарно-эпидемиологического благополучия населения.

2. Для принятия решения по результатам государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения в зависимости от установленных нарушений нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения должностными лицами, осуществляющими государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, издаются следующие акты:

1) акт о результатах проверки – документ, выдаваемый должностным лицом, осуществляющим государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, по результатам проверки на соответствие требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

2) предписание об устранении нарушений требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

3) постановления главных государственных санитарных врачей о:

проведении санитарно-противоэпидемических и санитарно-профилактических мероприятий;

временном отстранении от работы физических лиц;

запрещении ввоза, производства, применения и реализации продукции, оказывающей вредное воздействие на здоровье человека, предназначенной для использования и применения населением, а также в предпринимательской и (или) иной деятельности;

запрещении производства, применения и реализации новых видов сырья, продукции, химических веществ, технологического оборудования, механизмов, процессов, инструментария в случае признания их опасными для жизни и здоровья людей и среды обитания;

приостановлении действия разрешительного документа в области здравоохранения;

приостановлении деятельности или отдельных видов деятельности индивидуального предпринимателя или юридического лица в соответствии с законами Республики Казахстан;

введении ограничительных мероприятий, в том числе карантина, на соответствующих административно-территориальных единицах (на отдельных объектах).

Статья 39. Социальная защита должностных лиц, осуществляющих государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения

Должностные лица государственного органа в сфере санитарно-эпидемиологического благополучия населения, осуществляющие государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, имеют право на надбавку к должностным окладам в соответствии с единой системой оплаты труда работников для всех органов, содержащихся за счет государственного бюджета, утверждаемой Правительством Республики Казахстан по согласованию с Президентом Республики Казахстан.

Статья 40. Особый порядок проведения проверок при осуществлении государственного контроля и надзора в сфере санитарно-эпидемиологического благополучия населения

Сноска. Статью 40 исключена Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

Статья 41. Государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения в виде внеплановой проверки

1. Государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения в виде внеплановой проверки осуществляются в соответствии с Предпринимательским кодексом Республики Казахстан.

2. Внеплановые проверки проводятся в отношении эпидемически значимых объектов, подлежащих государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения.

Статья 42. Профилактический контроль в сфере санитарно-эпидемиологического благополучия населения с посещением субъекта (объекта) контроля и надзора

Профилактический контроль в сфере санитарно-эпидемиологического благополучия населения с посещением субъекта (объекта) контроля и надзора осуществляется в соответствии с Предпринимательским кодексом Республики Казахстан.

      Сноска. Статья 42 с изменениями, внесенными Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).
      Примечание ИЗПИ!
      Главу 5 предусмотрено дополнить статьей 42-1 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).
      Примечание ИЗПИ!
      Статья 43 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 43. Отбор и проведение санитарно-эпидемиологической экспертизы продукции

1. Отбор и санитарно-эпидемиологическая экспертиза продукции (товаров) проводятся для выявления, предупреждения и пресечения ввоза, производства, применения и реализации продукции, не соответствующей требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, без предварительного уведомления субъекта предпринимательства.

Отбор продукции для проведения санитарно-эпидемиологической экспертизы производится должностными лицами государственного органа в сфере санитарно-эпидемиологического благополучия населения и удостоверяется документом, подтверждающим факт приобретения продукции.

Государственным органом в сфере санитарно-эпидемиологического благополучия населения при выявлении по результатам санитарно-эпидемиологической экспертизы продукции, не соответствующей требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, составляется предписание об устранении нарушений без составления протокола об административном правонарушении с обязательным разъяснением порядка их устранения, за исключением случаев выявления продукции, опасной для жизни, здоровья человека и среды его обитания, в отношении которых проводится внеплановая проверка объектов в соответствии с Предпринимательским кодексом Республики Казахстан.

2. По результатам отбора и проведения санитарно-эпидемиологической экспертизы продукции для информирования населения о возможных рисках, связанных с потреблением и реализацией несоответствующей продукции, на официальном интернет-ресурсе государственного органа в сфере санитарно-эпидемиологического благополучия населения размещается Реестр несоответствующей продукции.

Статья 44. Профилактический контроль в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора

Примечание ИЗПИ!
Пункт 1 предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

1. Профилактический контроль в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора проводится путем анализа и сопоставления данных из информационных систем, а также других сведений о деятельности субъекта (объекта) контроля и надзора.

2. Целями профилактического контроля в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора являются:

1) своевременное выявление, пресечение и недопущение нарушений, предоставление субъектам (объектам) контроля и надзора права самостоятельного устранения нарушений, выявленных государственным органом в сфере санитарно-эпидемиологического благополучия населения по результатам профилактического контроля без посещения субъекта (объекта) контроля и надзора;

2) снижение административной нагрузки на них;

3) получение достоверной информации о воздействии среды обитания на здоровье человека для принятия решений в отношении целевых показателей безопасности продукции и услуг, качества окружающей среды и инструментов регулирования производственных процессов, потенциально оказывающих воздействие на продукцию, услуги и окружающую среду;

4) оценка эффективности выполняемых мероприятий по предупреждению возникновения отравлений и вспышек инфекционных заболеваний, профессиональных заболеваний, возможность прогнозирования их возникновения;

5) обеспечение соблюдения требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

6) оперативное упреждающее реагирование на нештатные ситуации;

7) формирование более высокого уровня санитарно-гигиенической информированности и ответственности руководителей и работников;

8) информирование общественности о деятельности субъектов (объектов) по охране общественного здоровья и рисках для здоровья населения.

3. Профилактический контроль в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора проводится не чаще одного раза в квартал.

4. В случае выявления нарушений по результатам профилактического контроля в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора оформляется рекомендация об устранении выявленных нарушений, за исключением камерального контроля. Форма рекомендации об устранении выявленных нарушений устанавливается государственном органом в сфере санитарно-эпидемиологического благополучия населения.

5. Рекомендация об устранении выявленных нарушений в ходе профилактического контроля в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора направляется субъекту (объекту) контроля и надзора в срок не позднее семи рабочих дней со дня выявления нарушений одним из следующих способов:

1) по почте заказным письмом с уведомлением;

2) вручается представителю или должностному лицу субъекта (объекта) контроля и надзора под роспись;

3) электронным способом в личный кабинет пользователя на веб-портале "электронного правительства".

6. Исполнением рекомендации субъектом (объектом) контроля и надзора признается надлежащее устранение выявленных нарушений, указанных в рекомендации об устранении выявленных нарушений в ходе профилактического контроля в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора, в течение тридцати рабочих дней со дня, следующего за днем ее вручения (получения).

Примечание ИЗПИ!
Статью 44 предусмотрено дополнить пунктом 6-1 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

7. Субъект (объект) контроля в случае несогласия с нарушениями, указанными в рекомендации об устранении выявленных нарушений, вправе направить в государственный орган в сфере санитарно-эпидемиологического благополучия населения возражение в течение пяти рабочих дней со дня, следующего за днем вручения (получения) рекомендации об устранении выявленных нарушений.

Примечание ИЗПИ!
В пункт 8 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

8. Неисполнение в установленный срок рекомендации об устранении выявленных нарушений в ходе профилактического контроля в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора является основанием для отбора субъекта (объекта) контроля и надзора для профилактического контроля с посещением субъекта (объекта) контроля и надзора.

9. Результаты профилактического контроля без посещения субъекта (объекта) контроля и надзора подлежат учету государственным органом в сфере санитарно-эпидемиологического благополучия населения и его территориальными подразделениями в специальном журнале регистрации профилактического контроля без посещения субъекта (объекта) контроля и надзора, который должен быть пронумерован, прошнурован и скреплен печатью государственного органа в сфере санитарно-эпидемиологического благополучия населения или его территориального подразделения.

      Примечание ИЗПИ!
      Статью 44 предусмотрено дополнить пунктом 10 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).
      Сноска. Статья 44 - в редакции Закона РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).
      Примечание ИЗПИ!
      Статья 45 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 45. Виды профилактического контроля в сфере санитарно-эпидемиологического благополучия населения без посещения субъекта (объекта) контроля и надзора

Сноска. Заголовок статьи 45 с изменением, внесенным Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

1. Камеральный контроль осуществляется на основе изучения и анализа сведений об участниках внешней экономической деятельности, о заявителях, обратившихся за проведением испытания, подтверждением соответствия продукции или регистрацией декларации о соответствии продукции, за признанием результатов подтверждения соответствия, о результатах испытаний, а также содержащихся в иных документах, представленных в качестве доказательств соответствия продукции, представляемых в государственный орган в сфере санитарно-эпидемиологического благополучия населения таможенными органами, уполномоченным органом в области технического регулирования.

Объектами камерального контроля являются участники внешней экономической деятельности, органы по подтверждению соответствия, испытательные лаборатории (центры), субъекты частного предпринимательства, декларирующие соответствие продукции требованиям законодательства Республики Казахстан.

Перечень сведений, необходимых для осуществления камерального контроля, а также порядок их представления таможенными органами, уполномоченным органом в области технического регулирования, органами по подтверждению соответствия и испытательными лабораториями (центрами) определяются государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Сведения об участниках внешней экономической деятельности, ввозимой ими продукции и документах по подтверждению соответствия ввозимой продукции представляются таможенными органами.

Сведения о заявителях, обратившихся за проведением испытания, подтверждением соответствия продукции или регистрацией декларации о соответствии продукции, за признанием результатов подтверждения соответствия, о результатах испытаний, а также содержащиеся в иных документах, представленных в качестве доказательств соответствия продукции, представляются уполномоченным органом в области технического регулирования, органами по подтверждению соответствия и испытательными лабораториями (центрами).

Государственный орган в сфере санитарно-эпидемиологического благополучия населения по результатам камерального контроля при выявлении нарушения требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, гигиенических нормативов и (или) технических регламентов, в том числе на основе анализа сопоставления сведений между ввезенной продукцией и выданными, зарегистрированными, признанными документами по подтверждению соответствия на ввезенную продукцию, в отношении субъектов камерального контроля принимает следующие меры в адрес:

1) участников внешней экономической деятельности и субъектов частного предпринимательства, декларирующих соответствие продукции требованиям законодательства Республики Казахстан, занимающихся ввозом и (или) реализацией продукции на территорию Республики Казахстан, направляется предписание об устранении нарушения требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения с обязательным разъяснением порядка его устранения;

2) уполномоченного органа в области технического регулирования направляется информация с указанием на факты нарушения требований законодательства Республики Казахстан в области технического регулирования.

2. Мониторинг результатов санитарно-эпидемиологического аудита проводится за:

1) предоставленной информацией о проведенном санитарно-эпидемиологическом аудите;

2) представленными аудиторскими заключениями о соответствии объекта нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения.

В рамках мониторинга результатов санитарно-эпидемиологического аудита проводится анализ полноты заполнения аудиторского заключения о соответствии объекта нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения.

Мониторинг результатов санитарно-эпидемиологического аудита проводится один раз в полугодие.

3. Мониторинг результатов производственного контроля основывается на передаваемых сведениях о результатах проведенного производственного контроля на эпидемически значимых объектах и по итогам проверок, профилактического контроля с посещением.

Субъект (объект) ведет внутренний учет, формирует и представляет периодические отчеты по результатам производственного контроля в соответствии с нормативными правовыми актами в сфере санитарно-эпидемиологического благополучия населения.

Мониторинг результатов производственного контроля проводится один раз в полугодие.

4. Мониторинг уведомлений проводится на основании анализа поступивших уведомлений от физических и юридических лиц, уведомивших о начале и прекращении деятельности в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях", а также поступивших обращений физических или юридических лиц, результатов проверок и профилактического контроля.

Мониторинг уведомлений проводится не реже одного раза в полугодие.

5. Санитарно-эпидемиологический мониторинг является государственной системой наблюдения за состоянием здоровья населения и средой обитания, их анализа, оценки и прогноза, а также определения причинно-следственных связей между состоянием здоровья населения и воздействием факторов среды обитания.

Анализ, оценка и прогноз – обоснованная оценка вероятности проникновения и распространения возбудителей или переносчиков инфекционных и паразитарных заболеваний, а также негативного воздействия факторов окружающей среды на состояние здоровья населения и связанных с этим потенциальных медико-биологических и экономических последствий.

Отбор проб в объектах внешней среды (вода, почва, атмосферный воздух) в рамках санитарно-эпидемиологического мониторинга проводится не реже одного раза в квартал.

      Сноска. Статья 45 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие с 01.01.2023).
      Примечание ИЗПИ!
      Главу 5 предусмотрено дополнить статьей 45-1 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 46. Санитарно-эпидемиологическая экспертиза

1. Санитарно-эпидемиологическая экспертиза – комплекс органолептических, санитарно-гигиенических, микробиологических, вирусологических, паразитологических, санитарно-химических, иммунобиологических, молекулярно-генетических, токсикологических, радиологических, радиометрических, дозиметрических замеров, замеров электромагнитных полей и физических факторов, других исследований и испытаний, а также экспертиза проектов в целях оценки соответствия проектов, продукции, объектов предпринимательской и (или) иной деятельности нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения.

2. Санитарно-эпидемиологическая экспертиза проводится государственными органами и организациями санитарно-эпидемиологической службы в пределах компетенции по постановлениям или предписаниям должностных лиц санитарно-эпидемиологической службы, таможенных органов и заявлениям физических или юридических лиц, за исключением санитарно-эпидемиологической экспертизы проектов.

Санитарно-эпидемиологическая экспертиза проводится для определения возможности проведения утилизации пищевой продукции с истекшим сроком годности, находящейся на хранении в государственном материальном резерве.

Санитарно-эпидемиологическая экспертиза проектов – часть экспертизы проектов, проводимая в составе комплексной вневедомственной экспертизы проектов (технико-экономических обоснований и проектно-сметной документации), предназначенных для строительства новых или реконструкции (расширения, технического перевооружения, модернизации) и капитального ремонта существующих объектов, комплексной градостроительной экспертизы градостроительных проектов.

Санитарно-эпидемиологическая экспертиза проектов строительства эпидемически значимых объектов, а также градостроительных проектов осуществляется экспертами, аттестованными в порядке, установленном законодательством Республики Казахстан об архитектурной, градостроительной и строительной деятельности.

Санитарно-эпидемиологическая экспертиза в части санитарно-эпидемиологических лабораторных исследований проводится государственными организациями в сфере санитарно-эпидемиологического благополучия населения.

Примечание ИЗПИ!
Статью 46 предусмотрено дополнить пунктом 2-1 в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

3. Санитарно-эпидемиологическая экспертиза проектов строительства проводится по:

1) проектам (технико-экономическим обоснованиям и проектно-сметной документации с установлением размера расчетной (предварительной) санитарно-защитной зоны), предназначенным для строительства эпидемически значимых объектов, государственными или аккредитованными экспертными организациями в составе комплексной вневедомственной экспертизы;

2) градостроительным проектам, подлежащим утверждению Правительством Республики Казахстан или местными представительными органами областей, городов республиканского значения и столицы.

4. Санитарно-эпидемиологическая экспертиза по проектам, не предусмотренным пунктом 3 настоящей статьи, проводится государственными органами в сфере санитарно-эпидемиологического благополучия населения, структурными подразделениями иных государственных органов, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения, на:

1) объекты промышленного и гражданского назначения;

3) продукцию, подлежащую государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, в том числе согласование сроков годности и условий хранения пищевой продукции;

4) материалы по химической, биологической, токсикологической, радиологической нагрузке на почву, водоемы и атмосферный воздух.

Статья 47. Порядок проведения санитарно-эпидемиологических лабораторных исследований

1. Санитарно-эпидемиологические лабораторные исследования являются частью санитарно-эпидемиологической экспертизы, связанной с проведением органолептических, санитарно-гигиенических, микробиологических, вирусологических, паразитологических, санитарно-химических, иммунобиологических, молекулярно-генетических, токсикологических, радиологических, радиометрических, дозиметрических замеров, замеров электромагнитных полей и физических факторов, других исследований и испытаний.

Перечень и объемы (количество) санитарно-эпидемиологических лабораторных исследований устанавливаются государственным органом в сфере санитарно-эпидемиологического благополучия населения.

2. Санитарно-эпидемиологические лабораторные исследования пищевой продукции, подлежащей государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, не проводятся в случае установления:

1) истекшего срока годности;

2) явных признаков недоброкачественности (порча, разложение, загрязнение).

3. Химические и биологические вещества, признанные по результатам санитарно-эпидемиологической экспертизы и научной экспертизы опасными для здоровья человека или будущих поколений, запрещаются к применению в Республике Казахстан.

Реестр опасных химических, биологических веществ, запрещенных к применению в Республике Казахстан, подлежит опубликованию на официальном интернет-ресурсе государственного органа в сфере санитарно-эпидемиологического благополучия населения.

4. Для проведения санитарно-эпидемиологической экспертизы по заявлениям физических или юридических лиц ими обеспечивается финансирование и представляется необходимая документация.

Статья 48. Санитарно-эпидемиологический аудит

1. Санитарно-эпидемиологический аудит проводится аудитором, включенным в государственный электронный реестр разрешений и уведомлений.

2. Санитарно-эпидемиологический аудит проводится по обращениям владельцев объектов, подлежащих государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, на основании договора на проведение санитарно-эпидемиологического аудита, заключенного между заявителем и аудитором в соответствии с Гражданским кодексом Республики Казахстан.

3. Аудиторы обязаны ежегодно к десятому января после отчетного года предоставлять в государственный орган в сфере санитарно-эпидемиологического благополучия населения информацию о проведенном аудите по форме, утвержденной государственным органом в сфере санитарно-эпидемиологического благополучия населения.

4. Результаты санитарно-эпидемиологического аудита отражаются в аудиторском заключении с выводами о соответствии или несоответствии объекта.

5. Аудиторское заключение с выводами о соответствии объекта требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения представляется аудитором в территориальное подразделение государственного органа в сфере санитарно-эпидемиологического благополучия населения не позднее пяти рабочих дней с момента завершения аудита.

6. Результаты санитарно-эпидемиологического аудита не могут быть основанием для освобождения объектов высокой эпидемиологической значимости от проверок.

Статья 49. Требования к аудиторам, осуществляющим деятельность по проведению санитарно-эпидемиологического аудита

1. Для проведения санитарно-эпидемиологического аудита физические и юридические лица должны соответствовать следующим квалификационным требованиям:

1) для физических лиц:

наличие высшего медицинского образования санитарно-эпидемиологического профиля;

стаж работы по соответствующей специальности не менее десяти лет;

наличие аккредитации на осуществление деятельности по проведению санитарно-эпидемиологического аудита;

2) для юридических лиц – наличие в штате квалифицированного персонала, соответствующего требованиям, установленным подпунктом 1) настоящего пункта.

2. Физические и юридические лица до начала и после прекращения деятельности по проведению санитарно-эпидемиологического аудита обязаны уведомить об этом государственный орган в сфере санитарно-эпидемиологического благополучия населения в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях".

3. Аудиторы, осуществляющие деятельность по проведению санитарно-эпидемиологического аудита, обязаны:

1) обеспечить комплексное, объективное, качественное проведение аудита;

2) соблюдать требования нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, иных нормативных правовых актов;

3) проводить аудит в сфере санитарно-эпидемиологического благополучия населения на основе документов государственного нормирования.

4. Запрещается проведение аудитором санитарно-эпидемиологического аудита, исполнители которого:

1) состоят в трудовых отношениях или являются близкими родственниками или свойственниками должностных лиц аудируемого субъекта, а также акционера (участника), владеющего десятью и более процентами акций (долями участия в уставном капитале) аудируемого субъекта;

2) связаны личными имущественными интересами с аудируемым субъектом;

3) уволены из государственных органов и организаций санитарно-эпидемиологического надзора за совершение коррупционных правонарушений.

5. Аудиторы несут ответственность в соответствии с законами Республики Казахстан за некачественное и ненадлежащее исполнение своих обязанностей и выданное ими аудиторское заключение о соответствии объекта нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения.

Статья 50. Процедура санитарно-эпидемиологического аудита

1. Процедура санитарно-эпидемиологического аудита включает:

1) регистрацию заявления о проведении санитарно-эпидемиологического аудита;

2) предварительный анализ представленных заявителем документов;

3) заключение договора на проведение санитарно-эпидемиологического аудита;

4) установление целей санитарно-эпидемиологического аудита;

5) составление плана проведения санитарно-эпидемиологического аудита;

6) проведение санитарно-эпидемиологического аудита (проверка объекта, аналитическая обработка материалов, проведение сравнительного анализа и оценки степени опасности на общественное здоровье планируемой либо осуществляемой деятельности, достаточности и достоверности обоснований реализации объекта);

7) составление и представление аудиторского заключения заявителю.

2. Для проведения санитарно-эпидемиологического аудита заявителем обеспечивается финансирование и представляются следующие документы:

1) заявление на проведение санитарно-эпидемиологического аудита;

2) материалы, касающиеся объекта, подлежащего санитарно-эпидемиологическому аудиту:

акты обследований государственных органов в сфере санитарно-эпидемиологического благополучия населения за последний год (при их отсутствии – за последние);

санитарно-эпидемиологическое заключение о соответствии объекта требованиям нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения или уведомление о начале деятельности;

3) предыдущие заключения санитарно-эпидемиологического аудита, при наличии, и документация по системе менеджмента хозяйствующего субъекта;

4) иные материалы, необходимые для оценки объекта.

3. По результатам проведенного в соответствии с планом санитарно-эпидемиологического аудита составляется аудиторское заключение о соответствии объекта санитарным правилам по форме, установленной порядком проведения санитарно-эпидемиологического аудита.

4. Порядок проведения санитарно-эпидемиологического аудита определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

5. Результаты санитарно-эпидемиологического аудита признаются недействительными в случае, когда при подготовке аудиторского отчета были допущены случаи:

1) нарушения процедуры проведения санитарно-эпидемиологического аудита;

2) невыполнения требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения.

Статья 51. Производственный контроль

1. Индивидуальные предприниматели и юридические лица, осуществляющие деятельность на объектах, подлежащих контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, разрабатывают, документально оформляют, внедряют и поддерживают в рабочем состоянии эффективную систему производственного контроля.

2. Обеспечение производственного контроля возлагается на индивидуального предпринимателя или руководителя юридического лица.

3. Обеспечение своевременности, полноты и достоверности осуществляемого производственного контроля возлагается на лиц, назначаемых индивидуальным предпринимателем или юридическим лицом.

4. Целью производственного контроля является обеспечение безопасности и (или) безвредности для человека продукции, работ и услуг путем организации и проведения на объекте самоконтроля за соблюдением требований нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения.

5. Производственный контроль включает в себя:

1) разработку программы производственного контроля;

2) осуществление (организацию) лабораторных исследований и замеров в соответствии с требованиями нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

3) контроль за своевременностью и полнотой прохождения медицинских осмотров;

4) контроль за наличием документов, подтверждающих безопасность и соответствие продукции;

5) оценку факторов риска, анализ выявленных опасностей, критериев безопасности и (или) безвредности факторов производственной и окружающей среды и определение методов контроля безопасности процессов;

6) ведение учета и отчетности документации, связанной с осуществлением производственного контроля;

7) разработку схемы информирования населения, местных исполнительных органов, государственного органа в сфере санитарно-эпидемиологического благополучия населения об аварийных ситуациях, остановках производства, нарушениях технологических процессов, о связанных с деятельностью объекта массовых (три и более случаев) инфекционных и паразитарных, профессиональных заболеваниях и отравлениях, создающих угрозу санитарно-эпидемиологическому благополучию населения;

8) контроль за выполнением мероприятий, предусмотренных программой производственного контроля.

6. Разработка программы производственного контроля осуществляется индивидуальным предпринимателем, юридическим лицом самостоятельно или с привлечением лиц, осуществляющих санитарно-эпидемиологический аудит.

7. Программа производственного контроля подлежит пересмотру при внедрении новой технологии, внесении изменений в технологический процесс, рецептуру пищевого продукта, других изменениях, влияющих на стабильность санитарно-эпидемиологической ситуации и (или) создающих угрозу санитарно-эпидемиологическому благополучию населения.

8. Требования к осуществлению производственного контроля устанавливаются в санитарных правилах, утверждаемых государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Параграф 3. Государственный контроль в сфере обращения лекарственных средств и медицинских изделий

Статья 52. Государственный контроль в сфере обращения лекарственных средств и медицинских изделий

1. Государственный контроль в сфере обращения лекарственных средств и медицинских изделий направлен на предупреждение, выявление, пресечение и устранение нарушений законодательства Республики Казахстан в области здравоохранения и нормативных правовых актов в сфере обращения лекарственных средств и медицинских изделий субъектами контроля.

2. Государственному контролю подлежат субъекты здравоохранения, осуществляющие реализацию лекарственных средств и медицинских изделий, осуществляющие фармацевтическую деятельность, а также юридические лица, осуществляющие контроль качества исходных материалов, лекарственных средств и медицинских изделий, государственная экспертная организация в сфере обращения лекарственных средств и медицинских изделий.

3. Государственный контроль в сфере обращения лекарственных средств и медицинских изделий осуществляется в форме:

1) проведения проверок в соответствии с Предпринимательским кодексом Республики Казахстан;

2) проведения профилактического контроля с посещением субъекта контроля в соответствии с Предпринимательским кодексом Республики Казахстан;

3) проведения профилактического контроля без посещения субъекта (объекта) в соответствии с настоящим Кодексом.

4) проверок, проводимых на соответствие квалификационным или разрешительным требованиям по выданным разрешениям, требованиям по направленным уведомлениям в соответствии с Законом Республики Казахстан "О разрешениях и уведомлениях";

5) расследования.

Сноска. Статья 52 с изменениями, внесенными Законом РК от 21.05.2022 № 123-VII (вводится в действие с 01.01.2023).

Статья 53. Должностные лица, осуществляющие государственный контроль в сфере обращения лекарственных средств и медицинских изделий

1. Должностными лицами, осуществляющими государственный контроль в сфере обращения лекарственных средств и медицинских изделий, являются:

1) Главный государственный фармацевтический инспектор Республики Казахстан и (или) его заместитель;

2) государственные фармацевтические инспекторы структурных подразделений государственного органа в сфере обращения лекарственных средств и медицинских изделий;

3) главные государственные фармацевтические инспекторы на соответствующих территориях, определяемые руководителем государственного органа в сфере обращения лекарственных средств и медицинских изделий;

4) государственные фармацевтические инспекторы территориальных подразделений государственного органа в сфере обращения лекарственных средств и медицинских изделий.

2. Вышестоящий главный государственный фармацевтический инспектор в соответствующей сфере вправе до вынесения решения по заявлению (жалобе) физических и (или) юридических лиц на действия (бездействие) нижестоящих должностных лиц приостановить исполнение, отменить либо отозвать принимаемые ими акты.

Статья 54. Права должностных лиц при осуществлении государственного контроля в сфере обращения лекарственных средств и медицинских изделий

1. Должностные лица, осуществляющие государственный контроль в сфере обращения лекарственных средств и медицинских изделий, помимо прав, предусмотренных пунктом 1 статьи 154 Предпринимательского кодекса Республики Казахстан, имеют право:

1) осуществлять отбор образцов лекарственных средств и медицинских изделий для проведения экспертизы;

2) осуществлять изъятие из обращения лекарственных средств и медицинских изделий в соответствии с законодательством Республики Казахстан;

3) запрещать и (или) приостанавливать ввоз, производство, изготовление, хранение, применение и реализацию на территории Республики Казахстан лекарственных средств и медицинских изделий, пришедших в негодность, с истекшим сроком годности, фальсифицированных, контрафактных лекарственных средств и медицинских изделий и других не соответствующих требованиям законодательства Республики Казахстан в области здравоохранения;

4) посещать объекты в сфере обращения лекарственных средств и медицинских изделий на предмет соблюдения требований законодательства Республики Казахстан;

5) получать от субъектов в сфере обращения лекарственных средств и медицинских изделий информацию, ведомственную отчетность по вопросам обращения лекарственных средств и медицинских изделий.

2. Для принятия решения по результатам государственного контроля сфере обращения лекарственных средств и медицинских изделий в зависимости от установленных нарушений нормативных правовых актов в сфере обращения лекарственных средств и медицинских изделий должностными лицами, осуществляющими государственный контроль в сфере обращения лекарственных средств и медицинских изделий, издаются следующие акты:

1) акт о результатах проверки – документ, выдаваемый должностным лицом, осуществляющим государственный контроль в сфере обращения лекарственных средств и медицинских изделий, по результатам проверки, профилактического контроля субъекта (объекта) на его соответствие требованиям нормативных правовых актов в сфере обращения лекарственных средств и медицинских изделий;

2) предписание об устранении нарушений требований нормативных правовых актов в сфере обращения лекарственных средств и медицинских изделий;

3) постановления главных государственных фармацевтических инспекторов о:

запрещении ввоза, производства, применения и реализации лекарственных средств и медицинских изделий при несоответствии требованиям нормативных правовых актов в сфере обращения лекарственных средств и (или) требованиям Евразийского экономического союза, создающих угрозу жизни и (или) здоровью человека;

приостановлении действия лицензии и (или) приложения к лицензии на фармацевтическую деятельность и (или) иного разрешительного документа в области здравоохранения в соответствии с законами Республики Казахстан;

приостановлении исполнения или об отмене либо отзыве актов, принятых нижестоящими должностными лицами.

3. Должностным лицам, осуществляющим государственный контроль в форме профилактического контроля, проверки и расследования, запрещается предъявлять требования и обращаться с просьбами, не относящимися к предмету профилактического контроля, проверки или расследования.

Сноска. Статья 54 с изменениями, внесенными Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.01.2023).

Статья 55. Профилактический контроль в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля

1. Профилактический контроль в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля проводится путем анализа и сопоставления данных информационных систем, а также других сведений о деятельности субъекта (объекта) контроля.

2. Целями профилактического контроля без посещения субъекта (объекта) контроля являются своевременные выявление, пресечение и недопущение нарушений, предоставление субъектам (объектам) контроля права самостоятельного устранения нарушений, выявленных государственным органом в сфере обращения лекарственных средств и медицинских изделий по результатам профилактического контроля без посещения субъекта (объекта) контроля, и снижение административной нагрузки на них.

3. Профилактический контроль в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля проводится не чаще одного раза в квартал.

4. В случае выявления нарушений по результатам профилактического контроля в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля оформляется рекомендация об устранении выявленных нарушений. Форма рекомендации об устранении выявленных нарушений устанавливается государственным органом в сфере обращения лекарственных средств и медицинских изделий.

5. Рекомендация об устранении выявленных нарушений в ходе профилактического контроля в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля направляется субъекту (объекту) контроля в срок не позднее семи рабочих дней со дня выявления нарушений одним из следующих способов:

1) по почте заказным письмом с уведомлением;

2) вручается его представителю и (или) должностному лицу субъекта (объекта) контроля под роспись;

3) электронным способом в личный кабинет пользователя на веб-портале "электронного правительства".

6. Исполнением рекомендации субъектом (объектом) контроля признается надлежащее устранение выявленных нарушений, указанных в рекомендации об устранении выявленных нарушений в ходе профилактического контроля в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля, в течение тридцати рабочих дней со дня, следующего за днем ее вручения (получения).

7. Субъект (объект) контроля в случае несогласия с нарушениями, указанными в рекомендации, вправе направить в государственный орган в сфере обращения лекарственных средств и медицинских изделий возражение в течение пяти рабочих дней со дня, следующего за днем вручения (получения) рекомендации.

8. Неисполнение в установленный срок рекомендации об устранении выявленных нарушений в ходе профилактического контроля в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля является основанием для отбора субъекта (объекта) контроля для профилактического контроля в сфере обращения лекарственных средств и медицинских изделий с посещением субъекта (объекта) контроля.

9. Результаты профилактического контроля без посещения субъекта (объекта) контроля подлежат учету государственным органом в сфере обращения лекарственных средств и медицинских изделий и его территориальными подразделениями в специальном журнале регистрации профилактического контроля без посещения субъекта (объекта) контроля, который должен быть пронумерован, прошнурован и скреплен печатью государственного органа в сфере обращения лекарственных средств и медицинских изделий или его территориального подразделения.

10. Профилактический контроль в сфере обращения лекарственных средств и медицинских изделий без посещения субъекта (объекта) контроля проводится по отношению:

1) лекарственных средств и медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи и (или) обязательного социального медицинского страхования, также лекарственных средств, подлежащих к сооплате;

2) всех лекарственных средств.

Глава 6. РЕКЛАМА В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 56. Реклама в области здравоохранения

1. Реклама лекарственных средств и медицинских изделий осуществляется в порядке, определяемом государственным органом в сфере обращения лекарственных средств и медицинских изделий.

Примечание ИЗПИ!
Часть вторая пункта 1 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Реклама биологически активных добавок к пище осуществляется в порядке, определяемом государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Реклама медицинских услуг (помощи) осуществляется в порядке, определяемом государственным органом в сфере оказания медицинских услуг (помощи).

Примечание ИЗПИ!
В пункт 2 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

2. Реклама медицинских услуг, методов и средств профилактики, диагностики, лечения и медицинской реабилитации (далее в целях настоящей статьи – услуги), лекарственных средств и медицинских изделий, биологически активных добавок к пище должна быть достоверной, распознаваемой без специальных знаний или применения специальных средств, исключать сравнения с другими услугами, лекарственными средствами и медицинскими изделиями, биологически активными добавками к пище, не вводить потребителей в заблуждение посредством злоупотребления их доверием, в том числе в отношении характеристик, состава, потребительских свойств, стоимости (цены), предполагаемых результатов применения, результатов исследований и испытаний.

3. Запрещается:

1) реклама лекарственных средств и медицинских изделий, биологически активных добавок к пище, средств профилактики, не зарегистрированных в Республике Казахстан;

2) реклама лекарственных средств рецептурного отпуска в средствах массовой информации;

3) распространение в целях рекламы образцов лекарственных препаратов, отпускаемых по рецепту врача;

4) использование детей, их изображения и голоса в рекламе лекарственных средств и медицинских изделий, кроме лекарственных средств и медицинских изделий для детей;

Примечание ИЗПИ!
В подпункт 5) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

5) распространение и размещение рекламы лекарственных средств и медицинских изделий, биологически активных добавок к пище в общественном транспорте, организациях, не имеющих отношения к их назначению, использованию и отпуску, за исключением рекламы лекарственных средств на медицинских, фармацевтических конференциях, конгрессах, симпозиумах и других научных совещаниях;

6) размещение рекламной информации на промышленной продукции, рецептурных бланках;

7) размещение наружной (визуальной) рекламы лекарственных средств и медицинских изделий;

8) использование медицинских работников, уполномоченных назначать лекарственные средства и медицинские изделия, в качестве распространителей рекламы, за исключением случаев предоставления достоверной информации о лекарственных средствах и медицинских изделиях с научной или образовательной целью, а также с целью информирования пациентов;

9) реклама услуг при отсутствии лицензии на осуществление соответствующего вида деятельности;

10) реклама услуг, оказываемых лицами, не имеющими сертификата специалиста в области здравоохранения, в том числе иностранными специалистами;

11) указание в рекламе для населения способов лечения следующих заболеваний: заболеваний, передающихся половым путем, онкологических, психических, поведенческих расстройств (заболеваний), опасных инфекционных заболеваний, ВИЧ-инфекции, туберкулеза, сахарного диабета;

12) ссылаться в рекламе на рекомендации ученых, специалистов здравоохранения, а также должностных лиц государственных органов, которые могут поощрять применение и (или) назначение лекарственных средств и медицинских изделий;

Примечание ИЗПИ!
В подпункт 13) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

13) представлять в рекламе услуги, лекарственные средства и медицинские изделия, биологически активные добавки к пище как уникальные, наиболее безопасные и эффективные;

14) утверждать, что безопасность и эффективность лекарственного препарата обусловлены его природным происхождением;

15) вызывать предположения, что эффективность предоставляемой услуги, лечения рекламируемым лекарственным препаратом, биологически активной добавкой к пище является гарантированной, применение средства не сопровождается развитием побочных эффектов;

16) приводить в рекламе информацию, не имеющую непосредственного отношения к рекламируемой услуге, лекарственному средству и медицинскому изделию;

17) реклама предложений о совершении сделок в отношении органов (части органа) и (или) тканей (части ткани) человека.

4. Распространение и размещение рекламы услуг, лекарственных средств и медицинских изделий допускаются в средствах массовой информации, электронных информационных ресурсах в организациях здравоохранения.

5. Реклама лекарственных средств должна содержать полные (включая соответствующие ограничения для использования лекарственного средства) и достоверные сведения, исключение которых может повлечь за собой нецелесообразное использование лекарственных средств или неоправданный риск для потребителя.

6. Контроль за производством, распространением и размещением рекламы осуществляется государственными органами в пределах их компетенции.

Глава 7. ЦИФРОВОЕ ЗДРАВООХРАНЕНИЕ

Статья 57. Основополагающие принципы цифрового здравоохранения

Принципами цифрового здравоохранения являются:

1) реализация принципов здравоохранения посредством цифровизации данных и процессов в отрасли;

2) главенство стандартов, являющихся инструментом реализации политики и стратегии, основой методологии, определяемой уполномоченным органом;

3) обеспечение защиты объектов информатизации здравоохранения, содержащих персональные медицинские данные физических лиц, сохранности и конфиденциальности персональных медицинских данных физических лиц, а также доступа пациента к своим персональным данным;

4) поддержка обеспечения доступности, объективности, непрерывности оказания медицинской помощи;

5) поддержка повышения эффективности системы здравоохранения;

6) поддержка повышения качества медицинских услуг.

Сноска. Статья 57 с изменениями, внесенными Законом РК от 02.01.2021 № 399-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 58. Основные понятия, используемые в настоящей главе

В настоящей главе используются следующие основные понятия:

1) цифровизация здравоохранения – использование цифровых технологий для трансформации медицинских и административно-управленческих процессов здравоохранения, направленное на повышение доступности, эффективности, качества и безопасности медицинской помощи;

2) персональные медицинские данные – персональные данные, содержащие сведения о здоровье физического лица и оказанных ему медицинских услугах, зафиксированные на электронных, бумажных или иных материальных носителях;

3) агрегатор персональных медицинских данных – оператор персональных данных, осуществляющий сбор, обработку, хранение, защиту и предоставление персональных медицинских данных в соответствии с правилами, утвержденными уполномоченным органом;

4) владелец персональных медицинских данных – субъект персональных медицинских данных (физическое лицо), в отношении которого эти данные сформированы;

5) национальная телемедицинская сеть Республики Казахстан – сеть стационарных и мобильных телемедицинских центров организаций здравоохранения, находящихся в ведении уполномоченного органа, объединенных защищенной телекоммуникационной инфраструктурой и оснащенных аппаратно-программными комплексами;

6) дистанционные медицинские услуги – предоставление медицинских услуг в целях диагностики, лечения, медицинской реабилитации и профилактики заболеваний и травм, проведения исследований и оценок посредством цифровых технологий, обеспечивающее дистанционное взаимодействие медицинских работников между собой, с физическими лицами и (или) их законными представителями, идентификацию указанных лиц, а также документирование совершаемых ими действий;

7) медицинская информационная система – информационная система, обеспечивающая ведение процессов субъектов здравоохранения в электронном формате;

8) мобильное здравоохранение – использование мобильных устройств, включающих мобильные телефоны, карманные персональные компьютеры, медицинские приборы и другие устройства, для целей здравоохранения;

9) носимые медицинские устройства – мобильные (носимые) устройства, предназначенные для сбора и передачи показателей состояния здоровья физического лица;

10) телездравоохранение – дистанционные медицинские услуги, включающие постановку клинического диагноза и мониторинг состояния физического лица на расстоянии, а также другие неклинические функции, такие как профилактика заболеваний, укрепление здоровья, поддержка общественного здравоохранения, медико-санитарное просвещение и научные медицинские исследования;

11) телемедицинская сеть – сеть стационарных и мобильных телемедицинских центров, оснащенных медицинским оборудованием и объединенных посредством информационно-коммуникационных технологий в единое информационное пространство для предоставления дистанционных медицинских услуг, обучения и обмена медицинской информацией в электронном формате;

12) Национальный электронный паспорт здоровья – электронный информационный ресурс уполномоченного органа, содержащий электронные паспорта здоровья, доступный как физическому лицу, так и работникам здравоохранения в соответствии с правилами, утвержденными уполномоченным органом;

13) объект цифрового здравоохранения – электронные информационные ресурсы, программное обеспечение, технологии мобильного здравоохранения, информационная и коммуникационная инфраструктура здравоохранения;

14) владелец объекта цифрового здравоохранения – субъект цифрового здравоохранения, обладающий правами владения и пользования объектами информатизации;

15) субъект цифрового здравоохранения – физические и юридические лица, государственные органы, осуществляющие деятельность или вступающие в общественные отношения в области цифрового здравоохранения;

16) электронный паспорт здоровья – набор структурированных персональных медицинских данных о состоянии здоровья физического лица и оказываемой ему медицинской помощи, формируемых субъектами цифрового здравоохранения из электронных источников на протяжении всей жизни и доступных как физическому лицу, так и работникам здравоохранения в соответствии с правилами, утвержденными уполномоченным органом;

17) электронная медицинская запись – набор структурированных персональных медицинских данных, относящихся к конкретному случаю оказания медицинской помощи.

Сноска. Статья 58 с изменениями, внесенными Законом РК от 02.01.2021 № 399-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 59. Деятельность в области цифрового здравоохранения

1. Деятельность в области цифрового здравоохранения включает:

1) нормативное правовое регулирование, разработку и утверждение стандартов цифрового здравоохранения;

2) развитие информационной и коммуникационной инфраструктуры отрасли здравоохранения;

3) обеспечение физических и юридических лиц данными и информацией в области здравоохранения;

4) сбор, обработку, хранение, защиту персональных медицинских данных;

5) оказание информационно-коммуникационных услуг в целях сбора, обработки, хранения, защиты и предоставления персональных медицинских данных;

6) переход к безбумажной медицине.

2. Электронные информационные ресурсы, посредством которых оказываются дистанционные медицинские услуги, должны соответствовать требованиям уполномоченного органа.

3. Уполномоченный орган осуществляет обработку, хранение и защиту персональных медицинских данных, хранящихся на национальном уровне.

4. Физическое лицо вправе делегировать субъектам цифрового здравоохранения хранение и обработку, защиту своих персональных медицинских данных в соответствии с правилами, утвержденными уполномоченным органом.

Статья 60. Взаимодействие объектов и субъектов цифрового здравоохранения

1. Сбор, обработка и хранение персональных медицинских данных для формирования электронных медицинских записей, содержащих персональные медицинские данные, осуществляются в рамках оказания медицинской помощи с учетом информированного согласия пациента на получение медицинской помощи.

1-1. Запрещается сбор, обработка копий документов, удостоверяющих личность, за исключением документов, удостоверяющих личность иммигрантов.

2. Субъекты здравоохранения обязаны обеспечить передачу данных в Национальный электронный паспорт здоровья и электронные информационные ресурсы уполномоченного органа в объеме и кратности, определяемых уполномоченным органом, за исключением случаев, предусмотренных Законом Республики Казахстан "О государственных секретах".

3. Передача персональных медицинских данных третьим лицам осуществляется с согласия физического лица, кроме случаев, указанных в пункте 4 настоящей статьи.

4. Передача персональных медицинских данных в Национальный электронный паспорт здоровья и электронные информационные ресурсы уполномоченного органа осуществляется без согласия физического лица, а также субъектам здравоохранения только для целей оказания медицинской помощи и в случаях, указанных в:

1) пункте 1 статьи 137 настоящего Кодекса;

2) Законе Республики Казахстан "О персональных данных и их защите".

5. Агрегаторы персональных медицинских данных оказывают информационно-коммуникационные услуги в целях сбора, обработки, хранения, защиты персональных медицинских данных субъектами здравоохранения.

6. Субъекты цифрового здравоохранения формируют, хранят, защищают электронные медицинские записи в соответствии с правилами, утвержденными уполномоченным органом.

7. Носимые медицинские устройства подлежат сертификации в соответствии с законодательством Республики Казахстан.

Сноска. Статья 60 предусс изменением, внесенным Законом РК от 11.12.2023 № 44-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 61. Ответственность субъектов цифрового здравоохранения

1. Правом доступа к персональным медицинским данным физического лица с его согласия обладают:

1) поставщики медицинских и фармацевтических услуг;

2) организация, ответственная за финансовое возмещение затрат на оказание медицинской помощи, в целях осуществления возмещения затрат на оказание медицинской помощи;

3) уполномоченный орган, местные органы государственного управления здравоохранением областей, городов республиканского значения и столицы, территориальные подразделения уполномоченного органа в области социальной защиты населения, государственные органы, осуществляющие государственный контроль в сфере оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий;

4) военно-медицинские (медицинские) подразделения центральных исполнительных органов и иных центральных государственных органов в отношении обслуживаемого контингента;

5) юридические лица, осуществляющие сбор, обработку, хранение, защиту и предоставление персональных медицинских данных в соответствии с законодательством Республики Казахстан.

Указанные организации получают право доступа к персональным медицинским данным только в части, необходимой для оказания соответствующих услуг.

2. Доступ к персональным медицинским данным физического лица в случаях оказания экстренной и неотложной медицинской помощи обеспечивается по умолчанию субъектам здравоохранения, оказывающим такие формы медицинской помощи.

3. Передача персональных медицинских данных физического лица запрещается, за исключением случаев, предусмотренных настоящим Кодексом и законами Республики Казахстан.

4. Лицам, указанным в пункте 1 настоящей статьи, право доступа к персональным медицинским данным физического лица предоставляется в порядке, определенном правилами разграничения прав доступа субъектов цифрового здравоохранения, утвержденными уполномоченным органом, по согласованию с уполномоченным органом в сфере защиты персональных данных.

5. Физическое лицо имеет право доступа к информации о своем здоровье и оказанной медицинской помощи в Национальном электронном паспорте здоровья, электронном паспорте здоровья, а также отслеживания журнала доступа к данным.

6. Отношения агрегатора медицинских данных с субъектами здравоохранения регулируются гражданским законодательством Республики Казахстан.

7. Медицинские работники и работники субъектов здравоохранения несут ответственность в соответствии с законами Республики Казахстан за качество, своевременность, достоверность и конфиденциальность вносимых электронных данных в электронные информационные ресурсы уполномоченного органа.

8. За несоблюдение мер по защите персональных медицинских данных, повлекшее утерю, незаконный сбор и обработку персональных медицинских данных, касающихся частной жизни физических лиц, в том числе составляющих тайну медицинского работника, лица несут ответственность, предусмотренную законами Республики Казахстан.

9. Для осуществления аналитической, статистической деятельности, научных и иных исследований медицинские данные используются в обезличенном виде.

Сноска. Статья 61 с изменениями, внесенными Законом РК от 02.01.2021 № 399-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 62. Обеспечение защиты персональных медицинских данных физических лиц

1. Особенности защиты электронных информационных ресурсов, содержащих персональные медицинские данные, устанавливаются в соответствии с законодательством Республики Казахстан об информатизации и о персональных данных и их защите.

2. Не допускается использование электронных информационных ресурсов, содержащих персональные медицинские данные, в целях причинения имущественного и (или) морального вреда, ограничения реализации прав и свобод, гарантированных законами Республики Казахстан.

3. Информация, полученная из электронных информационных ресурсов, содержащих персональные медицинские данные физических лиц, используется исключительно в рамках выполнения должностных обязанностей.

Сноска. Статья 62 с изменениями, внесенными Законом РК от 02.01.2021 № 399-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Глава 8. СТРУКТУРА СИСТЕМЫ ЗДРАВООХРАНЕНИЯ

Статья 63. Субъекты здравоохранения

1. Система здравоохранения состоит из государственного и негосударственного секторов здравоохранения.

2. Субъектами здравоохранения являются организации здравоохранения, а также физические лица, занимающиеся частной медицинской практикой и фармацевтической деятельностью.

3. Государственный сектор здравоохранения состоит из государственных органов в области здравоохранения, организаций здравоохранения, основанных на праве государственной собственности, а также военно-медицинских (медицинских) подразделений и организаций, осуществляющих экспертизы в сфере судебной медицины (судебно-медицинские, судебно-наркологические, судебно-психиатрические).

4. Негосударственный сектор здравоохранения состоит из организаций здравоохранения, основанных на праве частной собственности, а также физических лиц, занимающихся частной медицинской практикой и фармацевтической деятельностью.

5. Физические лица имеют право на занятие частной медицинской практикой при наличии сертификата специалиста в области здравоохранения, стажа работы не менее пяти лет по соответствующей специальности и лицензии на медицинскую деятельность.

Статья 64. Виды медицинской деятельности

Медицинская деятельность включает следующие виды:

1) медицинская помощь;

2) лабораторная диагностика;

3) патологоанатомическая диагностика;

4) деятельность в сфере заготовки крови и ее компонентов;

5) деятельность в сфере санитарно-эпидемиологического благополучия населения;

6) деятельность в сфере охраны общественного здоровья;

7) образовательная и научная деятельность в области здравоохранения;

8) экспертиза в области здравоохранения;

9) иные виды деятельности, не запрещенные настоящим Кодексом.

Статья 65. Развитие инфраструктуры здравоохранения

1. Объектами инфраструктуры здравоохранения являются здания и сооружения, имущественные комплексы, используемые в рамках осуществления медицинской, фармацевтической и образовательной деятельности в области здравоохранения.

2. Развитие инфраструктуры здравоохранения основывается на следующих принципах:

1) улучшения качества и доступности оказываемой медицинской помощи для всех групп населения, в том числе адаптации объектов медицинского назначения для лиц с инвалидностью и других групп населения с ограниченными возможностями;

2) использования передового международного опыта при проектировании и строительстве многопрофильных стационарных комплексов;

3) обеспечения равных возможностей для государственных и частных инвестиций и повышения инвестиционной привлекательности сектора здравоохранения для отечественных и зарубежных инвесторов;

4) стратегического планирования развития инфраструктуры здравоохранения.

3. Единым перспективным планом развития инфраструктуры является республиканский план, разработанный на основании региональных перспективных планов развития инфраструктуры здравоохранения, утверждаемый уполномоченным органом. Требованиями, устанавливаемыми в рамках разработки региональных перспективных планов развития инфраструктуры здравоохранения, являются:

1) приведение сети организаций здравоохранения в соответствие с государственным нормативом сети организаций здравоохранения;

2) приведение объектов здравоохранения в соответствие с требованиями нормативных правовых актов в сферах санитарно-эпидемиологического благополучия населения, архитектурной, градостроительной и строительной деятельности и нормами оснащения;

3) приведение коечного фонда стационаров и производственной мощности организаций, оказывающих первичную медико-санитарную и (или) консультативно-диагностическую помощь, в соответствие с потребностями населения;

4) открытие объектов инфраструктуры здравоохранения исходя из потребности населения, обеспечения доступности медицинской помощи.

4. Центральные государственные органы, местные исполнительные органы и автономная организация образования принимают меры по содержанию и эксплуатации медицинских организаций, находящихся в их ведении, в соответствии с требованиями нормативных правовых актов в сферах санитарно-эпидемиологического благополучия населения, архитектурной, градостроительной и строительной деятельности и нормами оснащения.

5. Инвестиционное планирование и развитие сети организаций здравоохранения осуществляются в соответствии с региональными перспективными планами развития инфраструктуры здравоохранения.

6. Перспективные планы развития инфраструктуры здравоохранения разрабатываются на десятилетний период.

