On public health and health care system

Updated Unofficial translation

The Code of the Republic of Kazakhstan dated on September 18, 2009 No 193-IV.

      Unofficial translation
      The order of enforcement of the Code of the Republic of Kazakhstan, see Art. 186

GENERAL PART
SECTION 1. GENERAL PROVISIONS
Chapter 1. BASIC PROVISIONS

Article 1. Basic terms used in this Code

      1. The following basic terms shall be used in this Code:

      1) an authorized generic - a medicinal product identical to the original product, manufactured by the same manufacturer, but differing in trade name and price;

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

      2) HIV - human immunodeficiency virus;

      3) an anonymous examination – a voluntary medical examination of a person without his identification;

      4) emergency medicine - a branch of medicine and healthcare, aimed at preventing and eliminating of medical and sanitary consequences of social, natural and man-made emergency situations (hereinafter - emergency situations), including prevention and medical treatment of population, sanitary and anti-epidemic and sanitary-preventive measures, protection and rehabilitation of health of participants in the emergency situations liquidation, as well as medical assistance to the employees of rescue services;

      5) potentially dangerous chemical and biological substances – the substances, which, under certain conditions and in certain concentrations, can be harmful to human health or the future generation, application and use of which shall be regulated by the legal acts on healthcare and epidemiological safety and health standards;

      5-1) social health insurance fund - a non-profit organization that accumulates deductions and contributions, and also purchases and pays for the services of healthcare subjects, providing medical assistance in the amounts and on terms stipulated in the contract for the purchase of medical services and other functions, determined by the laws of the Republic Kazakhstan;

      6) military medicine - the branch of medicine and health care, a system of scientific knowledge (a set of scientific and practical subjects) and practical military medical service, aimed at comprehensive medical support of troops in peace and wartime;

      7) military medical care – the medical care, provided by the specialists of military medical services to the military servants and those, injured by combat weapons;

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

      9) military-medical (medical) subdivisions:

      structural subdivisions of central executive authorities and other central government bodies, organizing and coordinating the military-medical (medical) institutions’ (organizations’) activity;

      military-medical (medical) institutions (organizations) and other subdivisions of the central executive authorities and other central government agencies, providing military-medical care to the appropriate contingent;

      10) military-medical (medical) supply - a set of actions for logistics and organization of medical care in military units, departments and departmental organizations in order to restore the combat capability and power of the staff;

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

      12) irreversible brain death – a complete loss of integral function of brain cells, accompanied by the death of the brain substance;

      13) a profile specialist – a medical specialist with higher medical education, having a certificate for a particular qualification;

      14) biologically active substances – the substances of different origin, normalizing the diseased body functions in humans and animals that are the potential sources for medicines production;

      15) biologically active supplements – the supplements to the products, designed to improve health under condition of regular drug use and containing the components of natural or identical to natural biologically active substances in order to enrich a diet of a person;

      15-1) medicines of biological origin – products, containing biological substances (hormones, cytokines, blood coagulation factors, insulins, monoclonal antibodies, enzymes, colony stimulating factors, drugs based on tissue cells, and others obtained with the help of biotechnological methods);

      15-2) biosimilary - a biotechnological medicine similar to the first produced (original) medicine on quality, safety, efficacy and submitted for registration after the expiration of the patent of original medicinal products;

      15-3) biotechnological medicine - a biological medicine, produced by biotechnological processes using recombinant deoxyribonucleic acid technology, the method of controlled expression of genes encoding the production of biologically active proteins, the hybrid method and monoclonal antibodies, as well as gene therapy and somatotherapeutic medicines of genetic engineering modification;

      15-4) certificate of assignment of qualification category - a document of a standard pattern, confirming the assignment of the appropriate qualification category;

      16) original medicine - a medicine, representing or containing new active substances, the effectiveness and safety of which shall be confirmed by the results of preclinical and clinical studies, and registered on the basis of a complete dossier;

      16-1) a single distributor - a legal entity, carrying out, within the guaranteed volume of free medical care and in the system of compulsory social health insurance, activities in accordance with Article 77 of this Code;

      16-2) hematopoietic stem cells - a part of the tissue of internal environment of the body, cells of the human bone marrow, possessing polypotency in the process of life, located in the bone marrow, peripheral blood (after stimulation) and cord blood;

      16-3) homeopathic remedies – medicines, containing substances of natural origin in small doses and manufactured by special technology;

      17) genetically modified objects – the raw materials and plant and (or) animal products, manufactured with the genetic engineering techniques, including genetically modified sources, organisms;

      18) medicine – products, representing or containing pharmacologically active substances that come in contact with the human body or penetrate into its organs and tissues, intended for prevention, diagnosis and treatment of diseases, as well as changes in the state and functions of the organism: drug substance, drug raw materials, bulk products of medicines, medicines;

      18-1) long-term contract for the supply of medicines, medical products - a civil-legal contract, concluded by a single distributor with a legal entity - a resident of the Republic of Kazakhstan for the supply of drugs, medical products, manufactured in accordance with the requirements of good manufacturing practice (GMP) for medicines and the requirements of international standard for medical products, having a certificate of origin of the goods for internal circulation in accordance with the legislation of the Republic of Kazakhstan, or with a legal entity, intending to establish the production of drugs, medical products in accordance with the requirements of good manufacturing practice (GMP) for medicines and the requirements of international standard for medical products;

      18-2) long-term contract for the storage and transportation of medicines, medical products - a civil-legal contract for the provision of services, concluded by a single distributor with a legal entity- resident of the Republic of Kazakhstan in accordance with the requirements of good distribution practice (GDP);

      19) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      20) retail sale of medicines, medical products and medical equipment - pharmaceutical activity related to acquisition (except for import), storage, distribution, sale (except for export) to the end user and destruction, carried out in accordance with the rules, approved by the authorized body;

      20-1) contract manufacturing of medicines, medical products and medical equipment - manufacture of medicines, medical products and medical equipment on request at the manufacturer's manufacturing facilities, which ensures full compliance with the requirements of good manufacturing practice (GMP) for medicines and international standard for medical products and medical equipment;

      21) wholesale sale of medicines, medical products and medical equipment - pharmaceutical activity related to the purchase, storage, import, export, sale (except for the sale of medicines to the public), without restriction, destruction, carried out in accordance with the rules approved by the authorized body;

      21-1) appropriate pharmaceutical practices in the sphere of medicinal products circulation (hereinafter - appropriate pharmaceutical practices) - health standards, covering all phases of the life cycle of medicines: 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 appropriate pharmaceutical practices;

      21-2) pharmaceutical inspectorate in the sphere of medicinal products circulation - structural subdivision of the authorized body carrying out pharmaceutical inspection;

      21-3) normative document on the control over the quality and safety of medicines, medical products - a document, that establishes a set of requirements for the quality of a medicine, medical products, as well as the methods for determining it, ensuring their identical safety and quality parameters;

      22) circulation of medicinal products, medical supplies and medical equipment – the activity, aimed at bringing of safe, effective and quality medicines, medical supplies and medical equipment from the developer and (or) manufacturer to the consumer;

      23) objects in the sphere of circulation of medicines, medical products and medical equipment - a pharmacy, a pharmacy in the healthcare organizations, providing primary health and / or consultative and diagnostic assistance, a mobile pharmacy for remote rural areas, organized from a pharmacy, pharmacy warehouse, temporary storage warehouse for medicines, medical products and medical equipment, optics store, medical equipment and medical products store , a warehouse of medical equipment and medical products, organizations for the production of medicines, medical products and medical equipment, operating in accordance with standard provisions, approved by the authorized body in the field of healthcare;

      24) subjects, involved in circulation of drugs, medical supplies and medical equipment – the individual persons or legal entities, engaged in pharmaceutical activities;

      24-1) monitoring of side effects of medicines, medical products and medical equipment - a set of measures aimed at identifying, collecting, evaluating and analyzing reports of side effects of medicines, medical products and medical equipment;

      24-2) safety of medicines, medical products and medical equipment - absence of unacceptable risk, associated with the possibility of harming life, human health and the environment;

      25) State register of drugs, medical supplies and medical equipment – the accounting document for drugs, medical supplies and medical equipment, that are registered and approved for medical use in the Republic of Kazakhstan;

      25-1) the effectiveness of medicines, medical products and medical equipment - a set of characteristics, ensuring the achievement of preventive, diagnostic, therapeutic and (or) rehabilitation effects;

      25-2) pharmacovigilance of medicines - a system for monitoring, analyzing and evaluating information on the safety of registered medicines;

      26) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      27) the expiration date of a drug - the date after which the drug is not applicable;

      28) packaging of a drug - a device or a set of tools, providing circulation of drugs via protecting them from damage and loss, as well as protecting the environment from pollution;

      29) quality of pharmaceuticals, medical devices and medical equipment – a set of properties and characteristics of a drug, medical device and medical equipment, affecting their ability to operate as intended;

      29-1) bulk product of a medicine or medical product - a dosed ready-made medicine or a prepared medical product, that has passed all the stages of technological process, except for final packaging;

      30) an international non-proprietary name of a drug - the name of the drug recommended by the World Health Organization;

      31) a drug – a drug in a certain dosage form;

      32) manufacturing of drugs - the pharmaceutical activities, related to manufacturing of medicines in drug stores, as well as acquisition of drug substances, storage, quality control, design and selling of the produced medicines;

      32-1) drug substance - a substance or a mixture of substances, regardless of the nature of origin, having a certain pharmacological activity, intended for production and manufacture of medicines;

      32-2) standard samples of medicinal substances and their impurities - reference substances, used in examination of the tested medicines;

      33) is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication);

      33-1) medicinal raw material - substances of vegetative, mineral, animal origin or products of chemical industry, used for production and manufacture of medicines;

      34) traditional medicine - a branch of medicine and activity of health workers, based on the accumulated public methods and means of prevention and treatment of disease, established in the old traditions of medical practice;

      34-1) disinsection - a complex of preventive and exterminating measures for destruction of insects and arthropods in order to protect humans, animals, premises and territory from them;

      34-2) disinfection - a set of special measures, aimed at destruction of pathogens of infectious and parasitic diseases in the external environment;

      35) health - a state of complete physical, mental (psychological) and social welfare and not only absence of disease or physical disabilities;

      36) health care - a system of political, economic, legal, social, cultural, and medical measures, aimed at prevention and treatment of diseases, maintenance of public hygiene and sanitation, saving and strengthening of physical and mental health of each person, his long years of life, provision of medical care in case of loss of health;

      37) health care system - a set of government and healthcare bodies, ensuring the citizens’ rights for health protection;

      37-1) qualification category in the field of healthcare (hereinafter - a qualification category) - the level of a specialist's qualification, characterized by the amount of professional knowledge, skills and abilities necessary to perform work within the relevant medical and pharmaceutical specialty;

      37-2) professional standard in the field of healthcare - the standard, defining requirements to a level of qualification, content, quality and working conditions of specialists in the field of healthcare;

      37-3) certification of specialists in the field of healthcare - an obligatory procedure for determining the compliance of medical professionals in the clinical specialty and their admission to clinical practice (work with patients) with the issuance of a corresponding specialist’s certificate;

      37-4) the standard of public service in the field of healthcare - a normative legal act that establishes the requirements for provision of public health services, as well as characteristics of the process, form, content and outcome of public health services;

      38) expertise in the field of healthcare - a set of organizational, analytical and practical activities aimed at establishing the level and quality of measures, methods, technologies, educational programs, services in various fields of healthcare activities in accordance with the legislation of the Republic of Kazakhstan;

      39) a standard for healthcare (hereinafter - the standard) – a legal act, defining the rules, common principles and characteristics in medical and pharmaceutical activity, medical and pharmaceutical education;

      40) standardization in healthcare (hereinafter - the standardization) – the activity, aimed at achieving the optimal level of regulation of processes, medical technologies and services via development, introduction and compliance with standards, requirements, rules, instructions and regulations;

      41) the authorized body in the field of healthcare (hereinafter - an authorized body) - a state body, exercising leadership in the field of health protection of citizens, medical and pharmaceutical science, medical and pharmaceutical education, circulation of medicines, medical products and medical equipment, control of medical services quality;

      42) National healthcare holding - the joint stock company, incorporated under the decision of the Government of the Republic of Kazakhstan, working in healthcare area, including nuclear medicine;

      43) a healthcare organization - a legal entity, working in healthcare area;

      43-1) drug formulary of the organization of healthcare - the list of medicines for rendering medical aid within the limits of the guaranteed volume of free medical aid and in the system of obligatory social medical insurance, formed on the basis of the Kazakhstani national drug formulary and approved by the head of healthcare organization in the manner determined by the authorized body;

      43-2) deratization - a complex of preventive and extermination measures aimed at destruction or reduction of the number of rodents;

      43-3) detoxification - a complex of medical measures aimed at removing toxic substances of endogenous or exogenous origin from the human body;

      44) diagnostics - a complex of medical services, aimed at detection of presence or absence of a disease;

      45) diagnostic reagents - reagents, reagent kits related to medical products, intended for the study outside the body and serving to obtain information about the parameters of the organism for the purpose of diagnosing or assessing physiological state of the patient;

      46) dynamic observation – a systematic monitoring of the population’s health, as well as providing of necessary medical assistance upon the results of this observation;

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

      48) treatment - a complex of medical services, aimed at elimination, slowing down and (or) relief of disease, and prevention of its progression;

      49) voluntary treatment – the treatment, carried out with the consent of a patient or his legal representative;

      50) falsified medicine, medical product and medical equipment - medicine, medical product and medical equipment, unlawfully and intentionally provided with inaccurate information and a fake label about their composition or assembly and (or) manufacturer, and secretly produced;

      51) personal medical card - a personal document, where the results of mandatory medical examinations with a note of admission to work are recorded;

      51-1) sanitary and epidemiological expertise of projects - a part of the project expertise, carried out as part of a comprehensive non-departmental project expertise (feasibility studies and design estimates), intended for the construction of new or reconstruction (expansion, retrofitting, modernization) and overhaul of existing facilities, integrated urban development expertise of urban development projects;

      51-2) high-tech medical services - services provided by specialized experts in diseases requiring the use of innovative, resource-intensive and (or) unique methods of diagnosis and treatment;

      51-3) planned medical care - medical care for preventive measures, diseases and conditions that do not require emergency and urgent medical care;

      52) an acquired immunodeficiency syndrome (AIDS) - the final phase of HIV infection with pathological manifestations, caused by deep immune system impairment of a person with HIV;

      52-1) immunobiological drugs - drugs for specific prevention, diagnosis and treatment of infectious and immune diseases (including allergic diseases) with the help of immunological methods of other diseases and physiological states, means for indicating infectious agents and their antigens in environmental objects, blood preparations (independently from the method of preparation), as well as drugs that provide therapeutic and preventive effects through the immune system;

      52-2) immunological typing system (hereinafter - the system-HLA) - an antigen system, located on human leukocytes and determining the tissue compatibility of the donor and recipient at transplantation of tissues (tissue parts) and (or) organs (parts of organs);

      53) invasive methods – the methods of diagnosis and treatment, conducted via penetration into the internal environment of the human body;

      54) innovative medical technologies - a set of methods and tools for scientific and technological activities, introduction of which in medicine (biomedicine), pharmacy and informatization in healthcare is cost-effective and (or) socially important;

      55) infectious and parasitic diseases – human diseases, occurrence and spreading of which is caused by biological environment factors and possibility of transmission of the disease from an infected person or an animal to a healthy person;

      56) iodine deficiency disorders - the pathological process of the body, caused by thyroid gland dysfunction, related to insufficient intake and assimilation of iodine in the body;

      57) an occupational disease – a chronic or acute disease, caused by harmful production factors when performing labor (official) duties;

      57-1) emergency medical care - medical care for sudden acute illnesses, trauma, severe deterioration of health status, exacerbation of chronic diseases, without obvious signs of a threat to the life of the patient;

      57-2) biological material of preclinical (non-clinical) and clinical researches - samples of biological fluids, tissues, secrets and products of vital activity of humans and animals, biopsy material, histological sections, smears, scrapings, flushes obtained during preclinical (non-clinical) and clinical studies and intended for laboratory research;

      58) preclinical (nonclinical) research - a complex of experimental pharmacological, toxicological and other scientific researches of biologically active substances, pharmacological and medicinal products, medical products and medical equipment with the purpose of studying their effectiveness and safety;

      59) a clinical research – a research with participation of a man as a subject, conducted to elucidate or confirm the safety and efficiency of tools, techniques and technologies for prevention, diagnosis and treatment;

      59-1) clinical protocol - a document that establishes general requirements for provision of medical care to a patient in a particular disease or clinical situation;

      60) council of physicians – examination of a person to make a diagnosis, determine a treatment strategy and prognosis, with involvement of no less than three doctors;

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

      61-1) Kazakhstani national drug formulary - a list of drugs with proven clinical efficacy and safety, containing information on medicines and prices, which is an obligatory basis for the development of drug formularies of healthcare organizations and formation of drug purchase lists within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      62) State pharmacopoeia of the Republic of Kazakhstan - a set of requirements for the quality and safety of medicines;

      62-1) reproduced drug (generic) - a drug identical to the original drug in the composition of active substances, dosage form, quality, safety, efficacy, produced by different manufacturers;

      63) public health - a comprehensive assessment of mental, physical and social welfare of the population, reflecting the society’s efforts on a healthy lifestyle, including healthy food, prevention of diseases and injuries, as well as prevention of effects of harmful environmental factors;

      64) confidential medical examination – an examination, based on doctor-patient confidentiality and patient privacy;

      64-1) assessment of professional preparedness and confirmation of compliance with the qualifications of specialists - the procedure for assessing knowledge and skills, conducted in order to confirm the compliance of the specialist's qualifications with the requirements of the professional standard in the field of healthcare;

      65) the certificate of a specialist - a document of a standard pattern that empowers an individual to conform to the clinical specialty and admit him to clinical practice (working with patients);

      66) compulsory treatment - treatment of a patient, pursuant to a court decision;

      67) health workers – the individuals with professional medical education, providing medical activities;

      68) medical and social rehabilitation - the recovery of health of patients and the disabled with a complex use of medical, social and occupational activities for their involvement into work, family and social life;

      68-1) medical education - the system of training, retraining and qualification development of medical workers, as well as the totality of knowledge and skills necessary for a medical worker, received during the study under the programs of training, retraining and qualification development in medical specialties, confirmed by an official document on the completion of training;

      69) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      70) medical assistance - a complex of medical services, including medicinal assistance, aimed at preserving and recovering of public health, as well as alleviating severe manifestations of incurable diseases;

      71) quality of medical care - the level of compliance of medical care with the standards, approved by the authorized body and established on the basis of the current level of medical science and technology development;

      72) medical examination - examination of an individual to establish or confirm the existence or absence of a disease, determine the health state, as well as temporary disability, vocational and other workability;

      73) medical activities - professional activities of individuals with higher or secondary vocational medical education, as well as legal entities, aimed at protecting the citizens’ health;

      74) medical services - actions of subjects of healthcare, having preventive, diagnostic, medical, rehabilitation or palliative orientation in relation to a special person;

      75) medical devices – the items and materials, used for preventive, diagnostic and therapeutic actions: medical instruments, dental supplies, expendables, dressings and sutures, appliances and medical optics items;

      76) medical rehabilitation - a set of medical services, aimed at reservation, partial or complete recovery of impaired and (or) lost body functions of patients and the disabled;

      77) medical optics products – the items and materials, used in medical and pharmaceutical activity for vision correction and light therapy;

      78) medical equipment - apparatus, instruments and tolls, used separately, in sets or systems in medical purposes to prevent, diagnose, treat and cure diseases, for rehabilitation and medical research;

      78-1) long-term contract for the supply of medical equipment - a civil-legal contract concluded by a single distributor with a legal entity that is a resident of the Republic of Kazakhstan for the supply of medical equipment, manufactured in accordance with the requirements of international standards and having a certificate of origin for internal circulation in accordance with the legislation of the Republic of Kazakhstan;