Сноска. Статья 65 с изменением, внесенным Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 66. Государственно-частное партнерство в области здравоохранения

1. Эксплуатация объекта здравоохранения, созданного (реконструированного) в результате реализации концессионного проекта в области здравоохранения (далее – объект концессии), – использование объекта концессии, которое может предусматривать техническое и функциональное обслуживание в порядке и на условиях, определенных договором концессии в области здравоохранения (далее – договор концессии).

2. Техническое обслуживание объекта концессии – использование объекта концессии с осуществлением комплекса технологических и организационных мероприятий, направленное на поддержание объекта концессии в исправном, безопасном, пригодном для его функционального обслуживания состоянии, а также осуществление его текущего и (или) капитального ремонта, управление, выполнение сервисной и (или) вспомогательной деятельности, в порядке и на условиях, определенных договором концессии.

3. Функциональное обслуживание объекта концессии – использование объекта концессии в соответствии с целевым назначением объекта концессии, в том числе в целях производства товаров и (или) выполнения работ, и (или) оказания услуг, в порядке и на условиях, определенных договором концессии.

4. Функциональный оператор в области здравоохранения – государственное юридическое лицо либо юридическое лицо со стопроцентным участием государства или его дочерняя организация, более пятидесяти процентов голосующих акций (долей участия) которой принадлежит ему на праве собственности, уставной деятельностью которых является оказание медицинской помощи, не являющиеся стороной договора концессии, предназначенные для осуществления деятельности, связанной с функциональным обслуживанием объекта концессии.

5. Создание (реконструкция) и эксплуатация объектов здравоохранения могут осуществляться путем реализации проектов государственно-частного партнерства, в том числе концессионных проектов, в соответствии с законодательством Республики Казахстан в области государственно-частного партнерства и о концессиях.

6. Эксплуатация объекта концессии, наряду с концессионером, может осуществляться также функциональным оператором в области здравоохранения.

В таком случае концессионер имеет право на возмещение затрат и получение доходов за реализацию произведенных товаров (работ, услуг) в рамках технического обслуживания объекта концессии.

7. При реализации концессионных проектов, предусматривающих заключение договора концессии на основании подпункта 1-1) пункта 1 статьи 21-1 Закона Республики Казахстан "О концессиях":

1) концедент передает созданный объект концессии по договору безвозмездного пользования государственным имуществом функциональному оператору в области здравоохранения для осуществления функционального обслуживания в порядке, определенном договором концессии;

2) концессионер обеспечивает техническое обслуживание объекта концессии в порядке и на условиях, предусмотренных договором концессии;

3) функциональный оператор в области здравоохранения, определяемый до проведения конкурса по выбору концессионера, обеспечивает функциональное обслуживание объекта концессии в порядке и на условиях, предусмотренных договором концессии.

8. Договор концессии, заключенный на основании подпункта 1-1) пункта 1 статьи 21-1 Закона Республики Казахстан "О концессиях", должен включать положения о функциональном операторе в области здравоохранения, а также порядок совместного использования концессионером и функциональным оператором в области здравоохранения объекта концессии.

9. Функциональный оператор в области здравоохранения должен иметь предусмотренные законодательством Республики Казахстан для такой деятельности разрешительные документы либо должен получить их до начала использования объекта концессии в соответствии с целевым назначением.

10. Функциональный оператор в области здравоохранения вправе:

1) осуществлять права в отношении объекта концессии на условиях, предусмотренных договором безвозмездного пользования государственным имуществом, заключенным с целью функционального обслуживания объекта концессии;

2) совместно с концессионером использовать объект концессии в порядке и на условиях, предусмотренных договором концессии;

3) осуществлять иные права в соответствии с законами Республики Казахстан.

11. Функциональный оператор в области здравоохранения обязан:

1) сохранять профиль объекта концессии;

2) производить товары и (или) выполнять работы, и (или) оказывать услуги, предусмотренные договором безвозмездного пользования государственным имуществом;

3) соблюдать законодательство Республики Казахстан в области труда, занятости населения и охраны окружающей среды;

4) возмещать нанесенный по его вине ущерб объекту концессии;

5) соблюдать условия совместного использования объекта концессии с концессионером в порядке, предусмотренном договором концессии;

6) соблюдать иные требования и условия, установленные законами Республики Казахстан и договором безвозмездного пользования государственным имуществом.

12. По проектам государственно-частного партнерства особой значимости, предусматривающим создание (реконструкцию) и (или) эксплуатацию объектов здравоохранения, в том числе концессионным проектам, к потенциальным частным партнерам, концессионерам или учредителям (участникам) нового юридического лица (консорциума), учрежденного в целях реализации проекта, предъявляется дополнительное (специальное) квалификационное требование о наличии опыта (опыта одного из учредителей (участников) реализации проектов по строительству или эксплуатации технически сложных объектов здравоохранения.

Сноска. Статья 66 с изменениями, внесенными законами РК от 02.01.2021 № 399-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Глава 9. ФИНАНСОВОЕ ОБЕСПЕЧЕНИЕ СИСТЕМЫ ЗДРАВООХРАНЕНИЯ

Статья 67. Источники финансового обеспечения системы здравоохранения

Источниками финансового обеспечения системы здравоохранения являются:

1) бюджетные средства;

2) активы фонда социального медицинского страхования;

3) средства добровольного медицинского страхования;

4) средства, полученные за оказание платных услуг;

5) средства, полученные от сооплаты;

5-1) единовременные пенсионные выплаты физических лиц в случаях, предусмотренных законами Республики Казахстан;

6) средства, поступившие в качестве добровольных пожертвований от физических и юридических лиц;

7) иные источники, не противоречащие законодательству Республики Казахстан.

Сноска. Статья 67 с изменениями, внесенными Законом РК от 02.01.2021 № 399-VI (вводится в действие с 01.01.2021).

Статья 68. Финансирование объемов медицинской помощи

1. Финансирование гарантированного объема бесплатной медицинской помощи осуществляется за счет:

1) бюджета;

2) средств граждан при сооплате.

2. Финансирование медицинской помощи в системе обязательного социального медицинского страхования осуществляется за счет:

1) активов фонда социального медицинского страхования;

2) средств граждан при сооплате.

3. Финансовое обеспечение дополнительного объема медицинской помощи осуществляется в соответствии с подпунктом 3) статьи 195 настоящего Кодекса.

Статья 69. Использование источников финансового обеспечения системы здравоохранения

1. Финансовые средства в области здравоохранения направляются на:

1) реализацию программ укрепления и развития общественного здравоохранения;

2) подготовку и повышение квалификации кадров в области здравоохранения;

3) развитие и внедрение достижений медицинской и фармацевтической наук;

4) оплату услуг субъектов здравоохранения в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

4-1) оплату лечения физическим лицам за счет единовременных пенсионных выплат в соответствии с законодательством Республики Казахстан;

4-2) оплату услуг по оказанию медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы;

5) приобретение лекарственных средств, медицинских изделий, крови и ее компонентов, вакцин и других иммунобиологических лекарственных препаратов;

6) обеспечение санитарно-эпидемиологического благополучия населения;

7) содержание государственных учреждений здравоохранения;

8) материально-техническое оснащение организаций здравоохранения;

9) развитие инфраструктуры здравоохранения;

10) иные расходы, не запрещенные законодательством Республики Казахстан.

2. Оплата услуг субъектов здравоохранения в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования производится с учетом результатов мониторинга договорных обязательств по качеству и объему медицинских услуг в порядке, определяемом уполномоченным органом.

2-1. Оплата услуг субъектов здравоохранения в рамках дополнительного объема медицинской помощи лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, производится с учетом результатов мониторинга договорных обязательств по качеству и объему медицинских услуг в порядке, определяемом уполномоченным органом.

3. Оплату стоимости фармацевтических услуг в рамках гарантированного объема бесплатной медицинской помощи и (или) медицинской помощи в системе обязательного социального медицинского страхования субъектам в сфере обращения лекарственных средств и медицинских изделий осуществляют администраторы бюджетных программ или фонд социального медицинского страхования в порядке, определяемом уполномоченным органом.

4. Закуп услуг у субъектов здравоохранения в рамках гарантированного объема бесплатной медицинской помощи осуществляется фондом социального медицинского страхования и (или) администраторами бюджетных программ.

Закуп услуг у субъектов здравоохранения в системе обязательного социального медицинского страхования осуществляется фондом социального медицинского страхования.

4-1. Ведение учета субъектов здравоохранения, оказывающих медицинскую помощь в рамках гарантированного объема бесплатной медицинской помощи, осуществляется фондом социального медицинского страхования.

База данных субъектов здравоохранения, претендующих на оказание медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования, формируется фондом социального медицинского страхования.

5. Оплата услуг при оказании гарантированного объема бесплатной медицинской помощи осуществляется фондом социального медицинского страхования и (или) администраторами бюджетных программ.

Оплата услуг субъектов здравоохранения при оказании медицинской помощи в системе обязательного социального медицинского страхования осуществляется фондом социального медицинского страхования.

5-1. Для закупа и оплаты услуг субъектов здравоохранения в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования фонд социального медицинского страхования производит объединение средств целевого взноса, выделяемого на гарантированный объем бесплатной медицинской помощи, и активов фонда.

6. Преимущественное право на заключение договоров в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования имеют аккредитованные организации здравоохранения.

Сноска. Статья 69 с изменениями, внесенными законами РК от 02.01.2021 № 399-VI (вводится в действие с 01.01.2021); от 24.06.2021 № 52-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 19.04.2023 № 223-VII (вводится в действие с 01.01.2024).

Статья 70. Национальные счета здравоохранения

1. Национальными счетами здравоохранения является система регулярного, всестороннего и последовательного мониторинга финансовых потоков в системе здравоохранения страны, используемая для оценки распределения ресурсов здравоохранения с целью их равного и эффективного распределения между мерами, направленными на предупреждение заболеваний и лечение населения.

2. Национальные счета здравоохранения формируются ежегодно на основе международной методологии с использованием:

1) статистических бюллетеней уполномоченного органа в области государственной статистики;

2) данных центрального уполномоченного органа по исполнению бюджета;

3) данных местных уполномоченных органов по исполнению бюджета в разрезе медицинских организаций;

4) статистических данных, опубликованных на официальных интернет-ресурсах Национального Банка Республики Казахстан, Всемирной организации здравоохранения и Организации экономического сотрудничества и развития.

На основе данных, указанных в части первой настоящего пункта, уполномоченный орган формирует аналитический отчет с описанием расходов в разрезе услуг и поставщиков медицинских услуг, а также информацию об источниках их финансирования.

3. Порядок формирования и использования данных национальных счетов здравоохранения определяется уполномоченным органом.

Глава 10. МЕЖДУНАРОДНОЕ СОТРУДНИЧЕСТВО В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 71. Международное сотрудничество в области здравоохранения

1. Международное сотрудничество в области здравоохранения осуществляется на основе общепризнанных принципов и норм международного права и международных договоров Республики Казахстан.

2. Международное сотрудничество включает в себя взаимодействие по вопросам здравоохранения с официальными представителями государств, международных организаций и международных интеграционных объединений, участие в мероприятиях международного характера, разработку международных договоров.

3. Органы управления здравоохранением, субъекты здравоохранения имеют право устанавливать прямые связи с органами управления здравоохранением иностранных государств, с иностранными предприятиями, учреждениями и организациями в соответствии с законодательством Республики Казахстан и международными договорами.

4. Соглашения, договоры, заключаемые в рамках международного сотрудничества в области здравоохранения, в том числе органами управления здравоохранением, субъектами здравоохранения, не должны ограничивать права и свободы человека и граждан Республики Казахстан в сфере охраны здоровья населения.

Статья 72. Приоритетные направления международного сотрудничества в области здравоохранения

Приоритетами международного сотрудничества в области здравоохранения являются:

1) защита интересов граждан Республики Казахстан и интересов Республики Казахстан в области здравоохранения;

2) участие в международных инициативах в области здравоохранения;

3) привлечение инвестиций и оказание технической помощи в области здравоохранения на межгосударственном уровне;

4) оказание медицинской помощи иностранцам, лицам без гражданства;

5) повышение уровня оказания медицинской помощи путем внедрения международных инновационных технологий и модернизации системы здравоохранения;

6) интеграция в мировую медицинскую и фармацевтическую науку;

7) содействие решению вопросов обеспечения медицинской помощью трудовых мигрантов;

8) межгосударственное взаимодействие по вопросам образовательной деятельности в области здравоохранения, подготовки и повышения квалификации медицинских кадров на основе современных достижений науки и практики;

9) оказание и получение международной помощи в области здравоохранения при возникновении чрезвычайных ситуаций;

10) обмен информацией, технологиями с иностранными государствами и международными организациями в сфере обращения лекарственных средств, медицинских изделий и гармонизация требований к безопасности и качеству фармацевтической и медицинской продукции;

11) санитарная охрана границ в соответствии с требованиями международных медико-санитарных правил, обеспечение безопасности ввозимой продукции.

Статья 73. Экономические и правовые основы международного сотрудничества в области здравоохранения

1. Экономическую основу международного сотрудничества в области здравоохранения составляют:

1) обязательные и добровольные членские взносы в международные организации;

2) привлечение и использование грантов, технической помощи;

3) финансирование в соответствии с заключенными международными договорами.

2. Правовой основой международного сотрудничества в области здравоохранения являются международные договоры.

РАЗДЕЛ 2. ОХРАНА ОБЩЕСТВЕННОГО ЗДОРОВЬЯ

Глава 11. ОБЩИЕ ПОЛОЖЕНИЯ ОХРАНЫ ОБЩЕСТВЕННОГО ЗДОРОВЬЯ

Статья 74. Приоритетные направления охраны общественного здоровья

1. Приоритетными направлениями охраны общественного здоровья являются:

1) укрепление здоровья через формирование у населения медико-социальной активности и установок на здоровый образ жизни;

2) повышение уровня информированности населения об основных аспектах здоровья и факторах риска;

3) эпидемиологический надзор за инфекционными и приоритетными неинфекционными заболеваниями;

4) организация взаимодействия всех заинтересованных государственных органов, организаций и ведомств, общественных объединений, бизнес-сообществ и других физических и юридических лиц.

2. Служба общественного здравоохранения – это деятельность государственных органов, физических и юридических лиц, общественных объединений, направленная на пропаганду здорового образа жизни, здорового питания, оценку влияния поведенческих факторов риска на здоровье, профилактику инфекционных и неинфекционных заболеваний.

Статья 75. Статистическое наблюдение в области общественного здравоохранения

1. Статистика здравоохранения – отрасль статистики, включающая в себя статистические данные о здоровье населения, деятельности субъектов здравоохранения и об использовании ресурсов здравоохранения.

2. Статистическое наблюдение в области здравоохранения осуществляется уполномоченным органом.

3. Порядок осуществления статистического наблюдения в области здравоохранения, формы статистического учета и отчетности в области здравоохранения, порядок их ведения, заполнения и сроки представления устанавливаются уполномоченным органом.

4. Статистические показатели здоровья применяются для статистического анализа, прогнозирования ресурсов и моделирования процессов в области здравоохранения, планирования политики системы здравоохранения, принятия управленческих решений.

5. Официальная статистическая информация в области здравоохранения является общедоступной и размещается уполномоченным органом в средствах массовой информации, в том числе на официальном интернет-ресурсе.

Глава 12. ПРАВА И ОБЯЗАННОСТИ ЛИЦ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 76. Гарантия обеспечения прав в области здравоохранения

1. Государство гарантирует гражданам Республики Казахстан:

1) равный доступ к медицинской помощи;

2) качество медицинской помощи;

3) качество лекарственного обеспечения;

4) доступность, эффективность и безопасность лекарственных средств;

5) проведение мероприятий по профилактике заболеваний, формированию здорового образа жизни и здорового питания;

6) свободу репродуктивного выбора, охрану репродуктивного здоровья и соблюдение репродуктивных прав;

7) санитарно-эпидемиологическое благополучие.

2. Республика Казахстан гарантирует гражданам Республики Казахстан защиту от любых форм дискриминации и стигматизации, обусловленных наличием у них каких-либо заболеваний и состояний.

Статья 77. Права граждан Республики Казахстан

1. Граждане Республики Казахстан имеют право на:

1) получение гарантированного объема бесплатной медицинской помощи;

2) обеспечение лекарственными средствами и медицинскими изделиями в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

3) свободный выбор врача и медицинской организации;

4) получение лечебного питания в случае нахождения пациента на лечении в стационарных условиях;

5) дополнительную медицинскую помощь сверх гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования за счет собственных средств, средств организаций, системы добровольного медицинского страхования и иных источников в соответствии с законодательством Республики Казахстан;

6) получение медицинских и иных услуг на платной основе;

7) получение медицинской помощи за пределами Республики Казахстан за счет бюджетных средств при наличии показаний в порядке, определяемом уполномоченным органом;

8) получение и предоставление соответствующих документов, удостоверяющих факт временной нетрудоспособности, в соответствии с законодательством Республики Казахстан;

9) безвозмездное и регулярное получение от государственных органов, организаций и лечащего врача в пределах их компетенции достоверной информации о методах профилактики, диагностики, лечения заболевания и медицинской реабилитации, клинических исследованиях, факторах, влияющих на здоровье, включая состояние среды обитания, условия труда, быта и отдыха, здоровом питании и безопасности пищевых продуктов;

10) получение от государственных органов, независимых экспертных организаций и субъектов в сфере обращения лекарственных средств, медицинских изделий информации о безопасности, эффективности и качестве реализуемых лекарственных средств, медицинских изделий;

11) защиту сведений, составляющих тайну медицинского работника;

12) возмещение вреда, причиненного здоровью при оказании им медицинской помощи, в соответствии с законодательством Республики Казахстан;

13) защиту своих прав и законных интересов в области охраны здоровья в соответствии с законодательством Республики Казахстан;

14) обжалование действий (бездействия) медицинских и фармацевтических работников в порядке, установленном законами Республики Казахстан;

Примечание ИЗПИ!
В подпункт 15) предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

15) ходатайство в вышестоящие органы о привлечении независимых экспертов в случае несогласия с выводами государственной медицинской экспертизы;

16) добровольное волеизъявление о возможности выступить в качестве донора;

17) дачу волеизъявления о согласии либо отказе на изъятие у них после смерти тканей (части ткани) и (или) органов (части органа) в целях трансплантации в порядке, определенном настоящим Кодексом;

18) дачу информированного согласия или отказа на лечение и проведение других медицинских вмешательств, в том числе профилактических прививок;

19) сооплату;

20) получение обезболивания при лечении хронических неизлечимых заболеваний;

21) получение в доступной форме информации о состоянии здоровья, в том числе сведения о результатах медицинского обследования, диагнозе и о прогнозе заболевания, методах оказания медицинской помощи, связанном с ними риске, возможных видах медицинского вмешательства, его последствиях и результатах оказания медицинской помощи;

22) получение достоверной и своевременной информации о факторах, способствующих сохранению здоровья или оказывающих на них негативное влияние, включая информацию о профилактике заболеваний, санитарно-эпидемиологическом благополучии, состоянии окружающей среды, потенциальной опасности для здоровья человека выполняемых работ и оказываемых услуг, рациональных нормах питания, качестве и безопасности продукции, товаров и услуг;

23) иные права в соответствии с законами Республики Казахстан.

1-1. Лица с ограниченными возможностями (лица с инвалидностью) имеют право на первоочередное обслуживание в организациях здравоохранения.

2. Женщины имеют право решать вопрос о материнстве и свободного выбора современных методов предупреждения нежелательной беременности в целях планирования семьи и охраны своего здоровья.

Право граждан на охрану материнства обеспечивается:

1) проведением медицинских осмотров, динамическим наблюдением и оздоровлением женщин репродуктивного возраста;

2) лечением по медицинским показаниям основных заболеваний, непосредственно влияющих на репродуктивное здоровье женщин и здоровье ребенка, при поступлении в стационар по уходу за больным ребенком.

Сноска. Статья 77 с изменением, внесенным Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 78. Права детей

1. Помимо прав, предусмотренных пунктом 1 статьи 77 настоящего Кодекса, каждый ребенок имеет право на:

1) пользование современными и эффективными услугами системы здравоохранения и средствами лечения болезней и восстановления здоровья;

2) образование в области охраны здоровья;

3) профилактические медицинские осмотры и динамическое наблюдение, лечение, лекарственное обеспечение, оздоровление и вакцинацию;

4) оказание медицинской помощи в период оздоровления и организованного отдыха в порядке, определяемом уполномоченным органом;

5) санитарно-гигиеническое просвещение, обучение и труд в условиях, соответствующих его физиологическим особенностям и состоянию здоровья и исключающих воздействие на него неблагоприятных факторов;

6) получение медицинской документации о состоянии здоровья на бесплатной основе по месту прикрепления при поступлении на учебу и трудоустройстве;

6-1. Дети с ограниченными возможностями (дети с инвалидностью) имеют право на первоочередное обслуживание в организациях здравоохранения.

7) получение информации о состоянии здоровья в доступной для него форме;

8) получение информации в доступной форме о здоровом образе жизни и правильном питании, о вреде курения, употребления психоактивных веществ;

9) получение в доступной форме информации об охране репродуктивного здоровья;

10) получение паллиативной медицинской помощи.

2. Несовершеннолетние в возрасте шестнадцати лет и старше имеют право на информированное согласие или отказ на оказание профилактической, консультативно-диагностической помощи, за исключением хирургических вмешательств, искусственного прерывания беременности, которые производятся с согласия их родителей или законных представителей.

3. При лечении детей в условиях стационара в возрасте до пяти лет, а также больных детей старшего возраста, нуждающихся по заключению врачей в дополнительном уходе, матери (отцу) или иному лицу, непосредственно осуществляющему уход за ребенком, предоставляется возможность находиться с ним в медицинской организации и выдается лист или справка о временной нетрудоспособности в соответствии с законодательством Республики Казахстан.

Кормящая мать ребенка до одного года жизни обеспечивается бесплатным питанием в медицинской организации на весь период пребывания по уходу за ребенком.

4. При лечении в амбулаторных и стационарозамещающих условиях детей в возрасте до пяти лет, а также больных детей старшего возраста, нуждающихся по заключению врачей в дополнительном уходе, матери (отцу) или иному лицу, непосредственно осуществляющему уход за ребенком, предоставляется возможность находиться с ним с выдачей листа или справки о временной нетрудоспособности в соответствии с законодательством Республики Казахстан.

5. Дети школьного возраста в период получения в стационарных условиях специализированной медицинской помощи, медицинской реабилитации, а также паллиативной медицинской помощи имеют право на непрерывное образование в порядке, определенном уполномоченным органом совместно с уполномоченным органом в области образования.

Организации здравоохранения, оказывающие медицинскую помощь детям, создают условия для игр, отдыха и проведения воспитательной работы.

6. Дети с ограниченными возможностями, зараженные ВИЧ-инфекцией, имеют право на получение бесплатной медико-педагогической коррекционной поддержки в организациях образования, здравоохранения в соответствии с законодательством Республики Казахстан.

Дети, зараженные ВИЧ-инфекцией, имеют право на пребывание в домах ребенка и иных организациях здравоохранения и образования.

Дети, рожденные от матерей, зараженных ВИЧ-инфекцией, имеют право на получение бесплатных адаптированных молочных смесей в соответствии с установленными нормами питания.

7. Перечень медицинских противопоказаний к помещению детей в дом ребенка и организации образования, организации для детей-сирот и детей, оставшихся без попечения родителей, утверждается уполномоченным органом.

8. Дети-сироты, дети, оставшиеся без попечения родителей, и дети, являющиеся получателями специальных социальных услуг, до достижения ими возраста трех лет включительно могут содержаться в государственных медицинских организациях в порядке, установленном уполномоченным органом.

Сноска. Статья 78 с изменениями, внесенными законами РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 20.04.2023 № 226-VII (вводится в действие с 01.07.2023).

Статья 79. Права граждан Республики Казахстан и семьи в сфере охраны репродуктивных прав

Сноска. Заголовок статьи 79 внесено изменение в текст на казахском языке, текст на русском языке не меняется в соответствии с Законом РК от 26.12.2022 № 168-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

1. Граждане Республики Казахстан вправе на:

1) свободный репродуктивный выбор;

2) получение услуг по охране репродуктивного здоровья и планированию семьи;

3) получение достоверной и полной информации о состоянии своего репродуктивного здоровья;

4) лечение бесплодия, в том числе с применением современных вспомогательных репродуктивных методов и технологий, разрешенных в Республике Казахстан;

5) предотвращение нежелательной беременности;

6) безопасное материнство;

7) донорство половых клеток, ткани репродуктивных органов;

8) использование и свободный выбор методов контрацепции;

9) хирургическую стерилизацию;

10) искусственное прерывание беременности;

11) защиту своих репродуктивных прав;

12) свободное принятие решения относительно количества детей и времени их рождения в браке или вне брака, интервалов между рождениями, необходимых для сохранения здоровья матери и ребенка;

13) хранение половых клеток, ткани репродуктивных органов, эмбрионов в порядке, установленном законодательством Республики Казахстан.

2. Граждане обязаны соблюдать права, свободы и законные интересы других лиц при осуществлении своих репродуктивных прав.

3. Граждане имеют право по медицинским показаниям на консультации по вопросам планирования семьи, наличия социально значимых заболеваний и заболеваний, представляющих опасность для окружающих, по медико-психологическим аспектам семейно-брачных отношений, а также на медико-генетические и другие консультации и обследования в медицинских организациях в целях предупреждения возможных наследственных и врожденных заболеваний у потомства.

4. Отцу ребенка или иному члену семьи предоставляется право при наличии согласия женщины с учетом состояния ее здоровья присутствовать при рождении ребенка, за исключением случаев оперативного родоразрешения, при наличии в организациях родовспоможения соответствующих условий (индивидуальных родовых залов) и отсутствии у отца или иного члена семьи инфекционных заболеваний. Реализация такого права осуществляется на безвозмездной основе.

5. Граждане Республики Казахстан, зараженные ВИЧ-инфекцией, имеют право на усыновление детей наравне с другими гражданами Республики Казахстан в соответствии с законодательством Республики Казахстан.

6. Граждане Республики Казахстан, зараженные ВИЧ-инфекцией, имеют право на применение вспомогательных репродуктивных методов и технологий в соответствии с законодательством Республики Казахстан.

Статья 80. Обязанности граждан Республики Казахстан

Граждане Республики Казахстан обязаны:

1) заботиться о сохранении своего здоровья, нести солидарную ответственность за сохранение и укрепление индивидуального и общественного здоровья;

2) уплачивать взносы на обязательное социальное медицинское страхование в соответствии с Законом Республики Казахстан "Об обязательном социальном медицинском страховании";

3) проходить профилактические медицинские осмотры, скрининговые исследования;

4) выполнять относящиеся к индивидуальному и общественному здоровью назначения медицинских работников;

5) принимать участие в процессе управления собственным здоровьем, в том числе в программах управления хроническими заболеваниями при их наличии, быть заинтересованными в получении информации о заболевании и методах его лечения, возможных рисках и осложнениях;

6) сообщать медицинским работникам об индивидуальных особенностях своего организма;

7) соблюдать меры предосторожности по охране собственного здоровья и здоровья окружающих, проходить обследование и лечение по требованию субъектов здравоохранения, информировать медицинский персонал о наличии у них инфекционных и иных заболеваний, представляющих опасность для окружающих;

8) соблюдать законодательство Республики Казахстан в области здравоохранения.

В случае уклонения от обследования и лечения граждане Республики Казахстан, больные заболеваниями, представляющими опасность для окружающих, за исключением ВИЧ-инфекции, подвергаются освидетельствованию и лечению в принудительном порядке в соответствии с настоящим Кодексом и законами Республики Казахстан.

Статья 81. Права и обязанности беременных женщин и матерей в сфере охраны здоровья

1. Материнство в Республике Казахстан охраняется и поощряется государством.

2. Граждане имеют право на поддержку грудного вскармливания, в том числе на защиту и пропаганду грудного вскармливания:

1) защита прав беременных женщин и кормящих направлена на обеспечение условий для подготовки и реализации грудного вскармливания (отпуск по беременности и родам, дополнительные перерывы работы для кормления детей раннего возраста, неполное рабочее время, внеочередное обслуживание в медицинских организациях, пользование услугами комнат матери и ребенка и другое);

2) включает информирование населения о преимуществах исключительно грудного вскармливания детей в возрасте до шести месяцев и продолжения грудного вскармливания со здоровым прикормом до двух лет и более.

3. Беременные женщины имеют право на:

1) охрану здоровья и помощь в период беременности, при родах и после родов, в том числе преждевременных, определяемых международными критериями живорождения и мертворождения плода, с применением методов, разрешенных на территории Республики Казахстан;

2) медицинскую помощь в период беременности, во время и после родов;

3) обследование, лечение и медицинское вмешательство в период беременности только с их согласия или законного представителя, за исключением случаев, когда промедление обследования, лечения и проведения медицинских вмешательств угрожает жизни женщины и ребенка (плода), когда решение об осуществлении обследования, лечения и медицинского вмешательства принимает врач или консилиум;

4) соблюдение режима рабочего времени, отпуска по беременности и родам, отпуска без сохранения заработной платы по уходу за ребенком до достижения им возраста трех лет и условий труда беременных женщин и кормящих матерей в соответствии с трудовым законодательством Республики Казахстан;

5) оказание кормящим матерям (родителям) квалифицированной поддержки, консультирование медицинскими работниками, обученными по вопросам лактации, методике исключительно грудного вскармливания и дополнительного кормления;

6) поддержку практики грудного вскармливания, которую реализуют медицинские организации, дружественные к ребенку;

7) предоставление работодателем времени на обследование и постановку на медицинский учет по беременности до двенадцати недель с сохранением места работы, должности и средней заработной платы;

8) иные гарантии и поощрения в соответствии с законами Республики Казахстан.

4. Беременные женщины обязаны:

1) в срок до двенадцати недель беременности встать на медицинский учет по беременности по месту прикрепления для медицинского обслуживания в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

2) выполнять рекомендации врача в период беременности, во время родов и после родов.

5. Если женщина планирует беременность при наличии противопоказаний для беременности, то она полностью берет на себя ответственность за все риски для здоровья самой женщины и плода, последующие во время беременности и до сорока двух календарных дней после родов.

Статья 82. Обязанности индивидуальных предпринимателей и юридических лиц по охране здоровья работников

1. Индивидуальные предприниматели и юридические лица в соответствии с осуществляемой ими деятельностью обязаны:

1) проводить санитарно-противоэпидемические и санитарно-профилактические мероприятия;

2) выполнять нормативные правовые акты в сфере санитарно-эпидемиологического благополучия населения, а также акты должностных лиц, осуществляющих государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения;

3) обеспечивать безопасность и качество выполняемых работ, оказываемых услуг и продукции при ее производстве, транспортировке, хранении и реализации населению, утилизации и уничтожении;

4) осуществлять производственный контроль;

5) своевременно информировать государственный орган в сфере санитарно-эпидемиологического благополучия населения об аварийных ситуациях, остановках производства, о нарушениях технологических процессов, создающих угрозу санитарно-эпидемиологическому благополучию населения, в случаях возникновения массовых и групповых инфекционных и паразитарных, профессиональных заболеваний и отравлений;

6) своевременно информировать государственный орган в сфере обращения лекарственных средств и медицинских изделий в случае выявления побочных действий лекарственных средств и медицинских изделий;

7) обеспечивать гигиеническое обучение работников, относящихся к декретированной группе населения;

8) предоставлять должностным лицам государственного органа в сфере санитарно-эпидемиологического благополучия населения возможность проводить отбор проб продукции, сырья, товаров, производственной среды для проведения лабораторных исследований в соответствии с их компетенцией;

9) не допускать к работе лиц, не имеющих документ, удостоверяющий прохождение медицинского осмотра, гигиенического обучения, а также отстранять от работы больных инфекционными, паразитарными заболеваниями и носителей возбудителей инфекционных, паразитарных болезней, лиц, имеющих противопоказания к работе во вредных и (или) опасных условиях труда, выявленных субъектами здравоохранения, за исключением зараженных ВИЧ-инфекцией;

10) не допускать к реализации товары, продукты, сырье при установлении их несоответствия нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения, а также принимать решение о возможности их использования или утилизации;

11) представлять на проверку в государственный орган в сфере санитарно-эпидемиологического благополучия населения учетную и отчетную документацию, касающуюся вопросов санитарно-эпидемиологического благополучия населения;

12) приостанавливать предпринимательскую и (или) иную деятельность в случае создания ими угрозы жизни или здоровью населения;

13) обеспечивать беспрепятственный доступ должностных лиц, осуществляющих государственный контроль и надзор в сфере санитарно-эпидемиологического благополучия населения, к объектам в целях их проверки на предмет соблюдения нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения;

14) за счет собственных средств проводить по эпидемиологическим показаниям и предписаниям, постановлениям должностных лиц государственного органа в сфере санитарно-эпидемиологического благополучия населения дезинфекцию, дезинсекцию и дератизацию;

15) уплачивать отчисления и (или) взносы на обязательное социальное медицинское страхование в соответствии с Законом Республики Казахстан "Об обязательном социальном медицинском страховании".

2. Работодатель создает благоприятные условия для укрепления здоровья и профилактики заболеваний среди работников.

Статья 83. Права и обязанности кандасов, иностранцев, лиц без гражданства и иных лиц

1. Кандасы, беженцы, а также иностранцы и лица без гражданства, постоянно проживающие на территории Республики Казахстан, имеют право на получение гарантированного объема бесплатной медицинской помощи наравне с гражданами Республики Казахстан.

2. Иностранцы и лица без гражданства, временно пребывающие в Республике Казахстан, лица, ищущие убежище, имеют право на получение гарантированного объема бесплатной медицинской помощи при заболеваниях, представляющих опасность для окружающих, по перечню и в объеме, определяемых уполномоченным органом, если иное не предусмотрено законами Республики Казахстан или международными договорами, ратифицированными Республикой Казахстан.

Иностранцы и лица без гражданства, выявленные и идентифицированные в качестве жертв торговли людьми на территории Республики Казахстан, имеют право на получение гарантированного объема бесплатной медицинской помощи по перечню и в объеме, которые определяются уполномоченным органом.

3. Кандасы, беженцы и лица, ищущие убежище, иностранцы и лица без гражданства, находящиеся на территории Республики Казахстан, несут те же обязанности в области здравоохранения, что и граждане Республики Казахстан.

Сноска. Статья 83 с изменением, внесенным Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Глава 13. ОСОБЕННОСТИ ОРГАНИЗАЦИИ ОХРАНЫ ОБЩЕСТВЕННОГО ЗДОРОВЬЯ

Статья 84. Профилактика заболеваний и формирование здорового образа жизни

1. Целью профилактики заболеваний является предупреждение возникновения или прогрессирования заболеваний, а также их последствий и осложнений.

2. Профилактика заболеваний подразделяется на первичную, вторичную и третичную.

Первичная профилактика заболеваний (массовая и индивидуальная) направлена на создание благоприятных условий жизнедеятельности в целях предупреждения возникновения заболеваний.

Вторичная профилактика заболеваний направлена на предупреждение прогрессирования заболеваний на ранних стадиях и их последствий.

Третичная профилактика заболеваний направлена на контролирование уже развившихся осложнений, повреждений органов и тканей.

3. Профилактические и оздоровительные мероприятия проводятся в отношении всех групп населения на протяжении всей жизни и учитывают половозрастные, психологические и социальные аспекты.

4. Формирование здорового образа жизни включает в себя регулярное занятие физической зарядкой, пропаганду здорового образа жизни, здорового питания и профилактику заболеваний путем информационного обеспечения, гигиенического обучения и воспитания населения в вопросах укрепления здоровья и предупреждения болезней, связанных с образом жизни.

Физическая зарядка в организациях проводится в рабочие дни.

Типовые правила проведения занятия физической зарядкой разрабатываются и утверждаются уполномоченным органом.

Статья 85. Проведение профилактических прививок

1. Профилактические прививки – введение в организм человека иммунобиологических лекарственных препаратов для иммунопрофилактики в целях создания специфической невосприимчивости к инфекционным заболеваниям.

2. Профилактические прививки подразделяются на обязательные и добровольные.

3. Определяются следующие виды обязательных профилактических прививок:

1) плановые профилактические прививки;

2) профилактические прививки по эпидемиологическим показаниям.

4. Физические лица, постоянно находящиеся на территории Республики Казахстан, обязаны получать обязательные профилактические прививки против инфекционных и паразитарных заболеваний.

5. Перечень заболеваний, против которых проводятся обязательные профилактические прививки в рамках гарантированного объема медицинской помощи, порядок, сроки их проведения и группы населения, подлежащие профилактическим прививкам, определяются Правительством Республики Казахстан.

6. Плановым профилактическим прививкам подлежат лица, достигшие возраста в соответствии с перечнем заболеваний, против которых проводятся обязательные профилактические прививки, не имеющие медицинских противопоказаний.

7. Перед проведением профилактической прививки медицинским работником производится осмотр прививаемого лица. Медицинский работник предоставляет ему либо его законному представителю полную и объективную информацию о профилактической прививке, возможных неблагоприятных проявлениях и последствиях отказа от нее.

Перечень медицинских противопоказаний к проведению профилактических прививок утверждается уполномоченным органом.

8. Профилактическим прививкам по эпидемиологическим показаниям согласно перечню подлежат физические лица, не имеющие медицинских противопоказаний.

9. Проведение профилактических прививок, не входящих в перечень заболеваний, против которых проводятся обязательные профилактические прививки, является добровольным и осуществляется на платной основе.

Примечание ИЗПИ!
В пункт 10 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

10. Порядок регистрации и расследования неблагоприятных проявлений после иммунизации устанавливается уполномоченным органом.

11. Допуск в дошкольные организации детей, не получивших плановые профилактические прививки, осуществляется только при достижении порогового уровня коллективного иммунитета в дошкольной организации.

Коллективный иммунитет – косвенная защита непривитых лиц за счет достижения порогового уровня охвата плановыми профилактическими прививками населения против инфекций, предупреждаемых вакцинами.

Правила допуска в дошкольные организации детей, не получивших плановые профилактические прививки, и пороговый уровень коллективного иммунитета определяются уполномоченным органом.

Статья 86. Медицинский осмотр

1. Медицинский осмотр проводится для обеспечения своевременного медицинского обследования, направленного на выявление и предупреждение распространения заболеваний, в том числе профессиональных, отравлений, несчастных случаев, а также на обеспечение безопасности труда и охраны здоровья работников.

2. Виды медицинских осмотров: обязательные и профилактические.

3. Обязательные медицинские осмотры подразделяются на предварительные, периодические, предсменные (предрейсовые), послесменные (послерейсовые).

Предварительные обязательные медицинские осмотры проводятся при поступлении на работу или учебу с целью выяснения пригодности к выполнению обязанностей по профессии или учебе, а также предупреждения общих, профессиональных и нераспространения инфекционных и паразитарных заболеваний.

Периодические обязательные медицинские осмотры проводятся с целью обеспечения динамического наблюдения за состоянием здоровья работающих, своевременного установления начальных признаков заболеваний, предупреждения общих, профессиональных и нераспространения инфекционных и паразитарных заболеваний.

Предсменные (предрейсовые) обязательные медицинские осмотры проводятся в целях установления или подтверждения наличия или отсутствия у физического лица заболевания, определения состояния здоровья, а также временной нетрудоспособности, профессиональной пригодности к работе в заступаемую смену (рейс), в том числе алкогольного, наркотического или иного токсического опьянения и остаточных явлений такого опьянения.

Послесменные (послерейсовые) медицинские осмотры проводятся по окончании рабочего дня (смены, рейса) в целях выявления признаков воздействия вредных и (или) опасных производственных факторов рабочей среды и трудового процесса на состояние здоровья работников, острого профессионального заболевания или отравления, признаков алкогольного, наркотического или иного токсического опьянения.

4. Перечень вредных и (или) опасных производственных факторов, профессий и работ, при выполнении которых проводятся предварительные обязательные медицинские осмотры при поступлении на работу и периодические обязательные медицинские осмотры, утверждается уполномоченным органом.

5. Работодатели обеспечивают за счет собственных средств своевременное прохождение предсменных (предрейсовых), послесменных (послерейсовых) обязательных медицинских осмотров работниками, занятыми на тяжелых работах, работах с вредными и (или) опасными условиями труда, машинами и механизмами, в соответствии с законодательством Республики Казахстан в области здравоохранения.

Декретированная группа населения проходит обязательные медицинские осмотры за счет собственных средств либо за счет средств работодателя по соглашению сторон.

6. Целевые группы лиц, подлежащих обязательным медицинским осмотрам, а также порядок и периодичность их проведения, объем лабораторных и функциональных исследований, медицинские противопоказания определяются уполномоченным органом.

7. Работодатели создают условия для прохождения работниками медицинских осмотров, а также обязаны беспрепятственно отпускать работников для их прохождения в период рабочего времени с сохранением места работы (должности), заработной платы.

8. Работодатели не допускают к работе лиц, не прошедших обязательные медицинские осмотры и признанных непригодными к работе по состоянию здоровья. Результаты обязательных медицинских осмотров вносятся в личные медицинские книжки.

9. Порядок выдачи, учета и ведения личных медицинских книжек определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

10. Профилактические медицинские осмотры проводятся среди детского населения и включают в себя комплекс медицинских и иных мероприятий, направленных на предупреждение возникновения заболеваний и их раннюю диагностику, с последующим динамическим наблюдением и оздоровлением.

11. Правила, объем и периодичность проведения профилактических медицинских осмотров целевых групп населения, включая детей дошкольного, школьного возрастов, а также учащихся организаций технического и профессионального, послесреднего и высшего образования, разрабатываются и утверждаются уполномоченным органом.

12. Своевременность, качество проведения и прохождения профилактических и обязательных медицинских осмотров контролируются государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Статья 87. Скрининговые исследования

1. Скрининговые исследования проводятся среди целевых групп населения с целью выявления заболеваний на ранних стадиях и предупреждения развития заболеваний, факторов риска, способствующих возникновению заболеваний, формирования и укрепления здоровья населения.

2. Целевые группы лиц, подлежащих скрининговым исследованиям, должны проходить скрининговые исследования в порядке, объеме и с периодичностью проведения данных исследований, определяемых уполномоченным органом.

3. Результаты проведенных скрининговых исследований вводятся субъектами здравоохранения, осуществляющими данные исследования, в электронный паспорт здоровья.

4. Работодатели создают условия для прохождения скрининговых исследований лицам, подлежащим данным осмотрам, в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования, а также беспрепятственно отпускают работников для их прохождения в период рабочего времени с сохранением места работы (должности), средней заработной платы в соответствии с трудовым законодательством Республики Казахстан.

5. Своевременность и качество скрининговых исследований контролируются государственным органом в сфере оказания медицинских услуг (помощи).

Статья 88. Динамическое наблюдение

1. Динамическое наблюдение осуществляется за пациентами с хроническими заболеваниями в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования.

2. Перечень хронических заболеваний, подлежащих динамическому наблюдению, утверждается уполномоченным органом.

3. Правила организации оказания медицинской помощи лицам с хроническими заболеваниями, периодичность и сроки наблюдения, обязательный минимум и кратность диагностических исследований утверждаются уполномоченным органом.

Статья 89. Экспертиза временной нетрудоспособности

1. Экспертиза временной нетрудоспособности проводится в целях официального признания нетрудоспособности физического лица и его временного освобождения от выполнения трудовых обязанностей на период заболевания.

2. Порядок проведения экспертизы временной нетрудоспособности, а также выдачи листа или справки о временной нетрудоспособности устанавливается уполномоченным органом.

Статья 90. Первая помощь

1. Первая помощь – это комплекс срочных базовых мероприятий для спасения жизни человека, предупреждения осложнений при экстренных состояниях, а также в целях снижения угрозы для здоровья и жизни пострадавшего лица при неотложном состоянии, проводимых на месте происшествия самим пострадавшим (самопомощь) или другим лицом, находящимся поблизости (взаимопомощь), до прибытия медицинских работников.

Первая помощь может оказываться лицами без медицинского образования, в том числе прошедшими соответствующую подготовку, в порядке, определяемом уполномоченным органом.

2. Подготовка сертифицированных тренеров для обучения граждан Республики Казахстан навыкам оказания первой помощи осуществляется организациями здравоохранения, соответствующими требованиям, определяемым уполномоченным органом.

3. Перечень профессий с указанием контингента работников, подлежащих обязательному прохождению курсов первой помощи, а также периодичность их прохождения утверждаются уполномоченным органом совместно с заинтересованными государственными органами.

4. Правила обучения граждан Республики Казахстан навыкам оказания первой помощи, а также перечень экстренных и неотложных состояний, при которых оказывается первая помощь, разрабатываются и утверждаются уполномоченным органом.

5. Обучение навыкам оказания первой помощи проводится за счет средств бюджета, средств работодателя или собственных средств граждан Республики Казахстан.

6. Стандарт оказания первой помощи разрабатывается и утверждается уполномоченным органом.

Статья 91. Дошкольная и школьная медицина

1. Деятельность дошкольной и школьной медицины направлена на охрану здоровья и динамическое наблюдение за состоянием здоровья воспитанников и школьников.

2. Мероприятия по охране здоровья воспитанников и школьников включают в себя:

1) проведение профилактических медицинских осмотров непосредственно в дошкольных и учебных заведениях, в том числе с привлечением выездных бригад специалистов;

2) организацию оздоровительных мероприятий в учебный период и во время каникул;

3) внедрение в организациях дошкольного и среднего образования здоровьесберегающих технологий, направленных на профилактику заболеваний, внедрение и соблюдение принципов рационального питания, охрану репродуктивного здоровья;

4) охрану психического здоровья, профилактику суицидального поведения и зависимостей, вызванных потреблением табачных изделий, немедицинским употреблением психоактивных веществ, а также патологическим влечением к азартным играм;

5) направление школьников на углубленное медицинское обследование по результатам профилактических осмотров;

6) вакцинацию согласно Национальному календарю прививок;

7) организацию и проведение обучающих семинаров, тренингов и лекций по профилактике заболеваний, пропаганде и формированию здорового образа жизни среди школьников, оказанию первой помощи;

8) вовлечение родителей и педагогов в охрану здоровья воспитанников и школьников с проведением образовательных и разъяснительных мероприятий;

9) соблюдение требований санитарных правил;

10) оказание первой помощи при неотложных состояниях до прибытия медицинских работников, оказывающих скорую медицинскую помощь.

3. Организация медицинской помощи воспитанникам и школьникам осуществляется субъектами здравоохранения, оказывающими первичную медико-санитарную помощь, на территории обслуживания которых находятся организации дошкольного и среднего (начального, основного среднего, общего среднего) образования.

4. Организация деятельности дошкольной и школьной медицины осуществляется местными органами государственного управления здравоохранением.

Статья 92. Особенности предоставления услуг по охране репродуктивного и психического здоровья несовершеннолетним в возрасте от десяти до восемнадцати лет и молодежи

1. Субъекты здравоохранения предоставляют несовершеннолетним в возрасте от десяти до восемнадцати лет и молодежи конфиденциальную комплексную помощь, включающую медицинские, психосоциальные и юридические услуги.

2. Доступ несовершеннолетних в возрасте от десяти до восемнадцати лет и молодежи к услугам и средствам охраны репродуктивного и психического здоровья осуществляется без наличия направления от специалистов первичного звена здравоохранения.

3. Правила организации медицинской помощи по охране репродуктивного и психического здоровья несовершеннолетних в возрасте от десяти до восемнадцати лет и молодежи разрабатываются и утверждаются уполномоченным органом.

Глава 14. ДЕЯТЕЛЬНОСТЬ В СФЕРЕ САНИТАРНО-ЭПИДЕМИОЛОГИЧЕСКОГО БЛАГОПОЛУЧИЯ НАСЕЛЕНИЯ

Статья 93. Система государственной санитарно-эпидемиологической службы

В единую систему государственной санитарно-эпидемиологической службы входят:

1) государственный орган в сфере санитарно-эпидемиологического благополучия населения и его территориальные подразделения;

2) структурные подразделения иных государственных органов, осуществляющие деятельность в сфере санитарно-эпидемиологического благополучия населения;

3) юридические и физические лица, осуществляющие деятельность в сфере санитарно-эпидемиологического благополучия населения.

Статья 94. Государственное санитарно-эпидемиологическое нормирование

1. Государственное санитарно-эпидемиологическое нормирование является деятельностью санитарно-эпидемиологической службы и включает в себя:

1) разработку единых требований по обоснованию документов санитарно-эпидемиологического нормирования и контроль за их разработкой;

2) разработку (переработку), экспертизу, утверждение и опубликование документов санитарно-эпидемиологического нормирования;

3) изучение, обобщение практики применения, контроль за применением документов санитарно-эпидемиологического нормирования;

4) формирование и ведение единого банка данных документов санитарно-эпидемиологического нормирования;

5) гармонизацию документов санитарно-эпидемиологического нормирования с общепринятыми международными требованиями.

2. Документами государственной системы санитарно-эпидемиологического нормирования являются санитарные правила, гигиенические нормативы, технические регламенты, единые санитарно-эпидемиологические и гигиенические требования к товарам Евразийского экономического союза, инструкции, методические рекомендации, методические указания, методики, приказы, правила и стандарты.

3. Порядок разработки и утверждения документов государственной системы санитарно-эпидемиологического нормирования определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

4. К нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения относятся санитарные правила, гигиенические нормативы, правила, технические регламенты и единые санитарно-эпидемиологические и гигиенические требования к товарам Евразийского экономического союза.

5. Государственные органы при разработке и утверждении нормативных правовых актов, касающихся вопросов в сфере санитарно-эпидемиологического благополучия населения, обязаны согласовывать их с государственным органом в сфере санитарно-эпидемиологического благополучия населения.

6. Нормативные правовые акты в сфере санитарно-эпидемиологического благополучия населения и документы государственной системы санитарно-эпидемиологического нормирования, содержащие требования к обращению с патогенными биологическими агентами, разрабатываются и применяются с учетом требований в области биологической безопасности.