      79) healthcare organization – a healthcare organization, providing medical care;

      80) a state healthcare and epidemiological supervision - the healthcare-epidemiological service on prevention, detection and suppression of violations of legislature of the Republic of Kazakhstan on healthcare and epidemiological welfare of the population, as well as monitoring of compliance with the regulations in healthcare and epidemiological safety and health standards in order to protect public health, the environment and safety of products, processes and services;

      80-1) certificate of state registration - a document confirming the safety of products (goods) in terms of its compliance with sanitary and epidemiological rules and hygienic standards;

      81) nicotine - an alkaloid, contained in tobacco leaves and tobacco smoke;

      82) nutraceuticals - nutritional supplements, composed of various combinations of specified essential (essential) food ingredients (some amino acids, vitamins, minerals and trace elements, fatty acids, disaccharides, and dietary fiber), that do not exceed the recommended daily requirement;

      83) orphan drugs – the drugs for treatment and diagnosis of orphan (rare) diseases;

      84) orphan (rare) disease - rare serious diseases, threatening human life or resulting in permanent disability, the frequency of which does not exceed an official level;

      84-1) focal disinfection - disinfection, conducted in the foci for the purpose of prevention and (or) elimination of infectious and parasitic diseases;

      84-2) production control - a set of measures, including laboratory research and testing of products, works and services, performed by an individual entrepreneur or a legal entity, aimed at ensuring safety and (or) harmlessness to humans and their environment;

      84-3) monitoring of product safety - a system of measures aimed at identifying, preventing and suppressing 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, hygienic standards and technical regulations;

      85) parapharmacy - biologically active substances of natural origin or their synthetic analogues in therapeutic doses with pharmacological activity, aimed at disease prevention, supportive therapy and regulation of functional activity of organs and systems;

      86) patented drugs - the medicines that have received legal protection in accordance with the legislature of the Republic of Kazakhstan in intellectual property area;

      87) a patient – an individual, who is (was) the consumer of health services;

      88) prevention – a set of comprehensive medical and non-medical actions, aimed at prevention of disease, progression of the early stages of disease and monitoring of the already developed complications, damage of organs and tissues;

      89) psycho-active substances - the substances of synthetic or natural origin, the one-time intake of which influences the mental and physical functions, behavior of a person, and during a long-lasting use they cause mental and physical abuse;

      90) mental disorders (diseases) - a disorder of human mental activity caused by disturbance of brain functions;

      90-1) psychological assistance - a set of activities aimed at:

      assistance to a person in preventing, resolving psychological problems, overcoming difficult life and crisis situations and their consequences, contributing to the maintenance of mental and physical health, optimizing mental development, adapting and improving the quality of life, including by activating one's own capabilities;

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

      development of the personality, its self-improvement and self-realization;

      90-2) psychological problem - the state of a person's mental discomfort, caused by dissatisfaction with him(her)self, his (her) activities, interpersonal relationships, family situation and (or) other personal problems;

      91) the recipient - a patient who is transfused with donor blood or components and(or) preparations extracted from it, insertion of male or female donor material (sperm, egg, embryos) or transplantation of tissue (tissue part) and (or) organ ) from the donor;

      91-1) sanatorium-resort treatment - a type of recovering treatment and (or) medical rehabilitation, conducted in the conditions of temporary stay of persons in the sanatorium- resort organization;

      92) sanitary and quarantine control - control over the sanitary and epidemiological condition of cargo and people’s health state, when transporting people and cargos across the State border of the Republic of Kazakhstan, coinciding with the customs border of the Eurasian economic union, conducted in order to prevent the importation of infectious and parasitic diseases into the country, as well as substances and products that are potentially hazardous to human health;

      93) healthcare protection zone - an area, separating the areas of ??special purpose, as well as industrial organizations and other industrial, utility and storage facilities in a human settlement from the surrounding residential areas, civil buildings and houses in order to mitigate influence of adverse factors;

      93-1) sanitary and preventive measures - measures taken to prevent infectious, parasitic, occupational and other diseases among the population, as well as to prevent infectious and parasitic diseases among the population from entering the territory of the Republic of Kazakhstan;

      94) healthcare-epidemiological situation - the status of public health and environment in a particular area at a particular time;

      94-1) sanitary and epidemiological audit - check of epidemically significant objects subject to state sanitary and epidemiological surveillance for identification and assessment of sanitary and epidemiological risks and development of recommendations on bringing these objects in compliance with the requirements of regulatory legal acts in the field of sanitary and epidemiological well-being of the population;

      94-2) sanitary and epidemiological conclusion - a document, certifying compliance (non-compliance) with normative legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and (or) technical regulations of the objects of state sanitary and epidemiological surveillance;

      95) sanitary and anti-epidemic measures - measures taken to localize and eliminate the emergent foci of infectious, parasitic diseases, poisoning among the population;

      95-1) sports medicine - a branch of medicine and healthcare, responsible for biomedical support of athletes, which includes medical and functional control in sports, functional and medical rehabilitation of athletes, improvement of their athletic performance, treatment of their systemic diseases, sports traumatology, emergency assistance in sport and sport's hygiene;

      95-2) a bone marrow - a central organ of hematopoiesis, located in the spongy substance of bones and bone-marrow cavities;

      96) enrichment (fortification) of food - introduction of vitamins, minerals and other substances in food products during their production or processing in order to increase nutritional and biological value, and to prevent diseases, caused by their deficiency;

      97) risk assessment - scientific assessment of likelihood of penetration and spread of pathogens or carriers of infectious and parasitic diseases, as well as the negative impact of environmental factors on human health and the related potential medical-biological and economic consequences;

      98) independent expertise - a procedure carried out by independent experts within the framework of external expertise in order to draw an opinion on the level of quality of medical services, provided by healthcare subjects, using indicators reflecting the indicator of effectiveness, completeness and compliance of provided medical services with standards;

      98-1) an independent expert - an individual, having a higher medical education and meeting the requirements for individuals applying for carrying out an independent expertise, by a certain authorized body;

      99) guaranteed volume of free medical care - the volume of medical assistance provided by budgetary funds according to the list determined by the Government of the Republic of Kazakhstan to the citizens of the Republic of Kazakhstan, repatriates, as well as foreigners and stateless persons permanently residing on the territory of the Republic of Kazakhstan;

      99-1) is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication);

      99-2) the maximum price for a medicine and a medical product within the guaranteed volume of free medical care and in the system of compulsory social health insurance (hereinafter - the marginal price) is the price of a medicine and a medical product above which no purchase can be made by a single distributor and healthcare organizations providing medical assistance within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      99-3) telemedicine - a complex of organizational, financial and technological measures ensuring the implementation of a distance medical consulting service, when a patient or a doctor directly examining or treating a patient, receives a distance consultation from another doctor using information and communication technologies that do not contradict national standards ;

      100) tobacco – a nicotine-containing plant used for tobacco production;

      101) tobacco products - products that are wholly or partly made of tobacco leaf as a raw material, prepared in such a way as to be used for smoking, sucking, chewing or sniffing;

      101-1) consumption of tobacco products - the process of consumption of a tobacco product that causes the dependence of the human body on nicotine, negatively affecting his/her health, as well as on the health of persons not consuming tobacco products and polluting the environment;

      102) an ingredient of tobacco product - any substance, except for tobacco, water or tobacco leaf, which is added to tobacco or to non-tobacco ingredients of tobacco products during the manufacturing;

      103) tobacco product packaging - a unit of a consumer packaging, containing a certain number of packs of tobacco products;

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

      104-1) sponsorship of tobacco - any type of contribution to any occasion, event or individual with the purpose, effect or likely effect of encouraging the sale of a tobacco product or the use of tobacco, directly or indirectly, with the exception of payments and contributions provided by the legislation of the Republic of Kazakhstan;

      105) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      105-1) pharmaceutical inspection for compliance with appropriate pharmaceutical practices (hereinafter - pharmaceutical inspection) - evaluation of the facility in the sphere of circulation of medicines and healthcare organizations with the aim of determining its compliance with the requirements of appropriate pharmaceutical practices;

      106) transplantation – a transplant, grafting of tissues and (or) organs (parts of organs) to another place in a body or to another body;

      107) a contagious form of TB - the disease, potentially dangerous to other people in the community in connection with TB bacteria discharge by a TB patient into the environment;

      107-1) tissue - a collection of cells and intercellular substance, having the same structure, functions and origin;

      107-2) the register of tissue donors (tissue parts) and (or) organs (parts of organs) - the database of persons who agree to the donation of tissue (parts of tissue) and (or) organs (parts of organs), typified by the HLA-system;

      107-3) the register of tissue recipients (tissue parts) and (or) organs (parts of organs) - the database of persons who need tissue transplantation (tissue parts) and (or) organs (parts of organs), typified by the HLA- system;

      107-4) temporary adaptation - the process of removing a person from the state of alcohol intoxication and his/her adapting to environmental conditions;

      108) poisoning - a disease (condition) that arises after acute (one-time) or chronic (long-term) impact of chemical, biological and other environmental factors on a person;

      109) reproductive health – the human health, reflecting the ability to reproduce a full-fledged generation;

      109-1) assisted reproductive methods and technologies - methods of treatment of infertility (artificial insemination, artificial insemination and embryo implantation), in application of which some or all stages of conception and early development of embryos shall be carried out outside the maternal organism (including using donor and (or) cryopreserved germ cells, tissues of reproductive organs and embryos, as well as surrogate motherhood);

      109-2) extra charge - a surcharge to the price of a medicine, a medical product, purchased under the guaranteed volume of free medical care and in the system of compulsory social health insurance, reflecting the cost of services provided by subjects in the sphere of circulation of medicines, medical products and medical equipment;

      110) pharmacological product - a substance or a mixture of substances with established pharmacological activity and toxicity, which are the subject of preclinical (non-clinical) and clinical studies; and a potential drug;

      111-1) pharmaceutical education - the system of training, retraining and qualification development of pharmaceutical workers;

      111-2) pharmaceutical service - activity of subjects in the sphere of circulation of medicines, medical products and medical equipment related to outpatient drug provision of the population, including purchase, transportation, storage, registration and sale of medicines and medical products, within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      112) pharmaceutical activity – the activity, carried out in healthcare area for production, manufacturing (except for medical equipment), wholesale and retail selling of medicines, medical supplies and medical equipment, which is related to procurement (acquisition), storage, import, export, quality control, design, distribution, use and disposal of medicines, medical devices and medical equipment, as well as their safety, efficiency and quality;

      112-1) certificate for a pharmaceutical product (CPP) - a document issued by an authorized body for registration of domestic medicines abroad and their export;

      112-2) the decreed group of population - people working in the service sector of population and being the greatest danger for infection of surrounding people with infectious and parasitic diseases;

      113) products posing a danger to public health - types of products established by the state body in the field of sanitary and epidemiological welfare of the population, which can have a harmful effect on human health when applied or used;

      114) healthcare-epidemiological welfare of the population - the health status of the population, when there are no harmful environmental factors, affecting human health and favorable conditions for life shall be provided;

      115) activity in the sphere of sanitary and epidemiological welfare of population - the activity of state bodies and organizations of sanitary and epidemiological service aimed at protecting the health of citizens, including state sanitary and epidemiological control and supervision, sanitary and quarantine control, radiation control, epidemiological control, sanitary - epidemiological regulation, state registration of food products and certain types of products and substances that have a harmful effect on the health of a person, sanitary and epidemiological monitoring, sanitary and epidemiological expertise, hygienic training, assessment of the degree of risks in the sanitary and epidemiological welfare of population;

      116) surgical sterilization - a surgical operation, in the result of which a man or a woman loses fertility;

      117) live births and stillbirths of a fetus - a state of a newborn baby (fetus), assessed by the relevant international standards of the World Health Organization on live births and stillbirths of a fetus;

      118) restrictive measures, including quarantine – the measures, aimed at prevention of infectious diseases’ spread and providing for a special mode of business and (or) other activities;

      118-1) emergency medical assistance - medical assistance, requiring immediate medical intervention to prevent significant harm to health or eliminate the threat to life in case of sudden acute illnesses, injuries, severe deterioration in health, exacerbation of chronic diseases in accordance with the list determined by the authorized body;

      119) euthanasia - satisfaction of a terminally ill person’s request on quickening of his death by any actions, including injection of drugs or other means, as well as cessation of artificial measures to maintain his life in the cases of an adverse outcome of a disease;

      120) epidemic – a mass spreading of infectious diseases, which is significantly higher than the usual registered incidence;

      121) epidemically significant objects - objects, which produced products and (or) activities, if the requirements of the legislation of the Republic of Kazakhstan in the sphere of sanitary and epidemiological welfare of the population are violated, may result in food poisoning and (or) infectious and parasitic diseases among the population and (or) inflict harm to the health of population from industrial and radioactive contaminations;

      122) nuclear medicine – the branch of a medicine, focused on prevention, diagnosis and treatment of various diseases of human organs and systems, including cancer diseases, where radioactive elements and ionizing radiation shall be applied.

      2. The content of other terms shall be defined by certain articles of this Code.

      Footnote. Article 1, as amended by the Laws of the Republic of Kazakhstan dated on 30.06.2010 No 297-IV (shall be enforced from 01.07.2011); dated on 29.12.2010 No 372-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 19.01.2011 No 395-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 27.04.2012 No 15-V (shall be enforced upon expiration often calendar days after its first official publication); dated on 10.07.2012 No 31-V (shall be enforced upon expiration often calendar days after its first official publication); dated 21. 06. 2013 № 107-V (shall be enforced upon expiry of thirty calendar days after its first official publication); by the Constitutional Law of the Republic of Kazakhstan dated 03.07.2013 No. 121-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29.12. 2014 No. 269-V (shall be enforced from 01.01.2015); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2017); dated 03.12.2015 No. 433-V (shall be enforced from 01.01.2016); dated 29.03.2016 No. 479-V (shall be enforced from 01.01.2017); dated 27.02.2017 No. 49-VI (shall be enforced upon expiry of ten calendar days after its first official publication); dated 30.06.2017 No. 80-VI (the procedure for enactment see Article 2); dated 26.12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 2. The scope of this Code

      1. This Code regulates public relations in healthcare area in order to implement the citizens’ constitutional right to health protection.

      2. Legal relations, regulated by the legislation of the Republic of Kazakhstan in the field of health care shall not apply to the legislation of the Republic of Kazakhstan on public procurement in the part of:

      1) purchase of services from healthcare subjects within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      2) purchase of medicines and medical products within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      3) purchase of services for storing and transporting medicines and medical products within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      4) purchase of medical equipment to provide a guaranteed volume of free medical care, treatment and prevention of epidemiological diseases and in the system of compulsory social health insurance;

      5) purchase of goods and services for implementation of expertise in the state registration of medicines, medical products and their safety and quality;

      6) purchase of pharmaceutical services;

      7) purchase of services for accounting and realization of medicines and medical products within the guaranteed volume of free medical care and in the system of compulsory social health insurance.

      3. Medical examination, medical check up in the field of civil aviation shall be carried out in accordance with the legislation of the Republic of Kazakhstan on the use of airspace of the Republic of Kazakhstan and aviation activities.

      Footnote. Article 2, as amended by the Law of the Republic of Kazakhstan, dated on 28.06.2012 No 22-V (shall be enforced from 07.01.2012); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 № 406-V (the procedure for enactment see Article 3); dated 10.05.2017 No. 64-VI (shall be enforced upon expiry of ten calendar days after its first official publication); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 3. Legislation of the Republic of Kazakhstan in healthcare area

      1. Legislation of the Republic of Kazakhstan in healthcare area is based on the Constitution of the Republic of Kazakhstan and consists 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 the rules other than those contained in the Code, the rules of the international treaty shall be applied.

Chapter 2. THE STATE REGULATION AND MANAGEMENT IN HEALTHCARE AREA

Article 4. Principles of the State Policy in healthcare area

      The state healthcare policy shall be based on the following principles:

      1) equal rights of citizens for safe, effective and qualitative medical care;

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

      3) maternal and child health;

      4) a guaranteed volume of free medical care;

      5) priority of preventive directions in healthcare system;

      6) accessibility of medical care;

      7) regular improvement of medical care quality;

      8) healthcare and epidemiological welfare of the population;

      9) continuity of the healthcare organizations’ activity in rendering medical assistance;

      10) continuity of medical and pharmaceutical education, using modern teaching technologies;

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

      12) encouragement of voluntary unpaid donorship;

      13) the state support of local development and expansion of competitive medical and pharmaceutical industries;

      14) involvement of social organizations in ensuring the citizens’ rights for health protection;

      15) social orientation of healthcare system to meet the needs of the population and improve the quality of life;

      16) promotion of a healthy lifestyle and healthy eating;

      17) assignment of public health, safety, efficacy and quality of drugs to the factors of national security.

      18) ensuring the availability of safe, effective and high-quality medicines, medical products and medical equipment.

      Footnote. Article 4 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 5. Principles of the state regulation in healthcare area

      1. The state healthcare regulation shall be performed by:

      1) the President of the Republic of Kazakhstan;

      2) the Government of the Republic of Kazakhstan;

      3) the authorized body;

      4) other central and local executive bodies within their competence, defined by this Code and other Laws of the Republic of Kazakhstan, decrees of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

      2. The state regulation of healthcare shall be conducted by:

      1) the state control over the medical and pharmaceutical activity and the state healthcare and epidemiological supervision;

      2) the licensing of medical and pharmaceutical activity;

      2-1) licensing of importation into the territory of the Republic of Kazakhstan from countries that are not members of the Eurasian economic union and export from the territory of the Republic of Kazakhstan to these countries of organs (parts of organs) and (or) human tissues, blood and its components;

      3) accreditation in healthcare area;

      4) certification in healthcare area;

      4-1) certification of specialists in the field of healthcare;

      5) the state registration, re-registration and amendments to the registration dossier of medicinal products, medical devices and medical equipment, certain types of products and substances that have harmful effects on human health;

      6) confirmation of goods’ (works’, services’) compliance with the healthcare requirements, defined by the technical regulations, regulatory standardization documents and contracts, except for the drugs, medical supplies and medical equipment;

      7) state regulation of prices for medicines, medical products and medical services within the guaranteed volume of free medical care.

      Footnote. Article 5 as amended by the Laws of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 10.07.2012 No 34-V (shall be enforced from the date of its first official publication); dated on 21.06.2013 No 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

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

      The Government of the Republic of Kazakhstan shall:

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

      2) publish, within its competence, normative legal acts in the field of public healthcare;

      3) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      4) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      5) is excluded by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      6) manage the central and local authorities on healthcare issues;

      7) is excluded by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016);
      8) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      9) determine the procedure, types and volume of medical assistance to the population in emergency situations, introduction of the state of emergency;

      10) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      11) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      12) determine the procedure for organizing and conducting the purchase of medicines, medical products within the guaranteed volume of free medical care and in the system of compulsory social health insurance, pharmaceutical services, and medical equipment to provide a guaranteed volume of free medical care, treatment and prevention of epidemiological diseases and in the system of compulsory social health insurance;

      12-1) is excluded by the Law of the Republic of Kazakhstan dated 29.09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      12-2) determine the procedure for purchasing services for the storage and transportation of medicines and medical products, services on registration and sale of medicines and medical products by a single distributor within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      13) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      14) is excluded by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      15) is excluded by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      16) is excluded by the Law of the Republic of Kazakhstan dated 29.09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      17) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      19) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      20) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      21) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      22) is excluded by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      23) define the cases for import of medicines, medical supplies and medical equipment as a humanitarian aid into the Republic of Kazakhstan that have not been officially registered in the Republic of Kazakhstan;

      24) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      25) is excluded by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      26) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      27) define a single distributor;

      27-1) is excluded by the Law of the Republic of Kazakhstan dated 03.07.2013 No. 124-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      27-2) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      28) perform other functions, assigned to it by the Constitution, the laws of the Republic of Kazakhstan and the acts of the President of the Republic of Kazakhstan.