Сноска. Статья 94 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 95. Санитарно-эпидемиологические требования

1. Санитарные правила устанавливают санитарно-эпидемиологические требования к объектам, подлежащим государственному контролю и надзору в сфере санитарно-эпидемиологического благополучия населения, и содержат требования к:

1) выбору земельного участка под строительство объекта;

2) проектированию, строительству новых, реконструкции, переоборудованию, перепланировке и расширению существующих объектов, ремонту и вводу в эксплуатацию объектов;

3) содержанию и эксплуатации производственных, общественных, жилых и других помещений, зданий, сооружений, оборудования, транспортных средств;

4) водоснабжению, водоотведению, теплоснабжению, освещению, вентиляции, кондиционированию объектов;

5) приему, хранению, переработке (обработке) сырья;

6) условиям производства, расфасовки, транспортировки, хранения, реализации, утилизации пищевой продукции, утилизации табачной продукции;

7) условиям производства, расфасовки, транспортировки, хранения, реализации, утилизации и уничтожения иммунологических лекарственных препаратов (иммунобиологических лекарственных препаратов);

8) применению и использованию потенциально опасных химических и биологических веществ (в том числе токсичных, радиоактивных, биологических и химических веществ, ядов и ядовитых веществ, биологических и микробиологических организмов и их токсинов, биологических средств и материалов), их утилизации (уничтожению), транспортировке, хранению, захоронению и условиям работы с ними;

9) условиям работы с источниками физических факторов, оказывающих воздействие на человека;

10) условиям промышленного производства лекарственных средств;

11) продукции производственно-технического назначения;

12) товарам хозяйственно-бытового и гигиенического назначения и технологиям их производства, утилизации и уничтожения;

13) условиям воспитания, обучения, проживания и производственной практики, физического развития, труда, отдыха, питания, водоснабжения и медицинского обслуживания различных групп населения;

14) учебно-трудовой нагрузке и режиму занятий в организациях образования;

15) условиям проведения стерилизации и дезинфекции медицинских изделий;

16) организации специализированного (детского, диетического лечебного и диетического профилактического), лечебно-профилактического, общественного питания населения;

17) водоисточникам (местам водозабора для хозяйственно-питьевых целей), хозяйственно-питьевому водоснабжению и местам культурно-бытового водопользования и безопасности водных объектов;

18) сбору, использованию, применению, обезвреживанию, транспортировке, хранению и захоронению отходов производства и потребления;

19) организации и осуществлению работ и услуг, включающих разработку, испытание, изготовление, производство, хранение, транспортировку, реализацию, применение средств дезинфекции, дезинсекции и дератизации, оборудования, материалов, содержание и эксплуатацию объектов дезинфекционной деятельности, а также контроль эффективности и безопасности работ и услуг;

20) условиям перевозки пассажиров;

21) ликвидации, консервации, перепрофилированию объектов;

22) осуществлению производственного контроля;

23) условиям труда, бытового обслуживания, медицинского обеспечения, специализированного диетического лечебного и диетического профилактического питания;

24) гигиеническому воспитанию и обучению населения;

25) организации и проведению санитарно-противоэпидемических и санитарно-профилактических мероприятий, в том числе осуществлению санитарной охраны территории Республики Казахстан, введению ограничительных мероприятий, в том числе карантина, в отношении больных инфекционными и паразитарными заболеваниями, проведению медицинских осмотров, профилактических прививок населения;

26) зонам санитарной охраны и санитарно-защитным зонам, санитарным разрывам;

27) оптимальным уровням шума на рабочих местах, допустимым уровням шума в помещениях жилых, общественных зданий и на территории жилой застройки;

Примечание ИЗПИ!
Подпункт 28) предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

28) организации и проведению профилактических прививок населению, расследованию случаев неблагоприятных проявлений после иммунизации;

29) организации и проведению дезинфекции, дезинсекции и дератизации на территории природных очагов инфекционных заболеваний, а также в очагах инфекционных заболеваний.

Примечание ИЗПИ!
Пункт 1 предусмотрено дополнить подпунктом 30) в соответствии с Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

2. Гигиенические нормативы устанавливают нормативы предельно допустимых концентраций вредных веществ (химических, биологических), физических воздействий, допустимых уровней радиационного воздействия, соблюдение которых обеспечивает человеку благоприятные для жизни и безопасные для здоровья условия жизнедеятельности.

3. Гигиенические нормативы устанавливаются к:

1) микроклимату, воздухообмену, воздуху рабочей зоны, физическим факторам производственных, жилых и других помещений, территории промышленной застройки;

2) радиационной, химической, микробиологической, токсикологической, паразитологической безопасности продукции (товаров) и среде обитания;

3) атмосферному воздуху в городских и сельских населенных пунктах, на территориях промышленных организаций;

4) физическим факторам, предельно допустимым выбросам и предельно допустимым сбросам вредных веществ в окружающую среду;

5) новым видам продукции, технологического оборудования, процессам.

Сноска. Статья 95 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 95-1. Коллекции патогенных и промышленных микроорганизмов

Сбор, идентификация, изучение, учет, паспортизация, хранение (депонирование) и содержание национальной и рабочих коллекций патогенных и промышленных микроорганизмов, используемых в сфере санитарно-эпидемиологического благополучия населения, осуществляются с учетом законодательства Республики Казахстан в области биологической безопасности.

Сноска. Глава 14 дополнена статьей 95-1 в соответствии с Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Глава 15. ПРОФИЛАКТИКА ИНФЕКЦИОННЫХ И НЕИНФЕКЦИОННЫХ ЗАБОЛЕВАНИЙ

Параграф 1. Профилактика инфекционных заболеваний

Статья 96. Гигиеническое обучение населения

1. Гигиеническое обучение декретированной группы населения –обучение по профилактике инфекционных и паразитарных, профессиональных заболеваний, нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения (содержанию, эксплуатации и размещению объектов, соблюдению личной и общественной гигиены) в соответствии с профессиями обучающихся.

Перечень декретированной группы населения, подлежащей гигиеническому обучению, определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

2. Оплата за гигиеническое обучение осуществляется декретированными лицами самостоятельно либо работодателем по соглашению сторон.

3. Контроль за качеством проведения гигиенического обучения декретированной группы населения осуществляется органами государственной санитарно-эпидемиологической службы посредством:

1) мониторинга уведомлений о начале и прекращении деятельности;

2) проверки соблюдения порядка и программы проведения гигиенического обучения;

3) проверки знаний лиц, относящихся к декретированной группе, в ходе проверок, профилактического контроля.

Статья 97. Требования к лицам, осуществляющим деятельность по гигиеническому обучению

1. Деятельность по гигиеническому обучению декретированных групп населения осуществляется физическими лицами или представителями юридических лиц, имеющими высшее образование санитарно-гигиенического (медико-профилактического) профиля.

2. Физические и юридические лица до начала и после прекращения деятельности по проведению гигиенического обучения обязаны уведомить об этом территориальное подразделение государственного органа в сфере санитарно-эпидемиологического благополучия населения в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях".

3. Лица, осуществляющие деятельность по гигиеническому обучению, обязаны:

1) обеспечить качественное проведение обучения;

2) соблюдать нормативные правовые акты в сфере санитарно-эпидемиологического благополучия населения;

3) проводить обучение на основе документов государственного санитарно-эпидемиологического нормирования согласно программам обучения, соответствующим профессиям декретированных групп населения;

4) соблюдать порядок проведения гигиенического обучения;

5) не допускать совмещения гигиенического обучения различных декретированных групп населения.

Статья 98. Профилактика туберкулеза

1. Мероприятия по профилактике туберкулеза осуществляются путем:

1) проведения эпидемиологического надзора за распространенностью туберкулеза среди населения;

2) специфической профилактики, включающей вакцинацию согласно Национальному календарю прививок;

3) раннего выявления туберкулеза;

4) лечения активного туберкулеза и латентной туберкулезной инфекции;

5) применения комплекса мер инфекционного контроля, направленного на предотвращение передачи возбудителя туберкулеза через окружающий воздух в обитаемой среде;

6) социальной профилактики: улучшение жилищно-бытовых условий жизни населения и качества питания; борьба с немедицинским употреблением психоактивных веществ, курением; привитие населению навыков личной гигиены в быту; развитие физической культуры и спорта;

7) информирования населения через средства массовой информации об эпидемической ситуации по туберкулезу и о мерах профилактики;

8) разработки и распространения информационных материалов по профилактике туберкулеза для различных групп населения, в том числе через социальные сети и средства массовой информации;

9) размещения и реализации государственных социальных грантов и государственных социальных заказов через неправительственные организации.

2. Проведение мероприятий по профилактике туберкулеза осуществляется в порядке, определяемом уполномоченным органом.

Статья 99. Профилактика ВИЧ-инфекции

1. Мероприятия по профилактике ВИЧ-инфекции осуществляются путем:

1) проведения эпидемиологического слежения за распространенностью ВИЧ-инфекции среди населения, в том числе ключевых групп населения;

2) информирования различных групп населения по вопросам ВИЧ-инфекции через информационные материалы, социальные сети и средства массовой информации;

3) интеграции вопросов профилактики ВИЧ-инфекции в систему образования и на рабочих местах;

4) предоставления ключевым группам населения лечебно-профилактических услуг в пунктах доверия, дружественных кабинетах.

Дружественный кабинет – специально организованный пункт предоставления профилактической и лечебно-диагностической помощи при инфекционных заболеваниях, передаваемых половым путем, зараженным ВИЧ-инфекцией и ключевым группам населения на бесплатной основе по принципам добровольности и конфиденциальности;

5) размещения и реализации государственных социальных грантов и государственных социальных заказов через неправительственные организации;

6) обеспечения инфекционной безопасности донорства и трансплантации, а также при оказании населению услуг, связанных с нарушением целостности кожных покровов и слизистых;

7) предупреждения передачи ВИЧ-инфекции от матери плоду и ребенку;

8) предоставления доконтактной и постконтактной профилактики;

9) предоставления антиретровирусной терапии для снижения риска передачи ВИЧ-инфекции с момента установления диагноза.

2. Проведение мероприятий по профилактике ВИЧ-инфекции осуществляется в порядке, определяемом уполномоченным органом.

Статья 100. Обращение медицинских отходов

1. Медицинские отходы относятся к одному из видов отходов производства и потребления, образующихся в процессе оказания медицинских услуг и проведения медицинских манипуляций.

2. Медицинские отходы по степени опасности подразделяются на 5 классов опасности:

1) класс А – неопасные медицинские отходы, подобные твердым бытовым отходам;

2) класс Б – опасные (эпидемиологически) медицинские отходы;

3) класс В – чрезвычайно (эпидемиологически) опасные медицинские отходы;

4) класс Г – токсикологически опасные медицинские отходы, по составу близкие к промышленным;

5) класс Д – радиоактивные медицинские отходы.

Медицинские отходы классов Б – Д являются опасными отходами.

3. Санитарно-эпидемиологические требования к сбору, транспортировке, хранению, обезвреживанию, использованию медицинских отходов определяются санитарными правилами, утверждаемыми государственным органом в сфере санитарно-эпидемиологического благополучия населения.

4. Собственники отходов в соответствии с экологическим законодательством Республики Казахстан предоставляют информацию в уполномоченный орган в области охраны окружающей среды в виде ежегодного отчета в области обращения с медицинскими отходами (далее – отчет) для внесения их в Государственный кадастр отходов производства и потребления.

5. Информация по медицинским отходам предоставляется ежегодно по состоянию на 1 января до 1 марта года, следующего за отчетным, на электронном и (или) бумажном носителях.

6. Собственники отходов обеспечивают полноту, непрерывность и достоверность данных отчетов.

7. Порядок предоставления информации по медицинским отходам определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Статья 101. Требования к лицам, осуществляющим деятельность по сбору, транспортировке, хранению, обезвреживанию, захоронению и (или) использованию медицинских отходов

1. Деятельность по сбору, транспортировке, хранению, обезвреживанию, использованию медицинских отходов осуществляется физическими и юридическими лицами.

2. Физические и юридические лица, осуществляющие деятельность по сбору, транспортировке, хранению, обезвреживанию, захоронению и использованию медицинских отходов, до начала деятельности обязаны получить разрешительные документы в порядке, установленном законодательством Республики Казахстан о разрешениях и уведомлениях.

3. Квалификационные требования к физическим и юридическим лицам, осуществляющим деятельность по сбору, транспортировке, хранению, обезвреживанию, захоронению и использованию медицинских отходов, устанавливаются государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Статья 102. Санитарно-противоэпидемические, санитарно-профилактические мероприятия

1. В целях предупреждения возникновения и распространения инфекционных и паразитарных заболеваний, отравлений населения проводятся санитарно-противоэпидемические, санитарно-профилактические мероприятия, в том числе по осуществлению санитарной охраны территории Республики Казахстан, введению ограничительных мероприятий, в том числе карантина, в отношении лиц, больных инфекционными и паразитарными заболеваниями, по проведению медицинских осмотров, профилактических прививок, гигиенического обучения лиц, относящихся к декретированной группе населения, и лиц, занятых на тяжелых работах, работах с вредными и (или) опасными условиями труда.

2. Санитарно-противоэпидемические, санитарно-профилактические мероприятия подлежат включению в разрабатываемые документы Системы государственного планирования Республики Казахстан.

Примечание ИЗПИ!
В пункт 3 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

3. Лица, больные инфекционными и паразитарными заболеваниями, а также лица с подозрением на инфекционное и паразитарное заболевания, бактерионосители подлежат изоляции и (или) лечению, а находившиеся в контакте с ними лица – медицинскому наблюдению и при необходимости изоляции и (или) лечению.

4. Лица, больные хроническими инфекционными и паразитарными заболеваниями (за исключением зараженных ВИЧ-инфекцией), хронические бактерионосители, представляющие опасность для окружающих, подлежат временному отстранению от работы в соответствии с трудовым законодательством Республики Казахстан.

Статья 103. Санитарная охрана территории Республики Казахстан

1. Санитарно-карантинный контроль в пунктах пропуска (санитарных карантинных пунктах) через Государственную границу Республики Казахстан проводится территориальными подразделениями государственного органа в сфере санитарно-эпидемиологического благополучия населения.

2. Не допускаются к ввозу на территорию Республики Казахстан опасные грузы и товары, ввоз которых запрещен, а также грузы и товары, в отношении которых при проведении санитарно-карантинного надзора установлено, что их ввоз на территорию Республики Казахстан создаст угрозу возникновения и распространения инфекционных заболеваний или массовых неинфекционных заболеваний и отравлений.

3. Радиологический контроль за грузом и товаром, пассажирами в пунктах пропуска через Государственную границу Республики Казахстан проводится органами государственных доходов Республики Казахстан.

Статья 104. Условия введения ограничительных мероприятий, в том числе карантина, в случае угрозы возникновения эпидемий, инфекционных заболеваний

1. В случае угрозы ввоза на территорию Республики Казахстан и (или) распространения на всей территории Республики Казахстан инфекционных и паразитарных заболеваний Главный государственный санитарный врач Республики Казахстан вводит ограничительные мероприятия, в том числе карантин, в пунктах пропуска через Государственную границу Республики Казахстан, совпадающую с таможенной границей Евразийского экономического союза, или на всей территории Республики Казахстан с особыми условиями предпринимательской и (или) иной деятельности и жизни населения.

2. В случае угрозы распространения инфекционных и паразитарных заболеваний на соответствующих административно-территориальных единицах (на отдельных объектах) главные государственные санитарные врачи вводят ограничительные мероприятия, в том числе карантин, на соответствующих административно-территориальных единицах (на отдельных объектах) с особыми условиями предпринимательской и (или) иной деятельности и жизни населения.

3. Ограничительные мероприятия, в том числе карантин, вводятся (отменяются) постановлением Главного государственного санитарного врача Республики Казахстан или главного государственного санитарного врача соответствующей административно-территориальной единицы (на транспорте), а также на ведомственных объектах иных государственных органов решением главного государственного санитарного врача структурных подразделений государственного органа в сфере санитарно-эпидемиологического благополучия населения.

Постановление главного государственного санитарного врача подлежит опубликованию (распространению) в средствах массовой информации и обязательному исполнению.

4. Оперативное руководство по координации деятельности центральных и местных исполнительных органов, физических и юридических лиц в случаях введения ограничительных мероприятий, в том числе карантина, возлагается на межведомственную государственную комиссию по предупреждению и ликвидации чрезвычайных ситуаций и территориальные комиссии по чрезвычайным ситуациям.

5. Порядок осуществления ограничительных мероприятий, в том числе карантина, и перечень инфекционных заболеваний, при угрозе возникновения и распространения которых вводятся ограничительные мероприятия, в том числе карантин, устанавливаются государственным органом в сфере санитарно-эпидемиологического благополучия населения.

6. Ограничительные мероприятия, в том числе карантин, вводятся в зависимости от территориальных особенностей, контагиозности, путей передачи, летальности и других эпидемически значимых факторов распространения инфекционных заболеваний в соответствии с критериями определения рисков завоза инфекционных заболеваний из-за рубежа на территорию Республики Казахстан и (или) возникновения случаев инфекционных заболеваний, устанавливаемыми уполномоченным органом.

6-1. В целях обеспечения соблюдения ограничительных мероприятий, в том числе карантина, в соответствующих административно-территориальных единицах местными исполнительными органами могут создаваться мониторинговые группы.

Информация о созданных мониторинговых группах, составе и полномочиях, а также алгоритм действия мониторинговой группы размещаются в средствах массовой информации и на сайтах местных исполнительных органов.

Деятельность таких групп осуществляется путем проведения мониторинга за соблюдением физическими и юридическими лицами общественного порядка, санитарно-противоэпидемических, санитарно-профилактических и ограничительных мероприятий, в том числе карантина, связанных с предупреждением угрозы распространения инфекционных заболеваний.

Проведение мониторинга не является проверкой и не относится к иным формам государственного контроля и надзора.

Для проведения мониторинга указанные группы осуществляют предварительную регистрацию на информационном ресурсе для получения в электронной форме акта о назначении мониторинга, предъявляемого при посещении объекта.

Мониторинговые группы имеют право на сбор фото- и видеоинформации, указывающей на признаки нарушения постановления Главного государственного санитарного врача Республики Казахстан и нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения, связанных с предупреждением угрозы распространения инфекции, для последующего ее направления в государственный орган в сфере санитарно-эпидемиологического благополучия населения в порядке, установленном законодательством Республики Казахстан, не вмешиваясь в работу субъектов предпринимательства и не создавая препятствий в осуществлении законной предпринимательской деятельности.

К компетенции мониторинговых групп не относится возбуждение дел об административных правонарушениях.

Примечание ИЗПИ!
Часть восьмую пункта 3 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

В случае присутствия в период введения ограничительных мероприятий, в том числе карантина, в составе мониторинговой группы представителя государственного органа в сфере санитарно-эпидемиологического благополучия населения в соответствии с порядком создания мониторинговых групп и проведения мониторинга мониторинговая группа вправе пресекать нарушения условий ограничительных мероприятий, в том числе карантина, на месте вплоть до приостановления деятельности субъектов предпринимательства. В этом случае возбуждение дел об административных правонарушениях производится непосредственно представителем государственного органа в сфере санитарно-эпидемиологического благополучия населения.

Мониторинговые группы осуществляют свою деятельность в рамках нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения и постановлений Главного государственного санитарного врача Республики Казахстан, связанных с предупреждением угрозы распространения инфекции.

По результатам мониторинга субъекта предпринимательства в случае выявления нарушений требований законодательства Республики Казахстан в сфере санитарно-эпидемиологического благополучия населения, связанных с предупреждением угрозы распространения инфекции, должностное лицо государственного органа в сфере санитарно-эпидемиологического благополучия населения выдает постановление о проведении санитарно-противоэпидемических и санитарно-профилактических мероприятий.

Порядок создания мониторинговых групп и проведения мониторинга определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

При осуществлении деятельности мониторинговых групп субъекты предпринимательства имеют право на защиту своих прав и законных интересов, включая неприкосновенность собственности, в соответствии с Предпринимательским кодексом и законодательством Республики Казахстан.

7. Ограничительные мероприятия, в том числе карантин, включают:

1) ограничение въезда на территорию Республики Казахстан из-за рубежа (выезда из территории Республики Казахстан) и передвижения в отдельных регионах (областях, городах республиканского значения и столице) транспортными средствами (воздушным, железнодорожным, автомобильным);

2) ограничение деятельности объектов предпринимательской и (или) иной деятельности;

3) ограничение организации и проведения мирных собраний, зрелищных, спортивных, религиозных и других массовых мероприятий, а также семейных обрядов, связанных с рождением, свадьбой, смертью;

4) ограничение производства, ввоза, вывоза, применения и реализации на территории Республики Казахстан продукции, предназначенной для использования и применения населением, а также в предпринимательской и (или) иной деятельности;

5) проведение в пунктах пропуска на Государственной границе Республики Казахстан бесконтактной термометрии, лабораторного обследования и, в случае необходимости, изоляцию лиц, прибывающих из неблагополучных по инфекционным заболеваниям стран;

6) направление на лабораторное обследование, изоляцию и госпитализацию (или изоляцию на дому), медицинское наблюдение, лечение больных инфекционными заболеваниями;

7) направление лиц, являющихся потенциальными источниками распространения инфекционных заболеваний, лиц, находившихся в контакте с инфекционными больными, а также лиц с подозрением на инфекционное заболевание на лабораторное и медицинское обследование и изоляцию;

8) применение мер личной и коллективной профилактики инфекционных заболеваний;

9) проведение профилактической и очаговой дезинфекции, дезинсекции и дератизации в помещениях и на транспортных средствах, территориях, в очагах инфекционных заболеваний.

      Сноска. Статья 104 с изменением, внесенным Законом РК от 30.12.2021 № 95-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      Примечание ИЗПИ!
      В заголовок статьи 105 предусмотрены изменения Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 105. Регистрация и расследование случаев инфекционных, паразитарных заболеваний и (или) отравлений

1. Все случаи инфекционных и паразитарных заболеваний и (или) отравлений, неблагоприятных проявлений после иммунизации подлежат регистрации субъектами здравоохранения по месту их выявления, государственному учету и ведению отчетности государственными органами и организациями санитарно-эпидемиологической службы.

Примечание ИЗПИ!
Пункт 2 предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

2. Случаи инфекционных и паразитарных заболеваний и (или) отравлений населения подлежат расследованию специалистами государственного органа в сфере санитарно-эпидемиологического благополучия населения.

Примечание ИЗПИ!
В пункт 3 предусмотрены изменения Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

3. Регистрация и расследование, ведение учета и отчетности случаев инфекционных, паразитарных заболеваний и (или) отравлений, неблагоприятных проявлений после иммунизации производятся в порядке, определяемом уполномоченным органом.

4. Расследование случаев заражения ВИЧ-инфекцией среди населения проводится специалистами субъектов здравоохранения, осуществляющих деятельность в сфере профилактики ВИЧ-инфекции, в порядке, определяемом уполномоченным органом.

Примечание ИЗПИ!
Пункт 5 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

5. Государственный орган в сфере санитарно-эпидемиологического благополучия населения, структурные подразделения иных государственных органов, осуществляющие деятельность в сфере санитарно-эпидемиологического благополучия населения, в течение семи календарных дней со дня поступления экстренного извещения проводят эпидемиологическое расследование случаев инфекционных и паразитарных заболеваний и (или) отравлений населения.

Примечание ИЗПИ!
Пункт 6 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

6. В случае регистрации карантинных и особо опасных заболеваний в войсках, подразделениях и ведомственных организациях сроки проведения эпидемиологических расследований, утверждаемые уполномоченным органом, могут изменяться решением главных государственных санитарных врачей иных государственных органов, осуществляющих деятельность в сфере санитарно-эпидемиологического благополучия населения, в зависимости от места регистрации.

Примечание ИЗПИ!
Заголовок статьи 106 предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 106. Регистрация и расследование случаев профессиональных заболеваний и (или) отравлений

Примечание ИЗПИ!
В пункт 1 предусмотрены изменения Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

1. Все случаи профессиональных заболеваний и (или) отравлений, в том числе подозрений на профессиональные заболевания и (или) отравления, обусловленные воздействием на работника вредных производственных факторов в связи с выполнением работником своих трудовых (служебных) обязанностей либо иных действий по собственной инициативе в интересах работодателя, подлежат регистрации субъектами здравоохранения по месту их выявления в порядке, определяемом уполномоченным органом.

Примечание ИЗПИ!
В пункт 2 предусмотрены изменения Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

2. Случаи профессиональных заболеваний и (или) отравлений подлежат учету в государственных организациях здравоохранения, оказывающих специализированную медицинскую помощь в области профессиональной патологии и экспертизы, и государственному учету и ведению отчетности государственными органами и организациями санитарно-эпидемиологической службы.

3. Случаи профессиональных заболеваний и (или) отравлений, обусловленные воздействием на работника вредных производственных факторов в связи с выполнением работником своих трудовых (служебных) обязанностей либо иных действий по собственной инициативе в интересах работодателя, подлежат расследованию.

4. Работодатель немедленно в течение суток сообщает в государственный орган в сфере санитарно-эпидемиологического благополучия населения обо всех случаях профессиональных заболеваний и (или) отравлений, связанных с выполнением работником своих трудовых (служебных) обязанностей либо иных действий по собственной инициативе в интересах работодателя, по форме, установленной уполномоченным государственным органом по труду.

5. Ответственность за организацию расследования профессиональных заболеваний и (или) отравлений на производстве несет работодатель.

6. Работодатель беспрепятственно допускает должностных лиц государственного органа в сфере санитарно-эпидемиологического благополучия населения для проведения расследования профессиональных заболеваний и (или) отравлений.

Примечание ИЗПИ!
Пункт 7 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

7. Организация расследования случаев профессиональных заболеваний и (или) отравлений, происшедших с прикомандированными работниками, возлагается на юридическое лицо, к которому работник был прикомандирован, с участием представителя работодателя.

Примечание ИЗПИ!
Пункт 8 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

8. Для решения вопросов, требующих экспертного заключения, к работе комиссии по расследованию профессиональных заболеваний и (или) отравлений привлекаются специалисты научно-исследовательских организаций и (или) организаций здравоохранения, оказывающих специализированную медицинскую помощь в области профессиональной патологии и экспертизы, за счет средств работодателя.

Примечание ИЗПИ!
Пункт 9 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

9. Расследование обстоятельств и причин возникновения хронического профессионального заболевания и (или) отравления у лиц, не имеющих на момент расследования контакта с вредным производственным фактором, вызвавшим это профессиональное заболевание, в том числе у неработающих, проводится по месту прежней работы с вредным производственным фактором с учетом ответственности всех работодателей пропорционально стажу работы во вредных условиях у каждого работодателя.

Примечание ИЗПИ!
Пункт 10 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

10. Условия расследования профессиональных заболеваний и (или) отравлений, связанных с трудовой деятельностью, на режимных объектах определяются с учетом особенностей доступа для нахождения на этих объектах.

Статья 107. Дезинфекция, дезинсекция и дератизация

1. В целях предупреждения возникновения, распространения инфекционных и паразитарных заболеваний физические и юридические лица обязаны за счет своих средств на систематической основе в соответствии с документами государственного санитарно-эпидемиологического нормирования проводить профилактические, а также по эпидемиологическим показаниям дезинфекцию, дезинсекцию и дератизацию.

2. При возникновении эпидемических чрезвычайных ситуаций решением местного исполнительного органа области, города республиканского значения и столицы по представлению государственного органа в сфере санитарно-эпидемиологического благополучия населения за счет бюджетных средств проводятся внеочередные обязательные дезинфекция, дезинсекция или дератизация.

3. Профилактические дезинсекция и дератизация (за исключением дезинсекции и дератизации на территории природных очагов инфекционных заболеваний, а также в очагах инфекционных заболеваний) проводятся местными исполнительными органами областей, городов республиканского значения, столицы, района, городов областного значения.

4. Очаговые дезинфекция, дезинсекция, дератизация в очагах инфекционных и паразитарных заболеваний человека и природных очагах инфекционных и паразитарных заболеваний проводятся организациями санитарно-эпидемиологической службы и медицинскими организациями в целях профилактики и (или) ликвидации инфекционных и паразитарных заболеваний.

Параграф 2. Профилактика неинфекционных заболеваний

Статья 108. Профилактика неинфекционных заболеваний, в том числе профессиональных заболеваний, и травматизма

1. Профилактика неинфекционных заболеваний, в том числе профессиональных, включает:

1) профилактику поведенческих факторов риска заболеваний и повышение информированности населения путем:

пропаганды здорового образа жизни и здорового питания;

информирования населения через средства массовой информации с внедрением обучающих программ по вопросам профилактики заболеваний;

2) внедрение программ управления хроническими неинфекционными заболеваниями;

3) мониторинг факторов риска заболеваний прикрепленного населения специалистами первичной медико-санитарной помощи, профессиональных заболеваний с временной утратой трудоспособности работников – специалистами государственных органов, осуществляющими деятельность в сфере санитарно-эпидемиологического благополучия населения;

4) минимизацию влияния производственных факторов риска заболеваний и контроль рисков для здоровья вследствие воздействия производственных вредных и (или) опасных факторов с учетом их оценки государственными органами в пределах их полномочий, иными органами и организациями, а также индивидуальными предпринимателями;

5) выявление лиц с хроническими неинфекционными заболеваниями, в том числе профессиональными, путем проведения скрининговых исследований, профилактических медицинских осмотров населения, мотивации раннего обращения;

6) динамическое наблюдение и своевременное оздоровление лиц с хроническими заболеваниями, в том числе профессиональными, включая амбулаторное лекарственное обеспечение отдельных категорий граждан Республики Казахстан, медицинскую реабилитацию;

7) временный перевод на более легкую работу по состоянию здоровья на срок, указанный в медицинском заключении, в порядке, определяемом уполномоченным органом.

2. Профилактика травматизма и профессиональных заболеваний осуществляется на межсекторальном уровне государственными органами в пределах их полномочий, физическими и юридическими лицами.

3. Медицинский работник организации обязан:

1) обладать знаниями по гигиене труда, о профессиональных заболеваниях, связанных с профессиональной деятельностью и условиями труда работников;

2) проводить анализ заболеваемости с временной утратой трудоспособности;

3) предоставлять в медицинскую организацию, осуществляющую проведение обязательных медицинских осмотров, характеристику профессиональной деятельности и условия труда работников, подлежащих обязательным предварительным и периодическим медицинским осмотрам.

Статья 109. Профилактика зависимости от психоактивных веществ

1. Профилактика зависимости от психоактивных веществ включает:

1) пропаганду знаний о вреде психоактивных веществ, а также медико-социально-правовых аспектах их употребления;

2) запрещение пропаганды наркотических средств, психотропных веществ и их аналогов, в том числе информации о способах, методах разработки, изготовления и использования, местах их приобретения, производства и распространения;

3) запрещение рекламы наркотических средств, психотропных веществ и их аналогов, внесенных в список наркотических средств, психотропных веществ и прекурсоров, подлежащих контролю в Республике Казахстан, кроме специализированных печатных изданий, рассчитанных для медицинских и фармацевтических работников, в том числе распространение в целях рекламы образцов лекарственных препаратов, содержащих наркотические средства или психотропные вещества;

4) добровольное, анонимное лечение лиц с зависимостью от психоактивных веществ;

5) добровольную медико-социальную реабилитацию наркологических больных.

2. Профилактика зависимости от психоактивных веществ осуществляется всеми физическими и юридическими лицами в пределах имеющихся у них прав.

Статья 110. Профилактика и ограничение потребления табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, и алкоголя

1. Профилактика и ограничение потребления табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, а также алкоголя направлены на защиту здоровья населения от последствий их потребления и предупреждение возникновения зависимости, в том числе вызываемой новыми видами средств доставки никотина и потребления табака, систем для нагрева табака, электронных систем потребления, кальяна, введение возрастного ценза для лиц, имеющих право приобретать табачные изделия, формирование отношения населения к потреблению табачных изделий и алкоголя как к факторам высокого риска для жизни и здоровья, проведение согласованных действий по профилактике распространения потребления алкоголя и табачных изделий согласно международным обязательствам.

2. Запрещается продажа табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них:

1) лицам в возрасте до двадцати одного года;

2) лицами в возрасте до восемнадцати лет;

3) из открытых пачек табачного изделия или штучная продажа табачных изделий;

4) без непосредственного участия продавца посредством торговых автоматов, иных электронных или механических устройств;

5) в зданиях и на территориях организаций здравоохранения, образования, физкультурно-оздоровительных, спортивных и спортивно-технических сооружений, стадионов;

6) без соответствующих документов, подтверждающих качество продукции;

7) без нанесенного на пачку табачного изделия средства идентификации;

8) если пачка табачного изделия содержит менее двадцати сигарет;

9) без нанесенных на пачку табачного изделия, упаковку табачного изделия сведений о не менее трех вредных соединениях – системных ядах, канцерогенных и мутагенных веществах, размещаемых на пачке табачного изделия, упаковке табачного изделия;

10) без нанесенного на пачку табачного изделия, в том числе изделия с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, предупреждения о вреде потребления табачных изделий и никотина;

11) без нанесенной на пачку табачного изделия, потребительскую упаковку, в том числе изделия с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, надписи о запрете продажи лицам в возрасте до двадцати одного года и лицами в возрасте до восемнадцати лет;

12) на которых содержится информация, прямо или косвенно вводящая потребителя в заблуждение, в том числе такие слова как "с низким содержанием смол", "легкие", "очень легкие", "мягкие", "экстра", "ультра" либо иные словосочетания, в том числе на иностранных языках, любые термины, описания, знаки, символы или иные обозначения, создающие ложное впечатление о меньшем вреде определенных изделий и (или) способов потребления по сравнению с другими изделиями и (или) способами потребления, а также вызывающие ассоциации с пищевыми продуктами (пищевыми добавками), в том числе с фруктами, ягодами, кондитерскими изделиями;

13) в составе наборов с другими товарами;

14) с полок самообслуживания;

15) в помещениях торговых организаций, осуществляющих торговлю товарами детского ассортимента;

16) с выкладкой и открытой демонстрацией табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них. Информация о табачной продукции, в том числе изделиях с нагреваемым табаком, табаке для кальяна, кальянной смеси, системах для нагрева табака, электронных системах потребления и жидкостях для них, при осуществлении розничной торговли доводится до сведения покупателей посредством размещения перечня продаваемой продукции, текст которого выполнен буквами одинакового размера черного цвета на белом фоне размером не более 40х30 сантиметров на одно место торговли и который составлен в алфавитном порядке, с указанием цены продаваемой табачной продукции без использования каких-либо графических изображений и рисунков. Демонстрация покупателю в торговом объекте табачной продукции, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, может осуществляться по его требованию после ознакомления с перечнем продаваемой табачной продукции, электронных систем потребления и жидкостей для них;

17) на территориях и в помещениях (за исключением беспошлинной торговли) железнодорожных вокзалов, автовокзалов, аэропортов, морских портов, речных портов, на станциях метрополитенов, предназначенных для оказания услуг по перевозкам пассажиров, в помещениях, предназначенных для предоставления жилищных и гостиничных услуг, услуг по временному размещению и (или) обеспечению временного проживания, бытовых услуг.

3. В местах, где осуществляется продажа табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, на видном месте должны быть размещены надпись следующего содержания: "Запрещена продажа табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, лицам в возрасте до двадцати одного года", а также предупреждение о вреде курения, утвержденное уполномоченным органом.

4. Лица, осуществляющие продажу табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, в случае возникновения сомнения в достижении покупателем двадцати одного года обязаны:

1) требовать предъявления документа, удостоверяющего личность;

2) отказать в продаже табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, в том случае, если не был предъявлен документ, удостоверяющий личность.

5. Потребление табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, запрещается:

1) в помещениях и на территории организаций образования, а также в организациях для отдыха несовершеннолетних;

2) в помещениях организаций здравоохранения;

3) в пунктах общественного питания;

4) в объектах культуры, музеях, библиотеках и лекториях, кинотеатрах, театрах, цирках, концертных, смотровых и выставочных залах, организациях спорта и физкультурно-оздоровительных организациях, на спортивных аренах и других сооружениях, предназначенных для массового отдыха;

5) в ночных клубах, на дискотеках;

6) в поездах местного и дальнего сообщения, на судах воздушного, морского и речного транспорта, а также в салонах городского, пригородного и междугороднего автомобильного общественного транспорта, в метро, в транспорте общего пользования, осуществляющем регулярные и нерегулярные автомобильные перевозки пассажиров и багажа, такси;

7) в зданиях аэропортов, железнодорожных, автомобильных и водных вокзалов, на закрытых остановках общественного транспорта;

8) в государственных органах и организациях;

9) в помещениях, являющихся рабочими местами и рабочими зонами;

10) в подъездах домов;

11) в помещениях и на территории автозаправочных станций;

12) на детских площадках;

13) в подземных переходах;

14) в автомобильном транспортном средстве во время нахождения в них несовершеннолетних лиц.

6. Нормы, предусмотренные подпунктами 3) и 7) пункта 5 настоящей статьи, не применяются в тех случаях, если для потребления табачных изделий, в том числе изделий с нагреваемым табаком, систем для нагрева табака, электронных систем потребления и жидкостей для них, выделены специальные оборудованные места.

7. Места, выделенные специально для потребления табачных изделий, в том числе изделий с нагреваемым табаком, систем для нагрева табака, электронных систем потребления и жидкостей для них, должны быть оборудованы в соответствии с требованиями, установленными государственным органом в сфере санитарно-эпидемиологического благополучия населения.

8. Запрещаются ввоз, производство, продажа и распространение курительных табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, электронных систем потребления и жидкостей для них, превышающих предельно допустимые уровни содержания никотина и смолистых веществ, определяемые государственным органом в сфере санитарно-эпидемиологического благополучия населения, а также табачных изделий, в отношении которых не установлены санитарно-эпидемиологические требования.

9. Запрещаются ввоз, производство, продажа и распространение некурительных табачных изделий.

10. Запрещаются производство, продажа и распространение товаров, имитирующих табачные изделия.

11. В местах, в том числе при входе, где запрещено потребление табачных изделий, в том числе изделий с нагреваемым табаком, систем для нагрева табака, электронных систем потребления и жидкостей для них, должны быть размещены знаки о запрете их потребления с указанием размера штрафа.

12. Пачка курительного табачного изделия, упаковка курительного табачного изделия должны содержать предупреждение о вреде потребления табачных изделий в соответствии с требованиями, утвержденными Техническим регламентом на табачную продукцию Евразийского экономического союза.

Потребительская упаковка табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, должна содержать предупреждение о вреде потребления табачных изделий и никотина, которое должно соответствовать следующим требованиям:

1) занимать не менее шестидесяти пяти процентов каждой большей по площади стороны пачки табачного изделия, упаковки табачного изделия, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси;

2) не должно печататься на прозрачной оберточной пленке или каком-либо другом внешнем оберточном материале;

3) выполняться в виде цветных рисунков (пиктограмм, графики) или фотоизображений, включающих текст.

Текст предупреждения о вреде потребления табачных изделий должен соответствовать требованиям Закона Республики Казахстан "О языках в Республике Казахстан".

Эскизы предупреждений о вреде потребления табачных изделий и никотина утверждаются уполномоченным органом.

Производитель, импортер должны обеспечить нанесение эскизов предупреждений на потребительскую упаковку табачной продукции в соответствии с эскизами в срок, не превышающий двенадцати месяцев со дня их утверждения.

Эскизы предупреждений наносятся на равное количество потребительских упаковок табачной продукции, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси.

13. Производитель, импортер табачных изделий, в том числе изделий с нагреваемым табаком, электронных систем потребления и жидкостей для них, обязаны ежегодно до 1 февраля года, следующего за отчетным периодом, представлять отчеты о результатах лабораторных исследований по предельно допустимому содержанию никотина во всех марках табака и табачных изделий, в том числе изделий с нагреваемым табаком, электронных систем потребления и жидкостей для них, в порядке, утвержденном уполномоченным органом.

14. Исследование содержания никотина и других вредных соединений, канцерогенных и мутагенных веществ в табачных изделиях, в том числе в изделиях с нагреваемым табаком, табаке для кальяна, кальянной смеси, электронных системах потребления и жидкостях для них, проводится производителем, импортером табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, электронных систем потребления и жидкостей для них, за счет собственных средств в лабораториях, аккредитованных в соответствии с законодательством Республики Казахстан.

15. Запрещается розничная реализация:

1) алкогольной продукции лицам в возрасте до двадцати одного года;

2) алкогольной продукции, за исключением реализации в ресторанах, барах и кафе:

с 23 до 8 часов следующего дня;

с объемной долей этилового спирта свыше тридцати процентов с 21 до 12 часов следующего дня;

3) в иных случаях, предусмотренных законами Республики Казахстан.

16. Запрещаются спонсорство и реклама табака, табачных изделий, реклама алкогольной продукции, продукции, имитирующей алкогольные напитки.

Допускается оказание физическими и юридическими лицами, осуществляющими ввоз, производство, продажу и распространение табака, благотворительной помощи в порядке, установленном законодательством Республики Казахстан.

17. Запрещается употребление алкогольных напитков, табака и табачных изделий, в том числе изделий с нагреваемым табаком, табака для кальяна, кальянной смеси, систем для нагрева табака, а также электронных систем потребления и жидкостей для них, несовершеннолетними лицами.

Родители и иные законные представители несовершеннолетних несут административную ответственность за употребление несовершеннолетними лицами алкогольных напитков в соответствии с законами Республики Казахстан.

18. При продаже алкогольной продукции лица, осуществляющие торговлю алкогольной продукции, в случае возникновения сомнения в достижении покупателем двадцати одного года обязаны:

1) требовать предъявления документа, удостоверяющего личность;

2) отказывать в продаже алкогольной продукции, в том случае, если не был предъявлен документ, удостоверяющий личность.

Сноска. Статья 110 с изменениями, внесенными законами РК от 02.01.2021 № 399-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 29.12.2021 № 94-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 31.12.2021 № 100 (вводится в действие с 01.01.2022).

Статья 111. Профилактика железодефицитных состояний

1. Железодефицитная анемия – патологический процесс организма, обусловленный недостаточным поступлением железа в организм с пищевой продукцией, усвоением железа в организме и увеличением потери железа при некоторых хронических заболеваниях желудочно-кишечного тракта, мочеполовой системы и системы крови, увеличенной потребностью в железе.

2. Мероприятия по профилактике железодефицитных состояний осуществляются на принципах:

1) ответственности государственных органов, физических и юридических лиц за обеспечение и соблюдение требований к производству, ввозу, вывозу, реализации и движению на других этапах оборота обогащенных пищевых продуктов в Республике Казахстан;

2) профилактического обеспечения железосодержащими препаратами целевых групп населения;

3) обогащения (фортификации) муки и иных пищевых продуктов железосодержащими витаминами, минералами и другими веществами.

3. Пшеничная мука высшего и первого сортов, реализуемая (находящаяся в обороте) на территории Республики Казахстан, подлежит обогащению (фортификации) железосодержащими витаминами, минералами и другими веществами.

Порядок обогащения (фортификации) и обращения на рынке пищевой продукции, подлежащей обязательной фортификации, определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Статья 112. Профилактика йододефицитных заболеваний

1. Йододефицитные заболевания – патологическое состояние организма, обусловленное нарушением функции щитовидной железы, связанное с недостаточным поступлением йода в организм.

2. Профилактика йододефицитных заболеваний – система мероприятий по предупреждению йододефицитных заболеваний, направленных на:

1) защиту здоровья населения;

2) проведение согласованных мероприятий по профилактике йододефицитных заболеваний на территории Республики Казахстан;

3) развитие производства и реализацию обогащенных соединениями йода пищевых продуктов.

3. Мероприятия по профилактике йододефицитных заболеваний осуществляются на принципах ответственности государственных органов, физических и юридических лиц за обеспечение и соблюдение требований к производству, ввозу, вывозу, реализации йодированной пищевой и кормовой соли в Республике Казахстан.

4. К производству, обороту и безопасности соли устанавливаются следующие требования:

1) пищевая и кормовая соль, ввозимая, производимая и (или) реализуемая на территории Республики Казахстан, должна быть йодированной, за исключением соли, предназначенной для:

лиц, имеющих противопоказания к применению йодированной соли;

производства отдельных видов пищевой продукции, в производстве которых используется нейодированная соль.

Порядок ввоза, производства и реализации нейодированной пищевой соли определяется государственным органом в сфере санитарно-эпидемиологического благополучия населения;

2) нормы содержания йода в соли, ее качество, безопасность, методы йодирования, процесс повторного йодирования при снижении содержания йода должны соответствовать нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения;

3) запрещаются производство, ввоз, а также реализация на территории Республики Казахстан нейодированной соли, за исключением случаев, предусмотренных абзацами вторым и третьим подпункта 1) пункта 4 настоящей статьи;

4) запрещаются производство, ввоз, вывоз и (или) реализация фальсифицированной соли.

5. К йодированной пищевой соли предъявляются следующие требования:

1) йодированная пищевая соль, предназначенная для реализации на территории Республики Казахстан, подлежит обязательному подтверждению соответствия в соответствии с законодательством Республики Казахстан в области технического регулирования;

2) не допускается ввоз и реализация йодированной пищевой соли без сертификата соответствия, выданного в соответствии с законодательством Республики Казахстан в области технического регулирования.

6. Производство обогащенных соединениями йода пищевых продуктов, а также условия их хранения, транспортировки и реализации должны соответствовать требованиям, установленным законодательством Республики Казахстан.

7. Физические и юридические лица, осуществляющие производство и реализацию обогащенных соединениями йода пищевых продуктов, должны гарантировать потребителям их качество и безопасность, соответствие нормативным правовым актам в сфере санитарно-эпидемиологического благополучия населения.

Статья 113. Здоровье населения и окружающая среда

1. При разработке стратегических документов государственного планирования должна проводиться оценка рисков на здоровье человека в рамках стратегической экологической экспертизы.

2. В целях улучшения состояния окружающей среды уполномоченным органом создается система мониторинга состояния окружающей среды, в том числе внутри помещений, и подготовки актуализированной оценки рисков воздействия загрязняющих веществ на здоровье населения.

3. Государственными органами и организациями санитарно-эпидемиологической службы проводится санитарно-эпидемиологический мониторинг в соответствии с порядком, определяемым государственным органом в сфере санитарно-эпидемиологического благополучия населения, с учетом методики управления биологическими рисками и требований к оценке биологических рисков.

Результаты санитарно-эпидемиологического мониторинга (состояния объектов окружающей среды) вносятся в Единую государственную систему мониторинга окружающей среды и природных ресурсов.

4. Местные представительные органы утверждают целевые показатели качества окружающей среды.

Целевые показатели качества окружающей среды определяются с учетом экологических проблем региона и предусматривают показатели состояния атмосферного воздуха с разработкой комплекса мер по снижению загрязнения.

5. В целях повышения осведомленности населения уполномоченным органом разрабатываются и направляются в местные исполнительные органы рекомендации о действиях населения в зависимости от уровня загрязнения атмосферного воздуха и других факторов окружающей среды.

Местные исполнительные органы обеспечивают информирование населения о состоянии атмосферного воздуха.

6. Вопросы здоровья населения и окружающей среды рассматриваются в рамках взаимодействия государственных органов и общественных объединений.

7. Местными исполнительными органами обеспечивается создание благоприятных условий для отдыха населения.

В целях снижения отрицательного воздействия шума на здоровье населения деятельность, сопровождаемая повышенным шумом, не связанная с неотложной необходимостью, препятствующая нормальному отдыху и спокойствию физических лиц, в помещениях жилых зданий и вне их осуществляется в дневное время и не должна превышать 8 часов в сутки.

8. В помещениях жилых зданий и на территориях жилой застройки ограничивается деятельность, сопровождаемая повышенным шумом, с 22 до 9 часов утра, развлекательных заведений – с 22 до 9 часов утра в будние, с 23 до 10 часов утра в выходные и праздничные дни.

Государственный орган в сфере санитарно-эпидемиологического благополучия населения организует проведение санитарно-эпидемиологического мониторинга за шумом.

Местные исполнительные органы обеспечивают разработку шумовых карт в жилых кварталах и ее реализацию в соответствии с результатами санитарно-эпидемиологического мониторинга.

9. В целях проведения оценки эпидемиологической обстановки на территории и определения потенциальной опасности влияния воды, используемой населением для хозяйственно-питьевых нужд, на здоровье населения государственным органом в сфере санитарно-эпидемиологического благополучия населения обеспечивается проведение санитарно-эпидемиологического мониторинга воды.

Использование населением воды для хозяйственно-питьевых нужд из источников водоснабжения, расположенных на территории, находящейся в частной собственности, допускается при соответствии показателей безопасности воды установленным гигиеническим нормативам.

Сноска. Статья 113 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 114. Санитарно-эпидемиологический мониторинг

1. Санитарно-эпидемиологический мониторинг является государственной системой наблюдения за состоянием здоровья населения и среды обитания, их анализом, оценкой и прогнозом, а также определением причинно-следственных связей между состоянием здоровья населения и воздействием среды обитания.

2. Целями проведения санитарно-эпидемиологического мониторинга является получение достоверной информации о воздействии среды обитания (химических, физических, биологических факторов) на здоровье человека, оценка эффективности выполняемых мероприятий по предупреждению возникновения отравлений и вспышек инфекционных, паразитарных и профессиональных заболеваний, возможность прогнозирования их возникновения.

3. Санитарно-эпидемиологический мониторинг и оценка эффективности выполняемых мероприятий проводятся на соответствие требованиям документов государственной системы санитарно-эпидемиологического нормирования.

4. Санитарно-эпидемиологический мониторинг проводится в отношении объектов и продукции, подлежащих санитарно-эпидемиологическому контролю и надзору, объектов окружающей среды (почва, вода, воздух) по результатам лабораторных и инструментальных исследований (замеров), показателей инфекционной, паразитарной, неинфекционной и профессиональной заболеваемости.

5. Санитарно-эпидемиологический мониторинг осуществляется государственными органами и организациями санитарно-эпидемиологической службы в порядке и с кратностью, определяемыми государственным органом в сфере санитарно-эпидемиологического благополучия населения.

Примечание ИЗПИ!
Пункт 6 предусмотрен в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

6. Санитарно-эпидемиологический мониторинг может проводиться с посещением (для отбора образцов с объектов окружающей среды, замеров физических факторов) и без посещения объекта. Результаты санитарно-эпидемиологического мониторинга не являются основанием для проведения проверок, профилактического контроля.

7. Проведение санитарно-эпидемиологического мониторинга осуществляется поэтапно и включает в себя:

1) сбор, обработку, систематизацию данных (цифровых, аналитических) о состоянии здоровья населения и среды обитания человека по результатам проведенных санитарно-эпидемиологических обследований объектов, подлежащих государственному санитарно-эпидемиологическому контролю и надзору, с применением лабораторных и инструментальных методов исследования;

2) анализ и выявление причинно-следственных связей между состоянием здоровья и средой обитания человека, причин и условий изменения санитарно-эпидемиологического благополучия населения на основании результатов лабораторных и инструментальных исследований продукции и объектов санитарно-эпидемиологического контроля и надзора;

3) идентификацию факторов среды обитания и отбор ведущих показателей нарушения здоровья для оптимизации лабораторного контроля в системе санитарно-эпидемиологического мониторинга;

4) в случае выявления инфекционных и массовых неинфекционных заболеваний (отравлений) установление причин и условий их возникновения и распространения;

5) межведомственное взаимодействие по ведению санитарно-эпидемиологического мониторинга в целях обеспечения санитарно-эпидемиологического благополучия населения;

6) оценку и прогноз изменения состояния здоровья населения в связи с изменениями среды обитания человека;

7) определение неотложных и долгосрочных мероприятий по предупреждению и устранению воздействия вредных факторов на здоровье населения;

8) создание информационно-аналитических систем, сетей, программных материалов и баз данных санитарно-эпидемиологического мониторинга района, города, области и республики и хранение данных санитарно-эпидемиологического мониторинга.

8. Данные санитарно-эпидемиологического мониторинга используются в работе органов санитарно-эпидемиологической службы, местных исполнительных и других государственных органов.

9. По результатам санитарно-эпидемиологического мониторинга:

1) составляются сводки, доклады, рекомендации, научные прогнозы, диаграммы, таблицы, характеризующие динамику, направленность и интенсивность развития изменений;

2) принимаются управленческие решения в целях устранения нарушений нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения на территории Республики Казахстан.

10. Результаты санитарно-эпидемиологического мониторинга размещаются на официальном интернет-ресурсе государственного органа в сфере санитарно-эпидемиологического благополучия населения и его территориальных органов по итогам полугодия, года.

11. В случаях превышения показателей заболеваемости, ухудшения показателей состояния подконтрольных объектов и объектов окружающей среды результаты санитарно-эпидемиологического мониторинга выносятся на рассмотрение заинтересованных государственных органов для принятия управленческих решений.

РАЗДЕЛ 3. ОРГАНИЗАЦИЯ ОКАЗАНИЯ МЕДИЦИНСКОЙ ПОМОЩИ

Глава 16. ОБЩИЕ ПОЛОЖЕНИЯ ОКАЗАНИЯ МЕДИЦИНСКОЙ ПОМОЩИ

Статья 115. Организация медицинской помощи

1. Организация медицинской помощи осуществляется уполномоченным органом, центральными исполнительными органами и иными центральными государственными органами, имеющими военно-медицинские (медицинские) подразделения, местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы, оказание медицинской помощи осуществляется субъектами здравоохранения в порядке, установленном настоящим Кодексом.

2. Субъекты здравоохранения, оказывающие медицинскую помощь, обязаны обеспечивать:

1) оказание своевременной и качественной медицинской помощи;

2) применение методов профилактики, диагностики, лечения и медицинской реабилитации, обладающих наибольшей доказанной эффективностью и безопасностью;

3) готовность к работе в условиях чрезвычайной ситуации, военного конфликта и акта терроризма;

4) проведение мероприятий по профилактике, предупреждению, диагностике, лечению и медицинской реабилитации заболеваний, которые представляют опасность для окружающих, а также профессиональных заболеваний;

5) предоставление лицам бесплатной, оперативной и достоверной информации о формах и видах медицинской помощи;

6) соблюдение нормативных правовых актов в сфере санитарно-эпидемиологического благополучия населения и гигиенических нормативов;

7) взаимодействие с другими субъектами здравоохранения и преемственность в своей деятельности;

8) формирование здорового образа жизни и здорового питания;

9) ведение первичной медицинской документации и представление отчетов по формам и в порядке, установленным уполномоченным органом, с учетом требований Закона Республики Казахстан "О государственных секретах" и специфики деятельности;

10) предоставление информации (экстренного извещения):

государственному органу в сфере санитарно-эпидемиологического благополучия населения о случаях инфекционных заболеваний, отравлений, представляющих опасность для окружающих;

государственному органу в сфере оказания медицинских услуг (помощи) о случаях наступления смерти беременных, рожениц, родильниц в течение сорока двух календарных дней после родов, внезапной смерти пациентов при оказании им плановой медицинской помощи (первичная медико-санитарная и специализированная, в том числе высокотехнологичная, медицинская помощь);

уполномоченному органу в сфере гражданской защиты об угрозе возникновения и (или) о возникновении медико-санитарных последствий чрезвычайных ситуаций;

органам внутренних дел сведений о лицах, обратившихся по поводу свежих травм, ранений, незаконного проведения искусственного прерывания беременности, бытового насилия, о случаях заболеваний, представляющих опасность для окружающих.

3. Субъекты здравоохранения оказывают медицинскую помощь в соответствии со стандартами организации оказания медицинской помощи, правилами оказания медицинской помощи, а также клиническими протоколами.

Статья 116. Уровни оказания медицинской помощи

В Республике Казахстан установлена трехуровневая система оказания медицинской помощи:

1) первичный уровень – уровень оказания медицинской помощи специалистами первичной медико-санитарной помощи в амбулаторных, стационарозамещающих условиях и на дому;

2) вторичный уровень – уровень оказания медицинской помощи профильными специалистами, осуществляющими специализированную медицинскую помощь в амбулаторных, стационарозамещающих и стационарных условиях, в том числе по направлению специалистов, оказывающих медицинскую помощь на первичном уровне;

3) третичный уровень – уровень оказания медицинской помощи профильными специалистами, осуществляющими специализированную медицинскую помощь с применением высокотехнологичных медицинских услуг, в амбулаторных, стационарозамещающих и стационарных условиях, в том числе по направлению специалистов первичного и вторичного уровней.

Статья 117. Формы медицинской помощи

Медицинская помощь предоставляется в следующих формах:

1) экстренная – медицинская помощь, оказываемая при внезапных острых заболеваниях и состояниях, обострении хронических заболеваний, требующих безотлагательного медицинского вмешательства для предотвращения существенного вреда здоровью и (или) устранения угрозы жизни;

2) неотложная – медицинская помощь, оказываемая при внезапных острых заболеваниях и состояниях, обострении хронических заболеваний, не представляющих явную угрозу жизни пациента;

3) плановая – медицинская помощь, оказываемая при заболеваниях и состояниях, не сопровождающихся угрозой жизни пациента, отсрочка оказания которой на определенное время не повлечет за собой ухудшение состояния пациента, а также при проведении профилактических мероприятий.

Статья 118. Условия оказания медицинской помощи

1. Медицинская помощь оказывается:

1) в амбулаторных условиях, не предусматривающих круглосуточного медицинского наблюдения и лечения, в том числе в приемных отделениях круглосуточных стационаров;

2) в стационарных условиях, предусматривающих круглосуточное медицинское наблюдение, лечение, уход, а также предоставление койко-места с питанием, в том числе при случаях терапии и хирургии "одного дня", предусматривающих круглосуточное наблюдение в течение первых суток после начала лечения;

3) в стационарозамещающих условиях, не требующих круглосуточного медицинского наблюдения и лечения и предусматривающих медицинское наблюдение и лечение в дневное время с предоставлением койко-места;

4) на дому: при вызове медицинского работника, мобильной бригады, активном патронаже медицинскими работниками, организации лечения на дому (стационар на дому);

5) в санаторно-курортных организациях;

6) вне медицинской организации: по месту вызова бригады скорой медицинской помощи, на санитарном автотранспорте и медицинской авиации при транспортировке, а также в медицинских поездах, передвижных (полевых) медицинских комплексах, полевых госпиталях, трассовых медико-спасательных пунктах и при оказании дистанционных медицинских услуг.

2. Маршрут оказания медицинской помощи пациентам на первичном, вторичном и третичном уровнях в разрезе профилей устанавливается местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы в соответствии с правилами и стандартами оказания медицинской помощи.

3. Медицинская помощь в организациях здравоохранения оказывается на основе триажа (медицинской или санитарной сортировки пациентов) в зависимости от степени тяжести их состояния и санитарно-эпидемиологического риска.

В медицинских организациях соблюдаются принципы инфекционного контроля, направленные на предупреждение возникновения и распространения инфекционных заболеваний внутри медицинской организации.

Статья 119. Особенности организации медицинской помощи на уровне сельского здравоохранения

1. Услуги по укреплению здоровья, профилактики, лечения и реабилитации должны быть доступны для сельского населения на всех уровнях сельского здравоохранения.

2. Для обеспечения доступности первичной медико-санитарной и специализированной медицинской помощи на уровне сельского здравоохранения используются передвижные медицинские комплексы, медицинские поезда и средства оказания дистанционных медицинских услуг.

3. При планировании объемов медицинской помощи для сельского здравоохранения учитываются географическая отдаленность, плотность населения, демографические показатели, особенности половозрастного состава и иные критерии, влияющие на доступность медицинской помощи.

4. Обеспечение доступности медицинской помощи сельскому населению на всех уровнях оказания медицинской помощи осуществляется местными органами государственного управления здравоохранением.

Статья 120. Виды медицинской помощи

Видами медицинской помощи являются:

1) скорая медицинская помощь;

2) доврачебная медицинская помощь;

3) первичная медико-санитарная помощь;

4) специализированная, в том числе высокотехнологичная, медицинская помощь;

5) медицинская реабилитация;

6) паллиативная медицинская помощь.

Статья 121. Скорая медицинская помощь

1. Скорая медицинская помощь – система организации медицинской помощи в экстренной и неотложной форме при острых заболеваниях и состояниях, угрожающих жизни, а также для предотвращения существенного вреда здоровью на месте происшествия и (или) в пути следования в медицинскую организацию.

2. Скорая медицинская помощь с привлечением медицинской авиации оказывается:

1) при невозможности оказания медицинской помощи из-за отсутствия медицинских изделий и (или) специалистов соответствующей квалификации в медицинской организации по месту нахождения пациента;

2) при необходимости доставки специалистов вторичного и третичного уровней оказания медицинской помощи к месту назначения;

3) для транспортировки больного в медицинские организации вторичного и третичного уровней оказания медицинской помощи при невозможности и неэффективности оказания медицинской помощи по месту нахождения пациента;

4) для транспортировки органов (части органа) и (или) тканей (части ткани) для последующей трансплантации в соответствующую медицинскую организацию.

3. Медицинская авиация может использоваться в случаях:

1) доставки пациента, находящегося в тяжелом состоянии, из зарубежных клиник в отечественные клиники;

2) доставки пациента, нуждающегося в медицинском сопровождении, в медицинские организации по месту жительства для продолжения лечения из медицинских организаций вторичного и третичного уровней оказания медицинской помощи.

4. Правила оказания скорой медицинской помощи, в том числе с привлечением медицинской авиации, разрабатываются и утверждаются уполномоченным органом.

5. Обеспечение доступности и своевременности оказания скорой медицинской помощи осуществляется местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы.

Статья 122. Доврачебная медицинская помощь

1. Доврачебная медицинская помощь – медицинская помощь, оказываемая средними медицинскими работниками самостоятельно или в составе мультидисциплинарной команды, включающая в себя пропаганду здоровья, оценку состояния пациента, постановку доврачебного диагноза, назначение плана доврачебных вмешательств, исполнение доврачебных манипуляций и процедур и уход за больными, лицами с инвалидностью и умирающими людьми.

2. Средние медицинские работники осуществляют медицинскую помощь согласно правилам оказания доврачебной медицинской помощи, утвержденным уполномоченным органом.

3. Обеспечение доступности доврачебной медицинской помощи осуществляется местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы.

Сноска. Статья 122 с изменением, внесенным Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 123. Первичная медико-санитарная помощь

1. Первичная медико-санитарная помощь – место первого доступа к медицинской помощи, ориентированной на нужды населения, включающей профилактику, диагностику, лечение заболеваний и состояний, оказываемых на уровне человека, семьи и общества, в том числе:

1) диагностику, лечение и управление наиболее распространенными заболеваниями;

2) профилактические осмотры целевых групп населения (детей, взрослых);

3) раннее выявление и мониторинг поведенческих факторов риска заболеваний и обучение навыкам снижения выявленных факторов риска;

4) иммунизацию;

5) формирование и пропаганду здорового образа жизни;

6) мероприятия по охране репродуктивного здоровья;

7) наблюдение за беременными и за родильницами в послеродовом периоде;

8) санитарно-противоэпидемические и санитарно-профилактические мероприятия в очагах инфекционных заболеваний.

2. Принципы работы организаций здравоохранения, оказывающих первичную медико-санитарную помощь:

1) семейный принцип обслуживания;

2) территориальная доступность первичной медико-санитарной помощи;

3) свободный выбор медицинской организации в пределах территориальной доступности согласно подпункту 2) пункта 2 настоящей статьи;

4) удовлетворенность пациента качеством медицинской помощи;

5) равноправие и добросовестная конкуренция независимо от формы собственности и ведомственной принадлежности;

6) услуги первичной медико-санитарной помощи, охватывающие профилактику, диагностику и лечение, доступные всем пациентам независимо от их места нахождения.

3. Первичная медико-санитарная помощь оказывается врачами общей практики (семейными врачами), участковыми терапевтами, педиатрами, фельдшерами, акушерами, медицинскими сестрами расширенной практики (общей практики), участковыми медицинскими сестрами, социальными работниками, психологами в области здравоохранения.

4. Физические лица для получения первичной медико-санитарной помощи прикрепляются к субъектам здравоохранения, оказывающим первичную медико-санитарную помощь.

Прикрепление физического лица к организации первичной медико-санитарной помощи является основанием для реализации права на получение медицинской помощи и выполнения обязательств организаций здравоохранения по оказанию медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования.

Правила прикрепления физических лиц к организациям здравоохранения, оказывающим первичную медико-санитарную помощь, разрабатываются и утверждаются уполномоченным органом.

5. В организациях первичной медико-санитарной помощи для оказания неотложной помощи создаются отделения (пункты) неотложной помощи.

6. Обеспечение доступности первичной медико-санитарной помощи осуществляется местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы.

Статья 124. Специализированная, в том числе высокотехнологичная, медицинская помощь

1. Специализированная медицинская помощь оказывается профильными специалистами при заболеваниях, требующих специальных методов диагностики, лечения, медицинской реабилитации, в том числе с использованием средств дистанционных медицинских услуг.

2. Специализированная медицинская помощь оказывается в виде консультативно-диагностической помощи в амбулаторных условиях, станционарозамещающей и стационарной помощи на вторичном и третичном уровнях оказания медицинской помощи.

3. Высокотехнологичная медицинская помощь является частью специализированной медицинской помощи, оказываемой профильными специалистами при заболеваниях, требующих применения инновационных и (или) уникальных методов диагностики и лечения с научно доказанной эффективностью и безопасностью и технологий, разработанных на основе достижений медицинской науки и смежных отраслей науки и техники.

4. Порядок определения и перечень видов высокотехнологичной медицинской помощи, а также критерии, согласно которым виды высокотехнологичной медицинской помощи переходят в перечень услуг специализированной медицинской помощи, определяются уполномоченным органом.

5. Правила оказания специализированной, в том числе высокотехнологичной, медицинской помощи разрабатываются и утверждаются уполномоченным органом.

Статья 125. Медицинская реабилитация

1. Медицинская реабилитация оказывается лицам с врожденными заболеваниями, после острых состояний, хирургических вмешательств, травм, а также их последствий по перечню, утвержденному уполномоченным органом.

2. Медицинская реабилитация лицам с врожденными заболеваниями, после острых состояний, хирургических вмешательств и травм оказывается при лечении основного заболевания в амбулаторных, стационарных, стационарозамещающих условиях медицинских организаций первичного, вторичного и третичного уровней.

2-1. Медицинская реабилитация лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, оказывается после острых состояний, хирургических вмешательств, травм, а также их последствий по перечню, определяемому уполномоченным органом.

3. Медицинская реабилитация врожденных заболеваний, последствий острых состояний, хирургических вмешательств и травм оказывается с учетом реабилитационного потенциала в соответствии с медицинской частью индивидуальной программы реабилитации пациента в амбулаторных, стационарных, стационарозамещающих условиях медицинских организаций первичного, вторичного и третичного уровней, а также на дому и в санаторно-курортных организациях в порядке, определенном уполномоченным органом.

4. По заключению мультидисциплинарной группы пациенту с отсутствием реабилитационного потенциала медицинская реабилитация не оказывается.

5. Медицинская абилитация – процесс медицинской реабилитации, направленный на приобретение или компенсацию несформированных функций и навыков детей с инвалидностью и интеграцию их в общество. Медицинская абилитация проводится детям с врожденными функциональными ограничениями до достижения ими возраста трех лет.

6. Порядок оказания медицинской реабилитации разрабатывается и утверждается уполномоченным органом.

Сноска. Статья 125 с изменениями, внесенными законами РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 126. Паллиативная медицинская помощь

1. Паллиативная помощь – комплекс услуг, направленных на улучшение качества жизни пациентов с тяжелыми и неизлечимыми заболеваниями (состояниями), а также их семей и ухаживающих лиц, включающий медицинские, специальные социальные услуги, духовную поддержку.

2. Паллиативная медицинская помощь – комплекс медицинских услуг, направленных на облегчение боли и тяжелых проявлений заболевания (состояния) неизлечимо больного пациента при отсутствии показаний к проведению радикального лечения.

Паллиативная медицинская помощь оказывается на основании стандарта в области здравоохранения, разрабатываемого и утверждаемого уполномоченным органом.

Статья 127. Сестринская деятельность

1. Сестринская деятельность включает сестринский уход, осуществляемый медицинскими сестрами и медицинскими сестрами расширенной практики самостоятельно или в рамках мультидисциплинарных команд.

Медицинская сестра – специалист с техническим и профессиональным медицинским образованием в области сестринского дела, осуществляющий сестринский уход самостоятельно или под супервизией медицинской сестры расширенной практики или врача.

Медицинская сестра расширенной практики – специалист с послесредним или высшим образованием в области сестринского дела, осуществляющий расширенные функции в рамках сестринского ухода.

2. Сестринский уход осуществляется в случаях, не требующих круглосуточного врачебного наблюдения, в специализированных структурных подразделениях (отделениях, палатах, койках, кабинетах) организаций здравоохранения, самостоятельных специализированных медицинских организациях (больницах сестринского ухода) в стационарных, стационарозамещающих условиях и на дому, в том числе с использованием мобильных бригад.

3. Медицинские сестры и медицинские сестры расширенной практики осуществляют сестринский уход согласно законодательству Республики Казахстан, правилам оказания сестринского ухода, а также руководствуются клиническими сестринскими руководствами.

4. Клинические сестринские руководства представляют собой научно доказанные рекомендации по передовой практике в определенной клинической области, разрабатываемые и обновляемые на систематической основе профессиональными медицинскими ассоциациями.

5. Медицинские сестры расширенной практики имеют право на осуществление независимого профессионального сестринского ухода, включающего сестринскую оценку состояния пациента (клиента), постановку сестринского диагноза, назначение плана сестринских вмешательств и мониторинг эффективности, в соответствии с клиническими протоколами и клиническими сестринскими руководствами.

6. Правила оказания сестринского ухода разрабатываются и утверждаются уполномоченным органом. В соответствии с указанными правилами устанавливаются права и обязанности медицинских сестер и медицинских сестер расширенной практики при осуществлении сестринского ухода.

7. Обеспечение доступности сестринского ухода осуществляется местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы.

Статья 128. Интегрированная модель оказания медицинской помощи

1. Интегрированная модель оказания медицинской помощи – модель организации оказания комплекса медицинских и социальных услуг на протяжении жизни человека для предупреждения, своевременного выявления, лечения и снижения риска развития осложнений заболевания с целью увеличения продолжительности жизни.

2. Интегрированная модель оказания медицинской помощи реализуется путем мультидисциплинарного подхода в соответствии с клиническими протоколами, стандартами и правилами оказания медицинской помощи.

Статья 129. Особенности оказания дистанционных медицинских услуг

1. Дистанционные медицинские услуги предоставляются для:

1) оказания консультативной помощи, в том числе специалистами научно-исследовательских институтов, научных центров, университетских больниц, а также зарубежными клиниками;

2) целесообразности направления пациента на очную консультацию в вышестоящие уровни оказания медицинской помощи;

3) оказания практической помощи специалистами вторичного и третичного уровней специалистам первичного уровня и сельского здравоохранения;

4) оценки эффективности лечебно-диагностических мероприятий, медицинского наблюдения за состоянием здоровья пациента;

5) уточнения диагноза, корректировки и определения дальнейшей тактики ведения пациента и назначения лечебно-диагностических мероприятий;

6) определения возможности транспортировки пациента на вышестоящие уровни оказания медицинской помощи, в том числе целесообразности использования средств медицинской авиации;

7) организации дистанционных консилиумов;

8) оказания услуг медицинской реабилитации.

2. Заключение врачей о состоянии здоровья и диагнозе пациента, предоставляющих дистанционные медицинские услуги, является официальным документом и подлежит внесению в электронный паспорт здоровья пациента с использованием электронной цифровой подписи врача, а в случаях, предусмотренных подпунктом 8) пункта 1 настоящей статьи, с использованием электронной цифровой подписи специалиста, оказавшего услуги медицинской реабилитации.

3. Сертифицированные носимые медицинские устройства используются для оценки физиологических параметров и состояния здоровья пациента.

4. Дистанционные медицинские услуги осуществляются с соблюдением требований, установленных законодательством Республики Казахстан в области защиты персональных данных, и соблюдением тайны медицинского работника.

5. Организация, порядок предоставления и оплаты дистанционных медицинских услуг определяются уполномоченным органом.

Статья 130. Лабораторная диагностика

1. Лабораторная диагностика – комплекс лабораторных исследований биоматериалов, полученных от пациентов, направленных на диагностику заболевания, контроль эффективности лечения и коррекцию лечения.

2. Стандарт организации проведения лабораторной диагностики разрабатывается и утверждается уполномоченным органом.

3. Внешняя оценка качества измерений лабораторных исследований контролируется и выполняется референс-лабораториями в порядке, определенном уполномоченным органом.

4. Перечень референс-лабораторий, положения об их деятельности, а также критерии и требования к их выбору утверждаются уполномоченным органом.

5. Обеспечение доступности лабораторной диагностики осуществляется местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы.

Статья 131. Патологоанатомическая диагностика

1. Патологоанатомическая диагностика проводится с целью установления диагноза путем анализа совокупности изменений в органах (фрагментах органов), тканях и клетках пациентов, изъятых путем хирургической операции и (или) биопсии (операционно-биопсийного материала), а также в тканях, органах и клетках трупа в ходе патологоанатомического вскрытия.

2. Патологоанатомическое вскрытие проводится в целях установления причины смерти и уточнения диагноза заболевания с выдачей документа, удостоверяющего факт наступления смерти, по форме, утверждаемой уполномоченным органом.

3. Патологоанатомическая диагностика основывается на результатах непосредственного осмотра (макроскопических исследований), исследований с использованием увеличительных приборов (микроскопических исследований), иных технологий, а также клинико-анатомического сопоставления.

4. При отсутствии подозрения на насильственную смерть выдача трупа разрешается без проведения патологоанатомического вскрытия, за исключением материнской, младенческой смертности или мертворождения.

При неустановленной непосредственной причине смерти патологоанатомическая диагностика осуществляется при наличии письменного согласия супруга (супруги) или одного из близких родственников, или законного представителя.

5. По требованию супруга (супруги), близких родственников или законного представителя умершего патологоанатомическое вскрытие может быть произведено независимым (независимыми) экспертом (экспертами) в порядке, определяемом уполномоченным органом.

6. Патологоанатомическое заключение о причине смерти и диагнозе заболевания выдается супруге (супругу), близким родственникам или законным представителям, а при их отсутствии иным родственникам, а также по требованию правоохранительных органов и (или) суда в случаях, предусмотренных подпунктом 3) пункта 4 статьи 273 настоящего Кодекса, государственным органом в сфере оказания медицинских услуг (помощи).

7. Стандарт организации оказания патологоанатомической диагностики разрабатывается и утверждается уполномоченным органом.

8. Заключение о результатах патологоанатомического вскрытия может быть обжаловано в суд супругом (супругой), близким родственником или законным представителем умершего в порядке, установленном законодательством Республики Казахстан.

9. Патологоанатомическое вскрытие проводится с соблюдением достойного отношения к телу умершего человека и максимальным сохранением его внешних анатомических форм.

Статья 132. Традиционная медицина. Целительство

1. Традиционная медицина – совокупность кодифицированных методов профилактики, диагностики, лечения и реабилитации, основанных на многовековых традициях народной медицины и разрешенных к медицинскому применению.

2. Право на деятельность в сфере традиционной медицины имеют лица с медицинским образованием, имеющие сертификат специалиста в области здравоохранения и лицензию в соответствии с законодательством Республики Казахстан о разрешениях и уведомлениях.

3. Целительство – совокупность эмпирических сведений о целительных средствах, приемах, навыках и их практическое применение с целью воздействия на здоровье.

4. Проведение сеансов целительства с привлечением двух и более лиц, в том числе с использованием средств массовой информации, запрещается.

5. Лицо, причинившее вред здоровью человека при применении методов целительства, несет ответственность в соответствии с законами Республики Казахстан.

Статья 133. Оценка технологий здравоохранения

1. Объектами оценки технологий здравоохранения являются технологии здравоохранения, предлагаемые к применению в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования или за счет иных источников, не запрещенных законодательством Республики Казахстан.

2. Порядок проведения оценки технологий здравоохранения и их применение определяются уполномоченным органом.

Статья 134. Права пациентов

1. Помимо прав, указанных в главе 12 настоящего Кодекса, пациент имеет право на:

1) достойное обращение в процессе профилактики, диагностики, лечения, уважительное отношение к своим культурным и личностным ценностям;

2) медицинскую помощь в очередности, определяемой исключительно на основе медицинских критериев, без влияния каких-либо дискриминационных факторов;

3) выбор, замену врача или медицинской организации, предоставляющей медицинскую помощь в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования, за исключением случаев оказания экстренной и неотложной помощи;

4) оповещение о том, что в медицинской организации ведутся аудио- и (или) видеонаблюдение и запись;

5) облегчение страданий в той мере, в какой это позволяет существующий уровень медицинских технологий;

6) получение информации (данные о возможном риске и преимуществах, предлагаемых и альтернативных методах лечения, сведения о возможных последствиях отказа от лечения, информация о диагнозе, прогнозе и плане лечебных мероприятий в доступной для пациента форме, а также разъяснение причин выписки его домой или перевода в другую медицинскую организацию) и независимого мнения о состоянии своего здоровья и проведение консилиума;

7) получение информации о своих правах и обязанностях, оказываемых услугах, стоимости платных услуг и размере сооплаты, порядке их предоставления с учетом доступности для лиц с нарушениями зрения и (или) слуха; назначаемом лекарственном средстве; медицинских работниках, оказывающих ему медицинские услуги;

8) отказ от участия в учебном процессе, а также от присутствия третьих лиц при проведении лечебно-диагностических процедур;

9) иные права, предусмотренные законами Республики Казахстан.

2. Информация о правах пациента размещается в местах наглядной агитации медицинских организаций.

3. Медицинская помощь предоставляется после получения информированного согласия пациента на получение медицинской помощи. Информированное согласие пациента при инвазивных вмешательствах составляется по форме, утвержденной уполномоченным органом.

4. Пациент может назначить лицо, которому следует сообщить информацию о состоянии его здоровья. Информация о состоянии здоровья может быть скрыта от пациента с учетом его состояния здоровья и сообщена супругу (супруге) пациента, его близким родственникам или законным представителям.

5. Защита прав пациентов осуществляется государственными органами, организациями здравоохранения, общественными объединениями в пределах их компетенции.

Статья 135. Обязанности пациентов

1. Помимо обязанностей, указанных в главе 12 настоящего Кодекса, пациент обязан:

1) принимать меры к сохранению и укреплению своего здоровья;

2) проявлять в общении с медицинскими работниками уважение и такт;

3) сообщать врачу всю информацию, необходимую для постановки диагноза и лечения заболевания; после дачи согласия на медицинское вмешательство неукоснительно выполнять назначения медицинских работников;

4) соблюдать правила внутреннего распорядка и бережно относиться к имуществу медицинской организации, сотрудничать с медицинским персоналом при получении медицинской помощи;

5) своевременно информировать медицинских работников об изменении состояния своего здоровья в процессе диагностики и лечения, а также в случаях возникновения заболеваний, представляющих опасность для окружающих, либо подозрения на них;

6) не совершать действий, нарушающих права других пациентов;

7) выполнять иные обязанности, предусмотренные законами Республики Казахстан.

2. Обязанности пациентов, указанные в подпунктах 2), 3) и 5) пункта 1 настоящей статьи, распространяются на родителей или иных лиц, непосредственно осуществляющих в стационаре уход за больным ребенком.

Статья 136. Право на отказ от медицинской помощи

1. Пациент или его законный представитель имеет право отказаться от медицинской помощи, за исключением случаев, предусмотренных статьей 137 настоящего Кодекса.

2. При отказе от медицинской помощи пациенту или его законному представителю медицинский работник дает разъяснения в доступной для пациента или его законного представителя форме о возможных последствиях.

3. Отказ от медицинской помощи с указанием возможных последствий оформляется записью в медицинских документах, в том числе в электронном формате, и подписывается пациентом либо его законным представителем, а также медицинским работником.

В случае отказа от подписания пациентом либо его законным представителем отказа от медицинской помощи осуществляется соответствующая запись об этом в медицинской документации, в том числе в электронном формате, и подписывается медицинским работником.

4. При отказе законных представителей несовершеннолетнего либо недееспособного лица от медицинской помощи, необходимой для спасения жизни указанных лиц, медицинская организация вправе обратиться в орган опеки и попечительства и (или) в суд для защиты их интересов.

Статья 137. Оказание медицинской помощи без согласия пациента

1. Оказание медицинской помощи без согласия пациента допускается в отношении лиц:

1) находящихся в шоковом, коматозном состоянии, не позволяющем выразить свою волю;

2) с заболеваниями, представляющими опасность для окружающих;

3) с тяжелыми психическими расстройствами (заболеваниями);

4) с психическими расстройствами (заболеваниями), совершивших общественно опасное деяние.

2. Согласие на оказание медицинской помощи в отношении несовершеннолетних, за исключением случаев, предусмотренных пунктом 2 статьи 78 настоящего Кодекса, и согласия для лиц, признанных судом недееспособными, дают их законные представители.

3. Решение об оказании медицинской помощи без согласия в отношении лиц, указанных в пункте 1 настоящей статьи, принимает консилиум, а при невозможности собрать консилиум – непосредственно медицинский работник с последующим уведомлением должностных лиц медицинской организации.

4. Оказание медицинской помощи без согласия пациента продолжается до исчезновения оснований, предусмотренных пунктом 1 настоящей статьи.

Статья 138. Требования к разработке стандартов организации оказания медицинской помощи

1. Стандарт организации оказания медицинской помощи – нормативный правовой акт, устанавливающий требования и правила к процессам организации оказания медицинской помощи в соответствии с законодательством Республики Казахстан в области здравоохранения.

2. Стандарт организации оказания медицинской помощи разрабатывается по профилям заболеваний (служб) и включает в себя следующие требования:

1) общие положения;

2) структуру организаций, оказывающих медицинскую помощь;

3) основные задачи и направления деятельности организаций, оказывающих медицинскую помощь;

4) порядок оказания медицинской помощи в разрезе уровней, видов, форм и условий ее оказания;

5) рекомендуемый штат работников;

6) рекомендуемое оснащение медицинскими изделиями;

7) иное с учетом особенностей профиля заболевания (службы).

3. Стандарты организации оказания медицинской помощи разрабатываются и утверждаются уполномоченным органом.

Глава 17. ВЕДОМСТВЕННАЯ МЕДИЦИНА

Статья 139. Военно-медицинское (медицинское) обеспечение военнослужащих, кандидатов в космонавты, космонавтов, сотрудников специальных государственных и правоохранительных органов, членов их семей, пенсионеров правоохранительных органов, а также граждан, уволенных с воинской службы, службы в специальных государственных органах

1. Военно-медицинское (медицинское) обеспечение – комплекс мероприятий, включающий организацию и оказание военно-медицинской (медицинской) помощи, проведение медицинских осмотров, обеспечение санитарно-эпидемиологического благополучия, снабжение лекарственными средствами и медицинскими изделиями, проведение экспертизы в области здравоохранения, а также научно-методические разработки и обучение по военной медицине в войсках, подразделениях и ведомствах специальных государственных и правоохранительных органов в целях восстановления боеспособности и трудоспособности личного состава.

2. Военно-медицинское (медицинское) обеспечение военнослужащих, кандидатов в космонавты, космонавтов, сотрудников специальных государственных и правоохранительных органов, членов их семей, пенсионеров правоохранительных органов, а также граждан, уволенных с воинской службы, службы в специальных государственных органах, осуществляется в соответствии с законодательством Республики Казахстан.

3. Порядок организации и проведения медицинских осмотров, оказания военно-медицинской (медицинской) помощи, обеспечения санитарно-эпидемиологического благополучия, снабжения лекарственными средствами и медицинскими изделиями в Вооруженных Силах Республики Казахстан, других войсках и воинских формированиях устанавливается с учетом особенностей воинской службы.

В Вооруженных Силах Республики Казахстан при оказании медицинской помощи допускается использование лекарственных средств, зарегистрированных в Республике Казахстан и не включенных в лекарственный формуляр военно-медицинских учреждений (организаций), перечень которых утверждается государственным органом в области обороны.

4. Лица, указанные в пункте 2 настоящей статьи, вправе получать медицинскую помощь в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования в иных субъектах здравоохранения в соответствии с законодательством Республики Казахстан.

Статья 140. Военно-врачебная экспертиза

1. Военно-врачебная экспертиза – вид медицинской деятельности, представляющий собой комплекс научных, методических, организационных и практических мероприятий, осуществляемых в целях оптимального комплектования и совершенствования медицинского обеспечения в Вооруженных Силах Республики Казахстан, других войсках и воинских формированиях Республики Казахстан, специальных государственных и правоохранительных органах и решения иных вопросов, предусмотренных законодательством Республики Казахстан.

2. Военно-врачебная экспертиза проводится в Вооруженных Силах Республики Казахстан, других войсках и воинских формированиях, специальных государственных и правоохранительных органах для определения:

1) категории годности граждан к воинской службе или службе в специальных государственных и правоохранительных органах, а также к воинским сборам, сборам специальных государственных органов или в учетных целях по состоянию здоровья;

2) причинной связи заболеваний, увечий (ранений, травм, контузий) (далее – увечья) и гибели (смерти) у граждан Республики Казахстан в связи с прохождением (исполнением обязанностей) ими воинской службы, службы в специальных государственных и правоохранительных органах и воинских сборах, сборах специальных государственных органов;

3) степени тяжести увечий, не повлекших инвалидности, полученных военнослужащими или сотрудниками при исполнении обязанностей службы, воинской службы (служебных обязанностей);

4) психофизиологических качеств личности граждан Республики Казахстан, поступающих на службу в специальные государственные и правоохранительные органы, их сотрудников, а также поступающих в государственную авиацию, авиационного персонала.

3. Для проведения военно-врачебной экспертизы при Вооруженных Силах Республики Казахстан, других войсках и воинских формированиях Республики Казахстан, специальных государственных органах и органах внутренних дел создаются штатные и внештатные (постоянно и временно действующие) военно-врачебные комиссии.

Для специальных государственных органов военно-врачебную экспертизу проводит военно-врачебная комиссия органов национальной безопасности и Службы государственной охраны Республики Казахстан.

Для правоохранительных органов и государственной фельдъегерской службы Республики Казахстан военно-врачебную экспертизу проводит военно-врачебная комиссия органов внутренних дел Республики Казахстан.

Для определения степени годности граждан к воинской службе на постоянной основе в областях, городах республиканского значения, столице, городах и районах решением местных исполнительных органов создаются медицинские комиссии.

4. Порядок проведения военно-врачебной экспертизы, а также состав и полномочия комиссии военно-врачебной экспертизы определяются Правилами проведения военно-врачебной экспертизы и Положением о комиссиях военно-врачебной экспертизы.

5. Категория годности граждан к воинской службе в Вооруженных Силах Республики Казахстан, других войсках и воинских формированиях Республики Казахстан, службе, воинской службе в специальных государственных и правоохранительных органах, а также государственной авиации определяются проведением медицинского освидетельствования.

При проведении медицинского освидетельствования применяются требования, предъявляемые к состоянию здоровья граждан для прохождения службы в Вооруженных Силах Республики Казахстан, других войсках и воинских формированиях Республики Казахстан, в специальных государственных и правоохранительных органах, а также в государственной авиации.

Статья 141. Судебно-медицинская, судебно-психиатрическая и судебно-наркологическая экспертизы

1. Процессуальный порядок назначения и производства судебно-медицинской, судебно-психиатрической и судебно-наркологической экспертиз установлен Уголовно-процессуальным кодексом Республики Казахстан, Гражданским процессуальным кодексом Республики Казахстан, Кодексом Республики Казахстан об административных правонарушениях.

2. Порядок организации указанных видов судебных экспертиз и проведения судебно-экспертных исследований установлен законодательством Республики Казахстан о судебно-экспертной деятельности.

Статья 142. Оказание медицинской помощи отдельным категориям государственных служащих и граждан Республики Казахстан

1. Оказание медицинской помощи отдельным категориям государственных служащих и граждан Республики Казахстан осуществляется в соответствии с перечнем, утвержденным Управлением делами Президента Республики Казахстан по согласованию с Администрацией Президента Республики Казахстан.

2. Медицинская помощь лицам, указанным в пункте 1 настоящей статьи, оказывается:

1) в рамках гарантированного объема бесплатной медицинской помощи в соответствии с настоящим Кодексом;

2) в системе обязательного социального медицинского страхования в соответствии с Законом Республики Казахстан "Об обязательном социальном медицинском страховании";

3) за счет бюджетных средств по видам и в объемах, определяемых Управлением делами Президента Республики Казахстан.

3. Оплата услуг за оказание медицинской помощи в соответствии с подпунктами 1) и 2) пункта 2 настоящей статьи осуществляется фондом социального медицинского страхования.

4. Лица, указанные в пункте 1 настоящей статьи, вправе получать медицинскую помощь в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования в иных субъектах здравоохранения.

Статья 143. Оказание медицинской помощи лицам, задержанным, заключенным под стражу, помещенным в специальные учреждения, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы

1. Лицам, задержанным, заключенным под стражу и помещенным в специальные учреждения, медицинская помощь оказывается в порядке, определяемом органами внутренних дел Республики Казахстан по согласованию с уполномоченным органом.

2. Лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, медицинская помощь оказывается в порядке, определяемом уполномоченным органом.

3. Лица, указанные в пунктах 1 и 2 настоящей статьи, пользуются правами граждан Республики Казахстан при получении медицинской помощи, указанными в подпунктах 1), 2), 4), 5), 6), 7), 8) и 9) пункта 1 статьи 134 настоящего Кодекса.

4. Иностранцы и лица без гражданства, свобода которых ограничена, а также отбывающие наказание по приговору суда в местах лишения свободы, задержанные, заключенные под стражу и помещенные в специальные учреждения, имеют право на получение гарантированного объема бесплатной медицинской помощи в соответствии с перечнем и в объеме, которые определяются уполномоченным органом, если иное не предусмотрено законами Республики Казахстан и международными договорами, ратифицированными Республикой Казахстан.

Сноска. Статья 143 - в редакции Закона РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022).

Статья 144. Оказание медицинской помощи спортсменам и тренерам

1. Медицинское обеспечение и оказание медицинской помощи спортсменам и тренерам осуществляются в соответствии с правилами медицинского обеспечения и оказания медицинской помощи спортсменам и тренерам при проведении спортивных мероприятий, в период восстановительных мероприятий после интенсивных физических нагрузок, заболеваний и травм у спортсменов, утверждаемыми уполномоченным органом в области физической культуры и спорта, по согласованию с уполномоченным органом.

2. Спортсмены, не прошедшие медицинское обследование в соответствии с правилами медицинского обследования спортсменов для участия в спортивных соревнованиях, утверждаемыми уполномоченным органом в области физической культуры и спорта по согласованию с уполномоченным органом, не допускаются к спортивным соревнованиям.

3. Организации спортивной медицины относятся к организациям здравоохранения.

Глава 18. РЕГУЛИРОВАНИЕ ОТДЕЛЬНЫХ ОТНОШЕНИЙ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 145. Порядок хирургического вмешательства, переливания крови, ее компонентов и применения инвазивных методов диагностики

1. Хирургическое вмешательство, переливание крови, ее компонентов и применение инвазивных методов диагностики применяются с информированного согласия пациентов.

Лицам с психическими, поведенческими расстройствами (заболеваниями), признанным судом недееспособными, и несовершеннолетним хирургическое вмешательство, переливание крови и ее компонентов, инвазивные методы диагностики проводятся с информированного согласия их законных представителей.

2. Согласие может быть отозвано, за исключением тех случаев, когда медицинские работники по жизненным показаниям уже приступили к хирургическому вмешательству и его прекращение невозможно в связи с угрозой для жизни и здоровья пациента.

3. В случаях, когда промедление выполнения хирургического вмешательства, переливания крови и ее компонентов, инвазивных методов диагностики угрожает жизни пациента, а получение согласия пациента или его законных представителей не представляется возможным, решение принимает лечащий врач или консилиум с последующим информированием пациента или его законных представителей о принятых мерах.

Статья 146. Вспомогательные репродуктивные методы и технологии

1. Вспомогательные репродуктивные методы и технологии – методы лечения бесплодия (искусственная инсеминация, искусственное оплодотворение и имплантация эмбриона), при применении которых отдельные или все этапы зачатия и раннего развития эмбрионов осуществляются вне материнского организма (в том числе с использованием донорских и (или) криоконсервированных половых клеток, тканей репродуктивных органов и эмбрионов, а также суррогатного материнства).

2. Женщина и мужчина, состоящие в браке, имеют право на применение вспомогательных репродуктивных методов и технологий при наличии обоюдного информированного согласия на медицинское вмешательство.

3. Женщина или мужчина, не состоящие в браке, имеют право на применение вспомогательных репродуктивных методов и технологий при наличии ее (его) информированного согласия на медицинское вмешательство.

4. Порядок и условия проведения вспомогательных репродуктивных методов и технологий определяются уполномоченным органом.

5. При использовании вспомогательных репродуктивных методов и технологий выбор пола будущего ребенка не допускается, за исключением случаев возможности наследования заболеваний, связанных с полом.

6. Человеческий эмбрион не может быть использован для коммерческих, военных и промышленных целей.

7. Вывоз из Республики Казахстан половых клеток, человеческого эмбриона в коммерческих, военных или промышленных целях не допускается.

Статья 147. Клонирование

В Республике Казахстан клонирование человека – воспроизведение генетически идентичных особей – запрещается.

Статья 148. Донорство половых клеток, тканей репродуктивных органов

1. Граждане Республики Казахстан в возрасте от восемнадцати до тридцати пяти лет, физически и психически здоровые, прошедшие медико-генетическое обследование, имеют право быть донорами половых клеток, тканей репродуктивных органов.

2. Доноры не имеют права на информацию о дальнейшей судьбе своих донорских половых клеток, тканей репродуктивных органов.

3. Порядок и условия проведения донорства половых клеток, тканей репродуктивных органов определяются уполномоченным органом.

Статья 149. Использование контрацепции

1. Граждане имеют право на выбор методов и средств контрацепции, в том числе медицинской, а также на отказ от них.

2. Гражданам оказывается медицинская помощь по индивидуальному подбору приемлемых методов и средств контрацепции с учетом состояния здоровья, возраста и индивидуальных особенностей.

Статья 150. Искусственное прерывание беременности

1. Женщина имеет право на искусственное прерывание беременности.

2. Искусственное прерывание беременности по желанию женщины проводится при сроке беременности до двенадцати недель.

В целях предупреждения искусственного прерывания беременности врачи обязаны проводить беседы, направленные на разъяснение морально-этических, психологических и негативных физиологических последствий, возможных осложнений.

3. Искусственное прерывание беременности по социальным показаниям проводится при сроке беременности до двадцати двух недель, а при наличии медицинских показаний и состояний, угрожающих жизни беременной и (или) плода (при наличии моногенных генетических заболеваний, не корригируемых врожденных пороков развития и состояния плода, несовместимых с жизнью), – независимо от срока беременности.

4. Искусственное прерывание беременности несовершеннолетним производится с согласия их родителей или иных законных представителей.

5. Искусственное прерывание беременности у совершеннолетней, признанной в установленном законом порядке недееспособной, если она по своему состоянию не способна выразить свою волю, возможно по решению суда, принимаемому по заявлению ее законного представителя и с участием совершеннолетней, признанной в установленном законом порядке недееспособной.

6. В медицинских организациях по желанию женщины проводится медико-социальное консультирование до и после искусственного прерывания беременности, включая индивидуальный подбор методов и средств контрацепции.

7. Порядок, перечень медицинских и социальных показаний, а также противопоказаний для проведения искусственного прерывания беременности определяются уполномоченным органом.

Статья 151. Хирургическая стерилизация

1. Хирургическая стерилизация как метод предупреждения нежелательной беременности может быть проведена в отношении пациента не моложе тридцати пяти лет или имеющего не менее двух детей, а при наличии медицинских показаний и согласия совершеннолетнего гражданина – независимо от возраста и наличия детей.

2. Хирургическая стерилизация проводится только с информированного согласия пациента субъектами здравоохранения, имеющими лицензию на осуществление данной деятельности, с обязательным предварительным уведомлением о необратимости данной операции.

3. Порядок и условия проведения хирургической стерилизации определяются уполномоченным органом.

Статья 152. Химическая кастрация

1. Химическая кастрация – прием пациентом препаратов, снижающих половое влечение, который осуществляется в медицинской организации на основании решения суда.

2. Вид используемого лекарственного препарата, периодичность его введения в рамках установленного судом срока действия принудительной меры медицинского характера, а также порядок применения данной меры определяются уполномоченным органом по согласованию с Генеральной прокуратурой Республики Казахстан.

Сноска. Статья 152 с изменением, внесенным Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022).

Статья 153. Определение биологической смерти, необратимой гибели головного мозга. Условия продолжения, прекращения искусственных мер по поддержанию функций органов

1. Биологическая смерть представляет собой прекращение жизнедеятельности организма, при котором жизненно важные функции необратимо угасли.

2. Биологическая смерть определяется медицинским работником на основании совокупности следующих признаков:

1) остановка сердечной деятельности;

2) прекращение дыхания;

3) прекращение функций центральной нервной системы.

3. Необратимая гибель головного мозга представляет собой прекращение деятельности головного мозга в связи с гибелью вещества головного мозга, при котором могут проводиться искусственные меры по поддержанию функций органов.

4. Необратимая гибель головного мозга констатируется консилиумом медицинской организации на основании совокупности признаков прекращения функций центральной нервной системы, а также клинических тестов и иных диагностических исследований в порядке, определенном уполномоченным органом.

5. Искусственные меры по поддержанию функций органов продолжаются в случае, если лицо, которому констатирована необратимая гибель головного мозга, при жизни выразило согласие на изъятие органов (части органа) и (или) тканей (части ткани) в целях трансплантации.

В случае отсутствия прижизненного волеизъявления лица искусственные меры по поддержанию функций органов могут быть продолжены в случае наличия согласия супруга (супруги), а при его (ее) отсутствии – одного из близких родственников лица на изъятие органов (части органа) и (или) тканей (части ткани) в целях трансплантации.

6. Искусственные меры по поддержанию жизни могут быть прекращены только при:

1) констатации биологической смерти;

2) необратимой гибели головного мозга, зафиксированной консилиумом, подтвержденной необходимыми диагностическими и иными исследованиями в порядке, определяемом уполномоченным органом, при наличии письменного согласия супруга (супруги), при его (ее) отсутствии – одного из близких родственников и (или) законного представителя.

Статья 154. Эвтаназия

Осуществление эвтаназии в Республике Казахстан запрещается.

Статья 155. Анатомический дар

1. Анатомический дар – добровольное пожертвование дееспособным лицом органов (части органа) и (или) тканей (части ткани) как при жизни, так и после его смерти, осуществляемое лицом посредством надлежаще оформленного договора или завещания.

2. Сведения об анатомическом даре разглашению не подлежат.

3. В качестве анатомического дара, помимо завещанных органов (части органа) и (или) тканей (части ткани), признается труп лица с установленной личностью, невостребованный для захоронения в течение двадцати дней со дня смерти в медицинской организации.

Неопознанные трупы не признаются в качестве анатомического дара.

4. Анатомический дар может быть использован в научных, научно-практических и учебных целях для проведения биомедицинских исследований.

5. Порядок и условия совершения и передачи организациям здравоохранения анатомического дара определяются уполномоченным органом.

Статья 156. Изменение половой принадлежности

1. Лица с расстройствами половой идентификации, достигшие двадцати одного года, дееспособные, кроме лиц с психическими, поведенческими расстройствами (заболеваниями), имеют право на смену пола.

2. Порядок медицинского освидетельствования и проведения смены пола для лиц с расстройствами половой идентификации определяется уполномоченным органом.

Глава 19. ОКАЗАНИЕ МЕДИЦИНСКОЙ ПОМОЩИ ПРИ ОСНОВНЫХ ИНФЕКЦИОННЫХ ЗАБОЛЕВАНИЯХ

Параграф 1. Оказание медико-социальной помощи лицам, больным туберкулезом

Статья 157. Оказание медицинской помощи лицам, больным туберкулезом

1. Лицам, больным туберкулезом, государством гарантируются:

1) медицинская помощь и лекарственное обеспечение в рамках гарантированного объема бесплатной медицинской помощи;

2) социальная и правовая защита;

3) недопущение каких-либо форм дискриминации в связи с характером заболевания;

4) осуществление профилактических мероприятий по снижению заболеваемости тяжелыми, остро прогрессирующими формами туберкулеза среди детей.

2. Лица, больные заразной формой туберкулеза, подлежат обязательной госпитализации, лечению и реабилитации.

3. Признание лица больным заразной формой туберкулеза осуществляется на основании заключения организации здравоохранения с учетом результатов лабораторных исследований.

4. Порядок проведения медицинского обследования с целью признания лица больным заразной формой туберкулеза определяется уполномоченным органом.

5. Лицо, признанное больным заразной формой туберкулеза, может обжаловать решение организации здравоохранения в порядке, установленном законами Республики Казахстан.

Статья 158. Основание и порядок направления лиц, больных туберкулезом, на принудительное лечение

1. Принудительное лечение лиц, больных туберкулезом, включает противотуберкулезное и симптоматическое лечение с изоляцией пациентов в фтизиопульмонологических организациях и осуществляется в рамках гарантированного объема бесплатной медицинской помощи.

2. Основаниями для принудительного лечения лиц, больных туберкулезом, являются:

1) отказ от лечения больного с заразной формой туберкулеза, зафиксированный в медицинской документации пациента;

2) самовольный уход и нарушение режима лечения в виде беспричинного пропуска приема семи суточных доз противотуберкулезных препаратов в течение календарного месяца, зафиксированного в медицинской документации пациента.

3. Лица, больные туберкулезом, подвергавшиеся принудительному лечению, после выписки из фтизиопульмонологических организаций обязаны встать на учет в медицинскую организацию по месту жительства.

Правила оказания медицинской помощи лицам, больным туберкулезом, направленным на принудительное лечение, разрабатываются и утверждаются уполномоченным органом.

4. Решение о принудительном лечении лиц, больных туберкулезом и уклоняющихся от лечения, принимается судом по заявлению организаций здравоохранения в соответствии с законодательством Республики Казахстан.

5. Лица, больные туберкулезом, находящиеся на принудительном лечении, пользуются всеми правами граждан Республики Казахстан с ограничениями, связанными с необходимостью соблюдения режима пребывания в фтизиопульмонологических организациях.

6. За лицом, больным туберкулезом, направленным на принудительное лечение, сохраняется место работы.

Время пребывания на принудительном лечении не прерывает трудовой стаж и засчитывается в общий трудовой стаж.

7. Направление на принудительное лечение в фтизиопульмонологическую организацию не влечет за собой судимости.

8. За лицом, больным туберкулезом, направленным на принудительное лечение, проживающим в жилище из государственного жилищного фонда, жилье сохраняется в течение всего времени нахождения на лечении.

Статья 159. Социальная и правовая защита лиц, больных или переболевших туберкулезом

1. Местные исполнительные органы оказывают:

1) социальную поддержку лицам, больным туберкулезом, находящимся на амбулаторном лечении;

2) содействие в трудовом и бытовом устройстве лицам, переболевшим туберкулезом.

2. Дети, больные туберкулезом, допускаются к обучению в школе и других учебных заведениях на общих основаниях по решению центрально-врачебной консультационной комиссии организаций здравоохранения, оказывающих фтизиопульмонологическую помощь.

3. Особенности поступления, прохождения и увольнения с воинской службы, службы в специальных государственных и правоохранительных органах, фельдъегерской службы лиц, болеющих или переболевших туберкулезом, определяются законодательством Республики Казахстан.

4. Лица, разглашающие сведения о лицах, заболевших и переболевших туберкулезом, несут ответственность в соответствии с законами Республики Казахстан.