      Footnote. Article 6 as amended by the Laws of the Republic of Kazakhstan, dated on 30.06.2010 No 297-IV (shall be enforced from 01.07.2011); dated on 19.01.2011 No 395-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 15.07.2011 No 461-IV (shall be enforced from 30.01.2012); dated on 10.07.2012 No 34-V (shall be enforced from the day of its first official publication); dated 03.07.2013 № 124-V (shall be enforced upon expiry of ten calendar days after its first official publication); by the Constitutional Law of the Republic of Kazakhstan dated 03.07.2013 No. 121-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 № 406-V (shall be enforced from 01.01.2016); dated 30.06.2017 № 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 7. The competence of the authorized body

      1. The authorized body shall:

      1) implement the state policy in healthcare;

      2) develop the state planning system in healthcare;

      3) prioritize scientific developments in healthcare;

      4) excluded by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011);

      5) develop and approve the regulations and forms of records and reports related to healthcare within its competence;

      6) development and approval of standards and regulations in the field of healthcare;

      6-1) development and approval of rules for the use of technical means of control, surveillance and fixation devices, photo and video equipment, used in medical organizations to ensure the protection of patients' rights;

      7) carry out the monitoring in the healthcare area;

      7-1) coordinate and provide the methodical management of local executive bodies in the field of health care;

      8) coordinating the activities of health subjects, with the exception of health organizations, carrying out activities in the field of sanitary and epidemiological welfare of population;

      9) provide departmental statistical surveillance in public health area;

      10) create and provide functioning of electronic information resources and information systems, information and communication networks in healthcare, their accessibility for individuals and legal entities in accordance with the legislature of the Republic of Kazakhstan on information;

      11) development and approval of rules for encouragement of employees of healthcare subjects providing medical services within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      11-1) development and approval of the rules for conferring honorary titles in the field of healthcare;

      12) develop medical and pharmaceutical science and coordinates research activities in healthcare;

      13) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      14) introduce new methods of prevention, diagnosis, treatment and rehabilitation, as well as control them;

      15) placement of the state educational order for training, retraining and qualification development of personnel in the field of healthcare;

      16) agree the appointment of heads of local state bodies for healthcare management;

      17) sign memorandum with the heads of local executive bodies, focused on the achievement of final results of activity in healthcare area;

      18) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);
      19) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      20) formation and approval of marginal prices and extra charges;

      21) carry out outputs on equipping of public healthcare organizations;

      22) is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced from 01.01.2018);
      22-1) is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced from 01.01.2018);
      23) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      24) organize and carry out the state certification of scientific organizations and educational organizations in healthcare area;

      25) holding the attestation for professional competence of specialists in the field of healthcare, specified in paragraph 3 of Article 15 of this Code;

      25-1) determining the procedure of attestation for professional competence of specialists in the field of healthcare;

      25-2) monitoring the activities of accredited subjects of healthcare;

      26) organize accreditation of healthcare subjects;

      27) is excluded by the Law of the Republic of Kazakhstan dated 29.03.2016 No. 479-V (shall be enforced from 01.01.2017);

      27-1) accreditation of organizations, carrying out an assessment of professional preparedness and confirmation of compliance with the qualifications of specialists in the field of healthcare;

      28) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      28-1) development and approval of standards for equipping preclinical simulations rooms of medical colleges;

      29) excluded by the Law of the Republic of Kazakhstan, dated on 13.06.2013 No 102-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      29-1) develop the rules for safety and quality assessment of medicines and medical devices, registered in the Republic of Kazakhstan;

      29-2) approve the order of formation of the registry of healthcare subjects, providing wholesale and retail selling of medical devices and medical equipment in the notification procedure;

      29-3) is excluded by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      29-4) licensing of importation into the territory of the Republic of Kazakhstan from countries that are not members of the Eurasian economic union and export from the territory of the Republic of Kazakhstan to these countries of organs (parts of organs) and (or) human tissues, blood and its components;

      29-5) determining the procedure for issuing conclusions (permits) for importation into the territory of the Republic of Kazakhstan and removal of hematopoietic stem cells from the territory of the Republic of Kazakhstan, bone marrow in case of their movement for the purpose of unrelated transplantation, as well as samples of cells, tissues, biological fluids and secrets, including the products of human vital activity, physiological and pathological discharge, smears, scrapings, washings intended for diagnostic scientific purposes or obtained in the process of conducting biomedical research;

      29-6) conduct the determination (consent documents) for the entry of medicine, health products and medical devices (as well as non-registered) as humanitarian supplies or attendance in emergency to the territory of the Republic of Kazakhstan;

      29-7) is excluded by the Law of the Republic of Kazakhstan dated 06. 04. 2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      30) recognize the standards of international and foreign pharmacopoeias and pharmacopoeial articles (monographs) and other normative documents on standardization of medicines, medical supplies and medical devices of foreign countries;

      31) conduct the state registration, re-registration and amends the registration dossier, revokes a decision on the state registration of medicines, medical supplies and medical equipment, keeps the State register of medicines, medical supplies and medical devices;

      32) approval of import (export) of registered and not registered in the Republic of Kazakhstan medicines, medical products and medical equipment;

      33) is excluded by the Law of the Republic of Kazakhstan dated 06 .04. 2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      34) is excluded by the Law of the Republic of Kazakhstan dated 06. 04. 2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      35) coordinate the projects of national and international standards for products, goods, processes, services, and design standards within its competence;

      36) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      37) excluded by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      38) implement joint international projects in healthcare;

      39) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      40) define the level of citizens' satisfaction with the quality of medical assistance;

      41) consider applications of individuals and legal entities on healthcare issues;

      42) organization of forming a healthy lifestyle and healthy nutrition;

      43) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);
      44) is excluded by the Law of the Republic of Kazakhstan dated 06.04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      45) is excluded by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      46) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      47) implementation of state control over the activities of healthcare subjects, with the exception of healthcare organizations, carrying out activities in the field of sanitary and epidemiological welfare of the population;

      48) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      49) implementation of state control in the sphere of provision of medical services;

      50) perform the state control in circulation of drugs, medical supplies and medical equipment, as well as trafficking of drugs, psychotropic substances and precursors in healthcare area;

      51) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      50-1) perform the state control over evaluation of safety and quality of medicines and medical devices, registered in the Republic of Kazakhstan;

      51) implement epidemiological surveillance of infectious diseases;

      52) control examinations in healthcare;

      53) control over advertising of medical services, medicines, medical products and medical equipment, as well as methods of prevention, diagnosis, treatment and medical rehabilitation;

      54) consider cases on administrative offenses and imposes administrative penalties in accordance with the legislature of the Republic of Kazakhstan on administrative offences;

      55) is excluded by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      56) organizing and conducting preventive vaccinations to the public;

      57) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      57-1) is excluded by the Law of the Republic of Kazakhstan dated April 6, 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      58) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      59) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);
      60) is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication);
      61) is excluded by the Law of the Republic of Kazakhstan dated 29. 12. 2014 No. 269-V (shall be enforced from 01.01.2015);
      62) excluded by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication);

      63) define a common methodology for all organizations eligible to conduct risk assessment, and establishes the order of risk assessment;

      64) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      65) develop and approve the State Pharmacopoeia of the Republic of Kazakhstan;

      66) conduct international cooperation in the healthcare area, including medical and pharmaceutical science, medical and pharmaceutical education;

      67) control rational prescribing, as well as the effective use of medical equipment in public health organizations;

      68) determining the List of medicines, medical products and medical equipment purchased from a single distributor;

      69) excluded by the Law of the Republic of Kazakhstan, dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      69-1) approval of the Kazakhstani national drug formulary;

      70) determining the procedure for the development and approval of the Kazakhstani national drug formulary, as well as the procedure for developing and harmonizing drug formularies of health organizations;

      70-1) approval of the composition and regulation on formulary commission of the authorized body;

      71) adopt the rules of inspection in circulation of drugs, medical supplies and medical equipment;

      71-1) approval of the lists of organizations for preclinical (non-clinical), clinical studies of biologically active substances, pharmacological and medicinal products, medical products and medical equipment;

      72) is excluded by the Law of the Republic of Kazakhstan dated 29.12.2014 No. 269-V (shall be enforced from 01.01.2015);

      73) approve the procedure for medical examinations of persons applying for a driving license.

      74) approval of qualification requirements for medical and pharmaceutical activities;

      75) is excluded by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.07.2017);

      76) determining the procedure for accreditation in the field of healthcare;

      77) development and approval of the rules for the receipt of guaranteed volume of free medical care by the citizens of the Republic of Kazakhstan, repatriates, as well as foreigners and stateless persons permanently residing on the territory of the Republic of Kazakhstan,;

      78) approval of the list of clinical databases;

      79) approval of the standard contract form for providing a guaranteed volume of free medical care and paid services in healthcare organizations;

      80) approval of the rules of sending citizens of the Republic of Kazakhstan for treatment abroad at the expense of budgetary funds;

      81) determining the procedure for reimbursement of costs to healthcare organizations at the expense of budgetary funds;

      82) determining the order of collection, storage and use of blood and tissues of persons exposed to ionizing radiation;

      83) approval of the procedure for providing medicines to citizens;

      83-1) development and approval of rules for the formation of purchase lists of medicines and medical products within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      84) approval of rules for assessing the safety and quality of medicines and medical products registered in the Republic of Kazakhstan;

      85) approval of the procedure and conditions for committing and transferring of anatomical gift to healthcare organizations;

      86) approval of the state standard of the network of healthcare organizations;

      87) determining the procedure and conditions for the provision of paid services in healthcare organizations;

      88) determining the procedure of payments to donors for the donation of blood and its components;

      89) approval of the list of socially significant diseases and diseases that are dangerous for others;

      90) approval of the procedure for the expertise of temporary incapacity for work, as well as issuing a leave and a certificate of temporary incapacity for work;

      91) approving the procedure for providing medical assistance;

      92) approval of the procedure for providing medical and social assistance to citizens suffering from socially significant diseases;

      93) approval of the procedure for providing consultative and diagnostic assistance;

      94) approving the procedure for providing inpatient assistance;

      95) approval of the procedure for providing hospital-replacement assistance

      96) approval of the procedure for providing emergency medical assistance;

      97) approval of the procedure for providing medical assistance in the form of sanitary aviation;

      98) approval of the order of rehabilitation treatment and medical rehabilitation, including children's medical rehabilitation;

      99) approving the procedure for providing palliative assistance and nursing care;

      100) approval of regulations on the activities of organizations and (or) structural units of healthcare organizations, performing laboratory diagnostics, as well as the volume and types of the researches, carried out by them;

      101) approval of regulations on the activities of organizations and (or) structural subdivisions of healthcare organizations, performing pathoanatomical diagnostics, as well as the procedure for performing pathoanatomical autopsy;

      102) approval of the procedure for organizing and conducting internal and external expertises of the quality of medical services;

      102-1) approval of the procedure for attracting independent experts in conducting an external expertise;

      102-2) development and approval of requirements to individuals, applying for carrying out an independent expertise as independent experts;

      103) approval of the procedure for providing primary health care, as well as the attachment of citizens to primary healthcare organizations.

      104) development and approval of a standard contract for the provision of medical assistance within the guaranteed volume of free medical care, concluded between the patient and the medical organization;

      105) development and approval of methods for implementation of peer review of optimal technical characteristics and clinical-technical justification of medical equipment;

      106) issue of a certificate for a pharmaceutical product (CPP);

      107) determining the order of interaction for contractual fractionation;

      108) approval of the list of orphan drugs;

      109) approval of the first-aid kit for providing first aid;

      110) approval of the list of orphan (rare) diseases;

      111) approval of the list of medical contra-indications for the conclusion of labor contracts in the field of heavy work, work with harmful and (or) dangerous working conditions, in underground works, and also for admission of persons of the decreed group of the population to work;

      112) development and approval of rules for the formation of marginal prices and extra charges;

      113) development and approval of the rules for implementation of service maintenance of medical equipment in the Republic of Kazakhstan;

      114) development and approval of the rules for admission of foreign specialists to clinical practice, with the exception of persons, invited to carry out professional medical activities in the National healthcare holding and its subsidiaries, as well as in “Nazarbayev University” or its medical organizations, in medical organizations of the Administration of the President of the Republic of Kazakhstan;

      115) development and approval of appropriate pharmaceutical practices;

      116) development and approval of rules for the provision of audiological assistance to the population of the Republic of Kazakhstan;

      117) development and approval of state services standards in the field of healthcare;

      118) determining the order of lifetime voluntary donation of tissues (parts of tissue) and (or) organs (parts of organs) after death for transplantation purposes;

      119) development and approval of rules for creation of conditions by the employers to undergo preventive medical examinations to persons, subject to these examinations within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      120) development and approval of instructions, algorithms and guidelines for organization of medical assistance;

      121) development and approval of the methodology for formation (calculation) of indicators in the field of healthcare;

      122) determining the procedure for the purchase of goods and services to carry out the expertise in the state registration of medicines, medical products and assessing their safety and quality;

      122-1) development and approval of rules for the provision of medical assistance to the students and pupils of educational organizations;

      122-2) development and approval of the rules for the conduct of a medical examination to establish the use of a psychoactive substance and the state of alcohol intoxication;

      122-3) development and approval of rules for the purchase of services from healthcare subjects within the guaranteed volume of free medical care and in the system of compulsory social health insurance;

      123) development and approval of the regulation on the activities of medical-consultative commission;

      124) development and approval of the size of tariffs for medical services, provided within the guaranteed volume of free medical care financed from the republican budget, as well as the methodology for their formation.

      2. The authorized body shall perform other functions, provided by this Code, other laws, acts of the President of the Republic of Kazakhstan and the Government of the Republic of Kazakhstan.

      Footnote. Article 7 as amended by the Laws of the Republic of Kazakhstan, dated on 30.06.2010 No 297-IV (shall be enforced from 01.07.2011); dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 15.07.2011 No 461 -IV (shall be enforced from 30.01.2012); dated on 28.06.2012 No 22-V (shall be enforced from 01.07.2012); dated on 10.07.2012 No 31-V (shall be enforced upon expiration often calendar days after its first official publication); dated on 10.07.2012 No 34-V (shall be enforced from the date of its first official publication); dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication); dated on 08.01.2013 No 64-V (shall be enforced from 01.01.2013), dated on 13.06.2013 No 102-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated on 21.06.2013 No 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated on 13.01.2014 No 159-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated 16.05.2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 12. 2014 No. 269-V (shall be enforced from 01.01.2015); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 № 406-V (shall be enforced from 01.07.2017); dated 21. 04. 2016 № 504-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 03. 2016 No. 479-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication); dated 22. 12. 2016 No. 29-VI (shall be enforced from 01.01.2017); dated 30.06.2017 № 80-VI (the procedure of enactment see Article 2); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 7-1. Competence of the state body in the field of sanitary and epidemiological welfare of the population

      1. The state body in the sphere of sanitary and epidemiological welfare of population shall perform the following functions:

      1) implementation of state policy in the sphere of sanitary and epidemiological welfare of population;

      2) development and approval within its competence of normative legal acts and forms of accounting and reporting documentation in the field of sanitary and epidemiological welfare of population;

      3) development and approval of regulations;

      4) implementation of monitoring in the field of sanitary and epidemiological welfare of population;

      5) coordination of activities of healthcare organizations, carrying out activities in the field of sanitary and epidemiological welfare of population;

      6) provision of departmental statistical supervision in the sphere of sanitary and epidemiological welfare of population;

      7) creation and operation of electronic information resources and information systems, information and communication networks in the field of sanitary and epidemiological welfare of population, organization of access of individuals and legal entities to them in accordance with the legislation of the Republic of Kazakhstan on informatization;

      8) ensuring the development of science and coordination of scientific activity in the sphere of sanitary-epidemiological welfare of population;

      9) concluding of memoranda with the heads of local executive bodies aimed at achieving the final results of activities in the field of sanitary and epidemiological welfare of population;

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

      11) organization and conducting of state attestation of scientific organizations in the field of sanitary and epidemiological welfare of population;

      12) organization of conducting qualification examinations in the field of sanitary and epidemiological welfare of population;

      13) introduction of restrictive measures, including quarantine, with special conditions of economic and (or) other activity and life of population;

      14) determining the order of keeping the register of potentially dangerous chemical, biological substances prohibited for the use in the Republic of Kazakhstan;

      14-1) identifying the hazard classes of waste in terms of their impact on humans and the environment (in terms of toxicity);

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

      16) consideration of applications of individuals and legal entities on the issues of sanitary and epidemiological welfare of population;

      17) organization of hygienic training of population;

      18) organization and implementation, within its competence, of sanitary and anti-epidemic and sanitary-preventive measures for food poisoning, infectious and other diseases;

      19) issue of sanitary-epidemiological conclusions on compliance (non-conformity) of the object of state sanitary-epidemiological control and supervision to normative legal acts in the field of sanitary and epidemiological welfare of population and hygienic standards;

      20) implementation of epidemiological control of infectious diseases;

      21) consideration of cases on administrative offenses and imposition of administrative penalties in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses;

      22) implementation of state sanitary and epidemiological control and supervision on the territory of the Republic of Kazakhstan;

      22-1) control over advertising of biologically active additives to food;

      23) monitoring the implementation of preventive vaccinations to the public;

      24) is excluded by the Law of the Republic of Kazakhstan dated 27. 02. 2017 No. 49-VI (shall be enforced upon expiry of ten calendar days after its first official publication);

      25) determining of a territory or its part, free from diseases or with a low prevalence of diseases;

      26) establishment of sanitary-quarantine points at checkpoints across the State border of the Republic of Kazakhstan, coinciding with the customs border of the Eurasian economic union;

      27) approval of the list of epidemically significant objects;

      28) determining of a unified methodology for all organizations, having the right to conduct a risk assessment, the procedure for conducting a risk assessment;

      29) control over the compliance with requirements established by technical regulations;

      30) implementation of state control over the activities of healthcare organizations, carrying out activities in the field of sanitary and epidemiological welfare of the population;

      31) determining the procedure for attestation of the heads of healthcare organizations, carrying out activities in the field of sanitary and epidemiological welfare of the population;

      32) approval of draft normative and technical documentation in the field of food safety, subject to sanitary and epidemiological supervision;

      33) coordination of the conformity of processes (stages) of development (creation), production (manufacture), turnover, utilization and destruction of food products, conformity of machines and equipment, materials and products used in the development (creation), production (manufacture), turnover, utilization and destruction, with the requirements established by the legislation of the Republic of Kazakhstan on the safety of food products, with the issuance of a sanitary and epidemiological conclusion;

      34) development and approval of the rules of hygienic education for persons of the decreed group of population;

      35) determining the procedure for assigning accounting numbers to food production facilities and maintaining their register;

      36) implementation of the receipt of notifications on the commencement or termination of the activities in the field of sanitary and epidemiological welfare of population in the manner prescribed by the Law of the Republic of Kazakhstan "On Permits and Notifications", as well as maintaining the state electronic register of permits and notifications;

      37) determining the procedure for state registration and re-registration of baby food products, food and biologically active additives, genetically modified objects, dyes, means of disinfection, disinsection and deratization, materials and products in contact with water and food.

      2. The state body in the sphere of sanitary and epidemiological welfare of population shall perform other functions stipulated 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. Chapter 2 is supplemented by Article 7-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 21. 04. 2016 No. 504-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29.03. 2016 No. 479-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication); dated 27.02.2017 No. 49-VI (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 8. Competence of central executive bodies and other central state bodies with military medical (medical), forensic, forensic and narcological, forensic psychiatric subdivisions

      Footnote. The title of Article 8 is in the wording of the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

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

      1) implement the state healthcare policy;

      2) carry out the management of activities of military medical (medical), forensic, forensic and narcological, forensic psychiatric subdivisions;

      3) approve the order of military-medical (medical) support to the military-medical (medical) subdivisions;

      4) appoint the heads of military medical (medical), forensic, forensic and narcological, forensic psychiatric subdivisions to posts and dismiss them;

      5) ensure establishment and operation of electronic information resources and information systems, information and communication networks in healthcare;

      6) approve the procedure for medical assistance in military-medical (medical) subdivisions;

      7) develop and approve the structure of organizations and subdivisions, regulations on their activities, model staff and staff standards in military medical (medical), forensic, forensic and narcological, forensic psychiatric subdivisions;

      8) excluded by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      9) submit proposals to the state body in the field of sanitary and epidemiological welfare of population on introduction (cancellation) of restrictive measures, including quarantine, on the territory of military medical (medical) units;

      10) define the order and frequency of medical examinations of the relevant contingent in military-medical (medical) subdivisions;

      11) approve the structure and the Regulation on military-medical commission.

      12) approve the Rules for the conduct of military medical expertise and the Regulation on the bodies of military medical expertise.

      Footnote. Article 8 as amended by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of yen calendar days after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 9. Competence of local self-government bodies of regions, town of republican importance and the capital

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

      1) is excluded by the Law of the Republic of Kazakhstan dated 03.07.2013 No. 124-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      2) define a system of social support measures for medical and pharmaceutical workers, sent to work in the countryside, as well as the procedure and amount of social support to them at the expense of budget funds;

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

      4) take a decision to provide free or reduced travel fee to the citizens, going outside a village for medical treatment at the expense of budget funds;

      5) take a decision on additional supply of pharmaceuticals, the specialized medical products, medical supplies for free and on preferential terms for certain categories of individuals in outpatient treatment;

      6) approve measures, aimed at development and operation of healthcare organizations;

      7) take a decision to provide additional encouragement for donors;

      8) take a decision on additional personnel and logistics supply for public healthcare organizations, if the minimal standards, approved by the authorized body, have been implemented in full;

      9) promote a healthy lifestyle and healthy eating;

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

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

      1) implement the state healthcare policy at the relevant administrative-territorial unit;

      2) is excluded by the Law of the Republic of Kazakhstan dated 03.07.2013 No. 124-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      3) ensure the realization of the right to a guaranteed volume of free medical care by citizens of the Republic of Kazakhstan, repatriates, as well as foreigners and stateless persons permanently residing on the territory of the Republic of Kazakhstan;

      3-1) carry out control of keeping the persons in the centers of temporary adaptation and detoxification centers;

      3-2) ensure stability in the activities of healthcare organizations that are municipal legal entities;

      3-3) ensure the availability of infrastructure for physical culture and sports, recreation and leisure;

      3-4) organize a set of measures to promote a healthy lifestyle;

      3-5) take measures for safety and protection of labor, prevention of domestic and road traffic injuries;

      3-6) ensure effective planning and use of healthcare resources;

      3-7) take measures to improve the quality of medical services;

      3-8) provide the population with access to information on health issues;

      4) implement measures to promote voluntary unpaid donation of blood and its components;

      4-1) pay for travel within the country to certain categories of citizens according to the list determined by the local representative bodies of oblasts, cities of republican significance and the capital, traveling outside the settlement of permanent residence for receiving highly specialized medical assistance within the guaranteed volume of free medical care;

      5) create local healthcare government agencies;

      5-1) appoint and dismiss the heads of local government health authorities of oblasts, cities of republican significance and the capital in agreement with the authorized body;

      6) organize control over staffing of public healthcare organizations;

      6-1) take measures to ensure the staffing of public health organizations, including measures of social support and consolidation of young specialists;

      7) take measures to build and develop a network of healthcare organizations, their financial and logistical support, including the development of a state pharmacies network and creation of pharmacy stores;

      8) coordinate the activities of public and private healthcare sectors;

      9) provide free medical care, medicines and medical supplies in emergency situations;

      10) conduct inter-regional and international cooperation in healthcare area;

      11) carry out licensing of pharmaceutical activities, types of activities related to trafficking of narcotic drugs, psychotropic substances and precursors in the field of healthcare, as well as medical activities, except for forensic, forensic and narcological, forensic psychiatric expertises, in accordance with the legislation of the Republic of Kazakhstan about permissions and notifications;

      12) provide training, qualification development and retraining of personnel in the field of healthcare;

      13) conduct the measures needed to improve health, prevent diseases, promote healthy lifestyles and healthy eating;

      14) organize provision of medical assistance to the population, including prevention and treatment of socially significant diseases and diseases that are dangerous to others, including medicines within the guaranteed volume of free medical care;

      15) send children with disabilities to psychological, medical and pedagogical counseling with the consent of parents or other legal representatives,;

      16) exercise the state control in healthcare area within their competence;

      17) conclude and implement a memorandum with the authorized body to progress in healthcare area;

      18) facilitate implementation of the court decision on sending a citizen, sick with tuberculosis to compulsory treatment;

      18-1) keep a register of subjects, engaged in retail selling of medical supplies and medical equipment;

      18-2) monitor compliance with the legislation of the Republic of Kazakhstan on permits and notifications for medical and pharmaceutical activities, as well as activities related to trafficking of narcotic drugs, psychotropic substances and precursors in the field of healthcare;

      18-3) maintain a register of healthcare subjects, carrying out wholesale realization of medical devices and medical equipment;

      18-4) conduct preventive disinsection and deratization (with the exception of disinsection and deratization on the territory of natural foci of infectious and parasitic diseases, as well as on the foci of infectious and parasitic diseases);

      18-5) conduct training of specialists with medical education for the sale of medicines, medical products in remote settlements from the regional center through pharmacy points in healthcare organizations providing primary medical-sanitary, counseling and diagnostic assistance, and mobile pharmacies in case of absence of a specialist with a pharmaceutical education;

      18-6) conduct attestation for professional competence of specialists in the field of healthcare, specified in paragraph 4 of Article 15 of this Code;

      18-7) ensure implementation of measures for the development of voluntary donation of tissue (part of the tissue) and (or) organs (parts of organs);

      18-8) carry out the receipt of notifications on the beginning or termination of activities in the field of healthcare in the manner prescribed by the Law of the Republic of Kazakhstan "On Permits and Notifications", as well as maintaining the state electronic register of permits and notifications;

      19) exercise other powers, delegated to local executive bodies by the legislation of the Republic of Kazakhstan in the interests of the local state management.

      Footnote. Article 9 as amended by the Laws of the Republic of Kazakhstan dated on 29.12.2010 No 372-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 10.07.2012 No 31-V (shall be enforced upon expiration often calendar days after its first official publication); dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication); dated on 13.06.2013 No 102-V (shall be enforced upon expiration of ten calendar days after its first official publication), by the Constitution Law of the Republic of Kazakhstan, dated on 03.07.2013 No 121-V ( shall be enforced upon expiration of ten calendar days after its first official publication); dated 03.07.2013 No.124-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.05.2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of 10 calendar days after its first official publication); dated 29. 03. 2016 No. 479-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 10. Competence of local state healthcare bodies of regions, a city of republican status and the capital

      Within their powers the local state healthcare bodies of regions, a city of republican status and the capital:

      1) implement the state healthcare policy and ensure implementation of regional healthcare programs;

      2) ensure fulfillment of the legislature of the Republic of Kazakhstan in healthcare area, education and science;

      3) provide citizens of the Republic of Kazakhstan, repatriates, as well as foreigners and stateless persons permanently residing on the territory of the Republic of Kazakhstan with medical assistance and medicines, medical products;

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

      5) conduct functions of administers of budgetary healthcare programs;

      6) carry out the purchase of pharmaceutical services;

      7) carry out the purchase and store of medicines, preventive (immunobiological, diagnostic, disinfectant) drugs, medical products within the guaranteed volume of free medical care and in the system of compulsory social health insurance in the manner determined by the Government of the Republic of Kazakhstan;

      on an outpatient basis – in compliance with the list, approved by the authorized body;

      on an inpatient basis - within the pharmaceutical forms;

      8) procure medical supplies and medical equipment, non-medical equipment, ambulances, as well as the services for overhaul reparations of public healthcare organizations;

      9) organize the human resourcing of public healthcare organizations;

      10) provide equipping of public healthcare organizations;

      11) provide creation and functioning of regional electronic information resources and information systems, information and communication networks in healthcare area;

      12) provide clinical facilities in public healthcare organizations, financed by the local budget, for higher and secondary medical schools;

      13) provide free medical care, medicines and medical supplies in emergency situations;

      14) organize and coordinate activities for training, qualification development and retraining of personnel in the field of healthcare;

      15) organize hygienic education, promotion and development of healthy lifestyles and healthy eating;

      16) inform the population about the prevalence rate of socially significant diseases that are dangerous to others;

      17) cooperate with international and non-governmental public organizations concerning the protection of public health;

      18) conduct institutional statistical surveys in healthcare within the relevant administrative-territorial unit in compliance with the statistical methodology requirements;

      19) conduct certification of professional competence of the leaders of subordinate state healthcare organizations.

      Footnote. Article 10 as amended by the Laws of the Republic of Kazakhstan, dated on 19.03.2010 No 258-IV; dated on 29.12.2010 No 372-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 28.06.2012 No 22-V (shall be enforced from 01.07.2012.); dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2018); dated 30.06.2017 No. 80-VI (the procedure of enactment see Art. 2).

Article 10-1. Competence of the authorized body in the field of physical culture and sport on the issues of sports medicine

      1. The authorized body in the field of physical culture and sport shall:

      1) carry out management of the activities of sports medicine organizations;

      2) appoint and dismiss the heads of republican sports medicine organizations;

      3) make proposals to the authorized body on introduction (cancellation) of restrictive measures, including quarantine, on the territory of sports medicine organizations;

      4) participate in the medical provision of trainings of national teams of the Republic of Kazakhstan on kinds of sport to sports events;

      5) ensure the activity of sports medicine organizations;

      6) determine the level of physical development of population;

      7) develop and approve the procedure for medical examination of athletes to participate in sports competitions;

      8) exercise other powers stipulated by this Law, other 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 authorized body in the field of physical culture and sport in coordination with the authorized body shall:

      1) develop and approve the procedure for medical support and medical assistance to athletes and coaches upon conducting of sporting events, in the period of rehabilitation after intense physical exertion, diseases and injuries of athletes;

      2) develop and approve the structure of sports medicine organizations and regulations on their activities.

      Footnote. Chapter 2 is supplemented with Article 10-1 in accordance with the Law of the Republic of Kazakhstan dated 03.07.2014 No. 229-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 11. Functions of the National Healthcare Holding

      1. The functions of the National Healthcare Holding shall be:

      1) participation in implementation of public healthcare policy;

      2) excluded by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      3) provision of all types of medical assistance;

      4) testing, introduction and transfer of innovative medical technologies to healthcare and education organizations of the Republic of Kazakhstan;

      5) participation in organization of pre-clinical (non-clinical) and clinical researches of drugs, medical devices and medical equipment;

      6) participation in the development and implementation of standards in healthcare organizations;

      7) provision of consulting, informative, electronic and other services;

      8) international cooperation in healthcare area;

      9) participation in healthcare projects;

      10) carrying out other functions provided by the constituent documents.

      2. The National Healthcare Holding may request and receive information from the state bodies in compliance with the requirements, established by the legislative acts of the Republic Kazakhstan on disclosure of information, containing commercial and other secrets, protected by the law in order to conduct the entrusted functions..

      Footnote. Article 11 as amended by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication).

Article 11-1. Joint commission on the quality of medical services

      1. The joint commission on the quality of medical services shall be established with the aim of developing recommendations for the improvement of clinical protocols, standards of medical education, drug provision, quality control system standards and accessibility of healthcare services.

      2. The joint commission on the quality of medical services shall be formed from the representatives of state bodies, non-governmental organizations.

      3. The procedure for forming a joint commission on the quality of medical services, the regulations on its activities shall be determined by the authorized body.

      Footnote. Chapter 2 is supplemented by Article 11-1 in accordance with the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2017).

Article 12. Inter-departmental cooperation in healthcare area

      1. In order to implement the state policy in healthcare, the state bodies and organizations within their competence must support the state bodies, regulating the healthcare area.

      2. In order to provide interaction between the state bodies, international and other healthcare organizations, a national coordinating healthcare authority is established under the Government of the Republic of Kazakhstan, the status and powers of which are defined by the Government of the Republic of Kazakhstan. Regional coordinating healthcare bodies shall be established in local executive bodies, the status and powers of which shall be defined by the local executive authorities.

      3. Coordination and interaction of state bodies and healthcare organizations in the field of emergency medicine shall be carried out by the authorized body in the field of civil protection.

      4. Normative legal acts and regulations that are directly or indirectly related to the public health and healthcare system, developed by the central executive bodies shall be be coordinated with the authorized body.

      5. Normative legal acts in healthcare area shall be subject to compulsory implementation by the authorities and organizations, regardless of their departmental affiliation.

      6. Public authorities with departmental medical services shall provide a departmental report on the work of subordinate healthcare organizations (departments) and health status of the attached contingent to the local public authorities for healthcare management.

      7. Is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      8. The integration of information systems of healthcare with information systems of other governmental agencies on the issues of information exchange shall be carried out in accordance with the legislation of the Republic of Kazakhstan on informatization.

      9. Public authorities with departmental medical services shall coordinate technical parameters of departmental medical information systems, as well as the content of electronic information resources with the authorized body.

      Footnote. Article 12 as amended by the Law of the Republic of Kazakhstan, dated on 19.03.2010 No 258-IV; dated 11.04.2014 No. 189-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 24.11.2015 № 419-V (shall be enforced from 01.01.2016).

Chapter 3. LICENSING, ACCREDITATION AND CERTIFICATION IN HEALTHCARE AREA

Article 13. Licensing of medical and pharmaceutical activities, as well as entry, export of organs (organ parts) and (or) Human tissues, blood and its components

      Medical and pharmaceutical activities shall be subject to licensing in accordance with the legislature of the Republic of Kazakhstan on licensing.

      Import to the territory of the Republic of Kazakhstan from countries that are not the members of Eurasian economic union and export from the territory of the Republic of Kazakhstan to these countries of organs (parts of organs) and (or) human tissues, blood and its components, with the exception of hematopoietic stem cells, bone marrow in case of their transfer for the purpose of carrying out unrelated transplantation, as well as samples of cells, tissues, biological fluids and secrets, including human waste products, physiological and pathological excreta, smears, scrapings, washings, intended for diagnostic and research purposes or received in the course of biomedical research, shall be carried out on the basis of licenses, issued by the authorized body.

      Footnote. Article 13 is in the wording of the Law of the Republic of Kazakhstan, dated on 21.06.2013 No 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 26.12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 13-1. Notification in healthcare area

      The following activities in healthcare area shall be performed upon notification:

      1) hygienic training of the decreed groups of population;

      2) wholesale trade of medical products;

      3) wholesale trade of medical equipment;

      4) retail trade of medical products;

      5) retail trade of medical equipment.

      6) conducting of preclinical (non-clinical) studies of biologically active substances.

      Notification on the commencement or termination of the activity, specified in part one of this Article shall be filed in accordance with the procedure established by the Law of the Republic of Kazakhstan "On Permits and Notifications".

      Footnote. Chapter 3 shall be supplemented by the Article 13-1 in accordance with the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its official publication.); as amended by the laws of the Republic of Kazakhstan dated 16. 05. 2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication); dated 29. 03. 2016 No. 479-V (shall be enforced upon expiry of twenty- one calendar days after its first official publication).

Article 14. Accreditation in healthcare area

      1. Subjects of healthcare in order to recognize the compliance of health services with the established requirements and standards in the field of healthcare, as well as to assess professional preparedness and confirm the conformity of the specialists’ qualifications shall be subjects to accreditation in the field of healthcare.

      Individuals shall be subjects to accreditation for carrying out an independent expertise of the activities of healthcare subjects.

      2. Accreditation is voluntary and shall be carried out at the expense of the subject, that is being accredited and other non-prohibited tools.

      3. Accreditation of medical organizations shall be carried out on the basis of an external comprehensive assessment of compliance of their activities with accreditation standards, approved by the authorized body and taken into account when concluding contracts for the purchase of services for provision of a guaranteed volume of free medical care and medical assistance in compulsory social health insurance system.

      Accreditation of medical organizations for the right to conduct clinical studies of pharmacological and medicinal products, medical devices and medical equipment shall be carried out on the basis of an assessment of compliance of their activity with the requirements for conducting clinical researches, approved by the authorized body.

      Accreditation of testing laboratories for the right to conduct preclinical (non-clinical) researches of biologically active substances and medical products shall be carried out on the basis of an assessment of their activity compliance with the requirements for preclinical (non-clinical) researches, approved by the authorized body.

      Accreditation of testing laboratories engaged in exclusive activity on expertise and evaluation of safety and quality of medicines, medical products, shall be carried out in the manner, determined by the authorized body.

      4. Is excluded by the Law of the Republic of Kazakhstan dated 29.03.2016 No. 479-V (shall be enforced from 01.01.2017).

      The order of involvement of independent experts shall be established by the Government of the Republic of Kazakhstan.

      5. Accreditation shall be performed by the authorized body or organization, accredited by the authorized body.

      6. The body (organization), carrying out the accreditation of healthcare subjects, shall establish the appropriate accreditation commissions and form a database of accredited subjects in the field of healthcare.

      The Charter of the accreditation commission shall be approved by the authorized body.

      Footnote. Article 14 as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 № 406-V (shall be enforced from 01.07.2017); dated 29. 03. 2016 No. 479-V (shall be enforced from 01.01.2017).

Article 15. Attestation of professional competence of specialists in the field of healthcare

      1. Attestation of professional competence of specialists in the field of healthcare (hereinafter - attestation) shall be a periodically performed procedure for determining the level of professional competence of the heads of local bodies of state healthcare authorities of oblasts, cities of republican significance and the capital and also their deputies, heads of healthcare organizations subordinate to the authorized body, their deputies, heads of branches, heads of healthcare organizations, subordinate to local bodies of state healthcare authorities of oblasts, cities of republican significance and the capital, heads of healthcare organizations, carrying out activities in the field of sanitary and epidemiological welfare of population.

      2. Attestation commissions shall be established for the objective and competent implementation of attestation by the authorized body, local public healthcare authorities of oblasts, cities of republican significance and the capital, as well as by the state body in the sphere of sanitary and epidemiological welfare of population.

      3. The authorized body shall conduct the attestation of the heads of local state healthcare authorities of oblasts, cities of republican significance and the capital and their deputies, the heads of organizations subordinate to the authorized body, their deputies, and the heads of branches.

      4. Local bodies of state healthcare authorities of oblasts, cities of republican significance and the capital shall conduct the attestation of the heads of healthcare organizations subordinate to them.

      5. The attestation of the heads of healthcare organizations, carrying out activities in the field of sanitary and epidemiological welfare of the population shall be conducted by the state body in the field of sanitary and epidemiological welfare of population.

      6. The attested persons shall undergo attestation at the end of each subsequent three years, but not earlier than one year from the day of the respective position.

      Footnote. Article 15 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 4. THE STANDARDS, VERIFICATION OF CONFORMITY OF GOODS (WORKS, SERVICES) AND ADVERTISING IN HEALTHCARE

Article 16. Standards in healthcare area

      1. Types of healthcare standards shall be:

      1) standards for accreditation of healthcare organizations;

      2) standards of operating procedures in healthcare;

      3) standards of medical and pharmaceutical education;

      4) standards for circulation of drugs, medical devices and medical equipment.

      5) standards for organization of medical assistance provision;

      6) standards of informatization in the field of healthcare.

      2. Standards in healthcare shall be approved in the order, defined by the legislature of the Republic of Kazakhstan.

      Footnote. Article 16 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 17. Confirmation of conformity of goods (works, services) in the field of healthcare

      Confirmation of conformity of goods (works, services) in the field of healthcare, except for medicines, medical products and medical equipment, shall be carried out in order to determine their safety for human life and health and shall be carried out in accordance with the legislation of the Republic of Kazakhstan in the field of technical regulation.

      Footnote. Article 17 is in the wording of the Law of the Republic of Kazakhstan dated 29. 10. 2015 No. 376-V (shall be enforced from 01.01.2016).

Article 18. Advertising in healthcare area

      1. Advertising of medicines, medical products and medical equipment shall be carried out in the manner determined by the authorized body.