Параграф 2. Оказание медико-социальной помощи лицам, зараженным ВИЧ-инфекцией

Статья 160. Оказание медицинской помощи лицам, зараженным ВИЧ-инфекцией

1. Лицам, зараженным ВИЧ-инфекцией, государством гарантируются:

1) доступность и качество конфиденциального медицинского обследования на бесплатной основе, обеспечение динамического наблюдения, предоставление психосоциальных, юридических и медицинских консультаций;

2) медицинская помощь и лекарственное обеспечение в рамках гарантированного объема бесплатной медицинской помощи;

3) осуществление профилактических мероприятий по снижению риска передачи ВИЧ-инфекции от матери к плоду и ребенку;

4) социальная правовая защита.

2. Граждане Республики Казахстан, кандасы, иностранцы, лица без гражданства, беженцы, зараженные ВИЧ-инфекцией, постоянно проживающие на территории Республики Казахстан, и дети, рожденные от зараженных ВИЧ-инфекцией матерей с неустановленным диагнозом, подлежат динамическому наблюдению и обеспечению лекарственными средствами в рамках гарантированного объема бесплатной медицинской помощи.

3. Лица, нуждающиеся в доконтактной и постконтактной профилактике ВИЧ-инфекции, подлежат медицинскому наблюдению и обеспечению лекарственными средствами в рамках гарантированного объема бесплатной медицинской помощи.

4. Лица, зараженные ВИЧ-инфекцией, в том числе иностранцы и лица без гражданства, свобода которых ограничена, отбывающие наказание по приговору суда в местах лишения свободы, задержанные, заключенные под стражу и помещенные в специальные учреждения, имеют право на получение гарантированного объема бесплатной медицинской помощи.

Статья 161. Социальная и правовая защита лиц, зараженных ВИЧ-инфекцией

1. Лицам, зараженным ВИЧ-инфекцией, не ограничиваются обучение в организациях образования, пребывание в санаторно-курортных организациях и оздоровительных организациях образования.

2. Не допускаются прекращение трудового договора, запрет на заключение трудового договора, за исключением случаев, установленных трудовым законодательством Республики Казахстан, прием в организации образования и социальные учреждения, а также ущемление прав и законных интересов лиц, зараженных ВИЧ-инфекцией, равно как ущемление жилищных и иных прав и интересов их близких родственников.

3. Не допускается запрос работодателем результатов обследования на ВИЧ-инфекцию, кроме медицинских работников, имеющих контакт с кровью, другими биологическими жидкостями и биоматериалами, подлежащих предварительным и периодическим медицинским осмотрам.

4. В случае выявления ВИЧ-инфекции работники с установленным диагнозом "ВИЧ-инфекция" подлежат переводу работодателем на другую работу, не связанную с нарушением целостности кожных покровов или слизистых.

5. Особенности поступления, прохождения и увольнения с воинской службы, службы в специальных государственных и правоохранительных органах лиц, зараженных ВИЧ-инфекцией, определяются законодательством Республики Казахстан.

6. Лица, у которых заражение ВИЧ-инфекцией произошло в результате ненадлежащего исполнения служебных обязанностей медицинскими работниками и работниками сферы бытового обслуживания, имеют право на возмещение вреда, причиненного жизни или здоровью, в соответствии с законодательством Республики Казахстан.

Статья 162. Обследование на ВИЧ-инфекцию

1. Граждане Республики Казахстан, кандасы, иностранцы, лица без гражданства, беженцы и лица, ищущие убежище, постоянно и временно проживающие на территории Республики Казахстан, имеют право на добровольное анонимное и (или) конфиденциальное медицинское обследование и консультирование по вопросам ВИЧ-инфекции в рамках гарантированного объема бесплатной медицинской помощи в государственных организациях здравоохранения, осуществляющих деятельность в сфере профилактики ВИЧ-инфекции, в порядке, определяемом уполномоченным органом.

2. Обязательному конфиденциальному медицинскому обследованию на наличие ВИЧ-инфекции в рамках гарантированного объема бесплатной медицинской помощи подлежат:

1) доноры и реципиенты крови, ее компонентов, органов (части органа) и (или) тканей (части ткани), половых клеток;

2) лица на основании запросов органов прокуратуры, следствия и (или) суда;

3) лица по клиническим и эпидемиологическим показаниям в порядке, определяемом уполномоченным органом;

4) лица, свобода которых ограничена, отбывающие наказание по приговору суда в местах лишения свободы, заключенные под стражу и помещенные в специальные учреждения.

Обязательное конфиденциальное медицинское обследование на наличие ВИЧ-инфекции осуществляется в государственных организациях здравоохранения, осуществляющих деятельность в сфере профилактики ВИЧ-инфекции, в порядке, определяемом уполномоченным органом.

3. Медицинское освидетельствование на ВИЧ-инфекцию несовершеннолетних проводится с согласия их законных представителей или по их желанию, недееспособных лиц – с согласия их законных представителей.

4. Сотрудники иностранных дипломатических представительств, работники иностранных консульских учреждений и иные лица, пользующиеся на территории Республики Казахстан привилегиями и иммунитетами, проходят обследование на наличие ВИЧ-инфекции только с их согласия. Предложение о необходимости их обследования уполномоченный орган предварительно согласовывает с Министерством иностранных дел Республики Казахстан.

5. Организации здравоохранения, выявившие при медицинском обследовании факт ВИЧ-инфекции, письменно уведомляют обследуемого о полученном результате, информируют о необходимости соблюдения мер предосторожности, направленных на охрану собственного здоровья и здоровья окружающих, а также предупреждают об административной и уголовной ответственности за уклонение от лечения и заражение других лиц.

Глава 20. ОКАЗАНИЕ МЕДИЦИНСКОЙ ПОМОЩИ ПРИ ОСНОВНЫХ НЕИНФЕКЦИОННЫХ ЗАБОЛЕВАНИЯХ

Параграф 1. Оказание медицинской помощи в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями)

Статья 163. Права лиц с психическими, поведенческими расстройствами (заболеваниями)

1. Лица с психическими, поведенческими расстройствами (заболеваниями) обладают всеми правами и свободами граждан, предусмотренными Конституцией Республики Казахстан и настоящим Кодексом.

Ограничение осуществления прав и свобод граждан, связанных с психическими, поведенческими расстройствами (заболеваниями), допустимо лишь в случаях, предусмотренных законами Республики Казахстан.

2. Лица с психическими, поведенческими расстройствами (заболеваниями) при оказании им медицинской помощи в области психического здоровья имеют право на:

1) получение медицинской помощи в области психического здоровья по месту жительства, а также в случае необходимости по месту нахождения;

2) отказ на любой стадии лечения от использования медицинских средств и методов, научных исследований или учебного процесса, от фото-, видео- или киносъемки;

3) приглашение специалиста, участвующего в оказании медицинской помощи в области психического здоровья (с согласия последнего), для работы во врачебной комиссии;

4) получение образования по программе общеобразовательной школы или специальной школы для детей с нарушением интеллектуального развития, если пациент не достиг восемнадцати лет;

5) ведение переписки, получение и отправление посылок, бандеролей, денежных, почтовых переводов, пользование телефоном, прием посетителей, подписку на периодические печатные издания;

6) владение предметами первой необходимости и их приобретение, пользование собственной одеждой;

7) ежедневную прогулку.

3. Лица с психическими, поведенческими расстройствами (заболеваниями), в отношении которых применяются принудительные меры медицинского характера в психиатрических организациях специализированного типа с интенсивным наблюдением, имеют помимо прав, указанных в пунктах 1 и 2 настоящей статьи, право на:

1) приобретение дополнительного питания;

2) получение медицинских услуг сверх гарантированного объема бесплатной медицинской помощи;

3) приобретение мягкого инвентаря, одежды, обуви;

4) пользование междугородней телефонной связью;

5) пользование контрольным счетом наличности.

Реализация указанных прав осуществляется за счет средств лица, которому они предоставляются.

Статья 164. Защита прав и интересов лиц с психическими, поведенческими расстройствами (заболеваниями)

1. Лица с психическими, поведенческими расстройствами (заболеваниями) при оказании им медицинской помощи в области психического здоровья вправе пригласить по своему выбору представителя для защиты своих прав и законных интересов. Оформление представительства производится в порядке, установленном законами Республики Казахстан.

2. Защиту прав и законных интересов несовершеннолетнего или лица, признанного судом недееспособным, осуществляет его законный представитель.

3. Защиту прав и законных интересов лиц с психическими, поведенческими расстройствами (заболеваниями) осуществляют их законные представители.

4. Медицинская организация, оказывающая медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями), обеспечивает возможность приглашения адвоката или законного представителя, за исключением случаев, предусмотренных пунктом 5 статьи 166 настоящего Кодекса.

Статья 165. Организация медицинской помощи в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями)

1. В целях организации медицинской помощи в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями) государство:

1) создает лечебно-производственные объекты и структурные подразделения для трудовой терапии, обучения новым профессиям, а также специальные производства, цеха или участки с облегченными условиями труда для трудоустройства лиц с психическими, поведенческими расстройствами (заболеваниями) в этих организациях, включая лиц с инвалидностью;

2) обеспечивает организацию и проведение медико-социальной реабилитации лицам с психическими, поведенческими расстройствами (заболеваниями) по месту жительства, а также в случае необходимости – по месту нахождения, по желанию пациента может осуществляться анонимно.

2. Несовершеннолетним лицам с психическими, поведенческими расстройствами (заболеваниями), а также лицам, признанным судом недееспособными, медико-социальная реабилитация проводится с согласия их законных представителей.

Сноска. Статья 165 с изменением, внесенным Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 166. Психиатрическое освидетельствование

1. Психиатрическое освидетельствование проводится в целях установления психических, поведенческих расстройств (заболеваний) у обследуемого лица, определения необходимости оказания медицинской помощи в области психического здоровья, а также для решения вопросов об опеке, определении временной нетрудоспособности, экспертизе профессиональной пригодности, в том числе при проведении военно-врачебной экспертизы.

2. Психиатрическое освидетельствование, а также профилактические осмотры проводятся врачом-психиатром:

1) с письменного согласия обследуемого лица или по письменному заявлению его законных представителей с указанием причины освидетельствования;

2) в отношении несовершеннолетнего или лица, признанного судом недееспособным, с письменного согласия его законного представителя;

3) при проведении военно-врачебной экспертизы в соответствии с законодательством Республики Казахстан.

Данные психиатрического освидетельствования и заключения о состоянии психического здоровья обследуемого лица фиксируются в медицинской документации, в которой указываются также причины обращения к врачу-психиатру и медицинские рекомендации.

3. В случае возражения или отсутствия согласия обследуемого лица или законного представителя несовершеннолетнего освидетельствование проводится по решению органа опеки и попечительства, которое может быть обжаловано в суд.

4. Врач, проводящий психиатрическое освидетельствование, обязан представиться обследуемому лицу и его законному представителю как психиатр, за исключением случаев, предусмотренных подпунктом 1) пункта 5 настоящей статьи.

5. Психиатрическое освидетельствование лица может быть проведено без его согласия или без согласия его законного представителя в случае, когда обследуемое лицо совершает действия, дающие основания предполагать наличие у него тяжелого психического расстройства (заболевания), которое обуславливает:

1) его непосредственную опасность для себя и окружающих;

2) его беспомощность, то есть неспособность самостоятельно удовлетворять основные жизненные потребности при отсутствии надлежащего ухода;

3) существенный вред его здоровью вследствие ухудшения психического состояния, если лицо будет оставлено без медицинской помощи в области психического здоровья.

6. Психиатрическое освидетельствование лица может быть проведено без согласия его законного представителя, если обследуемое лицо находится под динамическим наблюдением в порядке, предусмотренном пунктом 2 статьи 176 настоящего Кодекса.

7. Психиатрическая экспертиза и психиатрическое освидетельствование лица производятся в соответствии с законодательством Республики Казахстан.

8. В случаях, предусмотренных пунктом 5 настоящей статьи, решение о психиатрическом освидетельствовании принимается комиссией врачей-психиатров с уведомлением законного представителя лица.

9. Решение о психиатрическом освидетельствовании лица без его согласия или без согласия его законного представителя, за исключением случаев, предусмотренных пунктом 6 настоящей статьи, принимается врачом-психиатром по заявлению, содержащему сведения о наличии оснований для такого освидетельствования, перечисленных в пункте 5 настоящей статьи.

10. Заявление о психиатрическом освидетельствовании должно быть письменным, содержать подробные сведения, обосновывающие необходимость такого освидетельствования, и данные об отказе лица (либо его законного представителя) от обращения к врачу-психиатру. Врач-психиатр вправе запросить дополнительные сведения, необходимые для принятия решения, установив, что в заявлении отсутствуют обстоятельства, предусмотренные пунктом 5 настоящей статьи, или в письменном виде обоснованно отказать в психиатрическом освидетельствовании.

11. Несовершеннолетний или лицо, признанные судом недееспособными, помещенные в организацию, оказывающую медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями), подлежит обязательному освидетельствованию комиссией врачей-психиатров в порядке, предусмотренном настоящей статьей.

12. В течение первых шести месяцев несовершеннолетний или лицо, признанные судом недееспособными, подлежит освидетельствованию комиссией врачей-психиатров не реже одного раза в месяц для решения вопроса о продлении госпитализации. Решение о продлении госпитализации свыше шести месяцев производится по решению суда на основании обращения комиссии врачей-психиатров в порядке, установленном законодательством Республики Казахстан в области здравоохранения.

13. В случае обнаружения комиссией врачей-психиатров или администрацией организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями), злоупотреблений, допущенных при госпитализации законными представителями несовершеннолетнего или лица, признанного судом недееспособным, администрация организации в течение двадцати четырех часов с момента выявления указанных обстоятельств извещает об этом прокурора и орган опеки и попечительства по месту жительства подопечного.

Статья 167. Оказание медицинской помощи лицам с психическими, поведенческими расстройствами (заболеваниями)

1. Государством гарантируется:

1) экстренная и плановая медицинская помощь в области психического здоровья в рамках гарантированного объема бесплатной медицинской помощи;

2) психиатрическая экспертиза, определение временной нетрудоспособности;

3) социально-бытовая помощь и содействие в трудоустройстве лицам с психическими, поведенческими расстройствами (заболеваниями);

4) осуществление медицинских программ и мер, направленных на обеспечение равных возможностей для лиц с особыми потребностями.

2. Диагноз психического, поведенческого расстройства (заболевания) устанавливается врачом-психиатром в соответствии с критериями международной классификации болезней.

Врач первичной медико-санитарной помощи имеет право на диагностику и лечение пограничных психических, поведенческих расстройств в объеме, установленном уполномоченным органом, с письменного согласия пациента. Заключение врача первичной медико-санитарной помощи не является основанием для ограничения прав и свобод пациента, а также психиатрического освидетельствования.

3. Для диагностики и лечения лица с психическим, поведенческим расстройством (заболеванием) применяются медицинские средства и методы, разрешенные законодательством Республики Казахстан в области здравоохранения.

4. Медицинские средства и методы применяются только в диагностических и лечебных целях в соответствии с характером болезненных расстройств и запрещаются для использования в виде наказания лица.

5. Врач в течение сорока восьми часов с момента проведения психиатрического освидетельствования предоставляет лицу с психическим, поведенческим расстройством (заболеванием), если оно может правильно воспринимать суть изложенной информации, или его законному представителю письменную информацию о характере психического, поведенческого расстройства (заболевания), целях и методах лечения, а также данные о продолжительности рекомендуемого лечения, возможных болевых ощущениях, побочных эффектах и об ожидаемых результатах. О предоставленной информации делается запись в медицинской документации. В остальных случаях данная информация может быть предоставлена в соответствии с пунктом 4 статьи 273 настоящего Кодекса.

6. Лечение лица с психическим, поведенческим расстройством (заболеванием) производится после получения его согласия или его законного представителя, за исключением случаев, предусмотренных пунктом 7 настоящей статьи.

7. Лечение может проводиться без согласия лица с психическим, поведенческим расстройством (заболеванием) или его законного представителя только при применении принудительных мер медицинского характера по основаниям, установленным законами Республики Казахстан, а также при принудительной госпитализации по основаниям, предусмотренным пунктом 1 статьи 137 настоящего Кодекса. В этих случаях, за исключением экстренной госпитализации, лечение осуществляется по решению комиссии врачей-психиатров. При госпитализации лица без его согласия принятие решения о порядке лечения комиссией врачей-психиатров должно быть обеспечено в течение сорока восьми часов с момента его госпитализации.

8. Лицо с психическим, поведенческим расстройством (заболеванием) или его законный представитель имеет право отказаться от предлагаемого лечения или прекратить его, за исключением случаев, предусмотренных пунктом 7 настоящей статьи.

9. Лицу, отказавшемуся от лечения, либо его законному представителю должны быть разъяснены возможные последствия прекращения лечения. Отказ от лечения с указанием сведений о возможных последствиях оформляется записью в медицинской документации за подписью лица с психическим, поведенческим расстройством (заболеванием) или его законного представителя и врача-психиатра.

Статья 168. Госпитализация в стационар организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями)

1. Основаниями для госпитализации в стационар являются наличие у лица психического, поведенческого расстройства (заболевания) и решение врача-психиатра о необходимости проведения обследования или лечения в условиях стационара.

2. Госпитализация лица в стационар осуществляется добровольно по его просьбе или с его письменного согласия, за исключением случаев, предусмотренных статьей 137 настоящего Кодекса.

3. Несовершеннолетний госпитализируется в стационар с письменного согласия его законного представителя.

4. В случае возражения или отсутствия законного представителя госпитализация несовершеннолетнего в стационар проводится по решению органа опеки и попечительства, которое может быть обжаловано в суд, с письменным уведомлением прокурора в течение двадцати четырех часов с момента принятия решения о госпитализации.

5. Полученное согласие лица на госпитализацию оформляется записью в медицинской документации за подписью лица или его законного представителя и врача-психиатра.

6. Принудительная госпитализация в стационар допускается на основании решения суда.

Принудительная госпитализация лица в стационар до вынесения судом решения допускается исключительно в случаях, предусмотренных подпунктами 3) и 4) пункта 1 статьи 137 настоящего Кодекса.

По каждому случаю принудительной госпитализации без решения суда администрация организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическим, поведенческим расстройством (заболеванием), в течение сорока восьми часов с момента помещения лица в стационар направляет прокурору письменное уведомление в соответствии с законами Республики Казахстан, а также информирует супруга (супругу), близких родственников и (или) законных представителей при наличии сведений о них.

7. Пребывание лица в стационаре в принудительном порядке продолжается только в течение времени сохранения оснований, по которым была проведена госпитализация.

8. Лицо, госпитализированное в стационар в принудительном порядке, в течение первых шести месяцев подлежит не реже одного раза в месяц освидетельствованию комиссией врачей-психиатров для решения вопроса о продлении госпитализации. Продление госпитализации свыше шести месяцев производится по решению суда на основании заявления организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройством (заболеваниями), о необходимости продления срока принудительной госпитализации и лечения, к которому прилагается заключение комиссии врачей-психиатров.

9. Внеочередное освидетельствование лица, госпитализированного в принудительном порядке, может быть проведено по желанию самого пациента или его законного представителя.

Лицо, госпитализированное в стационар по основаниям, предусмотренным пунктом 1 статьи 137 настоящего Кодекса, подлежит обязательному освидетельствованию в течение сорока восьми часов с момента госпитализации комиссией врачей-психиатров, которая принимает решение об обоснованности госпитализации. В случаях, когда госпитализация признается необоснованной и госпитализируемое лицо не выражает желания остаться в стационаре, оно подлежит немедленной выписке.

10. В случае несогласия с принудительной госпитализацией лицо с психическим, поведенческим расстройством (заболеванием) или его законный представитель вправе обратиться в суд в порядке, установленном законами Республики Казахстан.

Статья 169. Выписка из стационара организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями)

1. Выписка из стационара производится по выздоровлении лица или улучшении его психического состояния, когда не требуется дальнейшего стационарного лечения, а также по завершении обследования или экспертизы, явившихся основаниями для помещения в стационар.

2. Выписка лица, добровольно находящегося в стационаре, производится по его личному заявлению, заявлению его законного представителя или по решению его лечащего врача.

3. Выписка лица, госпитализированного в стационар в принудительном порядке, производится по заключению комиссии врачей-психиатров, решению суда либо постановлению прокурора.

4. Выписка лица, к которому по определению суда применены принудительные меры медицинского характера, производится только по определению суда.

5. Лицу, помещенному в стационар добровольно, может быть отказано в выписке, если комиссией врачей-психиатров организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическим, поведенческим расстройством (заболеванием), будут установлены основания для госпитализации в принудительном порядке, предусмотренные пунктом 1 статьи 137 настоящего Кодекса. В таком случае вопросы о его пребывании в стационаре, продлении госпитализации и выписке из стационара решаются в порядке, установленном пунктами 7 – 9 статьи 168 настоящего Кодекса и пунктом 3 настоящей статьи.

Статья 170. Принудительные меры медицинского характера в отношении лица с психическими, поведенческими расстройствами (заболеваниями)

1. Принудительные меры медицинского характера применяются по решению суда в отношении лица с психическим, поведенческим расстройством (заболеванием), совершившего общественно опасные деяния, по основаниям и в порядке, установленным законодательством Республики Казахстан.

2. Принудительные меры медицинского характера осуществляются в организациях, оказывающих медицинскую помощь в области психического здоровья лицам с психическим, поведенческим расстройством (заболеванием), в виде:

1) принудительного наблюдения и лечения у психиатра в амбулаторных условиях;

2) принудительного лечения в психиатрическом стационаре общего типа;

3) принудительного лечения в психиатрическом стационаре специализированного типа;

4) принудительного лечения в психиатрическом стационаре специализированного типа с интенсивным наблюдением.

3. Лицо, помещенное в стационар для применения принудительных мер медицинского характера, признается нетрудоспособным на весь период пребывания в стационаре.

4. Правила использования денежных средств от физических и юридических лиц, в том числе пенсионных выплат и государственных социальных пособий, зачисляемых на контрольный счет наличности государственной психиатрической организации специализированного типа с интенсивным наблюдением, для использования лицами с психическими, поведенческими расстройствами (заболеваниями), находящимися на принудительном лечении, разрабатываются и утверждаются уполномоченным органом.

5. Учет и отчетность по использованию средств контрольного счета наличности государственной психиатрической организации специализированного типа с интенсивным наблюдением, а также контроль за их использованием осуществляются в соответствии с законодательством Республики Казахстан.

6. Охрана организации, оказывающей медицинскую помощь в области психического здоровья в виде принудительного лечения лиц с психическими, поведенческими расстройствами (заболеваниями), вызванными употреблением психоактивных веществ, возлагается на администрацию этой организации и осуществляется в соответствии с законодательством Республики Казахстан в области охранной деятельности.

7. Охрана государственной психиатрической организации специализированного типа с интенсивным наблюдением осуществляется в соответствии с порядком, определенным Министерством внутренних дел Республики Казахстан совместно с уполномоченным органом.

8. Оборудование государственной психиатрической организации специализированного типа с интенсивным наблюдением инженерно-техническими средствами охраны осуществляется уполномоченным органом в соответствии с порядком, определенным Министерством внутренних дел Республики Казахстан совместно с уполномоченным органом.

Статья 171. Принудительные меры медицинского характера в отношении лица с психическими, поведенческими расстройствами (заболеваниями), связанными с употреблением психоактивных веществ

1. Принудительные меры медицинского характера применяются по решению суда в отношении лица с психическими, поведенческими расстройствами (заболеваниями), связанными с употреблением психоактивных веществ, совершившего уголовное правонарушение, признанного нуждающимся в лечении, а также в отношении лица, совершившего административное правонарушение и уклоняющегося от добровольного лечения.

2. Направление на принудительное лечение в организации, оказывающие медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями), не влечет судимости.

3. За лицом, направленным на принудительное лечение, проживающим в жилище из государственного жилищного фонда, жилье сохраняется в течение всего времени нахождения на лечении.

4. Лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящееся на принудительном лечении, имеет право:

1) на ознакомление с правилами внутреннего распорядка организации для принудительного лечения и иными документами, регламентирующими порядок пребывания в данной организации;

2) на ведение переписки, получение и отправление посылок, бандеролей, денежных, почтовых переводов, пользование телефоном, прием посетителей, подписку на периодические печатные издания;

3) получать питание, материально-бытовое и медицинское обслуживание;

4) на трудовое устройство в соответствии с трудовым законодательством Республики Казахстан;

5) приобретать за счет средств, находящихся на персональном лицевом счете, продукты питания и предметы первой необходимости, а также иные вещи, не запрещенные к хранению и использованию на территории организации для принудительного лечения;

6) иметь встречи с близкими родственниками в порядке, определенном правилами внутреннего распорядка;

7) вести переписку без ограничения;

8) получать передачи, отправлять и получать посылки в порядке, определенном правилами внутреннего распорядка;

9) получать денежные переводы, которые зачисляются на его лицевой счет;

10) на ежедневную прогулку;

11) подавать жалобы на действия (бездействие) сотрудников организаций в уполномоченный орган, органы прокуратуры, суд в порядке, установленном законами Республики Казахстан.

5. Лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящееся на принудительном лечении в организации, обязано:

1) соблюдать установленные правила внутреннего распорядка;

2) выполнять законные требования администрации организации для принудительного лечения и медицинского персонала;

3) принимать назначенное лечение;

4) бережно относиться к имуществу организации;

5) поддерживать чистоту и порядок в организации для принудительного лечения, а также осуществлять уборку на ее территории не более двух часов в неделю;

6) соблюдать личную гигиену.

Статья 172. Оформление лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, на принудительное лечение

1. Лицо, оформляемое на принудительное лечение в связи с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, извещается о дате и месте медицинского освидетельствования организацией, оказывающей медицинскую помощь в области психического здоровья.

Извещение направляется заказным письмом, телеграммой с уведомлением о вручении.

2. Лицо, надлежащим образом уведомленное организацией, оказывающей медицинскую помощь в области психического здоровья, о дате и месте медицинского освидетельствования (за исключением наличия уважительных причин) и уклоняющееся от медицинского освидетельствования на основании мотивированного заключения организации, оказывающей медицинскую помощь в области психического здоровья, подвергается приводу органами внутренних дел для принудительного обследования.

3. Привод осуществляется путем принудительного препровождения уклоняющегося от медицинского освидетельствования лица к месту проведения принудительного обследования на срок не более трех часов только в рабочие дни с девяти до восемнадцати часов.

4. Уважительными причинами неявки лица на медицинское освидетельствование признаются: болезнь, лишающая возможности его явиться, смерть близких родственников, стихийные бедствия, иные причины, лишающие возможности явиться в назначенный срок. О наличии уважительных причин, препятствующих явке по вызову в назначенный срок, препровождаемое лицо обязано уведомить инициатора принудительного привода.

5. Заключение о приводе объявляется лицу, подвергаемому приводу, перед его исполнением, что удостоверяется его подписью на заключении.

В случае отказа препровождаемого лица от подписи об этом делается отметка в заключении.

Статья 173. Организация принудительного лечения лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ

1. Лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящееся на принудительном лечении в организации, оказывающей медицинскую помощь в области психического здоровья, обладает всеми правами и свободами граждан, предусмотренными Конституцией Республики Казахстан.

2. Ограничение осуществления прав и свобод лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящегося на принудительном лечении в организации, оказывающей медицинскую помощь в области психического здоровья, допустимо лишь в случаях, предусмотренных законами Республики Казахстан.

3. Лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящееся на принудительном лечении в организации, оказывающей медицинскую помощь в области психического здоровья, по его желанию обеспечивается работой, на него распространяется действие трудового законодательства Республики Казахстан.

4. В период принудительного лечения в организации, оказывающей медицинскую помощь в области психического здоровья, засчитывается время принудительной госпитализации для обследования.

5. Условия содержания лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, для принудительного лечения в организации, оказывающей медицинскую помощь в области психического здоровья, устанавливаются правилами внутреннего распорядка, утверждаемыми уполномоченным органом.

6. Лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящееся на принудительном лечении в организации, оказывающей медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями), нарушающее правила внутреннего распорядка или уклоняющееся от лечения, помещается в специальную палату, если его действия угрожают жизни и здоровью окружающих или лично ему. Помещение в специальную палату производится по письменному распоряжению руководителя организации, оказывающей медицинскую помощь в области психического здоровья, сроком до десяти суток с уведомлением прокурора в течение двадцати четырех часов с момента помещения лица. В случае отсутствия руководителя на рабочем месте решение о помещении в специальную палату принимается старшим по должности сотрудником организации, оказывающей медицинскую помощь в области психического здоровья, с последующим информированием руководителя, который определяет письменным распоряжением сроки содержания в специальной палате.

7. Самовольный уход лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, из организации, оказывающей медицинскую помощь в области психического здоровья, а равно неприбытие в организацию к установленному сроку являются уклонением от лечения и влекут ответственность в соответствии с законами Республики Казахстан. Доставление его на принудительное лечение осуществляется органами внутренних дел Республики Казахстан на основании постановления суда.

Период самовольного отсутствия лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, в организации, оказывающей медицинскую помощь в области психического здоровья, в срок лечения не засчитывается.

8. За совершение правонарушений и (или) причинение материального ущерба лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящееся на принудительном лечении в организации, оказывающей медицинскую помощь в области психического здоровья, несет ответственность, установленную законами Республики Казахстан.

Статья 174. Выписка лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, из организации, оказывающей медицинскую помощь в области психического здоровья

1. Лицо с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, прекращает принудительное лечение и выписывается из организации, оказывающей медицинскую помощь в области психического здоровья:

1) по истечении срока принудительного лечения, определенного судом;

2) в связи с выявлением сопутствующих тяжких заболеваний, препятствующих проведению принудительного лечения, по постановлению суда;

3) досрочно в связи с успешным излечением, но не ранее чем через шесть месяцев, по постановлению суда.

2. В случае уклонения от лечения лица с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, находящегося в организации, оказывающей медицинскую помощь в области психического здоровья, срок пребывания может быть продлен по решению суда на основании обращения администрации организации, оказывающей медицинскую помощь в области психического здоровья, основанного на медицинском заключении, но не более чем на один год. При этом время нахождения в организации, оказывающей медицинскую помощь в области психического здоровья, не должно превышать два года.

3. Лицу, выписанному из организации, оказывающей медицинскую помощь в области психического здоровья, возвращаются документы, деньги и вещи, изъятые и хранящиеся в камере хранения организации.

4. Условия труда лиц с психическим, поведенческим расстройством (заболеванием), связанным с употреблением психоактивных веществ, определяются трудовым законодательством Республики Казахстан.

5. О лицах, освобождающихся из организации, оказывающей медицинскую помощь в области психического здоровья, администрация организации, оказывающей медицинскую помощь в области психического здоровья, сообщает местному исполнительному органу по месту жительства для оказания содействия в бытовом и трудовом устройстве и в организацию здравоохранения по месту жительства для обеспечения наблюдения.

6. Лица, подвергавшиеся принудительному лечению, после выписки из организации, оказывающей медицинскую помощь в области психического здоровья, кроме выписанных по постановлению суда как излечившиеся досрочно, обязаны встать на учет в организацию, оказывающую медицинскую помощь в области психического здоровья лицам с психическими, поведенческими расстройствами (заболеваниями), по месту жительства и проходить в ней поддерживающее лечение в порядке, определяемом уполномоченным органом.

В случае уклонения от постановки на учет и прохождения поддерживающего лечения лицо может быть подвергнуто принудительному приводу органами внутренних дел.

7. Трудовое и бытовое устройство лица, выписанного из организации, оказывающей медицинскую помощь в области психического здоровья, осуществляется по месту жительства и возлагается на местные исполнительные органы.

Статья 175. Меры обеспечения безопасности при оказании медицинской помощи в области психического здоровья

1. Медицинская помощь в области психического здоровья в стационарных условиях осуществляется в наименее ограничительных условиях, обеспечивающих безопасность госпитализированного лица и других лиц, при соблюдении медицинским персоналом его прав и законных интересов.

2. Меры физического стеснения и изоляции при принудительной госпитализации и пребывании в стационаре применяются только в тех случаях, формах и на тот период времени, когда, по мнению врача-психиатра, иными методами невозможно предотвратить действия госпитализированного лица, представляющие непосредственную опасность для него или других лиц, и осуществляются при постоянном контроле медицинского персонала. О формах и времени применения мер физического стеснения или изоляции делается запись в медицинской документации с уведомлением его законного представителя.

3. Сотрудники правоохранительных органов обязаны оказывать содействие медицинским работникам при осуществлении принудительного освидетельствования, принудительной госпитализации, обеспечивать безопасные условия для доступа к госпитализируемому лицу с целью его осмотра, а также в случаях, угрожающих жизни и здоровью окружающих со стороны госпитализированного лица (лица, подлежащего госпитализации).

Статья 176. Динамическое наблюдение за лицами с психическими, поведенческими расстройствами (заболеваниями)

1. Динамическое наблюдение за лицами с психическими, поведенческими расстройствами (заболеваниями) может устанавливаться независимо от согласия лица с психическим, поведенческим расстройством (заболеванием) или его законного представителя в случаях, предусмотренных пунктом 2 настоящей статьи, и предполагает наблюдение за состоянием психического здоровья лица путем регулярных осмотров врачом-психиатром и оказание ему необходимой медико-социальной помощи.

2. Динамическое наблюдение может устанавливаться за лицом, страдающим хроническим или затяжным расстройством с тяжелыми, стойкими, часто обостряющимися болезненными проявлениями.

3. Правила динамического наблюдения, а также прекращения динамического наблюдения за лицами с психическими, поведенческими расстройствами (заболеваниями) разрабатываются и утверждаются уполномоченным органом.

4. При изменении психического состояния лицо с психическими, поведенческими расстройствами (заболеваниями) может быть освидетельствовано без его согласия или без согласия его законного представителя по основаниям и в порядке, которые предусмотрены пунктом 5 статьи 166 настоящего Кодекса. Динамическое наблюдение за лицами с психическими, поведенческими расстройствами (заболеваниями) может быть возобновлено в таких случаях по решению комиссии врачей-психиатров.

Параграф 2. Оказание медицинской помощи при орфанных заболеваниях

Статья 177. Оказание медицинской помощи при орфанных заболеваниях

1. К орфанным (редким) заболеваниям относятся редкие тяжелые болезни, угрожающие жизни человека или приводящие к инвалидности, частота которых не превышает официально определенного уровня.

2. Лечение орфанных заболеваний осуществляется в рамках гарантированного объема бесплатной медицинской помощи.

3. Перечень орфанных заболеваний и лекарственных средств для их лечения (орфанных) утверждается уполномоченным органом с учетом следующих критериев:

1) распространенность в Республике Казахстан;

2) необходимость в систематическом лечении, для проведения которого имеются разработанные и зарегистрированные на территории Республики Казахстан лекарственные средства (курабельные пациенты);

3) необходимость в систематическом лечении с применением лекарственных средств, которые разработаны и имеются в мире, но не зарегистрированы к применению на территории Республики Казахстан;

4) наличие заболеваний, для лечения которых в мире отсутствуют разработанные лекарственные средства;

5) необходимость оказания паллиативной медицинской помощи в связи с отсутствием радикальной терапии (инкурабельные пациенты).

4. Правила формирования перечня орфанных заболеваний и лекарственных средств для их лечения разрабатываются и утверждаются уполномоченным органом.

Глава 21. ЦЕНТРЫ ВРЕМЕННОЙ АДАПТАЦИИ И ДЕТОКСИКАЦИИ

Статья 178. Центры временной адаптации и детоксикации

1. Центры временной адаптации и детоксикации создаются по решению местных исполнительных органов.

2. Порядок организации деятельности центров временной адаптации и детоксикации и правила внутреннего распорядка центра временной адаптации и детоксикации определяются уполномоченным органом по согласованию с Министерством внутренних дел Республики Казахстан.

Статья 179. Основания помещения лиц в центры временной адаптации и детоксикации

Основанием помещения лиц в центры временной адаптации и детоксикации является заключение медицинского освидетельствования о нахождении помещаемого лица в состоянии алкогольного опьянения (интоксикации), проведенного персоналом организации, оказывающей медицинскую помощь в области психического здоровья.

Статья 180. Прием и регистрация лиц, помещаемых в центры временной адаптации и детоксикации

1. Порядок приема и регистрации лиц, помещаемых в центры временной адаптации и детоксикации, проведения личного досмотра, медицинского освидетельствования, а также перечень вещей, подлежащих изъятию, определяются в соответствии с правилами организации деятельности центров временной адаптации и детоксикации.

2. О помещении в центр временной адаптации и детоксикации лиц, находящихся в состоянии алкогольного опьянения (интоксикации), немедленно извещаются близкие родственники по месту жительства.

При помещении иностранца в центр временной адаптации и детоксикации медицинский персонал извещает об этом Генеральную прокуратуру Республики Казахстан, Министерство иностранных дел Республики Казахстан, Комитет национальной безопасности Республики Казахстан и Министерство внутренних дел Республики Казахстан.

Статья 181. Режим содержания в центрах временной адаптации и детоксикации

1. В центрах временной адаптации и детоксикации устанавливается режим, обеспечивающий безопасность содержащихся лиц и исключающий возможность их самовольного ухода. Условия содержания, требования к оборудованию помещений определяются правилами внутреннего распорядка центра временной адаптации и детоксикации.

2. Мужчины, помещенные в центры временной адаптации и детоксикации, размещаются отдельно от женщин.

3. Несовершеннолетние, помещенные в центры временной адаптации и детоксикации, госпитализируются в профильные отделения соответствующей медицинской организации с согласия их законных представителей.

4. Лица, больные инфекционными и паразитарными заболеваниями, не могут содержаться с другими лицами, помещенными в центры временной адаптации и детоксикации.

Статья 182. Права и обязанности лиц, помещаемых в центры временной адаптации и детоксикации

1. Лица, помещаемые в центры временной адаптации и детоксикации, имеют право:

1) получать информацию о своих правах и обязанностях, режиме содержания;

2) на личную безопасность в период нахождения в центре временной адаптации и детоксикации;

3) получать материально-бытовое и медико-санитарное обслуживание;

4) обращаться к медицинскому персоналу организации, оказывающей медицинскую помощь в области психического здоровья, а также в органы полиции, прокуратуры, суд по вопросам нарушения своих прав и законных интересов.

2. Лица, помещенные в центры временной адаптации и детоксикации, обязаны выполнять правила внутреннего распорядка центра временной адаптации и детоксикации, утверждаемые уполномоченным органом по согласованию с Министерством внутренних дел Республики Казахстан.

Статья 183. Освобождение лиц, помещенных в центры временной адаптации и детоксикации

1. Лица, помещенные в центры временной адаптации и детоксикации, подлежат незамедлительному освобождению в плановом порядке при достижении улучшения состояния, не требующего дальнейшего наблюдения и лечения в условиях центра, в течение суток с момента поступления.

2. Освобожденным лицам возвращаются под расписку изъятые у них на хранение документы, деньги и вещи, кроме вещей, хранение которых является незаконным.

3. При незаконном хранении лицами, помещаемыми в центры временной адаптации и детоксикации, огнестрельного или холодного оружия, взрывчатых, сильнодействующих или ядовитых веществ, наркотических средств, психотропных веществ и их прекурсоров решения принимаются в соответствии с законодательством Республики Казахстан.

4. При выписке лицу выдается справка о пребывании его в центре временной адаптации и детоксикации.

Глава 22. НАЦИОНАЛЬНЫЙ ПРЕВЕНТИВНЫЙ МЕХАНИЗМ

Сноска. В Главе 22 слова "Уполномоченный по правам человека", "Уполномоченном по правам человека", "Уполномоченного по правам человека", "Уполномоченным по правам человека", "Уполномоченному по правам человека" заменены соответственно словами "Уполномоченный по правам человека в Республике Казахстан", "Уполномоченном по правам человека в Республике Казахстан", "Уполномоченного по правам человека в Республике Казахстан", "Уполномоченным по правам человека в Республике Казахстан", "Уполномоченному по правам человека в Республике Казахстан" в соответствии с Законом РК от 05.11.2022 № 157-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 184. Национальный превентивный механизм

1. Национальный превентивный механизм действует в виде системы предупреждения пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания, функционирующей посредством деятельности участников национального превентивного механизма.

2. В рамках своей деятельности участники национального превентивного механизма посещают организации для принудительного лечения (специализированные противотуберкулезные организации, организации, оказывающие медицинскую помощь в области психического здоровья, для применения принудительных мер медицинского характера (для принудительного лечения – психиатрический стационар общего типа, психиатрический стационар специализированного типа, психиатрический стационар специализированного типа с интенсивным наблюдением) и иные организации, определяемые законами Республики Казахстан для посещения данными участниками.

3. Участниками национального превентивного механизма являются Уполномоченный по правам человека в Республике Казахстан, а также отбираемые Координационным советом члены общественных наблюдательных комиссий и общественных объединений, осуществляющих деятельность по защите прав, законных интересов граждан Республики Казахстан, юристы, социальные работники, врачи.

4. Уполномоченный по правам человека в Республике Казахстан координирует деятельность участников национального превентивного механизма, принимает в соответствии с законодательством Республики Казахстан меры для обеспечения необходимого потенциала и профессиональных знаний участников национального превентивного механизма.

5. Возмещение расходов участников национального превентивного механизма по превентивным посещениям осуществляется из бюджетных средств в порядке, определяемом Правительством Республики Казахстан.

Статья 185. Координационный совет

1. В целях обеспечения эффективной координации деятельности национального превентивного механизма при Уполномоченном по правам человека в Республике Казахстан создается Координационный совет.

Члены Координационного совета, за исключением Уполномоченного по правам человека в Республике Казахстан, избираются комиссией, создаваемой Уполномоченным по правам человека в Республике Казахстан, из числа граждан Республики Казахстан.

2. Уполномоченный по правам человека в Республике Казахстан утверждает:

1) положение о Координационном совете при Уполномоченном по правам человека в Республике Казахстан;

2) правила отбора участников национального превентивного механизма;

3) правила формирования групп из участников национального превентивного механизма для превентивных посещений;

4) методические рекомендации по превентивным посещениям;

5) правила подготовки ежегодного консолидированного доклада по итогам превентивных посещений.

3. Координационный совет взаимодействует с Подкомитетом по предупреждению пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания Комитета Организации Объединенных Наций против пыток.

Статья 186. Требования к участникам национального превентивного механизма

1. Участниками национального превентивного механизма не могут быть лица:

1) имеющие непогашенную или неснятую судимость в порядке, установленном законом Республики Казахстан;

2) подозреваемые или обвиняемые в совершении уголовного правонарушения;

3) признанные судом недееспособными или ограниченно дееспособными;

4) судьи, адвокаты, государственные служащие и военнослужащие, а также работники правоохранительных и специальных государственных органов;

5) состоящие на учете в организации, оказывающей медицинскую помощь в области психического здоровья.

2. Участниками национального превентивного механизма также не могут быть лица, освобожденные от уголовной ответственности на основании пунктов 3), 4), 9), 10) и 12) части первой статьи 35 или статьи 36 Уголовно-процессуального кодекса Республики Казахстан за совершение умышленного преступления; уволенные с государственной или воинской службы, из правоохранительных и специальных государственных органов, судов или исключенные из коллегии адвокатов по отрицательным мотивам; лишенные лицензии на занятие адвокатской деятельностью.

Статья 187. Права участника национального превентивного механизма

1. Участник национального превентивного механизма вправе:

1) получать информацию о количестве лиц, содержащихся в организациях, подлежащих превентивному посещению, количестве таких организаций и их месте нахождения;

2) иметь доступ к информации, касающейся обращения с лицами, содержащимися в организациях, подлежащих превентивному посещению, а также условий их содержания;

3) осуществлять превентивные посещения в установленном порядке в составе сформированных групп;

4) проводить беседы с лицами, содержащимися в организациях, подлежащих превентивным посещениям, и (или) их законными представителями без свидетелей, лично или при необходимости через переводчика, а также с любым другим лицом, которое, по мнению участника национального превентивного механизма, может предоставить соответствующую информацию;

5) беспрепятственно выбирать и посещать организации, подлежащие превентивному посещению;

6) принимать сообщения и жалобы о применении пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания.

2. Участник национального превентивного механизма является независимым при осуществлении законной деятельности.

Статья 188. Обязанности участника национального превентивного механизма

1. При исполнении своих полномочий участник национального превентивного механизма обязан соблюдать законодательство Республики Казахстан.

2. Не допускается вмешательство участника национального превентивного механизма в деятельность организаций, подлежащих превентивному посещению.

3. При наличии обстоятельств, вызывающих сомнение в беспристрастности участника национального превентивного механизма, входящего в группу по превентивному посещению, он обязан отказаться от участия в превентивном посещении.

4. Участник национального превентивного механизма обязан регистрировать принимаемые сообщения и жалобы о применении пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания в порядке, определяемом Уполномоченным по правам человека в Республике Казахстан.

Принятые сообщения и жалобы передаются на рассмотрение Уполномоченному по правам человека в Республике Казахстан в порядке, предусмотренном законодательством Республики Казахстан.

Информация о принятых и переданных сообщениях и жалобах включается в отчет по результатам превентивных посещений.

5. Участник национального превентивного механизма, нарушивший положения настоящего Кодекса, несет ответственность, установленную законами Республики Казахстан.

Статья 189. Прекращение полномочий участника национального превентивного механизма

Полномочия участника национального превентивного механизма прекращаются при:

1) нарушении положений настоящего Кодекса;

2) письменном заявлении о сложении своих полномочий;

3) его смерти либо вступлении в законную силу решения суда об объявлении его умершим;

4) выезде на постоянное жительство за пределы Республики Казахстан;

5) утрате гражданства Республики Казахстан;

6) вступлении в законную силу обвинительного приговора суда;

7) наступлении иных случаев, предусмотренных законами Республики Казахстан.

Статья 190. Виды и периодичность превентивных посещений

1. Превентивные посещения участников национального превентивного механизма подразделяются на:

1) периодические превентивные посещения, проводимые на регулярной основе не реже одного раза в четыре года;

2) промежуточные превентивные посещения, проводимые в период между периодическими превентивными посещениями с целью мониторинга реализации рекомендаций по результатам предыдущего периодического превентивного посещения, а также предупреждения преследования лиц, с которыми участники национального превентивного механизма проводили беседы, со стороны администрации организации, подлежащей превентивному посещению;

3) специальные превентивные посещения, проводимые на основании поступивших сообщений о применении пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания.

2. Координационный совет определяет сроки и перечень организаций, подлежащих превентивным посещениям, в пределах выделенных бюджетных средств.

Статья 191. Порядок превентивных посещений

1. Превентивные посещения проводятся группами, формируемыми Координационным советом из участников национального превентивного механизма, в порядке, определяемом Правительством Республики Казахстан по согласованию с Уполномоченным по правам человека в Республике Казахстан.

2. При формировании групп для превентивных посещений никто из участников национального превентивного механизма не может подвергаться какой-либо дискриминации по мотивам происхождения, социального, должностного и имущественного положения, пола, расы, национальности, языка, отношения к религии, убеждений, места жительства или по любым иным обстоятельствам.

3. Обеспечение безопасности участников национального превентивного механизма возлагается на администрацию организации, подлежащей превентивному посещению. В случае неправомерных действий участников национального превентивного механизма руководитель администрации организации, подлежащей превентивному посещению, письменно информирует Уполномоченного по правам человека в Республике Казахстан.

4. По результатам каждого превентивного посещения от имени группы составляется письменный отчет по форме, утвержденной Координационным советом, который подписывается всеми членами группы, осуществившей превентивное посещение. Член группы, имеющий особое мнение, оформляет его письменно и прилагает к отчету.

Статья 192. Ежегодный консолидированный доклад участников национального превентивного механизма

1. Координационный совет готовит ежегодный консолидированный доклад участников национального превентивного механизма с учетом их отчетов по результатам превентивных посещений.

2. В ежегодный консолидированный доклад участников национального превентивного механизма также включаются:

1) рекомендации уполномоченным государственным органам по улучшению условий обращения с лицами, содержащимися в организациях, подлежащих превентивному посещению, и предупреждению пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания;

2) предложения по совершенствованию законодательства Республики Казахстан.

К ежегодному консолидированному докладу участников национального превентивного механизма прилагается финансовый отчет по превентивным посещениям за прошедший год.

3. Ежегодный консолидированный доклад участников национального превентивного механизма направляется для рассмотрения уполномоченным государственным органам и размещается на интернет-ресурсе Уполномоченного по правам человека в Республике Казахстан в срок не позднее одного месяца со дня его утверждения Координационным советом.

Статья 193. Конфиденциальность

1. Участники национального превентивного механизма не вправе разглашать сведения о частной жизни лица, ставшие известными им в ходе превентивных посещений, без согласия данного лица.

2. Разглашение участниками национального превентивного механизма сведений о частной жизни лица, ставших известными им в ходе превентивных посещений, без согласия данного лица влечет ответственность, установленную законами Республики Казахстан.

Статья 194. Взаимодействие уполномоченных государственных органов с участниками национального превентивного механизма

1. Государственные органы и их должностные лица оказывают содействие участникам национального превентивного механизма в осуществлении ими законной деятельности.

Ни один государственный орган или должностное лицо не вправе ограничивать права и свободы граждан Республики Казахстан за сообщение участникам национального превентивного механизма о фактах применения пыток и других жестоких, бесчеловечных или унижающих достоинство видов обращения и наказания.

Должностные лица, воспрепятствующие законной деятельности участников национального превентивного механизма, несут ответственность, установленную законами Республики Казахстан.

2. Уполномоченные государственные органы в течение трех месяцев со дня получения ежегодного консолидированного доклада участников национального превентивного механизма в письменной форме информируют Уполномоченного по правам человека в Республике Казахстан о мерах, принятых по результатам рассмотрения полученных докладов.

3. На основании отчетов участников национального превентивного механизма по результатам превентивных посещений Уполномоченный по правам человека в Республике Казахстан в установленном законодательством Республики Казахстан порядке имеет право обращаться к уполномоченным государственным органам или должностным лицам с ходатайством о возбуждении дисциплинарного или административного производства либо уголовного дела в отношении должностного лица, нарушившего права и свободы человека и гражданина Республики Казахстан.

Глава 23. ОБЪЕМЫ МЕДИЦИНСКОЙ ПОМОЩИ

Статья 195. Объемы медицинской помощи

Медицинская помощь предоставляется в следующих объемах:

1) минимальный, представляющий собой гарантированный объем бесплатной медицинской помощи, предоставляемой в соответствии со статьей 196 настоящего Кодекса;

2) базовый, представляющий собой медицинскую помощь в системе обязательного социального медицинского страхования, предоставляемую в соответствии с Законом Республики Казахстан "Об обязательном социальном медицинском страховании";

3) дополнительный объем медицинской помощи, включающий медицинскую помощь:

в рамках добровольного и (или) вмененного медицинского страхования, оказываемую за счет взносов физических и юридических лиц;

предоставляемую за счет оказания платных услуг и иных источников, не запрещенных законодательством Республики Казахстан;

оказываемую военнослужащим, кандидатам в космонавты, космонавтам, сотрудникам специальных государственных и правоохранительных органов, членам их семей, пенсионерам правоохранительных органов, лицам, уволенным с воинской службы, службы в специальных государственных органах, а также отдельным категориям государственных служащих и граждан Республики Казахстан в военно-медицинских (медицинских) учреждениях (организациях) за счет средств, предусмотренных законодательством Республики Казахстан;

оказываемую лицам, содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, за счет средств, предусмотренных законодательством Республики Казахстан;

предоставляемую физическим лицам за счет единовременных пенсионных выплат в соответствии с законодательством Республики Казахстан.