      Advertising of biologically active additives to food shall be carried out in the manner determined by the state body in the field of sanitary and epidemiological welfare of population.

      2. Advertising of medical services, methods and tools for prevention, diagnosis, treatment and medical rehabilitation (hereinafter – the services), drugs, medical supplies and medical equipment, dietary supplements must be truthful, recognizable without special knowledge or use of special tools, exclude comparison with other services, drugs, medical supplies and medical equipment, biologically active supplements, and may not mislead consumers by abusing their trust, including in terms of performance, composition, consumer characteristics, cost (price), the expected results after their use, the results of research and testing.

      3. It shall be prohibited:

      1) to advertise drugs, medical devices and medical equipment, dietary supplements and prevention means, that are not registered in the Republic of Kazakhstan;

      2) to distribute the samples of drugs, which are put on doctor's prescription, for advertising purposes;

      3) to involve children, their images and voices in advertising drugs, medical devices, except for the drugs and medical supplies, produced for children;

      4) distribution and placement of advertisement of medicines, medical products and medical equipment, biologically active additives to food in public transport, in organizations, not related to their purpose, use and release, with the exception of advertising medicines at medical, pharmaceutical conferences, congresses, symposiums and other scientific meetings;

      4-1) placement of advertising information on industrial products, prescription forms;

      5) to place external (visual) advertising of drugs, medical devices and medical equipment, in the form of posters, stands, illuminated panels, billboards, banners, and other stationary advertising objects;

      6) use of medical personnel, authorized to prescribe medicines and medical products as advertising distributors, except for cases of providing reliable information about medicines and medical products for scientific or educational purposes, as well as for informing patients;

      7) advertising of medicines, medical products and medical equipment in the absence of a license to carry out the corresponding type of activity;

      7-1) advertising of services in the absence of a license for relevant activity;

      8) to advertise services rendered by the individuals, who do not have a license for medical activity.

      9) indication in the advertisement for the public of the following diseases: sexually transmitted diseases, cancer, psychic, dangerous infectious diseases, HIV / AIDS, tuberculosis, diabetes mellitus;

      10) refer in the advertisement to the recommendations of scientists, healthcare specialists, as well as officials of state bodies who, due to their own fame, may encourage the use and (or) prescription of medicines, medical products and medical equipment;

      11) present in the advertisement a service, a medicine, a medical product and medical equipment, biologically active food additives as unique, the most effective and safe;

      12) assert that the safety and efficacy of a medicinal product is due to its natural origin;

      13) suggest that the effectiveness of the provided service, the treatment with the advertised medical product, biologically active additive to food shall be guaranteed, the use of the medicine shall not be accompanied by development of side effects;

      14) use in the advertisement the information that is not directly related to the advertised services, medicine, medical product and medical equipment;

      15) advertisment of offers on fulfillment of illegal transactions concerning tissues (a part of a tissue) and (or) bodies (a part of bodies) of the person.

      4. Is excluded by the Law of the Republic of Kazakhstan dated 16. 05. 2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication).

      5. Distribution and placement of advertisement of medical services, methods and means of prevention, diagnosis, treatment and medical rehabilitation, medicines, medical products and medical equipment shall be allowed in periodicals, other mass media and in healthcare organizations.

      Advertisement of medicines, released on prescriptions, including those containing narcotic drugs, psychotropic substances and precursors, shall be carried out in specialized periodicals, intended for medical and pharmaceutical workers.

      5-1. Advertisement of medicines should contain complete (including appropriate restrictions for the use of the medicine) and reliable information, exclusion of which may lead to inappropriate use of medicines or unjustified risk to the consumer.

      6. Control over production, distribution and placement of advertising shall be conducted by the authorized body and the state bodies within their competence.

      Footnote. Article 18 as amended by the Law of the Republic of Kazakhstan, dated on 15.07.2011 No 461-IV (shall be enforced 30.01.2012); dated 16.05.2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 21. 04. 2016 No. 504-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 5. State control and supervision in the field of healthcare and pharmaceutical inspection in the sphere of medicines circulation

      Footnote. Title of Chapter 5 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 19. The state control and supervision in healthcare area

      1. The state control and supervision in healthcare is a complex of measures, aimed at verification of compliance and performance of the requirements of the legislation of the Republic of Kazakhstan, as well as the prevention, suppression and elimination of violations in healthcare area.

      2. The state control and supervision shall be performed in:

      1) provision of medical services;

      2) healthcare and epidemiological welfare of the population;

      3) circulation of drugs, medical devices and medical equipment.

      3. State control and supervision in the field of healthcare shall be carried out in the form of inspection and other forms.

      An inspection shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      Other forms of state control shall be carried out in accordance with this Code.

      4. A senior chief state inspector or a chief state healthcare inspector in the relevant area before making a decision on an application (complaint) of individuals and (or) legal entities against actions (inaction) or acts, may suspend, cancel or revoke the acts of an inferior chief state inspector or chief state healthcare inspector.

      5. Is excluded by the Law of the Republic of Kazakhstan dated 29.12.2014 No. 269-V (shall be enforced from 01.01.2015).

      6. In assessing the degree of risks of objects, subject to state sanitary and epidemiological surveillance, in addition to the criteria provided by the Entrepreneurial Code of the Republic of Kazakhstan, the set of the following qualitative indicators, related to the immediate activity of the audited subject shall be taken into account:

      results of previous inspections;

      organization and implementation of production control;

      conducting of an initiative audit in the field of sanitary and epidemiological welfare of population.

      Footnote. Article 19 as amended by the Laws of the Republic of Kazakhstan dated on 19.03.2010 No 258-IV; dated on 06.01.2011 No 378-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication); dated 29. 12. 2014 No. 269-V (shall be enforced from 01.01.2015); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29.10.2015 № 376-V (shall be enforced from 01.01.2016).

Article 20. The state control in medical services area

      1. The state control in medical services area is aimed at prevention, detection, suppression of violations of legislation of the Republic of Kazakhstan in medical services, as well as monitoring of healthcare subjects’ compliance with the regulations in medical services area.

      2. The objects of the state control in medical services area shall be the medical services rendered by individuals and legal entities.

      3. The state control in medical services shall be conducted in the form of inspections and other forms of supervision.

      An inspection shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      Other forms of the state control shall be carried out in accordance with this Code.

      4. The officials responsible for the state control in medical services area shall be:

      1) the Chief state inspector for control over the medical services area in the Republic of Kazakhstan and his deputies;

      2) the state inspectors for control over the medical services provision;

      3) the chief state inspectors for control in medical services areas of regions, a city of republican status and the capital, and their deputies;

      4) the state inspectors for control over medical services of regions, a city of republican status and the capital.

      5. The citizens of the Republic of Kazakhstan with a medical degree shall be appointed to the positions of the heads of the state bodies to conduct the state control in medical services area and healthcare organizations.

      6. The chief state inspector of the Republic of Kazakhstan for control over medical services, on the basis of an inspection results, may issue instructions to the head of local state body for healthcare management of regions, a city of republican status and the capital.

      7. The officials, conducting the state control in medical services shall have a right:

      1) to issue instructions to the healthcare subjects on elimination of violations of the legislature legislation of the Republic of Kazakhstan on healthcare;

      2) to request and obtain the necessary information from the healthcare subject on medical care, provided to the population;

      3) to make copies of the documents required for inspection in medical services area;

      4) to initiate suspension of an accreditation certificate for up to six months and its revocation in accordance with the legislature of the Republic of Kazakhstan on administrative offences;

      5) to consider cases on administrative offenses and impose administrative penalties for violating the legislature of the Republic of Kazakhstan on healthcare within their competence;

      5-1) initiate the creation of a commission with the involvement of independent experts to analyze cases for carrying out external expertise, determined by the authorized body;

      6) to initiate suspension of a license for medical activities in accordance with the legislature of the Republic of Kazakhstan on administrative offences;

      7) to initiate revocation of a license for medical activities in accordance with the legislature of the Republic of Kazakhstan on administrative offences;

      8) to initiate suspension and revocation of a specialist certificate in the order, prescribed by the laws of the Republic of Kazakhstan;

      9) to apply to the court for individuals’ and legal entities’ non-performance or improper performance of legal requirements or regulations, decrees, issued by the officials of the authorized body;

      10) to take measures to suspend the activities or certain types of activities of an individual entrepreneur or a legal entity in accordance with the legislature of the Republic of Kazakhstan on administrative offences.

      8. The decisions, made by the officials responsible for the state control in medical services area shall be obligatory for implementation by the healthcare subjects and may be appealed to a higher authority and (or) in the courts.

      Footnote. Article 20 as amended by the Law of the Republic of Kazakhstan, dated on 06.01.2011 No 378-IV (shall be enforced upon expiration of ten calendar days after its first official publication.); dated 29.10.2015 No. 376-V (shall be enforced from 01.01.2016); dated 29. 03. 2016 No. 479-V (shall be enforced from 01.01.2017).

Article 21. State sanitary and epidemiological control and supervision

      1. State sanitary and epidemiological control and supervision shall be aimed at preventing, identifying, suppressing violations of the legislation of the Republic of Kazakhstan in the field of sanitary and epidemiological welfare of population, as well as monitoring compliance with regulatory legal acts in sanitary and epidemiological welfare of population, hygienic standards and technical regulations to protect the health and environment of the population and the safety of products, processes, services.

      2. The state body in the sphere of sanitary and epidemiological welfare of population shall determine the procedure for implementation of sanitary and quarantine control over the delivery and spread of infectious and parasitic diseases on the State border of the Republic of Kazakhstan coinciding with the customs border of the Eurasian economic union and ensuring sanitary protection of the State border and the territory of the Republic of Kazakhstan.

      3. The objects of state sanitary and epidemiological control and supervision shall be individuals and legal entities, buildings, facilities, products, equipment, vehicles, soil, water, air, food and other objects, functioning, use, consumption, application and exploitation of which may harm the state of human health and environment.

      Objects of state sanitary and epidemiological control and supervision (epidemically significant objects) shall be divided into two groups:

      1) objects of high epidemiological significance;

      2) objects of low epidemiological significance.

      The distribution of epidemically significant objects by groups shall be carried out on the basis of the risk assessment system.

      The list of products and epidemically significant facilities subject to state sanitary and epidemiological control and supervision, with distribution to the groups, specified in part two of this paragraph, shall be approved by the state body in the field of sanitary and epidemiological welfare of population in agreement with the authorized bodies on entrepreneurship and in the field of environmental protection within their competence.

      4. State sanitary and epidemiological control and supervision shall be carried out in the form of inspection and other forms.

      An inspection shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      Inspections in respect of objects of high epidemiological significance shall be carried out in a special order with a frequency, based on the risk assessment system, in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      Objects of high epidemiological importance shall be exempted from inspections, conducted according to a special order in accordance with the risk management system, defined by the state body in the field of sanitary and epidemiological welfare of population.

      For the objects of low epidemiological importance, only unscheduled inspections shall be carried out.

      Other forms of state sanitary and epidemiological control shall be conducted in accordance with the principle of necessity and sufficiency without visiting the objects (subjects) of control, except for the cases:

      1) if the visit is associated with obtaining permits, with obligatory notification of the authorized body on legal statistics and special records at the location of the object (subject) one day before its visit;

      2) in conducting state sanitary and epidemiological control in the event of infectious and parasitic diseases, food poisoning of individuals (at home) for organizing and taking of sanitary and anti-epidemic and sanitary-preventive measures;

      3) if the visit is associated with selection of products for monitoring of product safety.

      5. Monitoring of product safety is another form of state sanitary and epidemiological control and shall be implemented by:

      1) carrying out cameral control;

      2) selection and conducting of sanitary-epidemiological expertise of products.

      6. Cameral control shall be carried out on the basis of studying and analyzing information about participants in external economic activities, applicants, applying for the test, confirming the conformity of products or registering a declaration of conformity of products, recognizing the results of conformity assessment, the test results, as well as containing in other documents, presented as evidences of the conformity of products submitted, to the state body in the sphere of sanitary-epidemiological welfare of the population by the customs authorities, the authorized body in the field of technical regulation.

      The objects of cameral control shall be the participants of external economic activity, the conformity assessment bodies, testing laboratories (centers), subjects of private entrepreneurship, declaring the conformity of products with the requirements of the legislation of the Republic of Kazakhstan.

      The list of information necessary for implementation of cameral control, as well as the procedure for their presentation by the customs authorities, the authorized body in the field of technical regulation, the conformity assessment bodies and testing laboratories (centers) shall be determined by the state body in the field of sanitary and epidemiological welfare of population.

      7. Information on the participants in external economic activities, on products imported and documents confirming the conformity of the imported products shall be submitted by the customs authorities.

      Information on applicants, applying for carrying out the test, confirming the conformity of products or registering the declaration of conformity of products, recognizing the results of conformity assessment, test results, as well as containing in other documents presented as evidences of conformity of products, shall be submitted by the authorized body in the field of technical regulation, conformity assessment bodies and testing laboratories (centers).

      8. The state body in the field of sanitary and epidemiological welfare of population based on the results of cameral control in detecting the violations of the requirements of regulatory legal acts in the sphere of sanitary and epidemiological welfare of population, hygienic standards and technical regulations, as well as on the basis of analysis of the comparison of information between imported products and issued, registered, recognized documents on the confirmation of conformity for the imported products, in respect of subjects of cameral control shall take the following measures:

      1) an instruction to eliminate violations of the requirements of regulatory legal acts in the sphere of sanitary and epidemiological welfare of population, hygienic standards and technical regulations with mandatory explanation of the procedure for its elimination shall be sent to the addresses of participants of external economic activities and subjects of private entrepreneurship declaring the conformity of products with the requirements of the legislation of the Republic of Kazakhstan engaged in importation and (or) realization of products on the territory of the Republic of Kazakhstan;

      2) information, indicating the facts of violation of the requirements of the legislation of the Republic of Kazakhstan in the field of technical regulation shall be sent to the authorized body in the field of technical regulation.

      9. Selection and sanitary-epidemiological expertise of products shall be conducted to identify and prevent violations of the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of population, hygienic standards and technical regulations.

      Selection of products for sanitary and epidemiological examination shall be carried out by the officials of the state body in the field of sanitary and epidemiological welfare of population and shall be certified by a document, confirming the fact of purchase of the product.

      The state body in the sphere of sanitary and epidemiological welfare of population, if it finds out products that do not meet the requirements of the legislation of the Republic of Kazakhstan on the basis of the results of sanitary epidemiological expertise, shall take the measures specified in paragraph 8 of this Article, except for cases of identifying products dangerous to life, human health and the environment, in relation to which an unscheduled inspection of objects shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      10. Control of implementation of instructions to eliminate violations of the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of population, hygienic standards and technical regulations shall be carried out during an unscheduled inspection in accordance with the Entrepreneurial Code of the Republic of Kazakhstan by the state body in the field of sanitary and epidemiological welfare of population.

      11. The officials of sanitary and epidemiological service, authorized in accordance with this Code to carry out state sanitary and epidemiological control and supervision shall be:

      1) The Chief state sanitary doctor of the Republic of Kazakhstan and his deputies, the chief state sanitary doctors on the relevant territories and transport, their deputies, determined by the head of the state body in the field of sanitary and epidemiological welfare of population;

      2) the heads, their deputies and specialists of the state body in the field of sanitary and epidemiological welfare of population;

      3) the heads, their deputies and specialists of territorial subdivisions of the state body in the sphere of sanitary and epidemiological welfare of population on the respective territories and transport;

      4) the heads and specialists of structural subdivisions of the Ministry of Defense of the Republic of Kazakhstan, national security and internal affairs bodies, departments of the Administration of the President of the Republic of Kazakhstan, carrying out activities in the field of sanitary and epidemiological welfare of population.

      12. Officials of sanitary and epidemiological Service, authorized in accordance with this Code to exercise state sanitary and epidemiological control and supervision shall have the right to:

      1) prohibit importation, use and realization on the territory of the Republic of Kazakhstan, including on epidemically significant objects, of products intended for the use and applying by the population, as well as in entrepreneurial and (or) other activities, with:

      non-compliance with sanitary and epidemiological requirements and requirements of technical regulations;

      absence of a document, certifying the safety, issued by the state body in the sphere of sanitary and epidemiological welfare of population;

      absence of a sanitary and epidemiological conclusion (during exploitation or use of the object, vehicle subject to state sanitary and epidemiological control);

      detection of falsified products;

      unidentified expiration date and (or) storage, expired shelf life and (or) storage;

      detection of insects, rodents and traces of their stay in the product itself;

      creation of a threat of the emergence and spread of infectious diseases or mass non-infectious diseases and poisonings, including its recognition as dangerous to the health and environment of the population based on the results of sanitary and epidemiological expertise;

      2) prohibit the production of products intended for use, applying by the population, as well as in entrepreneurial and (or) other activities, with:

      non-compliance of objects and production technology with sanitary and epidemiological requirements and requirements of technical regulations;

      absence of a sanitary and epidemiological certificate for the production object;

      absence of the production equipment necessary for the observance of technological process of product production, industrial and technological equipment, apparatus, inventory;

      absence of state registration for the first time introduced into production and previously unused substances and materials and preparations on their basis that are dangerous to the population;

      absence of a sanitary-epidemiological conclusion for new products, technology, equipment;

      use of prohibited food additives, ingredients and raw materials;

      creation of the threat of the emergence and spread of infectious diseases or mass non-infectious diseases and poisonings;

      absence of a veterinary and sanitary certificate at the object for the production of livestock products;

      3) prohibit or suspend the use of baby food, food and biologically active food additives, genetically modified objects, materials and products in contact with water and food, chemicals, certain types of products and substances harmful to human health;

      4) call individuals, officials and legal entities to consider the facts of violation of the legislation of the Republic of Kazakhstan in the field of sanitary and epidemiological welfare of population to the bodies of the sanitary and epidemiological service;

      5) make decisions on temporary suspension from work of persons, belonging to the decreed groups of the population that are the source of infectious and parasitic diseases, as well as those who did not pass mandatory medical examinations in time, until getting the result of a laboratory test and the conclusion of a specialist, confirming complete sanitation and compulsory medical examination;

      6) establish restrictive measures, including quarantine at certain sites, in the manner determined by the state body in the field of sanitary and epidemiological welfare of population;

      7) direct the persons, who are the potential sources of spreading of infectious and parasitic diseases, and having been in contact with infectious patients to a medical examination with their exclusion from work until getting the laboratory examination results, confirming the complete sanitation;

      8) direct the persons who are the sources of infectious and parasitic diseases to hospitalization on indications;

      9) demand mandatory vaccination of population, preventive and focal disinfection, disinfestation and deratization in premises and vehicles, territories, in foci of infectious and parasitic diseases;

      10) suspend certain types of works, operation of existing, constructing or reconstructing facilities in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses until the violation of regulatory legal acts in the sphere of sanitary and epidemiological welfare of population and hygienic standards is eliminated;

      11) prohibit the production, application and sale of new types of raw materials, products, chemicals, technological equipment, mechanisms, processes, tools in case of their recognition as hazardous to human life and health;

      12) request materials, necessary for studying the assessment of impact of the object of expertise on the environment and public health, as well as to take samples and to select samples of products in quantities sufficient and not exceeding the required volumes for its conduct, without compensation for the cost of these products to conduct sanitary and epidemiological expertise;

      13) make demands for bringing legal acts affecting sanitary and epidemiological welfare of population in accordance with the legislation of the Republic of Kazakhstan in the sphere of sanitary and epidemiological welfare of population;

      14) carry out radiation monitoring in the sphere of sanitary and epidemiological welfare of population on the territory of the Republic of Kazakhstan;

      15) establish sanitary protection zones and change their sizes;

      16) control introduction and application of the means of disinfection, disinfestation, deratization and biologically active food additives in practice;

      17) apply to the court in case of failure or improper fulfillment by individuals and legal entities of legal requirements or orders, decisions, issued by the officials of the sanitary-epidemiological service;

      18) suspend the license for sanitary-hygienic and anti-epidemic medical activities in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses;

      19) prohibit realization of non -iodinated salt, except for cases, established by the state body in the field of sanitary and epidemiological welfare of population;

      20) involve specialists of healthcare organizations in implementation of sanitary and anti-epidemic and sanitary-preventive measures at infectious and parasitic diseases, poisoning of population.