Программа гарантий оказания медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи и медицинской помощи в системе обязательного социального медицинского страхования определяется ежегодно Правительством Республики Казахстан на трехлетний период.

Сноска. Статья 195 с изменениями, внесенными законами РК от 02.01.2021 № 399-VI (вводится в действие с 01.01.2021); от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022); от 19.04.2023 № 223-VII (порядок введения в действие см. ст. 3).

Статья 196. Гарантированный объем бесплатной медицинской помощи

1. Гарантированный объем бесплатной медицинской помощи предоставляется гражданам Республики Казахстан, кандасам, беженцам, иностранцам и лицам без гражданства, постоянно проживающим на территории Республики Казахстан, за счет бюджетных средств, включает профилактические, диагностические и лечебные медицинские услуги, обладающие наибольшей доказанной эффективностью, а также лекарственное обеспечение.

Перечень гарантированного объема бесплатной медицинской помощи утверждается Правительством Республики Казахстан.

Иностранцы и лица без гражданства, временно пребывающие в Республике Казахстан, лица, ищущие убежище, имеют право на получение гарантированного объема бесплатной медицинской помощи при заболеваниях, представляющих опасность для окружающих, по перечню и в объеме, определяемым уполномоченным органом, если иное не предусмотрено законами Республики Казахстан или международными договорами, ратифицированными Республикой Казахстан.

2. Медицинская помощь, входящая в гарантированный объем бесплатной медицинской помощи, оказывается на основе клинических протоколов медицинскими работниками, допущенными к клинической практике на территории Республики Казахстан.

3. В гарантированный объем бесплатной медицинской помощи входят:

1) скорая медицинская помощь;

2) первичная медико-санитарная помощь;

3) специализированная медицинская помощь в амбулаторных условиях:

при оказании услуг по профилактике и диагностике ВИЧ-инфекции и туберкулеза;

при травмах, отравлениях или других неотложных состояниях;

при социально значимых заболеваниях;

при хронических заболеваниях, подлежащих динамическому наблюдению, по перечню, определяемому уполномоченным органом;

4) специализированная медицинская помощь в стационарозамещающих условиях:

при социально значимых заболеваниях;

5) специализированная медицинская помощь в стационарных условиях:

при изоляции лиц, находившихся в контакте с больным инфекционным или паразитарным заболеванием, представляющим опасность для окружающих, а также бактерионосителей, вирусоносителей и лиц с подозрением на инфекционное или паразитарное заболевание, представляющее опасность для окружающих, по перечню, определяемому уполномоченным органом;

при лечении инфекционных, паразитарных заболеваний и заболеваний, представляющих опасность для окружающих, по перечню, определяемому уполномоченным органом;

в экстренной форме для лиц, не являющихся потребителями услуг в системе обязательного социального медицинского страхования, в том числе проведение лечебно-диагностических мероприятий в приемном отделении круглосуточного стационара до установления диагноза, не требующего лечения в условиях круглосуточного стационара, по перечню, определяемому уполномоченным органом;

в плановой форме по перечню заболеваний, определяемому уполномоченным органом;

6) медицинская реабилитация при лечении основного заболевания, а также медицинская реабилитация больных туберкулезом;

7) паллиативная медицинская помощь по перечню заболеваний, определяемому уполномоченным органом;

8) обеспечение препаратами крови и ее компонентами;

9) патологоанатомическая диагностика;

10) подготовка посмертного донора к изъятию органов (части органа) и (или) тканей (части ткани), изъятие, консервация, заготовка, хранение, транспортировка органов (части органа) и (или) тканей (части ткани) с целью трансплантации органов (части органа) и (или) тканей (части ткани).

4. Обеспечение лекарственными средствами, медицинскими изделиями, специализированными лечебными продуктами, иммунобиологическими лекарственными препаратами в рамках гарантированного объема бесплатной медицинской помощи осуществляется:

1) при оказании скорой помощи, а также специализированной помощи, в том числе высокотехнологичных медицинских услуг, в стационарных и стационарозамещающих условиях в соответствии с лекарственными формулярами организаций здравоохранения;

2) при оказании первичной медико-санитарной помощи в соответствии с перечнем заболеваний, против которых проводятся профилактические прививки;

3) при оказании первичной медико-санитарной и специализированной помощи в амбулаторных условиях в соответствии перечнем лекарственных средств и медицинских изделий для бесплатного и (или) льготного обеспечения отдельных категорий граждан Республики Казахстан с определенными заболеваниями (состояниями).

5. При предоставлении гарантированного объема бесплатной медицинской помощи субъектами здравоохранения используются лекарственные средства, медицинские изделия и специализированные лечебные продукты, зарегистрированные в Республике Казахстан. Лекарственные средства должны быть включены в Казахстанский национальный лекарственный формуляр.

Допускается применение незарегистрированных в Республике Казахстан и не включенных в Казахстанский национальный лекарственный формуляр лекарственных средств и незарегистрированных медицинских изделий для оказания медицинской помощи по жизненным показаниям конкретного пациента либо оказания медицинской помощи ограниченному контингенту пациентов с редкими (орфанными) заболеваниями и (или) состояниями в порядке, определенном уполномоченным органом.

Сноска. Статья 196 с изменением, внесенным Законом РК от 03.01.2022 № 101-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 197. Принципы формирования гарантированного объема бесплатной медицинской помощи

1. Гарантированный объем бесплатной медицинской помощи формируется на основе принципов универсальности, доступности, доказательности, реалистичности и регулируемости.

2. Принцип универсальности подразумевает всеобщий и равный охват минимальным объемом медицинской помощи вне зависимости от уровня доходов и социального статуса лиц, указанных в пункте 1 статьи 196 настоящего Кодекса.

3. Принцип доступности заключается в возможности получения лицами, указанными в пункте 1 статьи 196 настоящего Кодекса, гарантированного объема бесплатной медицинской помощи на территории Республики Казахстан.

4. Принцип доказательности подразумевает наличие доказанных научных и клинических данных об эффективности и безопасности медицинских услуг, лекарственных средств и медицинских изделий.

5. Принцип реалистичности подразумевает соответствие гарантированного объема бесплатной медицинской помощи параметрам бюджета.

6. Принцип регулируемости заключается в государственном регулировании тарифов на медицинские услуги, цен на лекарственные средства и медицинские изделия, предоставляемые при оказании гарантированного объема бесплатной медицинской помощи.

Статья 198. Цели оказания медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи

Целями оказания медицинской помощи в рамках гарантированного объема бесплатной медицинской помощи являются:

1) диагностика и лечение заболеваний;

2) контроль за осложнениями хронических заболеваний, повреждениями органов и тканей;

3) предупреждение прогрессирования заболеваний на ранних стадиях и их последствий;

4) медицинский уход во время беременности и родов;

5) формирование у пациента навыков контроля собственного здоровья;

6) медицинский уход за неизлечимыми больными в терминальной (конечной) стадии заболевания.

Статья 199. Минимальные социальные стандарты в сфере здравоохранения

Гарантированный объем бесплатной медицинской помощи, обеспечение доступности услуг здравоохранения населению являются минимальными социальными стандартами в области здравоохранения в соответствии с Законом Республики Казахстан "О минимальных социальных стандартах и их гарантиях".

Статья 200. Медицинская помощь в системе обязательного социального медицинского страхования

1. В системе обязательного социального медицинского страхования предоставляются:

1) специализированная медицинская помощь в амбулаторных условиях, включающая:

профилактические медицинские осмотры в порядке и с периодичностью, которые установлены уполномоченным органом, за исключением профилактических осмотров в рамках гарантированного объема бесплатной медицинской помощи;

прием и консультации профильными специалистами пациентов по направлению врачей первичной медико-санитарной помощи;

динамическое наблюдение профильными специалистами лиц с хроническими заболеваниями в порядке и с периодичностью, которые установлены уполномоченным органом;

оказание стоматологической помощи в экстренной и плановой форме отдельным категориям населения по перечню, определяемому уполномоченным органом;

диагностические услуги, в том числе лабораторная диагностика, по перечню, определяемому уполномоченным органом;

процедуры и манипуляции по перечню, определяемому уполномоченным органом;

2) специализированная, в том числе высокотехнологичная, медицинская помощь в стационарозамещающих условиях (за исключением случаев лечения заболеваний в рамках гарантированного объема бесплатной медицинской помощи);

3) специализированная, в том числе высокотехнологичная, медицинская помощь в стационарных условиях в плановой форме (за исключением случаев лечения заболеваний в рамках гарантированного объема бесплатной медицинской помощи);

4) специализированная помощь в стационарных условиях в экстренной форме, в том числе проведение лечебно-диагностических мероприятий в приемном отделении круглосуточного стационара до установления диагноза, не требующего лечения в условиях круглосуточного стационара (за исключением случаев лечения заболеваний в рамках гарантированного объема бесплатной медицинской помощи);

5) медицинская реабилитация по перечню заболеваний, определяемому уполномоченным органом;

6) патологоанатомическая диагностика;

7) подготовка посмертного донора к изъятию органов (части органа) и (или) тканей (части ткани), изъятие, консервация, заготовка, хранение, транспортировка органов (части органа) и (или) тканей (части ткани) с целью трансплантации органов (части органа) и (или) тканей (части ткани).

2. Обеспечение лекарственными средствами, медицинскими изделиями, специализированными лечебными продуктами, иммунобиологическими препаратами при оказании медицинской помощи в системе обязательного социального медицинского страхования осуществляется при оказании:

1) специализированной, в том числе высокотехнологичной, медицинской помощи в стационарных и стационарозамещающих условиях в соответствии с лекарственными формулярами организаций здравоохранения;

2) первичной медико-санитарной и специализированной медицинской помощи в амбулаторных условиях в соответствии с утверждаемым уполномоченным органом перечнем лекарственных средств, медицинских изделий для отдельных категорий граждан с определенными заболеваниями (состояниями).

3. При оказании медицинской помощи в системе обязательного социального медицинского страхования субъектами здравоохранения используются лекарственные средства, изделия медицинского назначения и иммунобиологические препараты, зарегистрированные в Республике Казахстан, включенные в Казахстанский национальный лекарственный формуляр.

Статья 201. Медицинская помощь в рамках добровольного медицинского страхования

Добровольное медицинское страхование является видом личного страхования, позволяющим получать медицинские услуги, включенные в гарантированный объем бесплатной медицинской помощи и (или) объем медицинской помощи в системе обязательного социального медицинского страхования, а также дополнительные программы, расходы по которым компенсирует страховая организация.

Программа добровольного медицинского страхования предусматривает перечень:

медицинских услуг в рамках договора добровольного страхования, которые оплачиваются страхователем, с указанием общей страховой суммы или отдельных страховых сумм по каждому виду оказываемых медицинских услуг;

организаций здравоохранения, где страхователь (застрахованный) получает медицинские услуги.

Перечень медицинских услуг устанавливается страховой организацией по согласованию со страхователем (застрахованным).

Статья 201-1. Медицинская помощь в рамках вмененного медицинского страхования

1. Вмененное медицинское страхование является видом медицинского страхования для иностранцев, временно пребывающих в Республике Казахстан, в соответствии с Законом Республики Казахстан "О миграции населения" и международными договорами, ратифицированными Республикой Казахстан, позволяющим получать медицинские услуги на условиях, определенных типовым договором вмененного медицинского страхования, утвержденным уполномоченным органом по согласованию с уполномоченным органом по регулированию, контролю и надзору финансового рынка и финансовых организаций.

2. Объектом вмененного медицинского страхования является имущественный интерес застрахованного лица, связанный с необходимостью получения медицинских услуг в результате наступления страхового случая, определенного типовым договором вмененного медицинского страхования.

3. Страховым риском признается вероятность ухудшения состояния здоровья застрахованного лица, повлекшая необходимость обращения в медицинские организации.

4. Страховым случаем при вмененном медицинском страховании является ухудшение состояния здоровья застрахованного лица и связанное с ним получение медицинской помощи в медицинской организации:

1) первичной медико-санитарной помощи;

2) специализированной медицинской помощи в стационарных условиях в экстренной форме.

Минимальный перечень медицинской помощи при вмененном медицинском страховании определяется уполномоченным органом.

5. Размер страховой суммы по договору вмененного медицинского страхования определяется условиями соглашения сторон и должен быть не менее размера, определяемого в месячных расчетных показателях, установленных законом о республиканском бюджете на соответствующий финансовый год, для оказания:

1) первичной медико-санитарной помощи – не менее пятидесяти месячных расчетных показателей;

2) специализированной медицинской помощи в стационарных условиях – не менее ста месячных расчетных показателей.

6. Иные условия вмененного медицинского страхования определяются и устанавливаются типовым договором вмененного медицинского страхования.

Сноска. Глава 23 дополнена статьей 201-1 в соответствии с Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 202. Медицинская помощь, предоставляемая за счет оказания платных услуг и иных источников

1. Медицинская помощь, предоставляемая на платной основе (платные медицинские услуги), оказывается субъектами здравоохранения в соответствии со стандартами на договорной основе.

2. Источниками формирования платных медицинских услуг являются собственные средства граждан, средства добровольного медицинского страхования, средства работодателей и иные источники, не запрещенные законодательством Республики Казахстан.

3. Платные медицинские услуги предоставляются лицам, в том числе содержащимся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы, при:

1) оказании медицинской помощи по их инициативе, в том числе без направления специалистов первичного и вторичного уровней;

2) оказании медицинской помощи сверх гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

3) лечении лекарственными средствами, не включенными в лекарственный формуляр организации здравоохранения;

4) проведении медицинских исследований, не входящих в перечень гарантированного объема бесплатной медицинской помощи и (или) перечень медицинской помощи в системе обязательного социального медицинского страхования, и (или) без медицинских показаний;

5) восстановительном лечении и медицинской реабилитации, оказываемой в санаторно-курортных организациях сверх гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования, за исключением лиц, содержащихся в следственных изоляторах и учреждениях уголовно-исполнительной (пенитенциарной) системы;

6) медико-генетических исследованиях без медицинских показаний;

7) медицинском обследовании, не предусмотренном гарантированным объемом бесплатной медицинской помощи и сверх объема обязательного социального медицинского страхования;

8) оказании медицинской помощи по договору, в том числе по добровольному медицинскому страхованию;

9) оказании медицинской помощи иностранцам и лицам без гражданства, за исключением случаев, предусмотренных пунктами 1 и 2 статьи 83 настоящего Кодекса.

4. Платные немедицинские услуги лицам предоставляются при дополнительных сервисных услугах (дополнительные бытовые и сервисные услуги, включая пребывание в палатах повышенной комфортности; дополнительный уход, не обусловленный медицинскими показаниями; дополнительное питание; оснащение палат и кабинетов дополнительными видами немедицинского оборудования: телефоном, телевизором, оргтехникой, холодильником; транспортные и другие услуги).

5. Виды платных услуг и прейскурант цен на них доводятся до сведения населения через наглядную информацию, в том числе на интернет-ресурсах, субъектами здравоохранения.

6. При оказании платных услуг субъекты здравоохранения осуществляют ведение первичной учетной и отчетной документации в медицинских информационных системах здравоохранения по формам, утвержденным уполномоченным органом.

7. Организация здравоохранения несет ответственность за своевременное и качественное оказание платных медицинских услуг лицам с момента их обращения в порядке, установленном законодательством Республики Казахстан.

8. Порядок оказания платных услуг субъектами здравоохранения определяется уполномоченным органом в соответствии с настоящим Кодексом и законами Республики Казахстан.

9. Запрещается предоставление на платной основе медицинской помощи, оказываемой в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования.

Сноска. Статья 202 с изменениями, внесенными Законом РК от 30.12.2021 № 95-VII (вводится в действие с 01.07.2022).

Глава 24. ДОНОРСТВО И ТРАНСПЛАНТАЦИЯ

Параграф 1. Донорство крови и ее компонентов

Статья 203. Донорство, заготовка крови, ее компонентов и производство препаратов крови

1. Донорством крови, ее компонентов является добровольное участие доноров в охране здоровья граждан путем осуществления донорской функции.

2. Привлечение доноров для осуществления донорской функции производится на безвозмездной или возмездной основе.

Привлечение доноров на возмездной основе осуществляется при отсутствии доноров, выполняющих донорскую функцию на безвозмездной основе.

3. Процесс заготовки крови, ее компонентов включает донацию:

1) крови, являющуюся процессом взятия донорской крови;

2) компонентов крови, являющуюся процессом взятия отдельных компонентов крови (плазмы, клеток).

4. В процессе заготовки и переработки крови получают:

1) компоненты крови, являющиеся составными частями крови, выделяемыми в виде клеток и бесклеточных сред;

2) препараты крови, являющиеся лекарственными средствами, произведенными при переработке донорской крови.

Статья 204. Организации здравоохранения и иные организации, осуществляющие деятельность в сфере донорства, заготовки крови, ее компонентов и производства препаратов крови

1. Заготовку, переработку, хранение и реализацию крови, ее компонентов от аллогенных доноров осуществляют государственные организации здравоохранения, имеющие соответствующую лицензию.

2. Производство препаратов крови осуществляют организации, имеющие соответствующую лицензию.

3. Организации здравоохранения и иные организации, осуществляющие деятельность в сфере донорства, заготовки крови, ее компонентов и препаратов, несут ответственность за их качество, а также реализуют кровь, ее компоненты для следующих целей:

1) клинического применения;

2) производства препаратов крови;

3) использования для изготовления реагентов и (или) расходных материалов к медицинским изделиям для диагностики вне живого организма (in vitro) (в том числе из компонентов крови, непригодных к клиническому применению).

4. В случае введения чрезвычайного или военного положения на территории Республики Казахстан организация донорства осуществляется в соответствии с законодательством Республики Казахстан.

Статья 205. Обеспечение безопасности и качества донорской крови, ее компонентов и препаратов

1. Безопасность донорской крови, ее компонентов и препаратов обеспечивается путем соблюдения установленных требований к медицинскому освидетельствованию доноров, безопасности и качеству при производстве продуктов крови для медицинского применения, утвержденных уполномоченным органом.

Проведение оценки качества лабораторных исследований, выполняемых в организациях, осуществляющих деятельность в сфере службы крови, осуществляет республиканская референс-лаборатория службы крови.

2. Запрещаются использование и реализация донорской крови, ее компонентов, препаратов без соответствующей маркировки.

3. Организации здравоохранения и медицинские работники, осуществляющие переливание донорской крови, ее компонентов и препаратов, обязаны обеспечить соблюдение соответствующих требований по их безопасному применению, а также порядка оказания трансфузионной помощи.

Статья 206. Права и обязанности доноров крови и ее компонентов

1. Донором вправе быть физическое лицо, достигшее восемнадцатилетнего возраста, прошедшее соответствующее медицинское освидетельствование и не имеющее противопоказаний, изъявившее добровольное желание осуществить донацию крови и ее компонентов для медицинских целей.

2. Донор вправе:

1) осуществить донацию крови и ее компонентов безвозмездно;

2) осуществить донацию крови и ее компонентов за плату;

3) ознакомиться с результатами медицинского обследования;

4) быть поощренным в соответствии с настоящим Кодексом.

3. Донор обязан сообщить известные ему сведения обо всех существующих и ранее перенесенных заболеваниях, а также об употреблении наркотических средств, психотропных веществ, их аналогов и прекурсоров.

Статья 207. Медицинское обследование донора

1. Перед донацией крови и ее компонентов донор проходит обязательное медицинское обследование в рамках гарантированного объема бесплатной медицинской помощи в порядке, определяемом уполномоченным органом.

2. Справки о состоянии здоровья для осуществления донорской функции выдаются в государственных организациях здравоохранения на бесплатной основе.

3. Медицинское освидетельствование доноров крови и ее компонентов осуществляется в рамках гарантированного объема бесплатной медицинской помощи.

Статья 208. Гарантии, предоставляемые донору, права и обязанности работодателей и организаций по развитию донорства крови и ее компонентов

1. Работник при медицинском обследовании и донации крови и (или) ее компонентов в рабочие дни освобождается от работы с сохранением средней заработной платы.

2. Донору, осуществившему донацию крови и (или) ее компонентов на безвозмездной основе, предоставляется дополнительно один день отдыха с сохранением средней заработной платы, который может быть присоединен к ежегодному трудовому отпуску. Настоящие гарантии действительны в течение одного года с момента донации.

При несостоявшейся донации крови и ее компонентов дополнительный день отдыха не предоставляется.

3. В случае, если по соглашению с работодателем работник, являющийся донором, в дни донации крови и (или) ее компонентов приступил к работе, ему предоставляется по его желанию другой день отдыха с сохранением за ним средней заработной платы либо этот день может быть присоединен к ежегодному трудовому отпуску.

4. Не допускается привлечение работника, являющегося донором, в дни донации крови и (или) ее компонентов к работам в ночное время, сверхурочным работам, тяжелым работам, работам с вредными и (или) опасными условиями труда.

5. Военнослужащие, сотрудники правоохранительных и специальных государственных органов, а также студенты (учащиеся), являющиеся донорами, в дни донации крови и (или) ее компонентов освобождаются от несения нарядов, вахт и других форм службы и от учебно-воспитательного процесса.

6. Поощрение доноров осуществляется в соответствии с законодательством Республики Казахстан.

7. Донор, осуществивший донацию крови и (или) ее компонентов на безвозмездной основе, для восполнения объема своей крови и энергетических затрат организма после донации крови и (или) ее компонентов по выбору получает бесплатное питание либо его денежный эквивалент в размере, устанавливаемом уполномоченным органом.

При несостоявшейся донации крови и (или) ее компонентов бесплатное питание либо его денежный эквивалент для восполнения объема своей крови и энергетических затрат организма после донации крови и (или) ее компонентов не выдается.

8. Донору крови, ее компонентов, выполняющему донацию крови и ее компонентов на возмездной основе, организацией здравоохранения, осуществляющей деятельность в сфере заготовки крови, ее компонентов, производится выплата.

9. Порядок, критерии и размер выплат донорам, выполняющим донацию крови и ее компонентов на возмездной основе, устанавливаются уполномоченным органом.

10. Работодатели и руководители организаций в целях создания условий, обеспечивающих развитие донорства, обязаны:

1) оказывать содействие местным органам государственного управления здравоохранением, государственным организациям здравоохранения в привлечении граждан Республики Казахстан в ряды доноров;

2) безвозмездно предоставлять необходимые помещения и создавать условия для взятия крови, ее компонентов;

3) беспрепятственно освобождать от работы работника, являющегося донором, в день обследования и донации крови и ее компонентов;

4) предоставлять работнику, являющемуся донором, установленные настоящим Кодексом гарантии.

11. Работодатели и руководители организаций имеют право дополнительно поощрять доноров.

Параграф 2. Трансплантация органов (части органа) и (или) тканей (части ткани)

Статья 209. Трансплантация органов (части органа) и (или) тканей (части ткани) и условия их изъятия

1. Трансплантация органов (части органа) и (или) тканей (части ткани) проводится от донора реципиенту и состоит из следующих этапов: изъятие, консервация, хранение, транспортировка и пересадка органов (части органа) и (или) тканей (части ткани).

2. Изъятие, консервация, хранение, транспортировка и пересадка органов (части органа) и (или) тканей (части ткани) осуществляются в государственных медицинских организациях, медицинских организациях, сто процентов голосующих акций (долей участия в уставном капитале) которых принадлежат государству, а также в медицинских организациях "Назарбаев университет" при наличии лицензии на осуществление медицинской деятельности по оказанию услуг трансплантации органов (части органа) и (или) тканей (части ткани) согласно профилю медицинской деятельности.

3. Изъятие органов (части органа) и (или) тканей (части ткани) в целях дальнейшей трансплантации человеку (потенциальному реципиенту) производится у живого человека (прижизненного донора) или умершего (посмертного донора).

4. При трансплантации органов (части органа) и (или) тканей (части ткани) запрещается:

1) принудительное изъятие органов (части органа) и (или) тканей (части ткани) у человека;

2) принуждение человека к предоставлению своего органа (части органа) и (или) тканей (части ткани);

3) купля-продажа органов (части органа) и (или) тканей (части ткани) человека;

4) изъятие органов (части органа) и (или) тканей (части ткани) у прижизненного донора или посмертного донора, являющегося несовершеннолетним или недееспособным лицом;

5) изъятие органов (части органа) и (или) тканей (части ткани) у посмертного донора для трансплантации иностранцам и лицам без гражданства;

6) изъятие органов (части органа) и (или) тканей (части ткани) у лиц, которые по состоянию здоровья, возрасту или иным причинам не могли сообщить данные о своей личности и личность которых на момент констатации смерти не была установлена.

5. Изъятие органов (части органа) и (или) тканей (части ткани) от инфицированного прижизненного донора или посмертного донора для трансплантации реципиенту запрещается.

Перечень инфекционных заболеваний, при которых разрешается трансплантация органов (части органа) и (или) тканей (части ткани) от донора, утверждается уполномоченным органом.

6. Для обеспечения трансплантации органов (части органа) и (или) тканей (части ткани) формируется регистр:

1) потенциальных реципиентов органов (части органа) и (или) тканей (части ткани);

2) реципиентов органов (части органа) и (или) тканей (части ткани);

3) доноров органов (части органа) и (или) тканей (части ткани);

4) граждан, выразивших право на посмертное донорство органов (части органа) и (или) тканей (части ткани).

7. Порядок формирования и ведения регистра определяется уполномоченным органом.

8. Регистрация волеизъявления гражданина Республики Казахстан о согласии или отказе на изъятие у него после смерти органов (части органа) и (или) тканей (части ткани) в целях трансплантации в регистре граждан, выразивших право на посмертное донорство органов (части органа) и (или) тканей (части ткани), может быть произведена при непосредственном обращении в медицинскую организацию, оказывающую первичную медико-санитарную помощь, или на веб-портал "электронного правительства".

Доступ к регистру граждан, выразивших право на посмертное донорство органов (части органа) и (или) тканей (части ткани), возможен только уполномоченным лицам Координационного центра по трансплантации в порядке, определенном уполномоченным органом.

Сноска. Статья 209 с изменением, внесенным Законом РК от 31.03.2021 № 24-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 210. Порядок трансплантации органов (части органа) и (или) тканей (части ткани) от прижизненного донора

1. Прижизненным донором органа (части органа) и (или) тканей (части ткани) может быть человек в возрасте восемнадцати лет и старше, дееспособный, находящийся с реципиентом в генетической связи и (или) имеющий с ним тканевую совместимость, выразивший письменное нотариально удостоверенное согласие на изъятие органа (части органа) и (или) тканей (части ткани) для дальнейшей трансплантации.

2. Для трансплантации от прижизненного донора могут быть изъяты только один из парных органов, часть органа или ткань, изъятие которых не повлечет за собой необратимого расстройства здоровья.

3. Прижизненный донор должен пройти всестороннее медицинское обследование в порядке, установленном уполномоченным органом.

4. Для установления генетической связи между потенциальным реципиентом и прижизненным донором создается Этическая комиссия. Состав и положение Этической комиссии утверждаются уполномоченным органом.

Статья 211. Координация и сопровождение трансплантации органов (части органа) и (или) тканей (части ткани)

1. Координационный центр по трансплантации – организация здравоохранения, занимающаяся вопросами координации и сопровождения трансплантации органов (части органа) и (или) тканей (части ткани), положение о которой утверждается уполномоченным органом.

2. Определение иммунологической совместимости тканей при трансплантации выполняется в лабораториях тканевого типирования (HLA-лаборатории), функционирующих как структурное подразделение при государственных медицинских организациях, осуществляющих деятельность в сфере донорства, заготовки крови, ее компонентов и препаратов.

Правила определения иммунологической совместимости тканей при трансплантации органов (части органа) и (или) тканей (части ткани) и положение о деятельности HLA-лаборатории разрабатываются и утверждаются уполномоченным органом.

Определение иммунологической совместимости тканей при трансплантации осуществляется на основании направления на исследование от организации, имеющей лицензию на осуществление медицинской деятельности по оказанию услуг трансплантации органов (части органа) и (или) тканей (части ткани).

3. Деятельность банков тканей направлена на образование запасов биологических материалов и обеспечение ими организаций здравоохранения, осуществляющих трансплантацию.

4. Порядок осуществления деятельности банка тканей определяется уполномоченным органом.

Статья 212. Порядок трансплантации органов (части органа) и (или) тканей (части ткани) от посмертного донора

1. Посмертным донором может быть лицо в возрасте восемнадцати лет и старше, которому констатирована необратимая гибель головного мозга, органы (части органа) и (или) ткани (части ткани) которого могут быть использованы для трансплантации реципиенту.

2. Порядок дачи прижизненного волеизъявления человека на посмертное донорство органов (части органа) и (или) тканей (части ткани) и уведомления супруга (супруги) или одного из близких родственников об этом определяется уполномоченным органом.

3. Изъятие органов (части органа) и (или) тканей (части ткани) у посмертного донора для трансплантации не допускается, если медицинская организация на момент изъятия поставлена в известность о том, что данное лицо при жизни либо после его смерти иные лица, указанные в части второй настоящего пункта, заявили о своем несогласии на изъятие его органов (части органа) и (или) тканей (части ткани).

В случае отсутствия прижизненного волеизъявления человека право письменно заявить о своем несогласии (согласии) на изъятие его органов (части органа) и (или) тканей (части ткани) для трансплантации имеют супруг (супруга), а при его (ее) отсутствии – один из близких родственников.

4. Изъятие и консервация органов зрения от трупов с целью трансплантации производятся в организациях, осуществляющих деятельность патологической анатомии и судебно-медицинской экспертизы, в порядке, определяемом уполномоченным органом по согласованию с уполномоченным органом в области судебно-экспертной деятельности.

5. Порядок и условия изъятия, консервации, хранения, транспортировки и пересадки органов (части органа) и (или) тканей (части ткани) определяются уполномоченным органом.

6. Участие лиц, проводящих изъятие органов (части органа) и (или) тканей (части ткани) для последующей трансплантации, в констатации необратимой гибели головного мозга запрещается.

7. Действие настоящей статьи не распространяется на органы (части органа) и (или) ткани (части ткани), имеющие отношение к процессу воспроизводства человека, включающие в себя репродуктивные ткани (половые клетки), а также на кровь, ее компоненты, гемопоэтические стволовые клетки, клетки организма человека и (или) животного для использования в биомедицинских целях.

Статья 213. Права донора и реципиента органов (части органа) и (или) тканей (части ткани)

1. Донор вправе:

1) требовать от организаций здравоохранения полной информации о возможных осложнениях для его здоровья в связи с предстоящим вмешательством по изъятию органов (части органа) и (или) тканей (части ткани);

2) проходить медицинское обследование для включения в регистр доноров органов (части органа) и (или) тканей (части ткани) в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

3) получать лечение, в том числе медикаментозное, в организациях здравоохранения в связи с проведенным вмешательством по изъятию органов (части органа) и (или) тканей (части ткани) в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования;

4) отказаться до начала хирургического вмешательства по поводу трансплантации.

2. Реципиент вправе:

1) требовать от организации здравоохранения полной информации о возможных осложнениях для его здоровья в связи с предстоящим вмешательством по трансплантации органов (части органа) и (или) тканей (части ткани);

2) проходить медицинское обследование для включения в регистр потенциальных реципиентов органов (части органа) и (или) тканей (части ткани) в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования.

3) получать лечение, в том числе медикаментозное, в организации здравоохранения в связи с проведенным вмешательством по изъятию и пересадке донорских органов (части органа) и (или) тканей (части ткани) в рамках гарантированного объема бесплатной медицинской помощи;

4) отказаться до начала хирургического вмешательства по поводу трансплантации.

3. Медицинским и иным работникам организаций здравоохранения запрещается разглашать сведения о доноре и (или) реципиенте.

Статья 214. Обязанности работодателей и руководителей организаций по созданию условий, обеспечивающих развитие донорства органов (части органа) и (или) тканей (части ткани)

1. Работодатели и руководители организаций в целях создания условий, обеспечивающих развитие донорства органов (части органа) и (или) тканей (части ткани), обязаны беспрепятственно освобождать от работы работника, являющегося донором органов (части органа) и (или) тканей (части ткани).

2. Работнику, являющемуся донором органов (части органа) и (или) тканей (части ткани), предоставляется лист временной нетрудоспособности в соответствии с законодательством Республики Казахстан с учетом времени на проезд в медицинскую организацию, где производится забор органов (части органа) и (или) тканей (части ткани) с целью трансплантации, и обратно до места проживания с сохранением среднемесячной заработной платы.

3. Работодатели и руководители организаций имеют право дополнительно поощрять доноров органов (части органа) и (или) тканей (части ткани).

Статья 215. Регистр доноров гемопоэтических стволовых клеток (костного мозга)

1. Формирование и ведение регистра доноров гемопоэтических стволовых клеток (костного мозга) в целях обеспечения трансплантации гемопоэтических стволовых клеток осуществляются в порядке, определяемом уполномоченным органом.

2. Порядок поиска и активации донора гемопоэтических стволовых клеток, в том числе из международных регистров, и транспортировки гемопоэтических стволовых клеток до реципиента определяется уполномоченным органом.

Статья 216. Трансплантация искусственных органов (части органа) и (или) тканей (части ткани)

1. Трансплантация искусственных органов (части органа) и (или) тканей (части ткани) осуществляется при:

1) органной недостаточности;

2) отсутствии донорских органов (части органа) и (или) тканей (части ткани);

3) отсутствии противопоказаний для трансплантации искусственных органов и тканей.

2. Перечень показаний и противопоказаний для трансплантации искусственных органов (части органа) и (или) тканей (части ткани) разрабатывается и утверждается уполномоченным органом.

3. Граждане Республики Казахстан с искусственными органами (частями органа) и (или) тканями (частями ткани) при необходимости включаются в регистр потенциальных реципиентов органов (части органа) и (или) тканей (части ткани) в порядке, определяемом уполномоченным органом.

Параграф 3. Ввоз, вывоз органов (части органа) и (или) тканей (части ткани) человека, гемопоэтических стволовых клеток (костного мозга), крови и ее компонентов, образцов клеток, биологических жидкостей и секретов человека

Статья 217. Основания для ввоза, вывоза органов (части органа) и (или) тканей (части ткани) человека, гемопоэтических стволовых клеток (костного мозга), донорских лимфоцитов, половых клеток, эмбрионов

1. Ввоз органов (части органа) и (или) тканей (части ткани) человека, гемопоэтических стволовых клеток (костного мозга), донорских лимфоцитов на территорию Республики Казахстан осуществляется при:

1) необходимости трансплантации в организациях здравоохранения;

2) необходимости диагностических исследований на территории Республики Казахстан;

3) проведении совместных научных исследований.

2. Вывоз органов (части органа) и (или) тканей (части ткани) человека, гемопоэтических стволовых клеток (костного мозга), донорских лимфоцитов с территории Республики Казахстан осуществляется:

1) при необходимости оказания медицинской помощи гражданину Республики Казахстан, находящемуся за пределами Республики Казахстан;

2) при необходимости диагностических исследований;

3) при проведении совместных научных исследований;

4) в случаях, предусмотренных международными договорами, ратифицированными Республикой Казахстан;

5) при необходимости проведения трансплантации гемопоэтических стволовых клеток (костного мозга), донорских лимфоцитов донора, проживающего на территории Республики Казахстан, реципиенту, проживающему за рубежом и ожидающему трансплантацию.

3. Лицензию на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека в случаях, предусмотренных подпунктом 1) пункта 1 и подпунктами 1) и 4) пункта 2 настоящей статьи, выдает уполномоченный орган по заявлению организаций здравоохранения, осуществляющих деятельность по специальности "трансплантология", "гематология" в соответствии с лицензией на медицинскую деятельность, в случаях помещения органов (части органа) и (или) тканей (части ткани) человека под таможенные процедуры экспорта или выпуска для внутреннего потребления.

4. Заключение (разрешительный документ) на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека в случаях их помещения под таможенные процедуры переработки на таможенной территории, переработки вне таможенной территории, переработки для внутреннего потребления и в случае помещения под таможенные процедуры реэкспорта и реимпорта в целях завершения действия таможенных процедур переработки на таможенной территории, переработки вне таможенной территории и переработки для внутреннего потребления выдает уполномоченный орган.

5. Ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства гемопоэтических стволовых клеток (костного мозга), донорских лимфоцитов в случае их перемещения с целью проведения неродственной трансплантации осуществляются на основании заключения (разрешительного документа), выданного уполномоченным органом.

6. Ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства половых клеток и эмбрионов осуществляются на основании заключения (разрешительного документа), выданного уполномоченным органом, в случаях:

1) необходимости экстракорпорального оплодотворения в организациях здравоохранения Республики Казахстан;

2) необходимости диагностических исследований;

3) проведения совместных научных исследований;

4) при необходимости экстракорпорального оплодотворения гражданину Республики Казахстан, находящемуся за пределами Республики Казахстан;

5) при необходимости экстракорпорального оплодотворения находящимся за пределами Республики Казахстан близким родственникам и супругам граждан Республики Казахстан;

6) при необходимости проведения экстракорпорального оплодотворения донора, проживающего на территории Республики Казахстан, реципиента, проживающего за рубежом;

7) предусмотренных международными договорами, ратифицированными Республикой Казахстан.

7. Ввоз и вывоз органов (части органа) и (или) тканей (части ткани) человека, половых клеток и эмбрионов, гемопоэтических стволовых клеток (костного мозга), донорских лимфоцитов физическими лицами не допускаются.

8. Порядок исследования на биологическую безопасность, консервирования и транспортировки тканей (части тканей) человека и (или) органов (части органа), предназначенных для ввоза и вывоза, определяется уполномоченным органом.

Статья 218. Основания для ввоза, вывоза крови и ее компонентов, образцов биологических материалов человека

1. Ввоз крови и ее компонентов, образцов биологических материалов человека на территорию Республики Казахстан осуществляется при:

1) необходимости оказания медицинской помощи на территории Республики Казахстан;

2) необходимости диагностических исследований на территории Республики Казахстан;

3) проведении совместных научных исследований;

4) необходимости проведения лабораторных исследований по системе-НLА для подтверждения тканевой совместимости донора, проживающего за рубежом, и реципиента, проживающего в Республике Казахстан, а также проведения иммуностимуляции реципиента в рамках трансплантации гемопоэтических стволовых клеток.

2. Вывоз крови и ее компонентов, образцов биологических материалов человека с территории Республики Казахстан осуществляется:

1) при необходимости оказания медицинской помощи гражданину Республики Казахстан, находящемуся за пределами Республики Казахстан, а также реципиентам, проживающим за рубежом;

2) при необходимости оказания медицинской помощи находящимся за пределами Республики Казахстан близким родственникам и супругам граждан Республики Казахстан;

3) при необходимости диагностических исследований;

4) при проведении совместных научных исследований;

5) в случаях, предусмотренных международными договорами, ратифицированными Республикой Казахстан;

6) при направлении компонентов крови, заготовленных в государственных организациях здравоохранения, осуществляющих деятельность в сфере службы крови Республики Казахстан, за рубеж для производства плазменных препаратов крови на заводах иностранного производителя с целью обеспечения населения Республики Казахстан препаратами крови (контрактное фракционирование);

7) при необходимости проведения лабораторных исследований по системе-НLА в целях подтверждения тканевой совместимости донора, проживающего в Республике Казахстан, и реципиента, проживающего за рубежом, а также иммуностимуляции реципиента в рамках трансплантации гемопоэтических стволовых клеток;

8) при направлении компонентов крови и (или) образцов биологических материалов человека за рубеж в качестве сырья, используемого при изготовлении реагентов и (или) расходных материалов к медицинским изделиям для диагностики вне живого организма (in vitro).

3. Помимо случаев, предусмотренных пунктами 1 и 2 настоящей статьи, ввоз и вывоз крови и ее компонентов, образцов биологических материалов человека могут осуществляться в порядке обмена, осуществляемого только в случаях отсутствия крови и ее компонентов с необходимыми биологическими свойствами.

4. Лицензию на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства крови и ее компонентов в случаях, предусмотренных подпунктом 1) пункта 1 и подпунктами 1), 2) и 5) пункта 2 настоящей статьи, выдает уполномоченный орган по заявлению организаций здравоохранения, осуществляющих деятельность по специальности "заготовка крови" в соответствии с лицензией на медицинскую деятельность, а в случаях, предусмотренных подпунктом 6) пункта 2 настоящей статьи, выдает уполномоченный орган по заявлению юридического лица в случаях помещения крови и ее компонентов под таможенные процедуры экспорта или выпуска для внутреннего потребления.

5. Заключение (разрешительный документ) на ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства крови и ее компонентов в случаях их помещения под таможенные процедуры переработки на таможенной территории, переработки вне таможенной территории или переработки для внутреннего потребления и в случае помещения под таможенные процедуры реэкспорта и реимпорта в целях завершения действия таможенных процедур переработки на таможенной территории, переработки вне таможенной территории и переработки для внутреннего потребления выдает уполномоченный орган.

6. Ввоз на территорию Республики Казахстан и вывоз с территории Республики Казахстан образцов биологических материалов человека, используемых в диагностических и научных целях, предназначенных для проведения внешнего контроля качества исследований, в том числе для проведения референс-исследований, или полученных в процессе проведения биомедицинских исследований и (или) клинических исследований, осуществляются на основании заключения (разрешительного документа), выданного уполномоченным органом.

7. Ввоз и вывоз крови и ее компонентов, образцов биологических материалов человека физическими лицами не допускаются, за исключением случаев, предусмотренных подпунктом 4) пункта 1 и подпунктом 7) пункта 2 настоящей статьи.

Статья 219. Порядок ввоза, вывоза органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов

1. Ввоз на территорию Республики Казахстан из государств, не являющихся членами Евразийского экономического союза, и вывоз с территории Республики Казахстан в эти государства органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов организациями здравоохранения, указанными в пункте 3 статьи 217 и пункте 4 статьи 218 настоящего Кодекса, осуществляются на основании лицензии, выдаваемой в порядке, определенном Законом Республики Казахстан "О разрешениях и уведомлениях", или заключения (разрешительного документа).

2. Уполномоченный орган в течение трех рабочих дней принимает решение о выдаче или отказе в выдаче лицензии на ввоз, вывоз тканей (части тканей) человека, крови и ее компонентов, а на ввоз, вывоз органов (части органа) человека – в течение одного рабочего дня.

3. Решение о выдаче или отказе в выдаче заключения (разрешительного документа) на ввоз, вывоз органов (части органа) и (или) тканей (части ткани) человека, крови и ее компонентов в случаях помещения органов и тканей человека, крови и ее компонентов под таможенные процедуры переработки на таможенной территории, переработки вне таможенной территории или переработки для внутреннего потребления и в случае помещения под таможенные процедуры реэкспорта и реимпорта в целях завершения действия таможенных процедур переработки на таможенной территории, переработки вне таможенной территории и переработки для внутреннего потребления уполномоченный орган принимает в течение трех рабочих дней.

РАЗДЕЛ 4. ОБРАЗОВАТЕЛЬНАЯ И НАУЧНАЯ ДЕЯТЕЛЬНОСТЬ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Глава 25. ОБРАЗОВАТЕЛЬНАЯ ДЕЯТЕЛЬНОСТЬ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 220. Субъекты образовательной деятельности в области здравоохранения и условия ее осуществления

1. Образовательная деятельность в области здравоохранения осуществляется в организациях медицинского и фармацевтического образования, научных организациях в области здравоохранения и иных организациях образования, реализующих образовательные программы в области здравоохранения.

2. Образование в области здравоохранения включает:

1) программы медицинского образования, реализуемые по медицинским специальностям;

2) программы фармацевтического образования, реализуемые по фармацевтическим специальностям;

3) программы подготовки специалистов общественного здоровья и иных специалистов здравоохранения.

Организации высшего и (или) послевузовского образования, реализующие образовательные программы в области здравоохранения, созданные в организационно-правовой форме некоммерческого акционерного общества, обладают автономией во всех сферах деятельности в соответствии с законодательством Республики Казахстан и руководствуются принципами свободы преподавания, исследования и творчества.

3. Обязательными условиями реализации образовательных программ в области здравоохранения по медицинским специальностям являются:

1) наличие в структуре организации образования в области здравоохранения симуляционного кабинета (центра);

2) при подготовке врачей – реализация в организации высшего и (или) послевузовского образования программ интегрированного и послевузовского медицинского образования (резидентура, докторантура);

3) привлечение наставников из числа квалифицированных медицинских работников в период подготовки обучающихся на клинических базах;

4) формирование в организациях высшего и (или) послевузовского образования университетских больниц и (или) интегрированных академических медицинских центров, функционирующих на основе договоров с научными организациями в области здравоохранения и организациями здравоохранения.

4. Научно-практическими базами организаций образования в области здравоохранения являются клинические базы, клиники организации образования в области здравоохранения, университетские больницы, базы резидентуры.

Положения о клинической базе, клинике организации образования в области здравоохранения, университетской больнице, базе резидентуры, интегрированном академическом медицинском центре и требования, предъявляемые к ним, разрабатываются и утверждаются уполномоченным органом.

Клинические базы, клиники организаций образования в области здравоохранения, университетские больницы, базы резидентуры подлежат процедуре аккредитации, установленной пунктом 2 статьи 25 настоящего Кодекса, в целях признания соответствия оказываемых медицинских услуг установленным требованиям и стандартам в области здравоохранения, а также требованиям, предъявляемым к клиническим базам, клиникам организаций образования в области здравоохранения, университетским больницам, базам резидентуры.

5. Научные организации и организации образования в области здравоохранения в рамках достижения стратегических целей устойчивого развития имеют право заключать договоры с зарубежными высшими учебными заведениями и медицинскими организациями в сфере образовательной, научной, клинической деятельности.

Порядок осуществления стратегического партнерства в сфере медицинского образования и науки определяется уполномоченным органом.

6. Объединения организаций образования в области здравоохранения, аккредитованные уполномоченным органом для координации действий по обеспечению качества образовательной деятельности в области здравоохранения, имеют право:

1) разрабатывать Государственные общеобязательные стандарты по уровням образования в области здравоохранения, типовые учебные планы и программы, руководства и рекомендации, направленные на обеспечение качества образовательной деятельности в области здравоохранения;

2) представлять интересы субъектов образовательной деятельности в области здравоохранения в консультативно-совещательных и экспертных органах, рабочих группах, формируемых уполномоченным органом.

Статья 221. Особенности образовательной деятельности в области здравоохранения

1. Задачами образовательной деятельности в области здравоохранения являются подготовка профессиональных научно-педагогических, медицинских и фармацевтических кадров, специалистов общественного здоровья и иных специалистов для системы здравоохранения и повышение их квалификации.

2. Государственные общеобязательные стандарты по уровням образования в области здравоохранения утверждаются уполномоченным органом и определяют совокупность общих требований к объему учебной нагрузки (количеству кредитов) и компетентности выпускника.

Организации высшего и (или) послевузовского образования самостоятельно разрабатывают образовательные программы в соответствии с требованиями государственных общеобязательных стандартов, а также с учетом требований к уровню квалификации, установленных профессиональными стандартами в области здравоохранения.

Перечень образовательных программ содержится в реестре образовательных программ по уровням образования в области здравоохранения. Ведение реестра и порядок включения в реестр образовательных программ по уровням образования в области здравоохранения осуществляются в порядке, определяемом уполномоченным органом.

3. Подготовка врачебных кадров осуществляется по программам непрерывного интегрированного медицинского образования. По завершении обучения по программам непрерывного интегрированного медицинского образования выпускнику, прошедшему итоговую аттестацию, присуждается степень "магистр медицины". По завершении обучения в интернатуре выпускнику, прошедшему оценку профессиональной подготовленности, присваивается квалификация "врач".

Интернатура является формой подготовки обучающихся по клиническим специальностям в рамках непрерывного интегрированного медицинского образования, в рамках которой они проходят общую медицинскую практику под наблюдением наставника, в результате чего приобретают знания в области общей медицины и клинический опыт.

4. Для лиц, освоивших образовательные программы технического и профессионального, послесреднего, высшего, послевузовского и дополнительного образования, основанием для осуществления профессиональной деятельности в области здравоохранения является документ об образовании государственного образца, а по медицинским специальностям также сертификат специалиста в области здравоохранения, за исключением врачей-резидентов в период обучения в резидентуре.

5. Послевузовское медицинское и фармацевтическое образование включает резидентуру, магистратуру и докторантуру.

Лица, имеющие степень "магистр", имеют право поступить в докторантуру неклинического профиля.

Лица, завершившие обучение в резидентуре, имеют право поступить в докторантуру клинического профиля.

В организациях высшего и (или) послевузовского медицинского образования могут реализовываться программы непрерывного послевузовского медицинского образования, включающие в себя программы резидентуры и докторантуры клинического профиля.

6. Получение специалистами в области здравоохранения дополнительного объема знаний и навыков осуществляется через дополнительное и неформальное образование.

Дополнительное образование осуществляется в организациях образования и науки, реализующих образовательные программы дополнительного образования и прошедших институциональную аккредитацию в аккредитационных органах, внесенных в реестр признанных аккредитационных органов.

Дополнительное образование по вопросам дезинфекции, дезинсекции, дератизации в области здравоохранения осуществляется организациями образования и науки, профессиональными саморегулируемыми организациями, реализующими образовательные программы дополнительного образования и прошедшими институциональную аккредитацию в аккредитационных органах, внесенных в реестр признанных аккредитационных органов.

Примечание ИЗПИ!
Часть четвертая пункта 6 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Дополнительное образование по медицинским специальностям и неформальное образование медицинских работников осуществляются организациями высшего и (или) послевузовского образования, национальными и научными центрами, научно-исследовательскими институтами, высшими медицинскими колледжами на базе аккредитованных клинических баз, клиник организаций образования в области здравоохранения, университетских больниц.

Порядок дополнительного и неформального образования специалистов в области здравоохранения, квалификационные требования к организациям, реализующим образовательные программы дополнительного и неформального образования в области здравоохранения, а также правила признания результатов обучения, полученных специалистами в области здравоохранения через дополнительное и неформальное образование, определяются уполномоченным органом.

7. Организации образования в области здравоохранения определяют порядок аттестации научно-педагогических кадров и требования, предъявляемые к ним. Аттестация научно-педагогических кадров должна проводиться не реже одного раза в пять лет. Организации образования в области здравоохранения обеспечивают регулярное повышение педагогической, исследовательской и профессиональной компетентности научно-педагогических кадров.

Примечание ИЗПИ!
Часть вторая пункта 7 предусмотрена в редакции Закона РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Научно-педагогические кадры организаций высшего и (или) послевузовского медицинского образования со стопроцентным участием государства имеют право на повышение квалификации за счет бюджетных средств.

Сноска. Статья 221 с изменением, внесенным Законом РК от 21.05.2022 № 123-VII (вводится в действие по истечении шести месяцев после дня его первого официального опубликования).

Статья 222. Резидентура

1. Реализация программ резидентуры осуществляется организациями высшего и (или) послевузовского образования в аккредитованных клиниках организаций образования в области здравоохранения, университетских больницах, а также национальными и (или) научными центрами, научно-исследовательскими институтами, аккредитованными в качестве баз резидентуры. Программы резидентуры реализуются по медицинским специальностям, перечень которых утверждается уполномоченным органом.