      13. For taking decision on the results of state sanitary and epidemiological control and supervision, depending on the established violations of the requirements of the legislation of the Republic of Kazakhstan in the sphere of sanitary and epidemiological welfare of population, the following acts shall be issued by the officials of sanitary and epidemiological service:

      1) an act of sanitary-epidemiological examination - a document, issued by an official carrying out state sanitary and epidemiological control and supervision, based on the results of inspection of the object for its compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of sanitary and epidemiological welfare of population;

      2) an order on eliminating violations of the requirements of the legislation of the Republic of Kazakhstan in the field of sanitary and epidemiological welfare of population;

      3) a decision of the Chief state sanitary doctor of the Republic of Kazakhstan on imposing disciplinary punishment to the heads of state bodies and organizations of sanitary-epidemiological service;

      4) decisions of the chief state sanitary doctors on:

      conducting sanitary and anti-epidemic and sanitary-preventive measures;

      temporary suspension of individuals from work;

      prohibition of importation, production, use and realization of products intended for the use and consumption by the population, as well as in business and (or) other activities;

      prohibition of production, use and realization of new types of raw materials, products, chemicals, technological equipment, mechanisms, processes, tools in case of their recognition as hazardous to human life and health;

      suspension of activities or certain types of activities of an individual entrepreneur or legal entity in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses.

      14. Citizens of the Republic of Kazakhstan, having higher medical education of sanitary-epidemiological profile shall be appointed to the posts of the heads of state bodies and organizations of sanitary-epidemiological service.

      Footnote. Article 21 is in the wording of the Law of the Republic of Kazakhstan dated 29.12.2014 No. 269-V (shall be enforced from 01.01.2015); as amended by the laws of the Republic of Kazakhstan dated 29. 10. 2015 No. 376-V (see Article 2 for the procedure of enactment); dated 04.21.2016 № 504-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 10.02.2017 No. 45-VI (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 21-1. Permissions and notifications in the field of sanitary and epidemiological welfare of population

      1. The state body in the sphere of sanitary and epidemiological welfare of population in accordance with the Law of the Republic of Kazakhstan "On Permits and Notifications" shall issue the following permitting documents:

      1) is excluded by the Law of the Republic of Kazakhstan No. 49-VI dated 27. 02. 2017 (shall be enforced upon expiry of ten calendar days after its first official publication);

      2) a sanitary and epidemiological conclusion on compliance (non-compliance) of an object of high epidemiological importance with regulatory legal acts in the field of sanitary and epidemiological welfare of population and hygienic standards;

      3) sanitary and epidemiological conclusion on the agreement of expiration dates and conditions for the storage of food products;

      4) certificate of state registration or re-registration of baby food products, food and biologically active food additives, genetically modified objects, dyes, means of disinfections, disinsection and deratization, materials and products in contact with water and food, chemicals, certain types of products and substances, having a harmful effect on human health;

      5) is excluded by the Law of the Republic of Kazakhstan dated 29.03.2016 No. 479-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication);

      6) permission to work with microorganisms of the I-IV pathogenicity group and helminths.

      7) is excluded by the Law of the Republic of Kazakhstan dated 29.03.2016 No. 479-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication).

      2. It is prohibited to operate objects of high epidemiological significance without a sanitary and epidemiological conclusion on the compliance of the object with regulatory legal acts in the field of sanitary and epidemiological welfare of the population and hygienic standards.

      3. The activity (exploitation) of objects of low epidemiological significance shall be carried out without obtaining a sanitary-epidemiological conclusion on the object.

      Individuals and legal entities shall be obliged to notify the state body in the sphere of sanitary and epidemiological welfare of population about the beginning and termination of the activity (exploitation) of the object of low epidemiological significance in the order, established by the Law of the Republic of Kazakhstan "On Permits and Notifications".

      In this case, individuals and legal entities before the beginning of the activity (exploitation) of objects of low epidemiological significance shall be obliged to bring the object in accordance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of population and hygienic standards.

      Footnote. Chapter 5 is supplemented with Article 21-1 in accordance with the Law of the Republic of Kazakhstan dated 29.12.2014 No. 269-V (shall be enforced from 01.01.2015); as amended by the laws of the Republic of Kazakhstan dated 29. 03. 2016 No. 479-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication); dated 27.02.2017 No. 49-VI (shall be enforced upon expiry of ten calendar days after its first official publication)

Article 22. The state control in circulation of drugs, medical devices and medical equipment

      1. The state control in circulation of drugs, medical devices and medical equipment shall be aimed at prevention, detection, suppression of violations of the legislature of the Republic of Kazakhstan in circulation of drugs, medical devices and medical equipment, as well as control of observance of the legal regulatory acts, regulating circulation of drugs, medical devices and medical equipment in the Republic of Kazakhstan.

      2. The objects of state control in the sphere of circulation of medicines, medical products and medical equipment shall be individuals and legal entities engaged in pharmaceutical activities.

      3. The state control in circulation of drugs, medical devices and medical technology shall be performed in the form of inspections and other forms.

      An inspection shall be carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      Other forms of control shall be carried out in accordance with this Code.

      4. The officials, responsible for the state control in circulation of drugs, medical supplies and medical equipment shall be:

      1) the Chief state pharmaceutical inspector of the Republic of Kazakhstan and his deputies;

      2) the state pharmaceutical inspectors;

      3) the chief state pharmaceutical inspectors of regions, towns of republican significance and the capital and their deputies;

      4) the state pharmaceutical inspectors of regions, towns of republican significance and the capital.

      5. The officials responsible for the state control in circulation of drugs, medical devices and medical equipment might be the citizens of the Republic of Kazakhstan with higher pharmaceutical education.

      6. The officials of the authorized body shall be entitled:

      1) withdraw samples of medicines, medical products and medical equipment in accordance with the legislation of the Republic of Kazakhstan;

      2) to prohibit import, production, manufacturing, storage, use and sale in the territory of the Republic of Kazakhstan of the drugs, medical devices and medical equipment, that are degraded, counterfeit, expired, and those that do not comply with the requirements of the legislation of the Republic of Kazakhstan in healthcare area;

      3) to issue instructions on elimination of violations in circulation of drugs, medical devices and medical equipment;

      4) to suspend a license for pharmaceutical activity for up to six months in accordance with legislation of the Republic of Kazakhstan on administrative offences;

      5) to initiate revocation of a license for pharmaceutical activity in accordance with legislation оf the Republic of Kazakhstan on administrative offences;

      6) to apply to the court for individual’s and legal entities’ non-performance or improper performance of requirements or instructions, decisions, issued by the officials of the authorized body;

      7) visit objects in the sphere of circulation of medicines, medical products and medical equipment for compliance with the requirements of the legislation of the Republic of Kazakhstan;

      8) to obtain information and reports on circulation of drugs, medical devices and medical equipment from the subjects, involved in circulation of drugs, medical devices and medical equipment.

      Footnote. Article 22 is in the wording of the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 36-V (shall be enforced upon expiration of ten calendar days after its first official publication.); as amended by the laws of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29.10.2015 No. 376-V (shall be enforced from 01.01.2016).

Article 22-1. Pharmaceutical inspectorate in the field of medicines

      1. The pharmaceutical inspectorate in the sphere of circulation of medicines shall carry out the pharmaceutical inspection.

      2. The basis for the commencement of a pharmaceutical inspection shall be an application of the subject in the sphere of circulation of medicines, medical products and medical equipment, which has been received by the authorized body, on carrying out a pharmaceutical inspection of the object belonging to it.

      3. During the validity period of the certificate of compliance with the requirements of good pharmaceutical practice, pharmaceutical inspections shall be carried out at least once every three years.

      4. The subjects of pharmaceutical inspection shall be pharmacies for compliance with the requirements of good pharmacy practices (GPP), pharmacy warehouses for compliance with the requirements of proper distribution practices (GDP), drug manufacturing organizations for compliance with the requirements of good manufacturing practices (GMP), healthcare organizations, carrying out preclinical (non-clinical ) tests for compliance with the requirements of good laboratory practices (GLP), healthcare organizations, conducting clinical researches on compliance with the requirements of good clinical practices (GCP).

      5. The procedure for conducting pharmaceutical inspections for compliance with the requirements of appropriate pharmaceutical practices shall be determined by the authorized body.

      Footnote. Chapter 5 is supplemented with Article 22-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 6. FUNDING OF THE HEALTHCARE SYSTEM

Article 23. Sources of financial support for the healthcare system

      1. The sources of financial support for the healthcare system shall be:

      1) the budget funds;

      1-1) the assets of social health insurance fund;

      2) means of voluntary medical insurance;

      3) the funds received for rendering of the paid services;

      3-1) funds, received as voluntary donations from individuals and legal entities;

      4) other sources, not contradicting the legislation of the Republic of Kazakhstan.

      2. The procedure and methodology for formation of tariffs for medical services, provided within the guaranteed volume of free medical care and in the system of compulsory social health insurance shall be determined by the authorized body.

      Tariffs for medical services provided within the guaranteed volume of free medical care and in the system of compulsory social health insurance shall be approved by the authorized body.

      3. Is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).
      Footnote. Article 23 as amended by the laws of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2017); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 24. Forms of financing of healthcare subjects, providing a guaranteed volume of free medical care

      Footnote. Title of Article 24 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      Financing of healthcare subjects, providing a guaranteed volume of free medical care shall be carried out:

      1) for public healthcare organizations - on an individual plan of financing;

      2) for healthcare subjects, with the exception of state institutions, on a contractual basis with administrators of budget programs and (or) a fund for social health insurance.

      Footnote. Article 24 as amended by the laws of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2018).

Article 25. Use of sources of financial support of healthcare system

      1. The funds of the healthcare system shall be spent on:

      1) payment for services of healthcare subjects within the guaranteed volume of free medical care;

      2) excluded by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication);

      3) material and technical equipment of healthcare organizations;

      4) purchase of medicines, orphan preparations, blood and its components, vaccines and other immunobiological preparations, as well as medical products and medical equipment;

      5) elimination of cases and epidemics of infectious diseases;

      6) training, qualification development and retraining of personnel in the field of healthcare;

      7) development and introduction of medical science achievements;

      8) other expenses that are not prohibited by the legislation of the Republic of Kazakhstan.

      2. Is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced from 01.01.2018).

      3. Payment for services of healthcare subjects shall be carried out taking into account the results of monitoring contractual obligations on the quality and volume of medical services in the manner determined by the authorized body.

      4. Payment of the cost of pharmaceutical services to the subjects in the sphere of circulation of medicines, medical products and medical equipment shall be carried out by the administrators of budget programs or the social medical insurance fund in the manner determined by the authorized body.

      Footnote. Article 25, as amended by the Law of the Republic of Kazakhstan, dated on 03.07.2013 No 124-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 30.06.2017 No. 80-VI (shall be enforced from 01.01.2018).

Chapter 7. INFORMATISATION IN HEALTHCARE AREA

Article 26. Objects and subjects of informatization in healthcare

      1. The objects of information in healthcare shall be the electronic information resources, information systems and electronic healthcare services.

      2. The subjects of informatization in healthcare shall be the state bodies, individuals and legal entities, working or establishing legal relations in informatization area in healthcare.

      3. The activities in informatization in healthcare shall include development of information and communication infrastructure of the healthcare branch in the frames of "electronic government", providing individuals and legal entities with medical and statistical information, as well as provision of other e-services.

Article 27. Principles of informatization in healthcare area

      Informatization in healthcareshall be based on the following principles:

      1) standardization and formalization of administrative processes at all levels of management, development and implementation of a unified policy for healthcare management;

      2) a widespread use of international standards in healthcare and informatization;

      3) free access to electronic information resources, containing data on work of agencies and healthcare organizations, except for the electronic information resources, access to which is limited in accordance with legislation of the Republic of Kazakhstan;

      4) timeliness, objectivity, completeness and reliability of electronic information resources, public dissemination of which is mandatory;

      5) ensuring safety and confidentiality of electronic information resources of healthcare;

      6) confidentiality of electronic information recourses, containing personalinformation of individuals (patients) and patient’s access to the personal information;

      7) ensuring movement of medical information after the patient.

      Footnote. Article 27, as amended by the Law of the Republic of Kazakhstan, dated on 21.05.2013 No 95-V (shall be enforced upon expiration of six months after its first official publication); dated 24.11.2015 No. 419-V (shall be enforced from 01.01.2016).

Article 28. Ensuring confidentiality of information about individuals (patients)

      1. Electronic information resources of healthcare, containing personal information about individuals (patients) shall be classified as the confidential electronic information resources, receiving, processing and use of which shall be limited by the purposes for which they are collected.

      2. Collecting, processing of personal data for the formation of electronic information resources, containing personal data of individuals (patients), shall be carried out with the consent of individual (patient) or his legal representative, unless otherwise provided by this Code or other Laws of the Republic of Kazakhstan.

      3. Owners and keepers of information systems, that received electronic information resources, containing personal medical data, shall be obliged to take measures to protect them. Such an obligation shall arise from receipt of electronic information resources, containing personal data of individuals (patients), and until their amortization or a depersonalization or until the receipt of consent for their disclosure from the person to whom personal data relates.

      4. Use of electronic information resources, containing personal medical information about individuals (patients) shall not allowed for causing property and (or) moral damage, limiting the rights and freedoms, guaranteed by the Laws of the Republic of Kazakhstan.

      5. Access of medical personnel to electronic information resources, containing personal data of individuals (patients) shall be provided for implementation of medical activities stipulated by subparagraphs 1), 2), 3), 4), 5), 7) and 8) of Article 37 of this Code.

      Footnote. Article 28 is in the wording of the Law of the Republic of Kazakhstan; dated on 21.05.2013 № 95-V (shall be enforced upon expiration of six months upon its first official publication); as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 8. INTERNATIONAL COOPERATION IN HEALTHCARE AREA

Article 29. Priorities and directions of international cooperation in healthcare area

      1. The priorities of international cooperation in healthcare shall be:

      1) protection of interests of the Republic of Kazakhstan and its people in healthcare area;

      2) provision of epidemiological safety of the Republic of Kazakhstan;

      3) application of rules and principles of international law to address healthcare issues at the interstate level;

      4) formation of a healthy lifestyle and healthy food.

      2. The directions of international cooperation in healthcare shall be:

      1) participation in international healthcare initiatives;

      2) attraction and provision of technical assistance in healthcare at the international level;

      3) sending of the citizens of the Republic of Kazakhstan for a medical treatment abroad and provision of medical assistance to foreign nationals;

      4) introduction of international innovation technologies and upgrade of the healthcare system;

      5) integration into the global medical science;

      6) ensuring access of medical and pharmaceutical workers to information and intellectual resources;

      7) interstate cooperation in the sphere of training, qualification development and retraining of personnel in the field of healthcare;

      8) provision of international healthcare assistance in emergency situations;

      9) exchange of information, technologies in circulation of drugs, medical devices and medical equipment and harmonization of requirements to safety and quality of pharmaceutical and medical products;

      10) healthcare protection of the borders, safety of the imported products.

      Footnote. Article 29 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 30. Economic and legal framework for international cooperation in healthcare area

      1. The economic basis for international cooperation in healthcare shall be:

      1) compulsory and voluntary contributions to international organizations;

      2) participation in financing of international projects and events;

      3) attraction and use of grants;

      4) funding in accordance with the concluded international treaties.

      2. The legal framework for international cooperation in healthcare shall be the international treaties and agreements.

SPECIAL PART
SECTION 2. HEALTHCARE SYSTEM AND ORGANIZATION OF MEDICAL ASSISTANCE
Chapter 9. HEALTHCARE SYSTEM AND ORGANIZATION OF MEDICAL ASSISTANCE

Article 31. The structure of the healthcare system

      1. The healthcare system shall consist of public and private healthcare sectors.

      2. The public healthcare sector shall consist of the state healthcare bodies, healthcare organizations, established on the right of the state ownership.

      3. The non-state sector of health care consists of health care organizations, based on the right of a private property, as well as individuals, practising private medicine and pharmaceutical activity.

      The list of diseases, the treatment of which is prohibited in the non-state healthcare sector shall be defined by the authorized body.

32. Healthcare subjects

      1. Healthcare subjects shall be the healthcare organizations, as well as the individuals, engaged in private medical practice and pharmaceutical activity.

      2. The healthcare system shall have the following healthcare organizations:

      1) the organizations, providing outpatient assistance;

      2) the organizations, providing inpatient assistance;

      3) the organizations of emergency medical assistance and air ambulance;

      4) the organizations of emergency medicine;

      5) the organizations of medical rehabilitation;

      6) the organizations, providing palliative and nursing care;

      7) the organizations, providing blood supply services;

      8) the organizations, engaged in forensic medicine and pathoanatomy;

      9) the healthcare organizations, involved in pharmaceutical activities;

      10) the healthcare organizations, involved in healthcare and epidemiological welfare of the population;

      11) scientific healthcare organizations;

      12) education organizations in healthcare area;

      13) healthcare organizations, carrying out activities in the field of healthy lifestyle, healthy nutrition;

      14) the healthcare organizations, involved in HIV / AIDS prevention;

      14-1) is excluded by the Law of the Republic of Kazakhstan dated 03 .07. 2014 No. 229-V (shall be enforced upon expiry of ten calendar days after its first official publication);

      15) national holdings.

      16) organizations, carrying out an assessment of professional preparedness and confirmation of compliance of healthcare specialists’ qualification.

      17) organizations of healthcare for orphans, children left without parental care, from birth to three years, children with mental and physical development defects from birth to four years, carrying out psychological and pedagogical support for the families with the risk of abandoning the child.

      3. The authorized body shall develop and approve:

      1) the list of healthcare organizations and regulations on their activities;

      2) the range and qualification characteristics of the medical and pharmaceutical professions and positions of health professionals;

      3) the structure, typical staffing and HR standards of healthcare organizations;

      4) the order of interaction between healthcare organizations.

      4. Individuals shall have the right to engage in private medical practice if they have a relevant certificate, work experience of at least five years in this profession and a corresponding license.

      Footnote. Article 32, as amended by the Law of the Republic of Kazakhstan, dated on 27.04.2012 No 15-V (shall be enforced upon expiration of ten calendar days after its first official publication.); dated 03.07.2014 No. 229-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 33. Organization of medical assistance

      1. Organization of medical assistance shall be carried out by the authorized body, local state bodies for healthcare management of regions, city of republican status and the capital, the provision of medical assistance – by the healthcare entities in the order, defined by this Code.

      2. Healthcare subjects shall provide:

      1) provision of quality medical care;

      2) application of the methods of diagnosis, prevention and treatment as well as the drugs, approved by the authorized body;

      3) readiness to work in emergency situations, armed conflicts and terrorist acts;

      4) carrying out measures for prevention, caution, diagnosis and treatment of diseases that pose a danger to others, as well as professional diseases;

      5) the citizens with free, timely and reliable information on the types and forms of medical care;

      6) observance of regulations in healthcare and epidemiological welfare of the population and health standards;

      7) collaboration with other healthcare organizations and continuity of activities;

      8) promotion of a healthy lifestyle and healthy eating; 9) maintenance of primary medical records, and reporting on the forms, types, volumes, and deadlines, established by the authorized body;

      10) information to the authorized body about the cases of infectious diseases, poisonings, mental and behavioral disorders (diseases) that are dangerous for others, to the authorized body in the field of civil protection - about the threat of occurrence and (or) emergence of medical and sanitary consequences of emergencies, to internal affairs bodies - information about people, having applied to fresh injuries, wounds, criminal abortions, cases of diseases that are dangerous to others.

      3. The subjects of healthcare in provision of medical care shall be guided by clinical protocols.

      Footnote. Article 33, as amended by the Laws of the Republic of Kazakhstan, dated on 19.03.2010 No 258-IV; dated on 08.04.2010 No 266-IV (the order of enforcement see Article 2); dated 11.04.2014 No. 189-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 03.12.2015 No. 433-V (shall be enforced from 01.01.2016).

Article 33-1. Volumes of medical care

      Medical care shall be provided in the following volumes:

      1) basic - the guaranteed volume of free medical care provided in accordance with Article 34 of this Code;

      2) additional volume of medical care, including:

      medical assistance in the system of compulsory social health insurance, provided in accordance with the Law of the Republic of Kazakhstan "On Mandatory Social Health Insurance";

      medical assistance in the framework of voluntary medical insurance in accordance with the Law of the Republic of Kazakhstan "On Insurance Activities".

      Footnote. Chapter 9 is supplemented by Article 33-1 in accordance with the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016).

Article 34. The guaranteed volume of free medical care

      1. The guaranteed volume of free medical care shall be granted to the citizens of the Republic of Kazakhstan and repatriates at the expense of budgetary funds and includes preventive, diagnostic and therapeutic medical services that have the most proven effectiveness, in accordance with the list, approved by the Government of the Republic of Kazakhstan.

      2. The guaranteed volume of free medical care shall include:

      1) emergency medical assistance and sanitary aviation;

      2) out-patient – polyclinic assistance, including:

      primary health assistance;

      consultative and diagnostic assistance on the direction of a specialist in primary healthcare and profile specialists;

      3) inpatient medical assistance on the direction of a specialist in primary healthcare or a medical organization within the planned number of hospitalization cases determined by the authorized body, for emergency indications - regardless of the direction presence;

      4) stationary replaced medical care on the direction of a specialist in primary healthcare or a medical organization;

      5) rehabilitation treatment and medical rehabilitation;

      6) palliative care and nursing care for the categories of the population, established by the authorized body.

      3. Provision with medicines and medical products within the guaranteed volume of free medical assistance shall be carried out:

      1) when providing emergency, inpatient and stationary replaced assistance - in accordance with the drug formularies of healthcare organizations;

      2) when providing outpatient- polyclinic care - in accordance with the list of medicines, medical products and specialized medical products, approved by the authorized body for free and (or) preferential provision of certain categories of citizens with certain diseases (state).

      4. Is excluded by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced from 01.01.2018).

      4-1. The purchase of services from healthcare subjects within the guaranteed volume of free medical care shall be carried out by the social health insurance fund.

      5. The pre-emptive right to conclude contracts in the framework of guaranteed volume of free medical care shall have the accredited healthcare organizations, as well as subjects in the sphere of circulation of medicines, medical products and medical equipment, having received a certificate of compliance with the requirements:

      1) good manufacturing practices (GMP) when purchasing medicines and conclusion of long-term contracts for the supply of medicines, medical products;

      2) proper distribution practices (GDP) when purchasing medicines, pharmaceutical services for the provision of a guaranteed volume of free medical care and the conclusion of long-term contracts for the storage and transportation of medicines, medical products;

      3) good pharmacy practices (GPR) when purchasing pharmaceutical services.

      Footnote. Article 34, as amended by the Law of the Republic of Kazakhstan, dated on 28.06.2012 No 22-V (shall be enforced from 01.07.2012); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 № 406-V (for the procedure of enactment see Art. 3); dated 30.06.2017 No. 80-VI (for the procedure of enactment see Art. 2).

Article 34-1. Minimum social standards in the field of healthcare

      The guaranteed volume 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".

      Footnote. Chapter 9 is supplemented by Article 34-1 in accordance with the Law of the Republic of Kazakhstan dated 19. 05. 2015 No. 315-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 35. The grounds and procedure for obtaining the paid medical services

      1. The paid medical services shall be provided by public and private healthcare organizations, the individuals, engaged in private medical practice, if the profile of disease corresponds with the license for medical activity.

      2. The paid medical services shall be rendered during:

      1) the primary healthcare assistance, diagnostic and treatment services at the initiative of the patients, including without a referral of primary healthcare specialists and healthcare organizations;

      2) treatment with medicines not included in the drug formulary of the healthcare organization;

      3) medical examinations, that are not included in the list of the guaranteed volume of free medical care;

      4) sanatorium therapy without the proper referral;

      5) medical and genetic researches without medical indications;

      6) medical examination of citizens for employment and training;

      7) providing medical assistance under a contract with the organization, including voluntary medical insurance;

      8) provision of additional services;

      9) providing medical assistance to foreigners and stateless persons, except for cases stipulated by paragraph 5 of Article 88 of this Code.

      3. The paid medical services shall be provided on the basis of a contract, concluded between the patient and the healthcare subject, rendering these services.

      The contract for rendering of the paid medical services shall contain the following basic conditions:

      1) the types and amount of medical assistance;

      2) the deadlines for medical care;

      3) the tariffs for medical and non-medical services and procedures for their payment;

      4) the rights and obligations of the parties;

      5) the order of making changes, additions, and termination of the contract;

      6) establishment of civil liability of the parties for any failure to perform contractual obligations.

      4. The types of the paid services and a price list shall be advertised to the population through visual information in the public and private healthcare organizations and in the individuals’ offices, engaged in private medical practice.

      5. In public healthcare organizations, the prices for the paid services shall be calculated taking into account all expenses, associated with rendering of medical and other services, and other additional costs and may be revised twice a year only.

      Prices for the paid services shall not be below the tariff of a similar medical service, established by the administrator of budget programs for the guaranteed volume of free medical care.

      6. Keeping of records and reports on rendering the paid medical services shall be carried out in accordance with the forms, established by the authorized body.

      7. A healthcare organization shall be responsible for the timely and proper provision of the paid medical services to the citizens from the time they applied for treatment in the manner, specified by the Laws of the Republic of Kazakhstan.

      8. The procedure and conditions for provision of paid services in healthcare organizations shall be determined by the authorized body.

      Footnote. Article 35 as amended by the laws of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

SECTION 3. MEDICAL ACTIVITY
Chapter 10. CONTENT AND TYPES OF MEDICAL ACTIVITY

Article 36. The content of medical activity

      Medical activity shall include professional activity of individuals with higher or vocational secondary medical education, as well as the legal entities, working in healthcare area.

Article 37. The types of medical activity

      The following types of medical activities shall be performed in the Republic of Kazakhstan:

      1) healthcare assistance;

      2) laboratory diagnosis;

      3) pathologicoanatomic diagnosis;

      4) banking of blood and its components;

      5) healthcare and epidemiological welfare of the population;

      6) public health protection;

      7) educational and scientific activities in healthcare area;

      8) expertise in healthcare area;

      9) other types of activities, not prohibited by this Code.

Chapter 11. MEDICAL ASSISTANCE

Article 38. The types of medical assistance

      The main types of medical assistance shall be:

      1) pre-hospital medical care;

      2) adequate medical assistance;

      3) specialized medical assistance;

      4) high-tech medical service;

      5) medical and social assistance.

      Footnote. Article 38 as amended by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016).

Article 39. Pre-hospital medical care

      1. Pre-hospital medical care - the medical care, rendered by medical personnel with secondary medical education for prevention of diseases, as well as in diseases that do not require the use of methods of diagnosis, treatment and rehabilitation with the participation of a physician.

      2. In emergency cases, the pre-hospital medical care may be provided by the persons without medical education (paramedics), who have passed appropriate training in the order, defined by the authorized body, as well as by other persons in order to save the lives of the injured.

      3. The types and amount of pre-hospital medical assistance shall be defined by the authorized body.

Article 40. Adequate medical assistance

      1. Qualified medical assistance shall be medical assistance provided by medical personnel with higher medical education in diseases, that do not require specialized methods of diagnosis, treatment and medical rehabilitation, including using telemedicine.

      2. The types and amount of the adequate medical assistance shall be defined by the Government of the Republic of Kazakhstan.

      Footnote. Article 40, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 41. The specialized medical assistance

      1. Specialized medical assistance shall be medical assistance, provided by profile specialists in diseases, requiring special methods of diagnosis, treatment and medical rehabilitation, including using telemedicine.

      2. The specialized medical assistance shall be provided by multi-profile healthcare organizations in the form of consultative and diagnostic or inpatient medical care.

      3. The types and amount of the specialized medical assistance shall be defined by the authorized body and local state bodies for healthcare management of regions, city of republican significance and the capital.

      Footnote. Article 41 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 42. High-tech medical services

      1. Coordination of activities of medical organizations, providing high-tech medical services shall be carried out by the authorized body.

      2. The types and procedures for provision of high-tech medical services shall be determined by the authorized body.

      Footnote. Article 42 as amended by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016).

Article 43. Medical and social assistance

      1. Medical and social assistance shall be medical and socio-psychological assistance, provided to the citizens with socially significant diseases, the list of which shall be determined by the authorized body.

      2. The procedure of medical and social assistance provided to citizens suffering from socially significant diseases shall be established by the authorized body.

      Footnote. Article 43 is in the wording of the Law No. 239-V of the Republic of Kazakhstan dated 29. 09. 2014 (shall be enforced upon expiry of ten calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 44. The forms of providing medical assistance

      Medical assistance may be provided in the following forms:

      1) outpatient care:

      primary medical care;

      consultative and diagnostic assistance;

      2) inpatient assistance;

      3) hospital-replacing assistance;

      4) emergency medical assistance;

      5) the air ambulance;

      6) medical care in emergency situations;

      7) is excluded by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016);
      8) is excluded by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016);

      9) traditional medicine, alternative medicine (healing).

      Footnote. Article 44 as amended by the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016).

Article 45. Primary health care

      1. Primary health care - a pre-medical or qualified medical assistance without a round-the-clock medical supervision, including a range of available medical services, provided to an individual, a family and society:

      1) diagnosis and treatment of common diseases and injuries, poisonings and other emergencies;

      2) sanitary and anti-epidemic and sanitary-preventive measures in the foci of infectious diseases;

      3) hygienic education of the population, protection of family, motherhood, fatherhood and childhood;

      4) outreach work for safe water supply and nutrition education of the population.

      2. Primary health assistance shall be provided by the district therapists, pediatricians, general practitioners, paramedics, midwives, social workers in the field of healthcare and by nurses.

      3. The activities of organizations, providing primary health assistance shall be built on a territorial principle in order to ensure the availability of medical care to the citizens at their place of residence and (or) attachment, taking into account the right to choose a medical organization.

      4. Types and volume of primary health assistance shall be established by the Government of the Republic of Kazakhstan.

      4-1. The procedure for provision of primary health assistance, as well as attachment of citizens to primary healthcare organizations, shall be established by the authorized body.

      5. Organization of primary health care shall be performed by the local state governing bodies.

      Footnote. Article 45 as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016).

Article 46. Consultative and diagnostic assistance

      1. Consultative and diagnostic assistance - specialized medical assistance, including the use of high-tech medical services without round-the-clock medical supervision.

      2. The procedure for providing consultative and diagnostic assistance shall be established by the authorized body.

      Footnote. Article 46, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016).

Article 47. Inpatient care

      1. Inpatient care shall be the form of providing pre-medical, qualified, specialized medical assistance, including using high-tech medical services, with round-the clock medical supervision.

      2. Healthcare organizations, that provide inpatient care, shall ensure appropriate care and nutrition.

      3. The procedure for providing inpatient care shall be established by the authorized body.

      Footnote. Article 47, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 48. Hospital replacing assistance

      1. Hospital replaced assistance is the form of pre-medical, qualified, specialized medical assistance, including with the use of high-tech medical services, with medical supervision.

      2. The procedure for providing hospital-replaced assistance shall be established by the authorized body.

      Footnote. Article 48, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 49. Emergency medical assistance

      1. Emergency medical assistance shall be a form of medical care in case of illnesses and conditions, requiring emergency medical care to prevent significant harm to health and /or eliminate the threat to life, as well as at the need to transport organs (parts of organs) for subsequent transplantation.

      2. An emergency medical service shall be created in order to provide emergency medical care in the manner, established by the legislation of the Republic of Kazakhstan in the field of healthcare.

      Footnote. Article 49 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 50. Sanitary aviation

      Sanitary aviation shall be a form of providing emergency medical assistance to the population if it is impossible to provide medical assistance because of the lack of medical equipment and (or) specialists of appropriate qualifications in medical organization at the location of the patient. Provision of medical aid in the form of sanitary aviation shall be carried out by the delivery of qualified specialists to the destination or transportation of the patient, as well as organs (parts of organs) for subsequent transplantation to the relevant medical organization by air transport.

      Footnote. Article 50 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 51. Medical care in emergencies

      1. Medical care in emergency situations -a form of medical assistance of emergency medicine in natural and man-made emergency situations.

      2. The order of providing, the types and amount of medical assistance in emergency situations shall be defined by the Government of the Republic of Kazakhstan.

      Footnote. Article 51 as amended by the Constitutional Law of the Republic of Kazakhstan dated on 03.07.2013 No 121-V (shall be enforced upon expiration of ten calendar days after its first official publication).

Article 52. Rehabilitation and medical rehabilitation

      1. Rehabilitation and medical rehabilitation shall be provided to the citizens suffering from congenital and evoked diseases, and the effects of acute, chronic diseases and injuries.

      2. Rehabilitation and medical rehabilitation shall be performed in healthcare organizations, as well as sanatorium organizations.

      3. Citizens shall be given the vouchers for sanatorium treatment in accordance with the legislature of the Republic of Kazakhstan in healthcare area and the labor legislation of the Republic of Kazakhstan.

      4. The procedure for restorative treatment and medical rehabilitation, including children's medical rehabilitation, shall be established by the authorized body.

      Footnote. Article 52, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 53. Palliative and nursing care

      1. Under the guidance of a physician, the palliative care shall be provided in the specialized structural units, independent medical organizations (hospices) or in the form of home care to the incurable patients with the terminal (final) stage of the disease.

      2. Nursing care shall be provided in the cases, when medical supervision shall not be required, in specialized structural units, independent healthcare organizations (hospitals of nursing care) or in the form of home care.

      3. The procedure for providing palliative assistance and nursing care shall be established by the authorized body.

      Footnote. Article 53, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 54. Traditional medicine, alternative medicine (healing)

      1. The methods of traditional medicine shall include homeopathy, hirudotherapy, manual therapy, zone therapy, herbal medicine and treatment by natural medications.

      2. Individuals with medical education and a relevant license shall have the right to work in traditional medicine area.

      3. Alternative medicine (healing) - a set of accumulated empirical knowledge about the healing methods, as well as the medical and hygienic techniques and skills and their practical application to preserve health, prevent and treat diseases.

      4. excluded by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 36-V (shall be enforced upon expiration of ten calendar days after its first official publication.)

      5. Conduction of mass healing sessions, including through the media shall be prohibited.

      Footnote. Article 54, as amended by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication.)

Article 55. Laboratory diagnostics

      1. Laboratory diagnostics - a complex of medical services, aimed at confirming presence or absence of disease (status) through laboratory testing of biomaterials, taken from patients.

      2. The regulation on the activities of organizations and (or) structural units of healthcare organizations, performing laboratory diagnostics, as well as the types of research conducted by them, shall be established by the authorized body.

      Footnote. Article 55, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 56. Pathologicoanatomic diagnostics

      1. Pathologicoanatomic diagnostics shall be performed to make a diagnosis via analyzing a complex of changes in the tissues and organs of a corpse during its postmortem examination, as well as in the organs (fragments of organs) and tissues, taken out via surgery and (or) biopsy, and shall be based on the results of direct examination (macroscopic studies), the researches, made by magnifying arrangement (microscopic examination), other technologies, as well as clinical and anatomical comparisons.

      2. Postmortem examination shall be performed to ascertain the cause of death and the diagnosis.

      If there is no suspicion of violent death and if there is a written application from a spouse (wife), close relatives or legal representatives or a written will expression of a person, given while he was alive, the issuance of a corpse shall be permitted without a postmortem examination, except for the cases of maternal and infant mortality, and death from dangerous infections, with the issuance of the document certifying the fact of death, in the form, approved by the authorized body.

      At the request of the spouse, close relatives or legal representative of the deceased, the pathoanatomical autopsy may be performed by an independent expert (experts) in the manner established by the authorized body.

      3. The regulation on the activities of organizations and (or) structural units of healthcare organizations performing pathoanatomical diagnostics, as well as the procedure for performing pathoanatomical autopsy shall be established by the authorized body.

      Footnote. Article 56, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 12. TYPES OF EXPERTISE IN HEALTHCARE AREA

Article 57. An expertise in healthcare area

      1. An expertise in healthcare - an integral part of public health protection.

      2. In the Republic of Kazakhstan, the following types of expertise in healthcare shall be performed:

      1) evaluation of quality of medical services;

      2) examination of temporary disability;

      3) military medical examination;

      4) forensic-medical, forensic psychiatric and forensic-drug examination;

      5) healthcare and epidemiological expertise;

      6) examination of medications, medical devices and medical equipment;

      7) scientific and medical expertise.

      8) expertise of the connection of the disease with the performance of the employee's work (official) duties.

      3. The expertise in the field of healthcare, except for examination of medicines, medical products and medical equipment in the state registration, re-registration and modification of the registration dossier, shall be carried out by individuals and legal entities on the basis of a relevant license and (or) legal entities - on the basis of certificates of accreditation.

      Footnote. Article 57 as amended by the laws of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29.03. 2016 No. 479-V (shall be enforced from 01.01.2017).

Article 58. Examination of the quality of medical services

      1. Examination of medical services’ quality - a set of organizational, analytical and practical actions, aimed at assessment of the quality of medical services, provided by the individuals and legal entities, using indicators that reflect the performance indexes, completeness and compliance of medical services with the standards.

      2. Examination of the quality of medical services shall be divided into internal and external ones.

      3. For conducting internal expertise in the medical organization, a patient support and internal control (audit) service shall be created. The structure and composition of this service shall be approved by the head of the organization, depending on the volume of provided medical services.

      The patient support and internal control (audit) service shall conduct current analysis of organization of medical care, clinical activities of medical organization, detection of violations of the procedure for provision of medical assistance and standards, as well as consideration in a period not exceeding five calendar days, of appeals of patients being treated.

      Based on the results of the audit, the internal control (audit) service shall make proposals on eliminating the identified causes and conditions for reducing the quality of provided medical services to the head of the medical organization.

      For conducting an internal expertise of the quality of medical services, an internal expertise service for the quality of medical services, provided by its subordinate medical organizations shall be created by the Administration of the President of the Republic of Kazakhstan.

      The structure and composition of this service shall be approved by the head of the Administration of the President of the Republic of Kazakhstan.

      4. External expertise of the quality of medical services shall be conducted:

      1) by the authorized body, as well as with the involvement of independent experts at commission analysis on cases, determined by the authorized body;

      2) by independent experts when they are attracted by individuals or legal entities in cases of disagreement with the conclusion of internal and external expertise, as well as by healthcare subjects for conducting an independent expertise on a contractual basis.

      5. The procedure for organizing and conducting internal and external expertise of the quality of medical services shall be established by the authorized body.

      Footnote. Article 58, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 03. 2016 No. 479-V (shall be enforced from 01.01.2017).

Article 59. Examination of temporary disability

      1. Examination of temporary disability shall be conducted to recognize officially a disability of an individual and his temporary release from work during the disease.

      2. The procedure for the expertise of temporary incapacity for work, as well as the issuance of a sick leave and a certificate of temporary incapacity for work shall be established by the authorized body.

      Footnote. Article 59, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 60. Military medical examination

      1. Military medical expertise shall be conducted to confirm medical fitness for the military service in the Armed Forces, other troops and military units of the Republic of Kazakhstan or to the service in special state bodies, internal affairs bodies, criminal-executive system, firefighting service, anti-corruption service, bodies of the Prosecutor's Office, service of economic investigation of state revenue bodies (hereinafter - military service or service in special state bodies, law enforcement agencies (further - mutilation), as well as determining the causal connection of diseases, injuries (wounds, injuries, contusions) and death of citizens in connection with the passage (performance of duties) of military service or service in special state and law enforcement agencies and military gathering.