2. Организация высшего и (или) послевузовского образования, национальные и (или) научные центры, научно-исследовательские институты самостоятельно разрабатывают образовательные программы резидентуры в соответствии с требованиями Государственного общеобязательного стандарта образования Республики Казахстан, а также в соответствии с требованиями к уровням квалификации, установленными профессиональными стандартами в области здравоохранения.

Перечень образовательных программ резидентуры содержится в реестре образовательных программ по уровням образования в области здравоохранения.

3. Лицо, обучающееся в резидентуре с целью изменения профессиональной квалификации, осваивает программу в соответствии с самостоятельно разработанными организациями высшего и (или) послевузовского образования сокращенными образовательными программами на основе Государственного общеобязательного стандарта образования Республики Казахстан и требований к уровню квалификации выпускников с учетом признания ранее достигнутых результатов обучения формального образования.

4. Подготовка в резидентуре осуществляется на основе интеграции теории и клинической практики с привлечением врачей-резидентов к личному участию в предоставлении медицинских услуг и ответственности за деятельность по оказанию помощи пациентам под надзором наставника. В процессе подготовки обеспечивается возрастающая степень независимой ответственности врача-резидента по мере приобретения навыков, знаний и опыта.

Правила размещения государственного заказа, приема на обучение и подготовки медицинских кадров в резидентуре утверждаются уполномоченным органом.

5. Правовой основой обучения врача-резидента и привлечения к предоставлению услуг является:

1) на базе резидентуры организации высшего и (или) послевузовского образования – договор об обучении, заключаемый между организацией высшего и (или) послевузовского образования, базой резидентуры и врачом-резидентом;

2) в национальных и (или) научных центрах, научно-исследовательских институтах, аккредитованных в качестве баз резидентуры, – договор об обучении, заключаемый между национальным и (или) научным центром, научно-исследовательским институтом и врачом-резидентом.

Форма типового договора об обучении по программе резидентуры утверждается уполномоченным органом.

Обучение в резидентуре предусматривает предоставление рабочего места врачу-резиденту при равной ответственности базы резидентуры, организации высшего и (или) послевузовского образования, а также национального и (или) научного центра, научно-исследовательского института.

В период обучения на врача-резидента распространяются правила трудового распорядка, требования по безопасности и охране труда базы резидентуры организации высшего и (или) послевузовского образования, национального и (или) научного центра, научно-исследовательского института.

6. Освоение профессиональной учебной программы резидентуры является обязательным условием допуска к самостоятельной клинической практике граждан, окончивших программу непрерывного интегрированного медицинского образования и получивших квалификацию "врач".

Статья 223. Оценка обучающихся, выпускников по программам медицинского образования и специалистов в области здравоохранения

1. Оценка знаний и навыков обучающихся и профессиональной подготовленности выпускников образовательных программ в области здравоохранения основывается на:

1) требованиях к компетенциям выпускников образовательных программ соответствующей специальности;

2) отраслевой рамке квалификаций и профессиональном стандарте.

2. Оценка знаний и навыков обучающихся по образовательным программам в области здравоохранения проводится в соответствии результатами обучения.

3. Оценка профессиональной подготовленности выпускников образовательных программ в области здравоохранения проводится в соответствии с конечными результатами обучения по соответствующей образовательной программе.

Оценка профессиональной подготовленности выпускников образовательных программ в области здравоохранения входит в структуру итоговой аттестации (государственного экзамена), итогового контроля. Положительные результаты итоговой аттестации (государственного экзамена), итогового контроля выпускников образовательных программ в области здравоохранения дают право на получение документа об образовании и сертификата специалиста в области здравоохранения.

4. Оценка профессиональной подготовленности специалистов в области здравоохранения проводится в соответствии с требованиями профессионального стандарта.

5. Оценка знаний и навыков обучающихся, профессиональной подготовленности выпускников и специалистов в области здравоохранения проводится организацией, аккредитованной уполномоченным органом на проведение оценки знаний и навыков обучающихся и профессиональной подготовленности выпускников образовательных программ, специалистов в области здравоохранения.

6. Правила оценки знаний и навыков обучающихся, оценки профессиональной подготовленности выпускников образовательных программ в области здравоохранения, оценки профессиональной подготовленности специалистов в области здравоохранения определяются уполномоченным органом.

Статья 224. Профессиональная клятва медицинского работника Республики Казахстан

Выпускники организаций образования, реализующих образовательные программы технического и профессионального, послесреднего, высшего и непрерывного интегрированного медицинского образования, принимают профессиональную клятву медицинского работника Республики Казахстан следующего содержания:

"Принимая высокое звание медицинского работника, перед лицом своих учителей и коллег торжественно клянусь честно и преданно служить великому делу охраны здоровья человека. В своей деятельности клянусь руководствоваться только интересами своих пациентов, здоровье которых является высшей ценностью. Клянусь с равным усердием и терпением оказывать медицинскую помощь каждому, кто в ней нуждается, независимо от возраста, пола, национальности, вероисповедания, социального положения и гражданства. Клянусь хранить тайну медицинского работника, никогда не использовать ее в корыстных целях. Клянусь постоянно совершенствовать свои знания и навыки, быть требовательным к себе и своим ученикам, никогда не отказывать в бескорыстной помощи и самому обращаться за советом к коллегам, если того потребуют интересы пациента. Клянусь беречь и приумножать благородные традиции казахстанской медицины, хранить благодарность и уважение к тем, кто научил меня медицинскому искусству".

Глава 26. НАУЧНАЯ ДЕЯТЕЛЬНОСТЬ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 225. Субъекты научной деятельности

1. Субъектами научной деятельности в области здравоохранения являются физические и юридические лица, осуществляющие биомедицинские исследования.

К научным организациям в области здравоохранения относятся юридические лица, осуществляющие научную, научно-техническую и инновационную деятельность, а также проведение научно-исследовательских и опытно-конструкторских работ в области здравоохранения.

Статус научного центра и научно-исследовательского института присваивается организации здравоохранения уполномоченным органом. Уполномоченный орган принимает решение о сохранении статуса научного центра и научно-исследовательского института у организации здравоохранения по результатам оценки результативности научной, научно-технической и инновационной деятельности.

Порядок присвоения и пересмотра статуса научной организации в области здравоохранения, а также порядок проведения оценки результативности научной, научно-технической и инновационной деятельности определяются уполномоченным органом по согласованию с уполномоченным органом в области науки.

2. Субъекты научной деятельности в области здравоохранения проводят биомедицинские исследования с соблюдением стандартов и требований к проведению биомедицинских исследований, принятых на международном уровне и в Республике Казахстан, биоэтических норм.

Статья 226. Управление научной деятельностью

1. Уполномоченный орган осуществляет координацию и мониторинг развития биомедицинских исследований.

2. Уполномоченный орган организует проведение научно-медицинской экспертизы:

1) проектов программ прикладных научных исследований;

2) результатов завершенных научно-медицинских программ;

3) научных работ, выдвигаемых на соискание государственных наград Республики Казахстан;

4) научно-медицинских разработок, планируемых для внедрения в практику здравоохранения.

Порядок проведения научно-медицинской экспертизы определяется уполномоченным органом.

Статья 227. Биомедицинские исследования

1. Биомедицинские исследования могут проводиться на живых людях и экспериментальных (лабораторных) животных (субъекты исследования), биологических образцах живого и умершего человека и животного, а также на основе использования клинико-эпидемиологических данных и иной медицинской информации.

Биомедицинские исследования включают фундаментальные и прикладные биомедицинские исследования. Прикладные биомедицинские исследования включают медико-биологические эксперименты, доклинические (неклинические) исследования, клинические исследования и исследования в области общественного здоровья.

2. Создание человеческих эмбрионов для целей биомедицинских исследований и клонирование человека запрещены.

3. Биомедицинские исследования эмбрионов человека или плодов человека, во время которых или после которых человеческий эмбрион или человеческий зародыш разрушается, запрещены.

4. Клинические исследования проводятся при условии получения положительных результатов медико-биологических экспериментов, доклинических (неклинических) исследований.

5. Прикладные биомедицинские исследования могут проводиться только при одновременном соблюдении следующих требований:

1) биомедицинские исследования направлены на получение новых научных данных и внедрение их в практическое здравоохранение;

2) обеспечены защита интересов субъекта исследования и конфиденциальность его медицинской информации;

3) получено согласие субъекта исследования или его законного представителя на участие в исследовании или использование его биологических образцов и медицинской информации, в том числе для заполнения биобанка в научных целях;

4) интервенционные клинические исследования лекарственных средств, медицинских изделий проводятся с разрешения уполномоченного органа.

6. Для следующих категорий лиц биомедицинские исследования проводятся только в случае, когда не могут быть проведены на иных лицах и имеются научные основания ожидать, что участие в таких биомедицинских исследованиях принесет им непосредственную пользу, перевешивающую риски и неудобства, связанные с биомедицинским исследованием:

1) несовершеннолетние;

2) беременные;

3) недееспособные;

4) обучающиеся лица в случаях, если участие в биомедицинских исследованиях связано с их учебой;

5) пенсионеры по возрасту, нуждающиеся в посторонней помощи;

6) военнослужащие и сотрудники правоохранительных и специальных государственных органов;

7) персонал медицинских организаций, где проводятся биомедицинские исследования;

8) лица, содержащиеся в учреждениях уголовно-исполнительной системы.

Интервенционные клинические исследования на категориях лиц, указанных в подпунктах 1), 2), 3), 4) и 5) пункта 6 настоящей статьи, проводятся только для изучения лечебного эффекта.

Интервенционные клинические исследования на категориях лиц, указанных в подпунктах 6), 7) и 8) пункта 6 настоящей статьи, запрещены.

7. При получении письменного согласия на участие в биомедицинском исследовании добровольцу или пациенту, законному представителю несовершеннолетнего лица, опекуну недееспособного лица должна быть предоставлена информация:

1) о медицинской технологии, фармакологическом или лекарственном средстве, сущности и продолжительности медицинского исследования;

2) о степени безопасности, рисках и ожидаемой эффективности медицинской технологии, фармакологического или лекарственного средства;

3) о действиях в случае непредвиденных эффектов применения медицинской технологии, фармакологического или лекарственного средства на состояние здоровья;

4) об условиях страхования здоровья.

При этом до начала исследований доброволец или пациент, законный представитель несовершеннолетнего лица, опекун недееспособного лица должны быть информированы о возможности отказа от биомедицинских исследований на любой стадии исследования.

8. Биомедицинские исследования прекращаются на любом этапе:

1) по требованию участвующего в исследованиях несовершеннолетнего лица, его законного представителя, опекуна недееспособного лица, пациента или добровольца;

2) в случае возникновения угрозы жизни, здоровью добровольца или пациента, несовершеннолетнего лица, недееспособного лица.

9. Обязательными условиями проведения биомедицинских исследований являются положительное заключение комиссии по биоэтике, а для интервенционных клинических исследований также оформление документов о страховании жизни и здоровья участника исследования.

10. Правила проведения биомедицинских исследований и требования к исследовательским центрам определяются уполномоченным органом.

11. Правила применения новых методов диагностики, лечения и медицинской реабилитации определяются уполномоченным органом.

Сноска. Статья 227 с изменением, внесенным Законом РК от 30.12.2021 № 98-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 228. Комиссии по биоэтике

1. Комиссия по биоэтике является независимым экспертным органом, проводящим биоэтическую экспертизу документов, связанных с проведением биомедицинских исследований, на этапе их планирования, в ходе выполнения и после завершения с целью обеспечения безопасности и защиты прав участников биомедицинских исследований.

2. В Республике Казахстан функционируют Центральная комиссия по биоэтике и локальные комиссии по биоэтике.

3. Центральная комиссия по биоэтике создается при уполномоченном органе для выполнения следующих задач:

1) анализ и информирование специалистов и населения по вопросам биоэтики в контексте развития современного здравоохранения и внедрения инновационных медицинских технологий;

2) выдача заключений на проведение интервенционных клинических исследований лекарственных средств, медицинских изделий зарубежного производства, а также интервенционных и неинтервенционных клинических исследований лекарственных средств, медицинских изделий, проводимых в двух и более исследовательских центрах, расположенных на территории Республики Казахстан;

3) осуществление биоэтического мониторинга за ходом биомедицинских исследований, для проведения которых выданы заключение Центральной комиссии по биоэтике и разрешение уполномоченного органа;

4) координация деятельности локальных комиссий по биоэтике и оценка соответствия их деятельности стандартам, утвержденным Центральной комиссией по биоэтике;

5) участие в разработке документов по вопросам биоэтики;

6) осуществление сертификации локальных комиссий по биоэтике.

4. Центральная и локальные комиссии по биоэтике формируются на междисциплинарной основе и состоят из представителей медицинских, гуманитарных профессий, общественных организаций и специалистов в области права.

5. Состав и положение о Центральной комиссии по биоэтике утверждаются уполномоченным органом.

6. Локальные комиссии по биоэтике создаются при организациях здравоохранения для выполнения следующих задач:

1) выдача заключений на проведение биомедицинских исследований, за исключением случаев, указанных в подпункте 2) пункта 3 настоящей статьи;

2) осуществление биоэтического мониторинга за ходом биомедицинских исследований, для проведения которых выданы заключение данной локальной комиссией по биоэтике и разрешение уполномоченного органа;

3) представление ежегодного отчета в Центральную комиссию по биоэтике в определенном ею порядке.

7. Состав и положение о локальной комиссии по биоэтике утверждаются приказом первого руководителя организации здравоохранения, при которой создается данная комиссия, по согласованию с Центральной комиссией по биоэтике.

8. Локальные комиссии по биоэтике имеют право на выдачу заключений на проведение биомедицинских исследований при условии наличия сертификата соответствия стандартам деятельности биоэтических комиссий, выдаваемого Центральной комиссией по биоэтике.

9. Апелляция заявителя, несогласного с результатами биоэтической экспертизы, рассматривается комиссией с участием самого заявителя и привлечением независимых экспертов.

10. Срок действия сертификата соответствия требованиям деятельности биоэтических комиссий и порядок его выдачи определяются уполномоченным органом.

Статья 229. Биобанки

1. Биобанк создается на базе организации здравоохранения, организации высшего и (или) послевузовского образования и научной организации на основании положительного заключения Центральной комиссии по биоэтике.

2. Биологические материалы, хранящиеся в биобанках, должны быть собраны в соответствии с законодательством Республики Казахстан, нормами биоэтики с соблюдением всех требований, предъявляемых к пробоподготовке, транспортировке, лабораторной обработке и хранению.

3. Порядок создания и правила деятельности биобанков определяются уполномоченным органом.

РАЗДЕЛ 5. ФАРМАЦЕВТИЧЕСКАЯ ДЕЯТЕЛЬНОСТЬ, ОБРАЩЕНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ И МЕДИЦИНСКИХ ИЗДЕЛИЙ

Глава 27. ФАРМАЦЕВТИЧЕСКАЯ ДЕЯТЕЛЬНОСТЬ

Статья 230. Виды фармацевтической деятельности

Фармацевтическая деятельность включает следующие виды:

1) производство лекарственных средств;

2) производство медицинских изделий;

3) изготовление лекарственных препаратов;

4) изготовление медицинских изделий;

5) оптовая реализация лекарственных средств;

6) оптовая реализация медицинских изделий;

7) розничная реализация лекарственных средств;

8) розничная реализация медицинских изделий.

Статья 231. Производство лекарственных средств и медицинских изделий

1. Производством лекарственных средств и медицинских изделий является фармацевтическая деятельность, включающая совокупность всех работ, необходимых для серийного выпуска лекарственных средств и медицинских изделий, связанных с приобретением сырья, материалов, полуфабрикатов, оборудования, комплектующих и технологическим процессом, в том числе осуществлением одной из его стадий, хранением, реализацией произведенной продукции, а также всеми видами сопровождающего их контроля.

2. Производство лекарственных средств на территории Республики Казахстан осуществляется субъектами в сфере обращения лекарственных средств и медицинских изделий в соответствии с надлежащей производственной практикой (GMP) Республики Казахстан и (или) Евразийского экономического союза и на основании лицензии, полученной в порядке, установленном законодательством Республики Казахстан.

Субъекты в сфере обращения лекарственных средств и медицинских изделий при производстве лекарственных средств обязаны соблюдать требования надлежащей производственной практики (GMP).

3. Исследования стабильности, установление срока хранения и повторного контроля лекарственных средств проводятся производителем лекарственного средства в порядке, определяемом уполномоченным органом.

Исследования стабильности, установление срока хранения медицинских изделий проводятся производителем медицинских изделий в соответствии с международными стандартами.

4. Запрещается производство лекарственных средств и медицинских изделий:

1) не прошедших государственную регистрацию в Республике Казахстан, за исключением лекарственных средств и медицинских изделий, предназначенных для проведения экспертизы при их государственной регистрации, отладке и запуске оборудования и технологических процессов, доклинических (неклинических) и клинических исследований, контрактного производства и производства на экспорт лекарственных средств и медицинских изделий, а также лекарственных средств передовой терапии, произведенных для индивидуального применения с использованием аутологичных биологических материалов пациента или его донора, подобранного непосредственно для него;

2) без лицензии на право производства лекарственных средств и медицинских изделий;

3) с нарушением надлежащей производственной практики и правил производства медицинских изделий.

5. Произведенные и ввозимые лекарственные средства:

1) не должны содержать в своем составе красители и вспомогательные вещества, запрещенные к применению в Республике Казахстан, перечень которых утверждается уполномоченным органом;

2) должны подлежать контролю в соответствии с нормативным документом по качеству лекарственных средств, разработанным производителем лекарственных средств и согласованным государственной экспертной организацией при экспертизе лекарственных средств в порядке, определяемом уполномоченным органом;

3) должны производиться из фармацевтической субстанции (активной фармацевтической субстанции), произведенной в условиях не ниже требований надлежащей производственной практики (GMP) Республики Казахстан и (или) Евразийского экономического союза и заявленной при государственной регистрации, перерегистрации и внесении изменений в регистрационное досье лекарственного средства.

Лекарственные средства, производимые на территории Республики Казахстан только на экспорт, не подлежат государственной регистрации и реализации в Республике Казахстан.

6. Произведенные и ввозимые медицинские изделия должны подлежать контролю в соответствии с нормативным документом медицинского изделия, представленным производителем медицинского изделия при экспертизе медицинского изделия для целей государственной регистрации, перерегистрации и внесении изменений в регистрационное досье медицинского изделия.

Медицинские изделия, производимые на территории Республики Казахстан только на экспорт, не подлежат государственной регистрации и реализации в Республике Казахстан.

7. Производство и реализация запатентованных лекарственных средств и медицинских изделий осуществляются в соответствии с законодательством Республики Казахстан.

8. Производство медицинских изделий, предназначенных для проведения диагностики или лечения, должно обеспечивать их безопасность, предусматривать их использование в соответствии с функциональным назначением и исключать подход ошибок пользователя при интерпретации полученных результатов диагностики или лечения.

9. Производитель лекарственных средств обеспечивает наличие в штате не менее одного уполномоченного лица производителя, ответственного за выполнение обязанностей в соответствии с требованиями надлежащей производственной практики (GMP) Республики Казахстан и (или) Евразийского экономического союза.

Статья 232. Изготовление лекарственных препаратов и медицинских изделий

Изготовление лекарственных препаратов и медицинских изделий осуществляется субъектами в сфере обращения лекарственных средств и медицинских изделий, имеющими лицензию на изготовление лекарственных препаратов и медицинских изделий, в порядке, определяемом уполномоченным органом. Изготовленные лекарственные препараты подлежат внутриаптечному контролю в порядке, определяемом уполномоченным органом.

Статья 233. Оптовая и розничная реализация лекарственных средств и медицинских изделий

1. Оптовая реализация лекарственных средств и медицинских изделий осуществляется субъектами в сфере обращения лекарственных средств и медицинских изделий, получившими соответствующую лицензию на оптовую реализацию в аптечных складах либо уведомившими о начале деятельности через склад медицинских изделий в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях".

2. Розничная реализация лекарственных средств и медицинских изделий осуществляется субъектами в сфере обращения лекарственных средств и медицинских изделий, получившими соответствующую лицензию на розничную реализацию в аптеках, аптечных пунктах, передвижных аптечных пунктах либо уведомившими о начале деятельности через магазины оптики и медицинских изделий в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях".

Примечание ИЗПИ!
Часть первая пункта 3 вводится в действие для аптек с 01.01.2026 в соответствии с Кодексом РК от 07.07.2020 № 360-VI.

3. Субъекты в сфере обращения лекарственных средств и медицинских изделий, осуществляющие розничную реализацию лекарственных средств, обязаны соблюдать требования надлежащей аптечной практики (GРP).

Субъекты в сфере обращения лекарственных средств и медицинских изделий, осуществляющие оптовую реализацию лекарственных средств, обязаны соблюдать требования надлежащей дистрибьюторской практики (GDP).

Субъектам в сфере обращения лекарственных средств и медицинских изделий, получившим лицензию либо уведомившим о начале деятельности в порядке, установленном Законом Республики Казахстан "О разрешениях и уведомлениях", разрешается оптовая и розничная реализация товаров, не относящихся к лекарственным средствам и медицинским изделиям в соответствии с перечнем, утверждаемым уполномоченным органом.

4. Запрещается оптовая и розничная реализация лекарственных средств и медицинских изделий:

1) не прошедших государственную регистрацию в Республике Казахстан;

2) качество которых не подтверждено сертификатом соответствия в порядке, установленном законодательством Республики Казахстан в области здравоохранения;

3) не соответствующих требованиям законодательства Республики Казахстан в области здравоохранения;

4) с истекшим сроком годности;

5) медицинскими работниками в организациях здравоохранения, за исключением розничной реализации лекарственных средств и медицинских изделий в сельских населенных пунктах в случаях, предусмотренных пунктом 6 настоящей статьи;

6) через склады временного хранения лекарственных средств и медицинских изделий.

4-1. Запрещается оптовая и розничная реализация балк-продуктов лекарственных средств или медицинских изделий, за исключением оптовой реализации балк-продуктов лекарственных средств или медицинских изделий, используемых субъектами в сфере обращения лекарственных средств и медицинских изделий для производства лекарственных средств.

5. Запрещается безрецептурная реализация лекарственных средств, предназначенных для отпуска по рецепту врача. Рецепты выписываются в бумажном и (или) электронном видах.

Срок хранения рецепта в бумажном виде на лекарственное средство составляет не менее тридцати календарных дней, за исключением рецепта на лекарственное средство, содержащее наркотические средства, психотропные вещества, прекурсоры и ядовитые вещества, который хранится один год, на лекарственное средство, отпускаемое в рамках гарантированного объема бесплатной медицинской помощи и (или) обязательного социального медицинского страхования, срок хранения которого составляет два года.

Правила отнесения лекарственных препаратов с учетом действующих веществ, входящих в их состав, к категориям лекарственных препаратов, отпускаемых без рецепта и по рецепту, правила выписывания, учета и хранения рецептов утверждаются уполномоченным органом.

6. В сельских населенных пунктах, где отсутствуют аптеки, реализацию лекарственных средств и медицинских изделий могут осуществлять физические и юридические лица через аптечные пункты в организациях здравоохранения, оказывающих первичную медико-санитарную, консультативно-диагностическую помощь, и передвижные аптечные пункты. При отсутствии аптечных пунктов розничная реализация лекарственных средств и медицинских изделий может осуществляться через организации здравоохранения, оказывающие первичную медико-санитарную, консультативно-диагностическую помощь. В случае отсутствия специалистов с фармацевтическим образованием для осуществления розничной реализации лекарственных средств и медицинских изделий допускаются специалисты с медицинским образованием, прошедшие обучение для их реализации.

7. Ввезенные и произведенные на территории Республики Казахстан до истечения срока регистрационного удостоверения лекарственные средства и медицинские изделия применяются, обращаются и эксплуатируются на территории Республики Казахстан без ограничений.

Сноска. Статья 233 с изменениями, внесенными законами РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Глава 28. ОБРАЩЕНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ И МЕДИЦИНСКИХ ИЗДЕЛИЙ

Примечание ИЗПИ!
Статью 234 предусмотрено исключить Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 234. Система сферы обращения лекарственных средств и медицинских изделий

В единую систему сферы обращения лекарственных средств и медицинских изделий входят:

1) государственный орган в сфере обращения лекарственных средств и медицинских изделий и его территориальные подразделения;

2) государственная экспертная организация в сфере обращения лекарственных средств и медицинских изделий и ее территориальные подразделения;

3) субъекты в сфере обращения лекарственных средств и медицинских изделий.

Статья 235. Разработка лекарственных средств и медицинских изделий

1. Разработка лекарственных средств включает в себя поиск и (или) создание новых активных веществ или их новых комбинаций, последующее изучение фармакологических свойств, фармацевтическую разработку, доклинические (неклинические) и клинические исследования, а также разработку технологий промышленного производства лекарственных средств.

2. Разработка лекарственных средств осуществляется с соблюдением требований надлежащих фармацевтических практик, обеспечивающих их безопасность и эффективность.

3. Разработка медицинских изделий включает в себя поиск и (или) создание технического решения, изобретение, проектирование, конструирование и испытание опытных образцов, а также разработку технологий промышленного производства медицинских изделий.

4. Разработка медицинских изделий осуществляется с соблюдением требований международных стандартов, обеспечивающих их безопасность и эффективность.

5. Права разработчика лекарственного средства и медицинского изделия охраняются законодательством Республики Казахстан.

Статья 236. Доклинические (неклинические) исследования лекарственных средств и исследования (испытания) оценки биологического действия медицинских изделий

1. Целью доклинических (неклинических) исследований лекарственных средств является получение научными методами доказательств их фармакологической активности и безопасности.

Исследования (испытания) оценки биологического действия медицинских изделий проводятся для определения приемлемости любого потенциального неблагоприятного биологического ответа, возникающего в результате контакта материалов медицинского изделия с организмом человека.

2. Порядок проведения доклинических (неклинических) исследований и требования к доклиническим базам оценки биологического действия медицинских изделий определяются уполномоченным органом.

Доклинические (неклинические) исследования осуществляются в соответствии с надлежащей лабораторной практикой (GLP) Республики Казахстан и (или) Евразийского экономического союза.

Оценка материалов и соответствия условий проведения доклинических (неклинических) исследований требованиям надлежащей лабораторной практики (GLP) Республики Казахстан и (или) Евразийского экономического союза осуществляется в рамках фармацевтической инспекции в порядке, определяемом уполномоченным органом.

Статья 237. Технические испытания медицинских изделий

1. Технические испытания медицинских изделий проводятся в форме испытаний и (или) оценки и анализа данных для проверки качества и безопасности при использовании их в соответствии с назначением, предусмотренным документацией производителя медицинского изделия.

2. Технические испытания медицинских изделий проводятся в организациях, аккредитованных на проведение технических испытаний, в порядке, определенном законодательством Республики Казахстан в области технического регулирования.

3. Порядок проведения технических испытаний определяется уполномоченным органом.

Статья 238. Клинические исследования лекарственных средств, медицинских изделий и клинико-лабораторные испытания медицинских изделий для диагностики вне живого организма (in vitro)

1. Клинические исследования лекарственных средств и медицинских изделий проводятся с участием человека в качестве субъекта для выявления или подтверждения клинических и (или) фармакодинамических эффектов исследуемого фармакологического или лекарственного средства и (или) выявления нежелательных реакций и (или) в целях изучения всасывания, распределения, биотрансформации и выведения лекарственных средств, оценки безопасности и (или) функциональных характеристик медицинских изделий и (или) неблагоприятных событий медицинского изделия для установления безопасности и эффективности.

Клинико-лабораторные испытания медицинских изделий для диагностики вне живого организма (in vitro) проводятся на аналитические характеристики, клиническую эффективность (если применимо) для установления соответствия медицинского изделия для диагностики вне живого организма (in vitro).

2. Клинические исследования осуществляются в соответствии с правилами надлежащей клинической практики (GCP) Республики Казахстан и (или) Евразийского экономического союза.

3. Ускоренная экспертиза клинических исследований (далее – ускоренная процедура) проводится на лекарственные средства:

1) предназначенные для предотвращения чрезвычайных ситуаций;

2) орфанные препараты;

3) лекарственные средства передовой терапии, произведенные для индивидуального применения с использованием аутологичных биологических материалов пациента или его донора, подобранного непосредственно для него.

4. При проведении ускоренной процедуры не снижаются требования к безопасности, эффективности и качеству лекарственных средств.

5. Заявитель предоставляет обоснованные доказательства необходимости и возможности проведения экспертизы по ускоренной процедуре, подтвержденные уполномоченным органом.

6. Порядок проведения клинических исследований лекарственных средств и медицинских изделий, клинико-лабораторных испытаний медицинских изделий для диагностики вне живого организма (in vitro) и требования к клиническим базам определяются уполномоченным органом.

Статья 239. Экспертиза лекарственных средств и медицинских изделий

1. Экспертизой лекарственных средств и медицинских изделий является комплексная оценка безопасности, качества и эффективности, соотношения "польза-риск", оценка материалов для проведения клинических исследований лекарственных средств и медицинских изделий, оценка оптимальных технических характеристик и клинико-технического обоснования медицинского изделия, осуществляемая на основе материалов регистрационного досье, лабораторных испытаний на соответствие регламентируемому качеству, данных фармаконадзора, мониторинга безопасности, качества и эффективности медицинских изделий материалов для оценки клинических исследований, материалов для оценки оптимальных технических характеристик и клинико-технического обоснования медицинского изделия.

2. Экспертиза лекарственных средств и медицинских изделий относится к государственной монополии и осуществляется государственной экспертной организацией в сфере обращения лекарственных средств и медицинских изделий.

Цены на товары (работы, услуги), производимые и (или) реализуемые субъектом государственной монополии, устанавливаются уполномоченным органом по согласованию с антимонопольным органом.

3. Требования к безопасности, качеству и эффективности фармацевтических субстанций (активных фармацевтических субстанций), лекарственного сырья, лекарственного растительного сырья, балк-продуктов лекарственных средств или медицинских изделий, оригинальных лекарственных препаратов, лекарственных препаратов биологического происхождения, биотехнологических лекарственных препаратов, иммунологических лекарственных препаратов (иммунобиологических лекарственных препаратов), воспроизведенных лекарственных препаратов (генериков), гомеопатических лекарственных препаратов, биоаналогичных лекарственных препаратов (биоаналогов, биоподобных лекарственных препаратов, биосимиляров) и медицинских изделий предъявляются при экспертизе лекарственных средств и медицинских изделий в порядке, определяемом уполномоченным органом.

4. Основаниями отрицательного заключения экспертизы лекарственных средств и медицинских изделий являются:

1) непредставление полного комплекта регистрационного досье после выдачи замечаний заявителю в процессе проведения экспертизы в сроки, установленные в порядке, определенном уполномоченным органом;

2) представление заявителем недостоверных сведений;

3) отношение ожидаемой пользы к возможным рискам, связанным с применением лекарственного препарата, не является благоприятным;

4) более низкие показатели качества и безопасности, регламентированные Государственной фармакопеей Республики Казахстан или фармакопеями, признанными действующими на территории Республики Казахстан, или в сравнении с ранее зарегистрированными аналогами;

5) наличие в составе лекарственного средства веществ и материалов, запрещенных к применению в Республике Казахстан;

6) наличие в составе твердых лекарственных форм консервантов;

7) получение отрицательных результатов одного из этапов экспертизы и (или) отрицательных заключений экспертов профильных организаций;

8) несоответствие фактических условий производства и системы обеспечения качества условиям, обеспечивающим заявленную безопасность, эффективность и качество, по результатам оценки системы обеспечения качества;

9) отказ заявителя от организации посещения предприятия (производственной площадки) с целью оценки системы обеспечения качества в соответствии с требованиями законодательства Республики Казахстан;

10) выявление нерациональных комбинаций лекарственных средств;

11) заявителем не доказана клиническая эффективность и безопасность лекарственного препарата;

12) качество лекарственного препарата не подтверждено;

13) доказанное неблагоприятное соотношение "польза-риск" или выявленное отсутствие терапевтической эффективности при соблюдении условий применения лекарственного препарата, описанных в утвержденной общей характеристике лекарственного препарата, в пострегистрационный период;

14) установленные по данным фармаконадзора факты, указывающие на неблагоприятное соотношение "польза-риск" лекарственных средств, в том числе превышение частоты репортирования нежелательных реакций по сравнению с данными, указанными в утвержденной общей характеристике лекарственного препарата;

15) несоответствие качественного и количественного состава препарата заявленному или неоднократное несоответствие качества лекарственного препарата в период его обращения на рынке заявленному на момент его регистрации;

16) невыполнение держателем регистрационного удостоверения обязательств по фармаконадзору;

17) вносимые изменения оказывают отрицательное влияние на соотношение "польза-риск" лекарственного препарата.

Статья 240. Государственная фармакопея Республики Казахстан

1. Качество и безопасность лекарственных средств и изделий медицинского назначения на фармацевтическом рынке Республики Казахстан устанавливаются требованиями Государственной фармакопеи Республики Казахстан.

2. Государственная фармакопея Республики Казахстан гармонизируется с требованиями ведущих фармакопей мира и подлежит периодическому обновлению в связи с изменением их стандартов и особенностями развития фармацевтического рынка Республики Казахстан.

3. При отсутствии в Государственной фармакопее Республики Казахстан соответствующих статей (монографий) применяются текущие издания ведущих фармакопей мира, признанных уполномоченным органом.

4. Общие статьи Государственной фармакопеи Республики Казахстан определяют общие требования к:

1) качеству фармацевтических субстанций (активных фармацевтических субстанций), лекарственных средств;

2) реагентам, стандартным образцам, методам и методикам испытаний, применяемым для контроля их качества;

3) упаковочным материалам и контейнерам.

5. Частные статьи Государственной фармакопеи Республики Казахстан определяют конкретные требования к качеству фармацевтических субстанций (активных фармацевтических субстанций), лекарственных средств.

6. Государственная фармакопея Республики Казахстан является обязательным требованием для физических и юридических лиц, осуществляющих производство, изготовление, реализацию, хранение, контроль качества, экспертизу лекарственных средств и изделий медицинского назначения, при государственной регистрации, перерегистрации и внесении изменений в регистрационное досье.

7. Государственная фармакопея Республики Казахстан разрабатывается государственной экспертной организацией в сфере обращения лекарственных средств и медицинских изделий.

Порядок разработки, оформления, согласования, утверждения и внесения изменений и дополнений в Государственную фармакопею Республики Казахстан определяется уполномоченным органом.

8. Государственная фармакопея Республики Казахстан по структуре, оформлению монографий, нумерации разделов и фармакопейных статей (монографий), символам, изображению формул должна соответствовать ведущим фармакопеям мира, признанным уполномоченным органом.

Статья 241. Оценка качества лекарственных средств и медицинских изделий, зарегистрированных в Республике Казахстан

1. Оценка качества лекарственных средств и медицинских изделий, зарегистрированных в Республике Казахстан, проводится путем определения соответствия качества лекарственных средств и медицинских изделий данным регистрационного досье, нормативных документов по качеству лекарственных средств, на основании которых они были зарегистрированы в Республике Казахстан.

2. Оценка качества лекарственных средств и медицинских изделий, зарегистрированных в Республике Казахстан, относится к государственной монополии и осуществляется государственной экспертной организацией в сфере обращения лекарственных средств и медицинских изделий.

Статья 242. Маркировка лекарственных средств и медицинских изделий

1. Лекарственные средства должны поступать в обращение с маркировкой, нанесенной на упаковку (первичную и (или) вторичную) хорошо читаемым шрифтом на казахском и русском языках, и инструкцией по медицинскому применению (листок-вкладыш) на казахском и русском языках.

Тексты маркировки и инструкции по медицинскому применению (листок-вкладыш) должны соответствовать требованиям Закона Республики Казахстан "О языках в Республике Казахстан".

2. Для медицинских работников на интернет-ресурсах уполномоченного органа и государственной экспертной организации в сфере обращения лекарственных средств и медицинских изделий размещается общая характеристика лекарственного средства, утвержденная при государственной регистрации.

3. Медицинские изделия должны поступать в обращение с маркировкой, нанесенной непосредственно на медицинские изделия и (или) на упаковку, и инструкцией по медицинскому применению или эксплуатационным документом на медицинское изделие на казахском и русском языках.

Тексты маркировки, инструкции по медицинскому применению или эксплуатационного документа на медицинское изделие должны соответствовать требованиям Закона Республики Казахстан "О языках в Республике Казахстан".

4. Правила маркировки лекарственных средств и медицинских изделий утверждаются уполномоченным органом.

Порядок составления и оформления инструкции по медицинскому применению лекарственных средств и медицинских изделий, общая характеристика лекарственного средства определяются уполномоченным органом.

Сноска. Статья 242 с изменениями, внесенными Законом РК от 29.12.2021 № 94-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 243. Применение лекарственных средств передовой терапии

1. Лекарственные средства передовой терапии по способу производства и применения делятся на:

1) произведенные промышленным способом (рутинный способ) в условиях фармацевтического производства по серийному принципу;

2) произведенные для индивидуального применения с использованием аутологичных биологических материалов пациента или его донора, подобранного непосредственно для него.

2. Порядок допуска к применению, применения и мониторинга эффективности и безопасности применения лекарственных средств передовой терапии определяется уполномоченным органом.

3. Лекарственные средства передовой терапии подлежат клиническим исследованиям в порядке, установленном в статье 238 настоящего Кодекса.

4. Лекарственные средства передовой терапии, произведенные в промышленных условиях, в отношении которых получены положительные результаты клинических исследований, для допуска на рынок медицинских услуг подлежат государственной регистрации в соответствии с порядком Государственной регистрации лекарственного средства или медицинского изделия, установленным статьей 23 настоящего Кодекса.

5. Лекарственные средства передовой терапии, произведенные для индивидуального применения, в отношении которых получены положительные результаты клинических исследований, допускаются на рынок медицинских услуг на основании заключения экспертной организации в сфере обращения лекарственных средств и медицинских изделий без процедуры государственной регистрации.

6. В исключительных случаях лекарственные средства передовой терапии, произведенные для индивидуального применения, применяются без проведения клинических исследований в рамках исключения из стандартной процедуры допуска лекарственного средства на рынок при условии:

1) наличия положительного заключения локальной Комиссии по биоэтике;

2) наличия научных оснований ожидать, что применение лекарственного средства передовой терапии принесет непосредственную пользу пациенту;

3) получения информированного согласия пациента или его законного представителя на применение лекарственного средства передовой терапии.

Врач, назначающий лекарственное средство передовой терапии, обеспечивает соблюдение указанных условий и по результатам применения лекарственного средства передовой терапии в рамках исключения из стандартной процедуры допуска лекарственного средства на рынок представляет отчет в государственную экспертную организацию в сфере обращения лекарственных средств и медицинских изделий и Комиссию по биоэтике.

7. Порядок применения лекарственных средств передовой терапии в рамках исключения из стандартной процедуры допуска лекарственного средства на рынок, а также перечень медицинских организаций, имеющих право осуществлять лечение в рамках Hospital exemption, определяются уполномоченным органом.

Статья 244. Фармацевтический инспекторат по надлежащим фармацевтическим практикам

1. Фармацевтический инспекторат по надлежащим фармацевтическим практикам – структурные подразделения государственного органа в сфере обращения лекарственных средств и медицинских изделий, его территориальные подразделения и (или) организация, определяемая уполномоченным органом, осуществляющие инспекцию за соблюдением надлежащих фармацевтических практик на лекарственные средства и требований к внедрению, поддержанию и оценке системы менеджмента качества медицинских изделий в зависимости от потенциального риска их применения.

2. Государственный орган в сфере обращения лекарственных средств и медицинских изделий координирует деятельность фармацевтического инспектората по надлежащим фармацевтическим практикам.

Государственный орган в сфере обращения лекарственных средств и медицинских изделий и его территориальные подразделения выдают или отзывают сертификаты (заключения) на соответствие требованиям надлежащих фармацевтических практик.

3. Фармацевтическая инспекция проводится в следующих случаях:

1) на основании заявки субъекта в сфере обращения лекарственных средств и медицинских изделий на получение сертификата (заключения) или продление его действия, а также в соответствии с надлежащей практикой фармаконадзора (GVP);

2) на основании заявления субъекта в сфере обращения лекарственных средств и медицинских изделий, а также в целях лицензирования, регистрации, перерегистрации, экспертизы лекарственных средств или проведения расследований, связанных с безопасностью, качеством и эффективностью лекарственных препаратов в соответствии с программой проведения фармацевтической инспекции;

3) по результатам ранее проведенной фармацевтической инспекции с целью подтверждения устранения выявленных несоответствий;

4) для подтверждения субъектами, получившими сертификат, подтверждающий соответствие объекта требованиям надлежащих фармацевтических практик в сфере обращения лекарственных средств (далее – сертификат), не реже одного раза в два года в соответствии с графиком инспекций, утвержденным руководителем государственного органа в сфере обращения лекарственных средств и медицинских изделий;

5) по надлежащей клинической практике проводится в следующих случаях:

выявления в ходе проведения экспертизы клинических отчетов, связанных с регистрацией лекарственного средства, фактов, ставящих под сомнение достоверность сведений, представленных заявителем в регистрационном досье в отношении проведенных клинических исследований (испытаний) лекарственных средств;

до начала, в ходе или после завершения клинических исследований лекарственных средств, медицинских изделий классов потенциального риска применения 3, 2б и имплантируемых медицинских изделий;

инспекция системы фармаконадзора держателя регистрационного удостоверения в случаях, предусмотренных правилами надлежащей практики фармаконадзора Республики Казахстан и (или) Евразийского экономического союза.

4. Срок действия сертификата о соответствии объекта требованиям:

1) надлежащей производственной практики (GMP) составляет три года;

2) надлежащей дистрибьюторской практики (GDP), надлежащей лабораторной практики (GLP) – три года;

3) надлежащей аптечной практики (GPP) – первые два раза на пять лет, при последующем подтверждении – бессрочно.

5. Фармацевтической инспекции подлежат аптеки на соответствие требованиям надлежащей аптечной практики (GPP), аптечные (дистрибьюторские) склады – на соответствие требованиям надлежащей дистрибьюторской практики (GDP), организации по производству лекарственных средств – на соответствие требованиям надлежащей производственной практики (GMP), организации, осуществляющие доклинические (неклинические) исследования, – на соответствие требованиям надлежащей лабораторной практики (GLP), клинические исследования, осуществляемые организациями здравоохранения, – на соответствие требованиям надлежащей клинической практики (GCP), держатели регистрационных удостоверений лекарственных средств – на соответствие требованиям надлежащей практики фармаконадзора (GVP).

6. Проведение фармацевтических инспекций осуществляется в порядке, определяемом уполномоченным органом.

7. В рамках фармацевтической инспекции могут осуществляться отбор и проведение экспертизы, оценки безопасности и качества лекарственных средств.

8. Условия хранения и транспортировки отобранных образцов лекарственных средств не должны изменять параметры, по которым будут проводиться экспертиза, оценка безопасности и качества этих образцов лекарственных средств.

Фармацевтический инспектор по надлежащим фармацевтическим практикам обеспечивает сохранность образцов лекарственных средств и своевременность доставки к месту осуществления экспертизы, оценки безопасности и качества.

9. Проведение инспекций медицинских изделий осуществляется в соответствии с требованиями к внедрению, поддержанию и оценке системы менеджмента качества медицинских изделий в зависимости от потенциального риска их применения в порядке, определяемом уполномоченным органом.

10. В период чрезвычайного положения в соответствии с Законом Республики Казахстан "О чрезвычайном положении" фармацевтические инспекции для проведения расследований, связанных с безопасностью, качеством и эффективностью лекарственных средств, проводятся по решению государственного органа в сфере обращения лекарственных средств и медицинских изделий.

Статья 245. Государственное регулирование цен на лекарственные средства и медицинские изделия

1. Государственное регулирование цен осуществляется на зарегистрированные и находящиеся в обращении в Республике Казахстан лекарственные средства для оптовой и розничной реализации, включенные в перечень лекарственных средств, подлежащих ценовому регулированию, а также на зарегистрированные лекарственные средства и медицинские изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования в порядке, определенном уполномоченным органом.

Перечень лекарственных средств, подлежащих ценовому регулированию для оптовой и розничной реализации, утверждается уполномоченным органом не чаще одного раза в полугодие не позднее десятого числа третьего месяца полугодия по согласованию с антимонопольным органом.

2. Уполномоченный орган не чаще одного раза в полугодие не позднее десятого числа первого месяца полугодия утверждает по согласованию с антимонопольным органом предельные цены производителя на торговое наименование лекарственного средства, предельные цены на торговое наименование лекарственного средства для розничной и оптовой реализации, включенного в перечень лекарственных средств, подлежащих ценовому регулированию.

3. Уполномоченный орган утверждает предельную цену на торговое наименование лекарственного средства или медицинского изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования по согласованию с антимонопольным органом, предельную цену на международное непатентованное наименование лекарственного средства или техническую характеристику медицинского изделия в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования.

4. Уполномоченный орган на постоянной основе ведет учет и систематизацию указанной в пунктах 2 и 3 настоящей статьи информации в электронном виде в хронологическом порядке с учетом внесенных изменений и сохранением предыдущих версий и предоставлением возможности открытого доступа к данным сведениям в электронном формате.

Информация, указанная в пунктах 2 и 3 настоящей статьи, хранится в течение пяти лет, начиная с года, следующего за годом утверждения предельных цен на лекарственные средства.

Примечание ИЗПИ!
В пункт 5 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

5. Предельная розничная цена не может быть утверждена без соблюдения суммарной оптовой и розничной наценки к предельной цене производителя.

Примечание ИЗПИ!
В пункт 6 предусмотрено изменение Законом РК от 06.04.2024 № 71-VIII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

6. Уполномоченный орган осуществляет мониторинг и контроль за соблюдением предельных цен лекарственных средств по торговым наименованиям.

7. Не допускается оптовая и розничная реализация лекарственных препаратов, включенных в перечень лекарственных средств, подлежащих ценовому регулированию, без предельной цены на лекарственные средства по торговым наименованиям.

Сноска. Статья 245 с изменениями, внесенными законами РК от 03.01.2022 № 101-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования); от 04.07.2022 № 134-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 246. Закуп лекарственных средств и медицинских изделий, предназначенных для оказания минимального, базового и дополнительного объемов медицинской помощи

1. Лекарственные средства, предназначенные для оказания минимального, базового и дополнительного объемов медицинской помощи, закупаются под международными непатентованными наименованиями, а в случае индивидуальной непереносимости пациента – под торговыми наименованиями лекарственных средств, зарегистрированными в Республике Казахстан, на основании заключения врачебно-консультативной комиссии и решения местного представительного органа области, городов республиканского значения и столицы. В случае закупа многокомпонентного лекарственного средства указывается его состав.

2. В целях оптимального и эффективного расходования бюджетных средств, выделяемых для закупа лекарственных средств и медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи, и средств обязательного социального медицинского страхования лекарственные средства и медицинских изделий закупаются по ценам, не превышающим установленных уполномоченным органом, за исключением незарегистрированных лекарственных средств и медицинских изделий, ввезенных на территорию Республики Казахстан на основании заключения (разрешительного документа), выданного уполномоченным органом.

3. Закуп лекарственных средств и медицинских изделий, предназначенных для оказания гарантированного объема бесплатной медицинской помощи и (или) медицинской помощи в системе обязательного социального медицинского страхования, осуществляется в порядке и способами, установленными Правительством Республики Казахстан, в том числе посредством веб-портала закупа лекарственных средств и медицинских изделий, закупа услуг у субъектов здравоохранения.

4. Преимущественное право на заключение договоров в рамках гарантированного объема бесплатной медицинской помощи и (или) в системе обязательного социального медицинского страхования имеют субъекты в сфере обращения лекарственных средств и медицинских изделий, в том числе аптеки с правом изготовления лекарственных препаратов, имеющие сертификат о соответствии объекта требованиям:

1) надлежащей производственной практики (GMP), при закупе лекарственных средств и заключении долгосрочных договоров поставки лекарственных средств;

2) надлежащей дистрибьюторской практики (GDP), при закупе лекарственных средств, фармацевтических услуг и заключении долгосрочных договоров по хранению и транспортировке лекарственных средств и медицинских изделий;

3) надлежащей аптечной практики (GРP), при закупе фармацевтических услуг, услуг по учету и реализации лекарственных средств и медицинских изделий.

Сноска. Статья 246 с изменением, внесенным Законом РК от 03.01.2022 № 101-VII (вводится в действие по истечении шестидесяти календарных дней после дня его первого официального опубликования).

Статья 247. Единый дистрибьютор

Основными предметами деятельности единого дистрибьютора являются:

1) выбор поставщиков;

2) заключение договоров поставки лекарственных средств и медицинских изделий, а также на поставку и производство плазменных препаратов крови, в том числе производственных, в рамках контрактного фракционирования;

3) заключение долгосрочных договоров поставки лекарственных средств и медицинских изделий, а также на производство и поставку плазменных препаратов крови, в том числе в рамках контрактного фракционирования, а также услуг по производству плазменных препаратов крови (контрактного фракционирования) у производителя, в том числе у зарубежного производителя;

4) обеспечение лекарственными средствами и медицинскими изделиями по перечню, определяемому уполномоченным органом;

5) закуп лекарственных средств и медицинских изделий, плазменных препаратов крови, в том числе в рамках контрактного фракционирования, услуг по хранению и транспортировке по перечню, определяемому уполномоченным органом, а также услуг по производству плазменных препаратов крови (контрактного фракционирования) у производителя, в том числе у зарубежного производителя;

6) закуп фармацевтических услуг;

7) закуп услуг по учету и реализации лекарственных средств и медицинских изделий;

8) организация закупа медицинских изделий в рамках гарантированного объема бесплатной медицинской помощи;

9) поставка, хранение лекарственных средств и медицинских изделий мобилизационного резерва и их выпуск в порядке освежения и разбронирования в случаях изменения номенклатуры, предусмотренном законодательством Республики Казахстан о гражданской защите.

Статья 248. Принципы закупа лекарственных средств и медицинских изделий единым дистрибьютором

Принципами закупа лекарственных средств и медицинских изделий являются:

1) предоставление потенциальным поставщикам равных возможностей для участия в процедуре проведения закупок;

2) добросовестная конкуренция среди потенциальных поставщиков;

3) гласность и прозрачность процесса закупок;

4) поддержка отечественных товаропроизводителей.

Статья 249. Полномочия единого оператора

Единый оператор:

1) осуществляет создание, развитие, сопровождение и системно-техническое обслуживание веб-портала закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения;

2) осуществляет управление проектами по развитию веб-портала закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения;

3) оказывает субъектам здравоохранения услуги по использованию веб-портала закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения;

4) оказывает консультационную помощь субъектам здравоохранения по вопросам функционирования веб-портала закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения;

5) обеспечивает информационную безопасность хранения электронных информационных ресурсов субъектов системы государственных закупок, размещенных на веб-портале закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения;

6) осуществляет информационное наполнение веб-портала закупа лекарственных средств и медицинских изделий, услуг у субъектов здравоохранения;

7) взаимодействует с уполномоченными субъектами по вопросам интеграции информационных систем государственных органов, государственных электронных информационных ресурсов и обеспечения информационной безопасности.

Статья 250. Хранение, транспортировка и уничтожение лекарственных средств и медицинских изделий

1. Лекарственные средства и медицинские изделия хранятся и транспортируются в условиях, обеспечивающих сохранение их безопасности, качества и эффективности, в соответствии с правилами хранения и транспортировки лекарственных средств и медицинских изделий, утвержденными уполномоченным органом.

2. Запрещается продление срока годности лекарственных средств и медицинских изделий.

3. Субъекты в сфере обращения лекарственных средств и медицинских изделий, осуществляющие транспортировку и хранение лекарственных средств, обязаны соблюдать требования надлежащей дистрибьюторской практики (GDP) или надлежащей аптечной практики (GРP).

4. Лекарственные средства и медицинские изделия, пришедшие в негодность, с истекшим сроком годности, фальсифицированные лекарственные средства и медицинские изделия и другие, не соответствующие требованиям законодательства Республики Казахстан, считаются непригодными к реализации и медицинскому применению и подлежат уничтожению субъектами в сфере обращения лекарственных средств и медицинских изделий, в распоряжении которых они находятся, в порядке, определяемом уполномоченным органом.

Статья 251. Порядок ввоза лекарственных средств и медицинских изделий на территорию Республики Казахстан

1. Ввоз на территорию Республики Казахстан лекарственных средств и медицинских изделий осуществляется в порядке, определяемом уполномоченным органом, в соответствии с таможенным законодательством Республики Казахстан и (или) международными договорами и актами в сфере таможенного регулирования Евразийского экономического союза.

Допускается ввоз лекарственных препаратов, зарегистрированных в Республике Казахстан, с использованием стикеров с хорошо читаемым шрифтом на казахском и русском языках и медицинских изделий, зарегистрированных в Республике Казахстан, с использованием стикеров на казахском и русском языках и с инструкцией по медицинскому применению (листок-вкладыш) либо инструкцией по медицинскому применению или эксплуатационным документом на медицинское изделие на казахском и русском языках для их реализации ниже утвержденных предельных оптовой и розничной цен в Республике Казахстан в порядке, определяемом уполномоченным органом.

Тексты стикеров, инструкции по медицинскому применению (листок-вкладыш), инструкции по медицинскому применению или эксплуатационного документа на медицинское изделие должны соответствовать требованиям Закона Республики Казахстан "О языках в Республике Казахстан".

2. Не разрешается ввоз на территорию Республики Казахстан лекарственных средств и медицинских изделий, не прошедших государственную регистрацию в Республике Казахстан, за исключением случаев, указанных в пункте 3 настоящей статьи и статье 253 настоящего Кодекса.

3. Допускается ввоз на территорию Республики Казахстан не зарегистрированных в Республике Казахстан лекарственных средств и медицинских изделий на основании заключения (разрешительного документа), выданного уполномоченным органом, если они предназначены для:

1) проведения клинических исследований;

2) экспертизы лекарственных средств и медицинских изделий при государственной регистрации, перерегистрации и внесении изменений в регистрационное досье;

3) осуществления государственной регистрации лекарственных средств и медицинских изделий;

4) оказания медицинской помощи по жизненным показаниям конкретного пациента либо оказания медицинской помощи ограниченному контингенту пациентов с редкой и (или) особо тяжелой патологией с возможностью медицинского применения и закупа;

5) проведения выставок без права их дальнейшей реализации;

6) гуманитарной помощи (содействия), предотвращения и (или) устранения последствий чрезвычайных ситуаций;

7) внедрения инновационных медицинских технологий;

8) закупа единым дистрибьютором лекарственных средств и медицинских изделий, поставляемых международными организациями, учрежденными Генеральной ассамблеей Организаций Объединенных Наций, и (или) переквалифицированных Всемирной организацией здравоохранения, за исключением лекарственных средств и медицинских изделий в рамках долгосрочных договоров поставки лекарственных средств и медицинских изделий;

9) использования в качестве комплектующего, входящего в состав или устройства медицинского изделия и не предназначенного для самостоятельного использования вне состава или устройства медицинского изделия;

10) профилактики и лечения последствий воздействия радиоактивных, биологических и химических веществ (вакцины, антидот).

4. Запрещается ввоз на территорию Республики Казахстан в качестве гуманитарной помощи лекарственных средств и медицинских изделий, не прошедших государственную регистрацию, за исключением отдельных случаев, определяемых уполномоченным органом.

5. Ввезенные на территорию Республики Казахстан лекарственные средства и медицинские изделия, не соответствующие требованиям законодательства Республики Казахстан в области здравоохранения, подлежат конфискации и уничтожению.

Сноска. Статья 251 с изменениями, внесенными Законом РК от 29.12.2021 № 94-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 252. Лица, которым разрешен ввоз лекарственных средств и медицинских изделий на территорию Республики Казахстан

Ввоз лекарственных средств и медицинских изделий на территорию Республики Казахстан может осуществляться:

1) субъектами в сфере обращения лекарственных средств и медицинских изделий, имеющими лицензию на производство лекарственных средств и медицинских изделий;

2) субъектами в сфере обращения лекарственных средств и медицинских изделий, имеющими лицензию на оптовую реализацию лекарственных средств либо включенными в реестр субъектов здравоохранения, осуществляющих оптовую реализацию медицинских изделий, по уведомлению о начале деятельности;

3) научно-исследовательскими организациями, лабораториями для разработки и государственной регистрации лекарственных средств и медицинских изделий в соответствии с настоящим Кодексом;

4) иностранными производителями лекарственных средств и медицинских изделий, их уполномоченными представительствами (филиалами) или их доверенными физическими и юридическими лицами для проведения экспертизы при государственной регистрации, клинических исследований и (или) испытаний и для участия в выставках производителей лекарственных средств и медицинских изделий в Республике Казахстан;

5) организациями здравоохранения для осуществления медицинской деятельности.

Статья 253. Ввоз лекарственных средств и медицинских изделий, а также биологического материала доклинических (неклинических) и клинических исследований, стандартных образцов фармацевтических субстанций (активных фармацевтических субстанций) и их примесей на территорию Республики Казахстан для личного использования и иных некоммерческих целей

1. Лекарственные средства и медицинские изделия ввозятся на территорию Республики Казахстан без разрешения уполномоченного органа, если они предназначены для:

1) личного пользования физическими лицами;

2) лечения пассажиров и членов экипажей транспортных средств, поездных бригад и водителей транспортных средств, прибывших на таможенную территорию Евразийского экономического союза;

3) лечения участников международных культурных, спортивных мероприятий и участников международных экспедиций.

2. В случаях, предусмотренных пунктом 1 настоящей статьи, допускается ввоз на территорию Республики Казахстан лекарственных средств и медицинских изделий, не зарегистрированных в Республике Казахстан.

3. Биологический материал доклинических (неклинических) и клинических исследований, стандартные образцы фармацевтических субстанций (активных фармацевтических субстанций) и их примесей ввозятся на территорию Республики Казахстан без разрешения уполномоченного органа.

4. Ввоз на территорию Республики Казахстан биологического материала доклинических (неклинических) и клинических исследований, стандартных образцов фармацевтических субстанций (активных фармацевтических субстанций) и их примесей осуществляется:

1) производителями лекарственных средств и медицинских изделий;

2) иностранными производителями лекарственных средств и медицинских изделий, их уполномоченными представительствами (филиалами) или их доверенными физическими и юридическими лицами;

3) научно-исследовательскими организациями, лабораториями в области здравоохранения, образования и науки.

Статья 254. Взаимодействие уполномоченного органа и уполномоченного органа в сфере таможенного дела

1. При перемещении через таможенную границу Евразийского экономического союза, совпадающую с Государственной границей Республики Казахстан, лекарственных средств и медицинских изделий в уполномоченный орган в сфере таможенного дела должны быть представлены сведения, подтвержденные уполномоченным органом, о государственной регистрации каждого из ввозимых лекарственных средств и медицинских изделий с указанием даты и номера государственной регистрации, за исключением случаев, предусмотренных пунктами 3 и 4 статьи 251 и статьей 253 настоящего Кодекса.

2. Уполномоченный орган в сфере таможенного дела представляет в уполномоченный орган сведения о ввозе на территорию Республики Казахстан через таможенную границу Евразийского экономического союза, совпадающую с Государственной границей Республики Казахстан, и вывозе с территории Республики Казахстан через таможенную границу Евразийского экономического союза, совпадающую с Государственной границей Республики Казахстан, лекарственных средств и медицинских изделий.

Статья 255. Порядок вывоза лекарственных средств и медицинских изделий, а также биологического материала доклинических (неклинических) и клинических исследований, стандартных образцов фармацевтических субстанций (активных фармацевтических субстанций) и их примесей с территории Республики Казахстан

1. Вывоз лекарственных средств и медицинских изделий с территории Республики Казахстан осуществляется в порядке, определяемом уполномоченным органом.

2. Лекарственные средства и медицинские изделия могут быть вывезены с территории Республики Казахстан без согласования с уполномоченным органом:

1) для личного использования физическими лицами, выбывающими с территории Республики Казахстан, в количестве, необходимом на курс лечения;

2) в составе аптечки первой помощи;

3) ввезенные по разрешению уполномоченного органа для проведения выставок выставочные образцы;

4) ввезенные для проведения доклинических (неклинических) или клинических исследований медицинские изделия;

5) в составе медицинских аптечек, используемых военнослужащими и сотрудниками специальных государственных органов, по перечню, определяемому государственными органами по согласованию с уполномоченным органом.

3. Вывоз лекарственных средств и медицинских изделий с территории Республики Казахстан в составе материально-технических средств медицинских и аварийно-спасательных организаций и формирований, выбывающих с территории Республики Казахстан для участия в ликвидации чрезвычайных ситуаций, осуществляется в порядке, определяемом уполномоченным органом.

4. Биологические материалы доклинических (неклинических) и клинических исследований, стандартные образцы фармацевтических субстанций (активных фармацевтических субстанций) и их примесей могут быть вывезены с территории Республики Казахстан без разрешения уполномоченного органа.

5. Вывоз с территории Республики Казахстан биологического материала доклинических (неклинических) и клинических исследований, стандартных образцов фармацевтических субстанций (активных фармацевтических субстанций) и их примесей осуществляется:

1) производителями лекарственных средств и медицинских изделий;

3) научно-исследовательскими организациями, лабораториями в области здравоохранения, образования и науки.

Сноска. Статья 255 с изменением, внесенным Законом РК от 19.04.2023 № 223-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 256. Монтаж, ремонт, техническое и метрологическое обслуживание медицинской техники

1. Монтаж, ремонт, техническое и метрологическое обслуживание медицинской техники осуществляются физическими или юридическими лицами, имеющими право на выполнение этих работ, в соответствии с законодательством Республики Казахстан.

2. Уровень безопасности медицинской техники после ремонта не должен быть ниже уровня безопасности, установленного техническим паспортом медицинских изделий.

3. Организация метрологического обеспечения средств измерений медицинского назначения, эксплуатируемых в организациях здравоохранения, регулируется в соответствии с законодательством Республики Казахстан об обеспечении единства измерений.

4. Медицинская техника, являющаяся средством измерения, подлежит внесению в реестр государственной системы обеспечения единства измерений Республики Казахстан и допускается к применению в соответствии с законодательством Республики Казахстан об обеспечении единства измерений.

Перечень медицинской техники, являющейся средством измерения, утверждается уполномоченным органом по согласованию с уполномоченным органом, осуществляющим государственное регулирование в области технического регулирования и метрологии.

Статья 257. Общие требования к эффективности, безопасности и качеству медицинских изделий

1. Медицинские изделия проектируются и изготовляются таким образом, чтобы при использовании в условиях и в целях, соответствующих их назначению, определенному производителем, и при необходимости с учетом технических знаний, опыта, образования или специальной подготовки, клинического и физического состояния пользователя они действовали согласно назначению, определенному производителем, и были безопасны для пользователя и третьих лиц, при условии, что риск, связанный с их применением, является приемлемым при сопоставлении с пользой для пользователя.

2. Медицинские изделия проектируются, изготавливаются и упаковываются таким образом, чтобы их эксплуатационные характеристики и эффективность не нарушались при транспортировке и в процессе хранения в соответствии с инструкцией по применению.

3. Медицинские изделия должны быть эффективными, как это предусмотрено производителем, спроектированы и изготовлены таким образом, чтобы в нормальных условиях эксплуатации они соответствовали целям применения по назначению, определенному производителем.

4. Эксплуатационные характеристики и эффективность медицинского изделия не должны изменяться до такой степени, чтобы ставить под угрозу жизнь и здоровье пользователей и третьих лиц в течение срока эксплуатации, определенного производителем, при условии, что медицинское изделие подвергается воздействиям, которые могут возникать в нормальных условиях эксплуатации, и техническое обслуживание проводится в соответствии с инструкцией по применению.

5. Для каждого медицинского изделия предоставляется информация, необходимая для идентификации этого медицинского изделия и его производителя, страны происхождения, а также информация для пользователя (профессионального или непрофессионального), касающаяся безопасности медицинского изделия, его функциональных свойств и эксплуатационных характеристик. Такая информация размещается на самом медицинском изделии, на упаковке или в инструкции по применению.

Статья 258. Классификация безопасности и переклассификация безопасности медицинских изделий в зависимости от степени потенциального риска применения

1. Медицинские изделия, применяемые в Республике Казахстан, подразделяются на классы в зависимости от степени потенциального риска применения и на виды в соответствии с номенклатурой медицинских изделий Республики Казахстан.

2. Правила классификации медицинских изделий в зависимости от степени потенциального риска применения утверждаются уполномоченным органом.

3. Класс медицинских изделий по степени потенциального риска применения утверждается при государственной регистрации уполномоченным органом. Каждое медицинское изделие может быть отнесено только к одному классу.

4. Порядок формирования и ведения номенклатуры медицинских изделий Республики Казахстан определяется уполномоченным органом.

5. Уполномоченный орган может вносить в классификацию изменения, основанные на детальном учете принципов, явлений, медицинских методик, положенных в основу работы медицинских изделий.

Статья 259. Приостановление, запрещение или изъятие из обращения либо ограничение применения лекарственных средств и медицинских изделий

1. Уполномоченный орган может приостановить или запретить применение, реализацию или производство лекарственных средств и медицинских изделий, а также принять решение об изъятии из обращения или ограничении применения в случаях:

1) несоответствия лекарственных средств и медицинских изделий требованиям законодательства Республики Казахстан в области здравоохранения;

2) выявления нежелательных реакций лекарственных средств, опасных для здоровья человека, не указанных в инструкции по медицинскому применению лекарственного средства, или повышения частоты выявления случаев серьезных нежелательных реакций, указанных в инструкции, или низкой терапевтической эффективности (отсутствие терапевтического эффекта), или наличия информации о приостановлении и (или) отзыве его с рынка других стран в связи с выявлением серьезных нежелательных реакций с неблагоприятным соотношением "польза-риск";

3) обнаружения в процессе применения медицинских изделий дефектов конструкции, принципа действия, производственного исполнения, влияющих на безопасность их применения;

4) нарушения утвержденного процесса производства лекарственных средств и медицинских изделий, влияющего на безопасность, качество и эффективность их применения;

5) наличия данных о нанесении вреда здоровью пациента или потребителя в связи с применением лекарственных средств и медицинских изделий;

6) получения данных о недостаточности научно-технического уровня технологии производства и контроля качества, обеспечивающих снижение уровня безопасности применения лекарственных средств и медицинских изделий;

7) обращения держателя регистрационного удостоверения о приостановлении, об отзыве регистрационного удостоверения или изъятии из обращения либо ограничении применения лекарственного средства и медицинского изделия;

8) несоответствия лекарственных средств требованиям надлежащих фармацевтических практик Республики Казахстан и (или) Евразийского экономического союза, выявленного по результатам фармацевтической инспекции;

9) невыполнения обязательств по фармаконадзору держателем регистрационного удостоверения лекарственного средства и производителем медицинского изделия по мониторингу безопасности, качества и эффективности медицинских изделий.

2. Правила приостановления, запрета или изъятия из обращения либо ограничения применения лекарственных средств и медицинских изделий утверждаются уполномоченным органом.

Статья 260. Фальсифицированные, контрафактные лекарственные средства и медицинские изделия

1. Запрещаются производство, ввоз, хранение, применение и реализация на территории Республики Казахстан фальсифицированных, контрафактных лекарственных средств и медицинских изделий.

2. К фальсификации лекарственных средств и медицинских изделий (представление недостоверных сведений о характеристиках и (или) об источнике происхождения) также относятся аксессуары, части и материалы, изготовленные и предназначенные для производства фальсифицированной продукции.

3. Предотвращение и борьба с фальсификацией лекарственных средств и медицинских изделий осуществляются уполномоченным органом совместно с заинтересованными государственными органами, организациями производителей лекарственных средств и медицинских изделий, субъектами здравоохранения и общественными организациями.

4. Уполномоченный орган осуществляет международное сотрудничество в борьбе с фальсифицированными, контрафактными лекарственными средствами и медицинскими изделиями.

Статья 261. Фармаконадзор и мониторинг безопасности, качества и эффективности медицинских изделий

1. Уполномоченный орган обеспечивает функционирование системы фармаконадзора и проводит мониторинг безопасности, качества и эффективности медицинских изделий на территории Республики Казахстан.

2. Государственная экспертная организация в сфере обращения лекарственных средств и медицинских изделий в целях обеспечения защиты здоровья населения и повышения безопасности пациентов проводит:

1) сбор, анализ, оценку и верификацию сообщений о нежелательных реакциях лекарственного средства, неблагоприятных событиях медицинского изделия, поступающих от субъектов здравоохранения и сферы обращения лекарственных средств и медицинских изделий, потребителей;

2) оценку соотношения "польза-риск" лекарственных средств и медицинских изделий на основании данных фармаконадзора и мониторинга безопасности, качества и эффективности медицинских изделий в Республике Казахстан, данных, предоставляемых держателями регистрационных удостоверений лекарственных средств, производителями медицинских изделий, данных, получаемых из других источников.

3. Порядок проведения фармаконадзора и мониторинга безопасности, качества и эффективности медицинских изделий определяется уполномоченным органом.

4. Фармаконадзор и мониторинг безопасности, качества и эффективности медицинских изделий проводятся субъектами здравоохранения, субъектами в сфере обращения лекарственных средств и медицинских изделий, а также держателями регистрационных удостоверений лекарственных средств и производителями медицинских изделий, организациями по сервисному обслуживанию медицинских изделий.

5. Субъекты здравоохранения обязаны письменно и своевременно информировать уполномоченный орган о фактах проявления нежелательных реакций, в том числе не указанных в инструкции по применению лекарственного препарата, об особенностях взаимодействия лекарственного препарата с другими лекарственными препаратами, о передозировке, лекарственной зависимости, злоупотреблении, об отсутствии или низкой эффективности лекарственного препарата и о неблагоприятных событиях медицинских изделий.

Держатель регистрационного удостоверения лекарственного средства и производитель медицинского изделия обязаны в полном объеме представлять в уполномоченный орган сведения о безопасности лекарственного препарата, а также своевременно информировать уполномоченный орган о фактах проявления нежелательных реакций и (или) неблагоприятных событий при применении лекарственного препарата или медицинского изделия.

6. Уполномоченный орган учитывает данные фармаконадзора и мониторинга безопасности, качества и эффективности медицинских изделий в других странах при принятии решений о приостановлении, запрете или об изъятии из обращения либо ограничении применения лекарственных средств и медицинских изделий на территории Республики Казахстан.

Статья 262. Информация о лекарственных средствах и медицинских изделиях

Информация о лекарственных средствах и медицинских изделиях, допущенных к применению и использованию на территории Республики Казахстан, о лекарственных средствах, не прошедших государственную регистрацию, не соответствующих требованиям законодательства Республики Казахстан в области здравоохранения, об отзыве решения о государственной регистрации, а также о лекарственных препаратах, отпускаемых по рецепту врача, предоставляется в специализированных печатных изданиях, предназначенных для медицинских и фармацевтических работников.

Статья 263. Казахстанский национальный лекарственный формуляр

1. Казахстанский национальный лекарственный формуляр разрабатывается на основе фармако-терапевтической и (или) анатомо-терапевтической классификации лекарственных средств.

2. Для формирования Казахстанского национального лекарственного формуляра используется Государственный реестр лекарственных средств и медицинских изделий.

3. Лекарственное средство вносится в Казахстанский национальный лекарственный формуляр под международным непатентованным наименованием лекарственного средства с указанием каждого торгового наименования лекарственного средства, зарегистрированного на территории Республики Казахстан.

4. Правила формирования Казахстанского национального лекарственного формуляра разрабатываются и утверждаются уполномоченным органом.

Статья 264. Рациональное использование лекарственных средств

1. Рациональное использование лекарственных средств проводится для улучшения качества медицинской помощи и результатов лечения путем развития формулярной системы.

2. Формулярная система обеспечивает оптимальное использование безопасных, эффективных, экономически доступных лекарственных средств. Деятельность формулярной системы осуществляется в порядке, определяемом уполномоченным органом.

3. Организации здравоохранения обеспечивают рациональное использование лекарственных средств, подготовку клинических фармакологов, клинических фармацевтов и регулярное повышение квалификации специалистов в области здравоохранения по рациональному использованию лекарственных средств.

Статья 265. Этика продвижения лекарственных средств и медицинских изделий

1. Этикой продвижения лекарственных средств и медицинских изделий является деятельность, осуществляемая в процессе продвижения безопасных, качественных и эффективных лекарственных средств и медицинских изделий от разработчика и (или) производителя лекарственного средства или медицинского изделия до применения потребителем, основанная на добросовестной конкуренции и ответственности всех участвующих сторон.

2. Этика продвижения лекарственных средств и медицинских изделий осуществляется в порядке, определяемом уполномоченным органом.

3. В целях рационального использования лекарственных средств и медицинских изделий субъекты здравоохранения, члены профессиональных ассоциаций, субъекты в сфере обращения лекарственных средств и медицинских изделий обязаны соблюдать следующие условия этики продвижения лекарственных средств и медицинских изделий:

1) продвижение лекарственных средств и медицинских изделий на рынок должно обеспечивать полноту и точность предоставляемой информации в отношении безопасных, качественных и эффективных лекарственных средств и медицинских изделий;

2) пациенты, фармацевтические и медицинские работники должны получать необходимую и доступную информацию о лекарственных средствах и об их побочных действиях;

3) продвижение лекарственных средств и медицинских изделий на рынок должно быть объективным с соблюдением этических норм и осуществляться в соответствии с требованиями законодательства Республики Казахстан в области здравоохранения.

4. В медицинских организациях и организациях образования в области здравоохранения запрещается продвижение лекарственных средств и медицинских изделий представителями производителей лекарственных средств и медицинских изделий и (или) дистрибьюторов, за исключением проведения ежедневных врачебных конференций, научно-практических конференций и (или) специализированных семинаров.

Ежедневная врачебная конференция – плановое совещание медицинской организации с целью подведения итогов за прошедшие сутки, обсуждения и разбора клинических случаев, а также информирования коллектива о новых достижениях медицинской науки и клинической практики.

РАЗДЕЛ 6. КАДРОВАЯ ПОЛИТИКА В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Глава 29. КАДРОВЫЕ РЕСУРСЫ В ОБЛАСТИ ЗДРАВООХРАНЕНИЯ

Статья 266. Национальная система учета кадровых ресурсов в области здравоохранения

1. Национальная система учета кадровых ресурсов в области здравоохранения (профессиональный регистр) является базой для регистрации, учета, миграции, оттока с целью обеспечения персонифицированного учета, а также непрерывного профессионального развития работников здравоохранения.

Порядок учета кадровых ресурсов в области здравоохранения (ведения профессионального регистра) определяется уполномоченным органом.

2. На основе данных профессионального регистра работников здравоохранения осуществляются мониторинг и прогнозирование развития рынка труда и человеческих ресурсов, планирование подготовки кадров.

3. Лица, имеющие сертификат специалиста в области здравоохранения, подлежат обязательной регистрации в Национальной системе учета кадровых ресурсов в области здравоохранения. Сертификат специалиста в области здравоохранения действителен в случае его регистрации в Национальной системе учета кадровых ресурсов в области здравоохранения.

4. Национальный координатор по кадровым ресурсам в области здравоохранения определяется уполномоченным органом.

Статья 267. Особенности отраслевой системы квалификаций в области здравоохранения

1. Отраслевая система квалификаций в области здравоохранения – совокупность механизмов правового и институционального регулирования спроса на квалификации работников здравоохранения со стороны рынка труда и предложения квалификаций со стороны системы образования в области здравоохранения, включающая в себя:

1) отраслевую рамку квалификаций в области здравоохранения;

2) профессиональные стандарты в области здравоохранения;

3) государственные общеобязательные стандарты образования в области здравоохранения;

4) сертификацию специалистов в области здравоохранения;

5) систему непрерывного профессионального развития работников здравоохранения.

2. Профессиональные стандарты в области здравоохранения разрабатываются по медицинским и фармацевтическим специальностям.

Статья 268. Принципы реализации кадровой политики в области здравоохранения

1. Реализация кадровой политики в области здравоохранения основывается на принципах:

1) совместной ответственности государства и профессионального медицинского сообщества, включая профессиональные медицинские ассоциации, работодателей, медицинских и фармацевтических работников, за своевременное и качественное оказание медицинской помощи;

2) регулирования кадровых ресурсов в области здравоохранения в целях удовлетворения реальных потребностей отрасли;

3) контроля и содействия в осуществлении обучения (подготовки) кадровых ресурсов в области здравоохранения;

4) рациональной и эффективной реализации потенциала кадровых ресурсов в области здравоохранения;

5) укрепления статуса административных кадровых ресурсов в области здравоохранения;

6) подготовки кадровых ресурсов в области здравоохранения с учетом текущих и будущих потребностей системы здравоохранения;

7) непрерывного совершенствования программ подготовки кадровых ресурсов в области здравоохранения;

8) независимой оценки знаний, компетенций, профессиональной подготовки кадровых ресурсов в области здравоохранения;

9) развития профессиональных медицинских ассоциаций;

10) социальной защищенности медицинских работников;

11) доступности необходимых кадровых ресурсов в области здравоохранения;

12) формирования надлежащей компетенции и навыков работников;

13) непрерывного профессионального развития (обучение на протяжении всей жизни);

14) повышения продуктивности кадровых ресурсов в области здравоохранения;

15) социального признания.

2. Кадровая политика в области здравоохранения формируется:

1) на республиканском уровне – уполномоченным органом, утверждающим национальную политику управления кадровыми ресурсами в области здравоохранения;

2) на региональном уровне – местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы, утверждающими региональную политику управления кадровыми ресурсами в области здравоохранения;

3) на уровне организаций здравоохранения – организациями здравоохранения, реализующими корпоративную кадровую политику.

3. Планирование подготовки медицинских и фармацевтических кадров осуществляет уполномоченный орган, центральные исполнительные органы и иные центральные государственные органы, имеющие военно-медицинские (медицинские) подразделения, а также местные органы государственного управления здравоохранением областей, городов республиканского значения и столицы в пределах своей компетенции с учетом потребности отрасли.

Статья 269. Непрерывное профессиональное развитие работников здравоохранения

1. Непрерывное профессиональное развитие медицинских и фармацевтических работников направлено на совершенствование профессиональных знаний и умений, освоение дополнительных компетенций, учитывающих потребности специалистов, с целью повышения безопасности медицинской помощи.

2. Результаты непрерывного профессионального развития медицинских и фармацевтических работников подтверждаются на основании учетных данных профессионального регистра о получении дополнительного и неформального образования, иных мероприятиях по профессиональному развитию, уровне компетентности, практическом стаже работы.

3. Подтверждение результатов непрерывного профессионального развития медицинского и фармацевтического работника производится с учетом требований к уровню квалификации, установленных профессиональным стандартом, и квалификационных требований к должностным обязанностям работников здравоохранения.

4. Профессиональные медицинские ассоциации участвуют в разработке профессиональных стандартов и образовательных программ дополнительного и неформального образования.

Глава 30. СТАТУС МЕДИЦИНСКИХ И ФАРМАЦЕВТИЧЕСКИХ РАБОТНИКОВ

Статья 270. Статус медицинских и фармацевтических работников и их права

1. Медицинские и фармацевтические работники имеют право на основные гарантии, предусмотренные трудовым законодательством Республики Казахстан и иными нормативными правовыми актами, в том числе на:

1) создание соответствующих условий для выполнения работником трудовых обязанностей, включая обеспечение необходимыми медицинскими изделиями в порядке, установленном законодательством Республики Казахстан;

2) повышение квалификации или изменение профессиональной квалификации за счет работодателя или бюджетных средств, предусмотренных на эти цели законодательством Республики Казахстан, при невозможности выполнять трудовые обязанности по состоянию здоровья и при увольнении работников в связи с сокращением численности или штата работников, в связи с ликвидацией организации;

3) оплату труда, соответствующую уровню квалификации;

4) мотивацию труда в соответствии с уровнем квалификации, со спецификой и сложностью работы, с объемом и качеством труда, а также конкретными результатами деятельности;

5) создание профессиональных объединений и участие в них;

6) страхование профессиональной ответственности медицинских работников на случай причинения вреда жизни и (или) здоровью пациента при оказании ими медицинской помощи;

7) возмещение вреда, причиненного жизни и здоровью при исполнении должностных обязанностей, в соответствии с законодательством Республики Казахстан;

8) осуществление частной медицинской практики и фармацевтической деятельности при наличии разрешительных документов на медицинскую и фармацевтическую деятельность;

9) беспрепятственное и бесплатное использование средств связи, принадлежащих физическим и юридическим лицам, в случае транспортировки пациента в ближайшую медицинскую организацию для оказания экстренной медицинской помощи;

10) возмещение транспортных расходов, связанных с проездом.

2. Правом на занятие медицинской деятельностью владеют работники, имеющие техническое и профессиональное, послесреднее образование, высшее, послевузовское медицинское образование, подтвержденное сертификатом специалиста в области здравоохранения.

3. Врачи-резиденты в период обучения имеют право на работу в медицинских организациях в соответствии с сертификатом специалиста в области здравоохранения под надзором наставника.

4. Лица, получившие медицинское образование за рубежом, допускаются к медицинской или фармацевтической деятельности после признания документов об образовании, положительного результата оценки профессиональной подготовленности в организации, аккредитованной уполномоченным органом, с выдачей сертификата специалиста в области здравоохранения.

Оценка профессиональной подготовленности лиц, получивших медицинское образование за рубежом, проводится в соответствии с правилами оценки профессиональной подготовленности выпускников по программам медицинского образования.

5. Медицинский инцидент – событие, связанное с оказанием медицинской помощи в соответствии со стандартами организации оказания медицинской помощи и с использованием технологий, оборудования и инструментов, обусловленное отклонением от нормального функционирования организма, которое может нанести вред жизни и здоровью пациента, а также привести к смерти пациента, за исключением случаев, предусмотренных административным и уголовным законодательством Республики Казахстан.

Анализ медицинского инцидента осуществляется посредством внутреннего аудита медицинской организации, а также местными органами государственного управления здравоохранением областей, городов республиканского значения и столицы, государственными органами, осуществляющими государственный контроль в сферах оказания медицинских услуг (помощи), санитарно-эпидемиологического благополучия населения, обращения лекарственных средств и медицинских изделий, уполномоченным органом.

Сноска. Статья 270 с изменением, внесенным Законом РК от 08.01.2021 № 410-VI (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 03.01.2022 № 101-VII (вводится в действие с 01.01.2023).

Статья 271. Обязанности медицинских и фармацевтических работников

1. Медицинские и фармацевтические работники осуществляют деятельность в соответствии с законодательством Республики Казахстан и, руководствуясь принципами медицинской этики и деонтологии, обязаны:

1) содействовать профилактике заболеваний, укреплению здоровья, пропагандировать здоровый образ жизни среди населения Республики Казахстан;

2) оказывать медицинскую помощь в соответствии со своей квалификацией, служебными и должностными обязанностями;

3) привлекать в необходимых случаях для консультации специалистов другого профиля или более высокой квалификации;

4) соблюдать и хранить тайну медицинского работника, не разглашать сведения о болезнях, интимной и семейной жизни пациента;

5) непрерывно повышать профессиональный уровень;

6) быть зарегистрированными в Национальной системе учета кадровых ресурсов в области здравоохранения;

7) при назначении лекарственных средств выписывать рецепты на лекарственные средства в пределах своей компетенции при наличии соответствующих медицинских показаний под международным непатентованным наименованием, за исключением случаев индивидуальной непереносимости пациента.

2. Медицинские и фармацевтические работники, руководители медицинских организаций не вправе:

1) участвовать в рекламе лекарственных средств и медицинских изделий;

2) рекомендовать пациентам определенные объекты розничной реализации лекарственных средств и медицинских изделий в целях личной заинтересованности в получении вознаграждения за свои услуги;

3) продвигать лекарственные средства и медицинские изделия с участием представителей производителей лекарственных средств и медицинских изделий и (или) дистрибьюторов, за исключением проведения ежедневных врачебных конференций, научно-практических конференций и (или) специализированных семинаров.

Статья 272. Социальные гарантии. Социальная защита медицинских и фармацевтических работников

1. Медицинским работникам государственных медицинских организаций, работающим в сельской местности и в поселках, городах районного значения, предусматриваются меры социальной поддержки:

1) обязательное предоставление жилища по решению местных исполнительных органов, в том числе служебного, в соответствии с законодательством Республики Казахстан;

2) обязательная выплата пособий в порядке, установленном местным исполнительным органом;

3) оказание социальной поддержки по компенсациям коммунальных расходов и другие льготы по решению местных исполнительных органов;

4) иные меры.

2. Медицинские и фармацевтические работники государственных медицинских организаций имеют приоритетное право после социально уязвимых слоев населения на получение мер социальной поддержки, дополнительные льготы и стимулирующие выплаты за счет средств местных бюджетов.

3. Местные исполнительные органы для повышения престижа медицинского работника и обеспечения повышения его личностного и профессионального роста присваивают статус "Лучший по профессии" с предоставлением ему стимулирующих выплат за счет средств местных бюджетов.

4. Вмешательство в профессиональную деятельность медицинских и фармацевтических работников со стороны государственных органов и должностных лиц, а также граждан Республики Казахстан запрещается, за исключением случаев, предусмотренных настоящим Кодексом.

5. При осуществлении медицинским или фармацевтическим работником профессиональной деятельности не допускаются:

1) привлечение его к видам работ, не связанным с профессиональными обязанностями, за исключением случаев, предусмотренных законами Республики Казахстан;

2) истребование у него отчетности либо информации, не предусмотренной законодательством Республики Казахстан;

3) возложение на него обязанности по приобретению товаров (работ) и услуг, не предусмотренных законодательством Республики Казахстан.

Статья 273. Тайна медицинского работника

1. Персональные медицинские данные, информация о факте обращения за медицинской помощью, состоянии здоровья лица, диагнозе его заболевания и иные сведения, полученные при его обследовании и (или) лечении, составляют тайну медицинского работника.

2. Не допускается разглашение сведений, составляющих тайну медицинского работника, лицами, которым они стали известны при обучении, исполнении профессиональных, служебных и иных обязанностей, кроме случаев, установленных пунктами 3 и 4 настоящей статьи.

3. С информированного согласия пациента или его законного представителя допускается передача сведений, составляющих тайну медицинского работника, для проведения научных исследований, использования этих сведений в учебном процессе.

4. Предоставление сведений, составляющих тайну медицинского работника, без согласия лица допускается в следующих случаях:

1) в целях обследования и лечения лица, не способного из-за своего состояния выразить свою волю, в случае отсутствия законного представителя;

2) при угрозе распространения заболеваний, представляющих опасность для окружающих, в том числе при донорстве крови, ее компонентов, трансплантации органов (части органа) и (или) тканей (части ткани);

3) по запросу органов дознания и предварительного следствия, прокурора, адвоката и (или) суда в связи с проведением расследования или судебного разбирательства;

4) при оказании медицинской помощи несовершеннолетнему или недееспособному лицу для информирования его законного представителя;

5) при наличии оснований полагать, что вред здоровью гражданина Республики Казахстан причинен в результате противоправных деяний;

6) при обнаружении у лица психических отклонений и склонностей к сексуальному насилию;

7) при проведении государственного контроля качества оказания медицинских услуг (помощи), мониторинга договорных обязательств по качеству и объему медицинских услуг;

8) при проведении проверок органами прокуратуры в порядке, установленном Конституционным законом Республики Казахстан "О прокуратуре";

9) по запросу специальных государственных органов в целях решения задач контрразведывательной деятельности.

5. Не является разглашением тайны медицинского работника:

1) передача на хранение резервной копии электронного информационного ресурса на единую платформу резервного хранения электронных информационных ресурсов в соответствии с порядком и сроками, определяемыми уполномоченным органом в сфере обеспечения информационной безопасности, за исключением случаев, когда такие электронные информационные ресурсы содержат информацию, связанную с разведывательной, контрразведывательной деятельностью и охранными мероприятиями по обеспечению безопасности охраняемых лиц и объектов, передача которой осуществляется в соответствии с законодательством Республики Казахстан о государственных секретах;

2) обмен информацией с использованием информационно-коммуникационных технологий в целях оказания медицинской помощи и осуществления деятельности правоохранительных и специальных государственных органов.

6. Не допускается подключение электронных информационных ресурсов, содержащих персональные медицинские данные физических лиц, к сетям телекоммуникаций, связывающим их с другими базами данных, без согласия физических лиц при использовании персональных медицинских данных, касающихся их частной жизни, кроме случаев, связанных с донорством крови и ее компонентов, органов (части органа) и (или) тканей (части ткани), а также запросами правоохранительных, специальных государственных органов по предоставлению информации в форме электронного документа, составляющей медицинскую тайну, о состоянии на учете лиц, болеющих или переболевших туберкулезом, с психическими, поведенческими расстройствами (заболеваниями), связанными с употреблением психоактивных веществ.

7. Не являются нарушением тайны медицинского работника случаи, когда данные о здоровье пациента стали общедоступными по причинам, не зависящим от медицинского работника.

Сноска. Статья 273 с изменениями, внесенными законами РК от 05.11.2022 № 157-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования); от 23.12.2023 № 51-VIII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Статья 274. Кодекс чести медицинских и фармацевтических работников Республики Казахстан

1. Кодекс чести медицинских и фармацевтических работников Республики Казахстан (далее – Кодекс чести) устанавливает морально-этическую ответственность медицинских и фармацевтических работников Республики Казахстан за свою деятельность перед обществом.

2. Кодекс чести разрабатывается и утверждается уполномоченным органом.

РАЗДЕЛ 7. ЗАКЛЮЧИТЕЛЬНЫЕ ПОЛОЖЕНИЯ

Статья 275. Ответственность за нарушение законодательства Республики Казахстан в области здравоохранения

Нарушение законодательства Республики Казахстан в области здравоохранения влечет ответственность, установленную законами Республики Казахстан.

Статья 276. Порядок введения в действие настоящего Кодекса

1. Настоящий Кодекс вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования, за исключением:

1) статьи 39, подпункта 1) пункта 10 статьи 55, которые вводятся в действие с 1 января 2021 года;

2) части второй пункта 2 статьи 231 и части второй пункта 3 статьи 233, которые вводятся в действие для организаций по производству лекарственных средств, аптечных складов с 1 января 2021 года;

3) пункта 7 статьи 240, который вводится в действие с 1 июня 2021 года;

4) подпункта 16) пункта 2 статьи 110, подпунктов 2), 3) пункта 1, подпунктов 2), 3) пункта 4, пунктов 7 и 8 статьи 27, которые вводятся в действие с 1 июля 2021 года;

5) подпункта 2) пункта 10 статьи 55, который вводится в действие с 1 января 2022 года;

6) части первой пункта 3 статьи 233, которая вводится в действие для аптек с 1 января 2026 года;

      7) Исключен Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      2. Исключен Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).
      3. Исключен Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

4. Приостановить до введения в действие подпункта 1) пункта 22 статьи 1 Закона Республики Казахстан от 13 мая 2020 года "О внесении изменений и дополнений в некоторые законодательные акты Республики Казахстан по вопросам регулирования миграционных процессов" действие заголовка статьи 83 в оглавлении, заголовка, пунктов 1 и 3 статьи 83, пункта 2 статьи 160, пункта 1 статьи 162 и части первой пункта 1 статьи 196 настоящего Кодекса, установив, что в период приостановления данные нормы действуют в следующей редакции:

1) заголовок статьи 83 в оглавлении:

"Статья 83. Права и обязанности оралманов, иностранцев, лиц без гражданства и иных лиц";

2) заголовок статьи, пункты 1 и 3 статьи 83:

"Статья 83. Права и обязанности оралманов, иностранцев, лиц без гражданства и иных лиц

1. Оралманы, беженцы, а также иностранцы и лица без гражданства, постоянно проживающие на территории Республики Казахстан, имеют право на получение гарантированного объема бесплатной медицинской помощи наравне с гражданами Республики Казахстан.";

"3. Оралманы, беженцы и лица, ищущие убежище, иностранцы и лица без гражданства, находящиеся на территории Республики Казахстан, несут те же обязанности в области здравоохранения, что и граждане Республики Казахстан.";

3) пункт 2 статьи 160:

"2. Граждане Республики Казахстан, оралманы, иностранцы, лица без гражданства, беженцы, зараженные ВИЧ-инфекцией, постоянно проживающие на территории Республики Казахстан, и дети, рожденные от зараженных ВИЧ-инфекцией матерей с неустановленным диагнозом, подлежат динамическому наблюдению и обеспечению лекарственными средствами в рамках гарантированного объема бесплатной медицинской помощи.";

4) пункт 1 статьи 162:

"1. Граждане Республики Казахстан, оралманы, иностранцы, лица без гражданства, беженцы и лица, ищущие убежище, постоянно и временно проживающие на территории Республики Казахстан, имеют право на добровольное анонимное и (или) конфиденциальное медицинское обследование и консультирование по вопросам ВИЧ-инфекции в рамках гарантированного объема бесплатной медицинской помощи в государственных организациях здравоохранения, осуществляющих деятельность в сфере профилактики ВИЧ-инфекции, в порядке, определяемом уполномоченным органом.";

5) часть первую пункта 1 статьи 196:

"1. Гарантированный объем бесплатной медицинской помощи предоставляется гражданам Республики Казахстан, оралманам, беженцам, иностранцам и лицам без гражданства, постоянно проживающим на территории Республики Казахстан, за счет бюджетных средств, включает профилактические, диагностические и лечебные медицинские услуги, обладающие наибольшей доказанной эффективностью, а также лекарственное обеспечение.".

5. Признать утратившими силу:

1) Кодекс Республики Казахстан от 18 сентября 2009 года "О здоровье народа и системе здравоохранения" (Ведомости Парламента Республики Казахстан, 2009 г., № 20-21, ст.89; 2010 г., № 5, ст.23; № 7, ст.32; № 15, ст.71; № 24, ст.149, 152; 2011 г., № 1, ст.2, 3; № 2, ст.21; № 11, ст.102; № 12, ст.111; № 17, ст.136; № 21, ст.161; 2012 г., № 1, ст.5; № 3, ст.26; № 4, ст.32; № 8, ст.64; № 12, ст.83; № 14, ст.92, 95; № 15, ст.97; № 21-22, ст.124; 2013 г., № 1, ст.3; № 5-6, ст.30; № 7, ст.36; № 9, ст.51; № 12, ст.57; № 13, ст.62; № 14, ст.72, 75; № 16, ст.83; 2014 г., № 1, ст.4; № 7, ст.37; № 10, ст.52; № 11, ст.65; № 14, ст.84, 86; № 16, ст.90; № 19-I, 19-II, ст.96; № 21, ст.122; № 23, ст.143; 2015 г., № 1, ст.2; № 7, ст.33; № 10, ст.50; № 19-II, ст.102; № 20-IV, ст.113; № 20-VII, ст.115; № 22-I, ст.143; № 22-V, ст.156; № 23-II, ст.170; 2016 г., № 6, ст.45; № 8-II, ст.67, 70; № 23, ст.119; 2017 г., № 1-2, ст.3; № 4, ст.7; № 9, ст.22; № 13, ст.45; № 22-III, ст.109; № 23-III, ст.111; № 24, ст.115; 2018 г., № 10, ст.32; № 14, ст.42; № 15, ст.47; № 19, ст.62; № 23, ст.91; № 24, ст.93, 94; 2019 г., № 7, ст.36; № 8, ст.46; № 21-22, ст.90; № 23, ст.106; Закон Республики Казахстан от 4 мая 2020 года "О внесении изменений и дополнений в некоторые законодательные акты Республики Казахстан по вопросам труда", опубликованный в газетах "Егемен Қазақстан" и "Казахстанская правда" 5 мая 2020 г.; Закон Республики Казахстан от 13 мая 2020 года "О внесении изменений и дополнений в некоторые законодательные акты Республики Казахстан по вопросам регулирования миграционных процессов", опубликованный в газетах "Егемен Қазақстан" и "Казахстанская правда" 14 мая 2020 г.; Закон Республики Казахстан от 25 мая 2020 года "О внесении изменений и дополнений в некоторые законодательные акты Республики Казахстан по вопросам мобилизационной подготовки и мобилизации", опубликованный в газетах "Егемен Қазақстан" и "Казахстанская правда" 26 мая 2020 г.);

2) Закон Республики Казахстан от 7 апреля 1995 года "О принудительном лечении больных алкоголизмом, наркоманией и токсикоманией" (Ведомости Верховного Совета Республики Казахстан, 1995 г., № 3-4, ст.32; Ведомости Парламента Республики Казахстан, 2004 г., № 23, ст.142; 2010 г., № 24, ст.152; 2012 г., № 8, ст.64; 2013 г., № 13, ст.62; 2014 г., № 19-I, 19-II, ст.96; 2018 г., № 24, ст.93);

3) Закон Республики Казахстан от 14 октября 2003 года "О профилактике йододефицитных заболеваний" (Ведомости Парламента Республики Казахстан, 2003 г., № 19-20, ст.149; 2006 г., № 1, ст.5; 2007 г., № 4, ст.95; 2011 г., № 11, ст.102; 2012 г., № 14, ст.92; 2013 г., № 14, ст.75; 2014 г., № 1, ст.4; № 23, ст.143; 2018 г., № 24, ст.93).

Сноска. Статья 276 с изменениями, внесенными Законом РК от 27.06.2022 № 129-VII (вводится в действие по истечении десяти календарных дней после дня его первого официального опубликования).

Президент
Республики Казахстан

К. ТОКАЕВ

ON PUBLIC HEALTH AND HEALTHCARE SYSTEM

SECTION 1. GENERAL PROVISIONS

Chapter 1. PRINCIPAL PROVISIONS

Article 1. Basic concepts used in this Code

Article 2. Legislation of the Republic of Kazakhstan in the field of healthcare

Article 3. Relations regulated by this Code

Article 4. Purpose and objective of the legislation of the Republic of Kazakhstan in the field of healthcare

Article 5. Principles of the legislation of the Republic of Kazakhstan in the field of healthcare

Chapter 2. STATE REGULATION AND GOVERNANCE IN THE FIELD OF HEALTHCARE

Article 6. Competence of the Government of the Republic of Kazakhstan

Article 8. Competence of the state body in the field of healthcare services (assistance)

Article 9. Competence of the state body in the field of sanitary and epidemiological welfare of the population

Article 10. Competence of the state body in the field of circulation of pharmaceuticals and medical devices

Article 11. Competence of central executive bodies and other central state bodies with military medical (medical), forensic medical, forensic narcological, forensic psychiatric subdivisions

Article 12. Competence of local representative and executive bodies of regions, cities of republican status and the capital

Article 13. Competence of local government health authorities in regions, cities of republican status and the capital

Article 14. Power and authority of the national healthcare operator

Article 15. Joint commission on the quality of healthcare services

Article 16. Interdepartmental interaction of state bodies and public associations in the field of healthcare

Chapter 3. PERMITS AND NOTIFICATIONS IN THE FIELD OF PUBLIC HEALTH

Paragraph 1. Licensing in the field of public health

Article 17. Licensing of activities in the field of public health

Paragraph 2. Permitting procedure and notification procedure in the field of public health

Article 19. Permits in the field of public health

Article 20. Issuance of a sanitary and epidemiological conclusion

Article 22. Issuance of a certificate of state registration of products

Article 23. Issuance of a registration certificate for a pharmaceutical product or medical device

Article 24. Notifications in the field of public health

Chapter 4. ACCREDITATION, ASSESSMENT AND CERTIFICATION IN THE FIELD OF PUBLIC HEALTH

Article 25. Accreditation in the field of public health

Article 26. Assessment of professional competence of healthcare specialists

Article 27. Certification of a healthcare specialist and a manager

Chapter 5. STATE CONTROL AND SUPERVISION IN THE FIELD OF PUBLIC HEALTH

Article 28. General provisions on state control and supervision in the field of public health

Article 29. Procedure for considering a complaint by the appeal commission

Paragraph 1. State control over the provision of healthcare services (assistance)

Article 30. State control over the provision of healthcare services (assistance)

Article 31. Officials exercising state control over the provision of healthcare services (assistance)

Article 32. The rights of officials in the exercise of state control over the provision of healthcare services (assistance)

Article 33. Special procedure for conducting inspections in the exercise of state control over the provision of healthcare services (assistance)

Article 34. Preventive control over the provision of healthcare services (assistance) without visiting the entity (object) subject to control

Article 35. Expertise on the quality of healthcare services (assistance)

Paragraph 2. State control and supervision in the field of sanitary and epidemiological welfare of the population

Article 36. State control and supervision in the field of sanitary and epidemiological welfare of the population

Article 37. Officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population

Article 38. The rights of officials in the exercise of state control and supervision in the field of sanitary and epidemiological welfare of the population

Article 39. Social protection of officials exercising state control and supervision in the field of sanitary and epidemiological welfare of the population

Article 40. Special procedure for conducting inspections in the implementation of state control and supervision in the field of sanitary and epidemiological welfare of the population

Article 41. State control and supervision in the field of sanitary and epidemiological well-being of the population in the form of an unscheduled inspection

Article 43. Selection and implementation of sanitary and epidemiological expertise of products

Article 46. Sanitary and epidemiological expertise

Article 47. Procedure for conducting sanitary and epidemiological laboratory tests

Article 48. Sanitary and epidemiological audit

Article 49. Requirements to auditors carrying out activities for conducting sanitary and epidemiological audit

Article 50. Sanitary-epidemiological auditing procedure

Article 51. Production control

Clause 3. State control in the field of distribution of medicines and medical products

Article 52. State control in the field of distribution of medicines and medical products

Article 53. Officials exercising state control in the field of distribution of medicines and medical products

Article 54. Rights of officials exercising state control in the field of distribution of medicines and medical products

Article 55. Preventive control in the field of distribution of medicines and medical products without visiting the subject (object) of control

Chapter 6. HEALTHCARE ADVERTISING

Article 56. Healthcare advertising

Chapter 7. DIGITAL HEALTH

Article 57. Fundamental principles of digital health

Article 58. Basic terms used in this chapter

Article 59. Activities in the field of digital health

Article 60. Interaction of digital health facilities and entities

Article 61. Responsibility of digital health entities

Article 62. Security of personal health data of individuals

Chapter 8. STRUCTURE OF THE HEALTHCARE SYSTEM

Article 63. Public health entities

Article 64. Types of medical activities

Article 65. Development of the healthcare infrastructure

Article 66. Public-private partnership in the field of healthcare

Chapter 9. FINANCIAL SUPPORT FOR THE HEALTHCARE SYSTEM

Article 67. Sources of financial support for the healthcare system

Article 68. Financing of medical care volumes

Article 69. The use of sources of financial support for the healthcare system

Article 70. National health accounts