      For special state bodies, military medical expertise shall be carried out by the bodies of military medical expertise of national security agencies and the State security service of the Republic of Kazakhstan.2. Military medical examination shall be carried out:

      1) for medical examination of:

      the citizens, attached to the enlistment offices, called up for military service or military duties and entering the military (special) schools, republican military boarding schools (lyceums);

      the citizens, applying for military service or service in special state and law enforcement agencies, including on the contract basis;

      the soldiers, performing military service under conscription or contract;

      the employees of special state bodies;

      the cadets of the military (special) schools, the schools of special state agencies, the cadets and attendees;

      the military servants (the servants of the Armed Forces), employees (workers) of special state agencies, selected for the service (work) and those, working with radioactive substances, ionizing radiation sources, the components of rocket fuel, sources of electromagnetic fields; the aircraft staff of the state aviation;

      the citizens in reserve when called up for military gatherings, the gatherings of the special state bodies or for military service, the service in special state bodies or for registration purposes;

      2) during psycho-physiological selection of citizens, entering military service in the special state and law enforcement agencies;

      3) in revealing causation of injuries, diseases of the military servants, employees of the special state bodies or the citizens, that passed military service (military gatherings) or service (gatherings) in special state and law enforcement agencies;

      4) in estimating the level of military fitness for military service or service in special state and law enforcement agencies at the time of their discharge from military service or service in special state and law enforcement agencies;

      5) in revealing causation of death (death) of military servants, and those, liable to military service, employees during the military service (military gatherings), or service in special state and law enforcement agencies or after discharge from military service (military gatherings) or service (gatherings) in special state bodies, law enforcement agencies, caused by injury, disease, received during the military service (military gatherings) or service (gatherings) in special state and law enforcement agencies.

      3. The military medical examination bodies shall conduct military medical expertise in the Armed Forces, other troops and military units of the Republic of Kazakhstan, special state and law enforcement bodies.

      Military medical examination for the special state bodies shall be conducted by the military physician expertise agencies of the national security bodies.

      4. Requirements for the conformity of health state for the service in the Armed Forces, other troops and military units of the Republic of Kazakhstan, special state bodies, internal affairs bodies and state aviation shall be approved by central executive bodies in the field of defense, internal affairs, national security agencies and the service of State protection of the Republic of Kazakhstan in agreement with the authorized body.

      Footnote. Article 60 as amended by the Law of the Republic of Kazakhstan, dated on 13.02.2012 No 553-IV (shall be enforced upon expiration often calendar days after its first official publication.); as amended by the Law of the Republic of Kazakhstan dated 07.11. 2014 No. 248-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 10.01.2015 No. 275-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 61. Forensic medical, forensic psychiatric and forensic drug expertise

      1. The procedural order of scheduling and conducting a forensic-medical, forensic-psychiatric, and forensic drug testing shall be established by the Criminal Procedure Code of the Republic of Kazakhstan, the Civil Procedure Code of the Republic of Kazakhstan, the Code of Republic of Kazakhstan on administrative offences.

      2. The procedure for organizing the mentioned types of forensic expertise and performance of forensic investigations shall be established by the legislation of the Republic of Kazakhstan on forensic activities.

Article 62. Healthcare-epidemiological expertise

      1. Sanitary-epidemiological expertise - a complex of organoleptic, sanitary-hygienic, epidemiological, microbiological, virological, parasitological, sanitary-chemical, biochemical, toxicological, radiological, radiometric, dosimetric measurements of physical factors, other studies and tests, as well as expertise of projects for the purposes of assessment of the conformity of projects, products, objects of entrepreneurial and (or) other activity with normative legal acts in the field of sanitary epidemiological welfare of population and hygienic standards.

      2. Sanitary-epidemiological expertise shall be carried out by state bodies and organizations of sanitary-epidemiological service within the limits of competence by orders or instructions of officials of sanitary-epidemiological service, customs bodies and applications of individuals and legal entities in the manner determined by the state body in the field of sanitary and epidemiological welfare of population, with the exception of sanitary-epidemiological expertise of projects.

      Sanitary and epidemiological expertise of construction projects for epidemically significant objects, as well as urban development projects shall be carried out by experts certified in the manner prescribed by the legislation of the Republic of Kazakhstan on architectural, urban development and construction activities.

      3. Sanitary-epidemiological expertise of projects shall be carried out:

      1) for the projects (feasibility studies and design estimates) intended for construction of epidemically significant objects by state or accredited expert organizations as part of a comprehensive non-departmental expertise;

      2) for urban development projects, subject to approval by the Government of the Republic of Kazakhstan or maslikhats of oblasts, cities of republican significance and the capital.

      3-1. For the projects, not provided by paragraph 3 of this Article, sanitary and epidemiological expertise shall be carried out by the state bodies of the sanitary and epidemiological service.

      Sanitary-epidemiological expertise in the part of sanitary-epidemiological laboratory researches shall be carried out by state organizations of sanitary-epidemiological service.

      4. Sanitary-epidemiological laboratory researches shall be the part of sanitary-epidemiological expertise, related to organoleptic, sanitary-hygienic, toxicological, sanitary-chemical, biochemical, microbiological, epidemiological, bacteriological, virological and parasitological laboratory reseraches, energy and biological value studies of food products , noise measurements, vibration, electromagnetic fields and physical factors, radiation studies, including radiometry and dosimetry.

      The list and volumes (quantity) of sanitary-epidemiological laboratory studies shall be established by the state body in the field of sanitary and epidemiological welfare of population.

      5. For the conduct of sanitary and epidemiological expertise upon applications of individuals and legal entities, financing and submission of the required documentation shall be provided by them.

      6. Healthcare-epidemiological expertise shall not be conducted if there is unfit food and food stock.

      7. Chemical and biological agents, recognized potentially hazardous to human health or the future generations upon the results of healthcare-epidemiological expertise or scientific examination, shall be prohibited for use in the Republic of Kazakhstan. Register of potentially hazardous chemical and biological substances, prohibited for use in the Republic of Kazakhstan, shall be published in the print media.

      8. State bodies of sanitary-epidemiological service on the basis of the results of inspection and (or) other forms of control, and (or) sanitary-epidemiological expertise shall issue a sanitary-epidemiological conclusion on:

      1) operated objects of industrial and civil purpose;

      2) the location of epidemically significant objects in the allocation of land;

      3) drafts of normative documentation on maximum permissible emissions and maximum permissible discharges of harmful substances and physical factors into the environment, zones of sanitary protection and sanitary-defended zones, raw materials and products;

      4) products, subject to state sanitary and epidemiological supervision, including the approval of shelf life and storage conditions for food products;

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

      9. On the basis of sanitary-epidemiological expertise, a sanitary-epidemiological conclusion shall be issued.

      10. Is excluded by the Law of the Republic of Kazakhstan, dated on 15.07.2011 No 461-IV (shall be enforced from 30.01.2012).
      Footnote. Article 62, as amended by the Laws of the Republic of Kazakhstan dated on 30.06.2010 No 297-IV (shall be enforced from 01.07.2010); dated on 06.01.2011 No 378-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 15.07.2011 No 461-IV (shall be enforced from 30.01.2012); dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication.); dated 16.05.2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication); dated 07.11.2014 No. 248-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 12. 2014 No. 269-V (shall be enforced from 01.01.2015); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 27.02.2017 No. 49-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 62-1. Sanitary and epidemiological audit

      1. Sanitary-epidemiological audit shall be conducted by the auditor.

      2. Sanitary-epidemiological audit shall be conducted on the basis of the requests of the objects owners, subject to state sanitary and epidemiological supervision (hereinafter- the "applicant"), taking into account specific tasks, terms and volumes of sanitary and epidemiological audit envisaged by the contract for conducting sanitary and epidemiological audit between the applicant and the auditor, which shall be concluded in accordance with the Civil Code of the Republic of Kazakhstan.

      3. The results of sanitary-epidemiological audit shall influence the determination of the degree of risk of epidemic-significant objects, subject to state sanitary-epidemiological supervision.

      Positive results of sanitary-epidemiological audit shall be the basis for releasing epidemically significant objects from inspections, conducted in a special order.

      4. For conducting sanitary-epidemiological audit, individuals and legal entities must meet the following qualification requirements:

      1) for individuals:

      availability of higher medical education of sanitary-hygienic profile;

      availability of the highest qualification category of a doctor of sanitary-hygienic profile in the relevant

      specialty or specialty of a general hygiene doctor;

      2) for legal entities, the presence of qualified personnel, meeting the requirements, established by subparagraph 1) of this paragraph in the staff.

      5. Individuals and legal entities shall be obliged to inform the state body in the sphere of sanitary and epidemiological welfare of population before the beginning of the activity on conducting sanitary and epidemiological audit in the order established by the Law of the Republic of Kazakhstan "On Permits and Notifications".

      6. The procedure for sanitary-epidemiological audit shall be carried out in several stages and shall include:

      1) registration of an application for a sanitary and epidemiological audit;

      2) preliminary analysis of the documents submitted by an applicant;

      3) conclusion of a contract for the conduct of sanitary and epidemiological audit;

      4) establishment of the objectives of sanitary and epidemiological audit;

      5) drawing up a plan for conducting sanitary and epidemiological audit;

      6) conducting of sanitary and epidemiological audit (inspection of the object, analytical processing of materials, conducting comparative analysis and assessment of the degree of sanitary and epidemiological danger of planned or ongoing activities, sufficiency and reliability of justifications for the realization of an object);

      7) compilation and submission of an audit report to the applicant.

      7. For conducting of sanitary-epidemiological audit, financing shall be provided and the required documentation shall be submitted in the manner established by paragraph 8 of this Article by the applicant.

      8. For conducting of sanitary-epidemiological audit of the object, the applicant shall submit the following documents to the auditor:

      1) an application for conducting of sanitary-epidemiological audit;

      2) materials, relating to the object, subject to sanitary and epidemiological audit (acts of examinations of the bodies of state sanitary and epidemiological service for the last year (in the absence of the latter), approved by the head of the state body in the field of sanitary and epidemiological welfare of the population, the form of determining the degree of risk of an epidemic-significant object, sanitary and epidemiological conclusion on the compliance of the object with the requirements of sanitary regulations);

      3) in the presence, documentation on the management system of the economic subject and previous conclusions on sanitary-epidemiological audit;

      4) other materials, necessary for the assessment of the object.

      9. Auditors, included in the state electronic register of permits and notifications shall be obliged to provide annually to the state body in the sphere of sanitary and epidemiological welfare of population, by the fifteenth October of the reporting year, information on the conducted sanitary and epidemiological audit in accordance with the form, approved by the state body in the sphere of sanitary and epidemiological welfare of population.

      10. Based on the results of sanitary and epidemiological audit carried out in accordance with the plan, an audit report shall be prepared on the compliance (non-compliance) of the object with sanitary rules in accordance with the form, established by the procedure for conducting sanitary epidemiological audit.

      11. Criteria for assessing the degree of risk of epidemic-significant objects and calculation of criteria for sanitary and epidemiological risks shall be determined by the procedure for conducting sanitary-epidemiological audit.

      The procedure for conducting sanitary and epidemiological audit shall be approved by the state body in the field of sanitary and epidemiological welfare of population.

      12. The results of sanitary-epidemiological audit shall be recognized as invalid in cases when in preparation of the audit report the following cases were admitted:

      1) violation of the procedure for conducting sanitary and epidemiological audit;

      2) non-fulfillment or distortion of the requirements of the legislation of the Republic of Kazakhstan, sanitary rules and hygienic standards;

      3) violations of the rights of citizens to a favorable environment for life and health, other sanitary and epidemiological rights and interests of population, the rights of the participants in sanitary and epidemiological process;

      4) other violations of the rights of parties, involved in sanitary-epidemiological audit.

      13. Auditors, carrying out sanitary epidemiological audit shall:

      1) provide comprehensive, objective, high-quality audit;

      2) comply with the requirements of the legislation of the Republic of Kazakhstan in the field of sanitary and epidemiological welfare of population and other regulatory legal acts;

      3) conduct sanitary-epidemiological audit on the basis of documents of state sanitary-epidemiological regulation, normative technical documents;

      4) observe the established deadlines and the procedure for conducting sanitary and epidemiological audit, provided by the terms of the contract.

      Footnote. Chapter 12 is supplemented by Article 62-1 in accordance with the Law of the Republic of Kazakhstan dated 29.12.2014 No. 269-V (shall be enforced from 01.01.2015).

Article 62-2. Restriction of the right for conducting sanitary and epidemiological audit

      It is prohibited to conduct sanitary-epidemiological audit by the auditor, the executors of which are:

      1) the participant, creditor of the audited subject;

      2) in labor contract or close relatives or possessors of the officials of the subject being audited, as well as of a shareholder (participant), owning ten or more percent of shares (stakes in the charter capital) of the subject being audited;

      3) have personal property interests in the subject being audited;

      4) have monetary obligations to the audited subject or such obligations are available to the audited subject before them, with the exception of the obligations to conduct sanitary and epidemiological audit.

      Footnote. Chapter 12 is supplemented by Article 62-2 in accordance with the Law of the Republic of Kazakhstan dated 29.10.2015 No. 376-V (shall be enforced from 01.01.2016).

Article 63. Expert examination of drugs, medical devices and medical equipment

      1. Expert examination of drugs, medical devices and medical equipment - a research or testing of drugs, medical devices and medical equipment for their safety, effectiveness and quality through physical, chemical, biological, pre-clinical (non-clinical) research, clinical studies, determination of bioequivalence as well as the study of documents of the registration dossier, regulations on standardization, submitted for registration of drug, medical device and medical equipment in the manner, defined by the authorized body.

      2. Expert examination of drugs, medical devices and medical equipment shall be referred to the state monopoly and shall be performed by a republican state enterprise on the basis of economic control rights, which is the state expert organization for circulation of drugs, medical devices and medical equipment.

      Prices for goods (works, services), produced and (or) realized by a state monopoly subject shall be established by the authorized body in agreement with the antimonopoly body.

      3. Requirements for the safety, effectiveness and quality of medicinal substances, medicinal raw materials, bulk products of medicines, original medicines, medicinal products (reproduced (generic), biological origin, biotechnological, immunobiological, homeopathic, biosimilars, authorized generics), medical equipment, medical products, bulk products of medical products shall be presented in the expertise of medicines, medical products and medical equipment in the manne,r determined by the authorized body.

      4. The grounds for negative conclusion of the expertise of safety, efficacy and quality of medicines, medical products and medical equipment shall be:

      1) failure to submit the complete set of the registration dossier after the issuance of comments to an applicant in the process of conducting the expertise within the time limits, established by the procedure determined by the authorized body;

      2) submission of inaccurate information by an applicant;

      3) lower safety and efficiency compared to previously registered analogues;

      4) lower quality and safety indicators, regulated by the State Pharmacopoeia of the Republic of Kazakhstan or pharmacopoeias recognized as operating on the territory of the Republic of Kazakhstan, or in comparison with previously registered analogues;

      5) the presence of substances and materials in the composition of a medicine prohibited for the use in the Republic of Kazakhstan;

      6) obtaining negative results of one of the stages of the expertise;

      7) discrepancy between actual production conditions and the quality assurance system for the conditions, ensuring the declared safety, efficiency and quality based on the results of the production assessment and the quality assurance system;

      8) an applicant's refusal to organize a visit to the enterprise (production site) in order to assess the production conditions and the quality assurance system, in accordance with the requirements of the legislation of the Republic of Kazakhstan.

      Footnote. Article 63, as amended by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 34-V (shall be enforced from the date of its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 63-1. Evaluation of safety and quality of drugs and medical devices, registered in the Republic of Kazakhstan

      1. Evaluation of safety and quality of drugs and medical devices, registered in the Republic of Kazakhstan shall be performed to reveal compliance of safety and quality of drugs, medical devices with the registration dossier, regulations on standardization, on the basis of which they were registered in the Republic of Kazakhstan.

      2. Evaluation of safety and quality of drugs, medical devices, registered in the Republic of Kazakhstan shall be referred to a state monopoly, and shall be performed by a republican state enterprise on the basis of economic control rights, which is the state expert organization for drugs, medical devices and medical equipment, that has testing laboratories, accredited in accordance with the legislature of the Republic of Kazakhstan.

      Prices for goods (works, services) produced and (or) realized by a state monopoly subject shall be established by the authorized body in agreement with the antimonopoly body.

      Footnote. Chapter 12 as amended by adding Article 63-1 in accordance with the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 34-V (shall be enforced from the date of its first official publication); as amended by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 64. Scientific and medical expert examination

      1. The objects of scientific and medical expert examination shall be:

      1) the draft programs of basic and aplied scientific researches;

      2) republican target scientific and medical programs;

      3) the results of the completed scientific and medical programs;

      4) scientific papers, nominated for the state awards of the Republic of Kazakhstan;

      5) scientific and medical developments, planned for practical application in healthcare.

      2. The order of scientific and medical expert examination shall be defined by the authorized body.

SECTION 4. PHARMACEUTICAL ACTIVITIES AND CIRCULATION OF MEDICATIONS, MEDICAL SUPPLIES AND MEDICAL EQUIPMENT
Chapter 13. PHARMACEUTICAL ACTIVITY

Article 65. The system of circulation of medications, medical devices and medical equipment

      A single system of circulation of medications, medical devices and medical equipment shall include:

      1) a state body for circulation of medications, medical devices and medical equipment;

      2) a state expert organization for circulation of medications, medical devices and medical equipment and its territorial subdivisions.

Article 66. Types of pharmaceutical activity

      1. Pharmaceutical activities shall include professional activities of individuals with higher or vocational secondary pharmaceutical education, as well as the legal entities, involved in healthcare.

      2. Pharmaceutical activity shall include the following types:

      1) production of drugs;

      2) production of medical supplies;

      3) production of medical equipment;

      4) manufacturing of drugs;

      5) manufacturing of medical devices;

      6) wholesale trade of medications;

      7) wholesale trade of medical products;

      8) wholesale trade of medical equipment;

      9) retail sale of medications;

      10) retail sale of medical products;

      11) retail sale of medical equipment.

Article 66-1. State Pharmacopoeia of the Republic of Kazakhstan

      1. The quality and safety of medicines on 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 establish a minimum level of quality and safety requirements for medicines guaranteed by the state.

      3. General Articles of the State Pharmacopoeia of the Republic of Kazakhstan shall define general requirements for:

      1) the quality of medicinal substances, medicinal raw materials and medicinal preparations;

      2) reagents, standard samples, methods and test methods used to control their quality;

      3) packaging materials and containers.

      4. Private Articles of the State Pharmacopoeia of the Republic of Kazakhstan shall define specific requirements for the quality of medicinal substances, medicinal raw materials and medicinal products.

      5. The requirements of the State Pharmacopoeia of the Republic of Kazakhstan shall be mandatory for individuals and legal entities, carrying out production, manufacture, selling, store, control and use of medicines.

      6. The State Pharmacopoeia of the Republic of Kazakhstan shall be harmonized with the leading pharmacopoeias of the world and shall be periodically updated in connection with a change in their standards.

      Footnote. Chapter 13 is supplemented with Article 66-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 67. Production of medications, medical devices and medical equipment

      1. Production of medications, medical devices and medical equipment - a pharmaceutical activity, including the range of all works, required for mass production of medications, medical devices and medical equipment, related to the purchase of raw materials and semi-products, technological process, including fulfillment of one of its phases, storage, sale of the produced output, as well as all kinds of the associated control.

      2. Production of medicines, medical products and medical equipment shall be carried out by subjects in the sphere of circulation of medicines, medical products and medical equipment in accordance with the rules, approved by the authorized body and on the basis of a license, obtained in accordance with the procedure, established by the legislation of the Republic of Kazakhstan.

      Subjects in the sphere of circulation of medicines, medical products and medical equipment in the production of medicines shall comply with the requirements of good manufacturing practices (GMP)

      3. The rules of production and quality control, as well as testing of stability and establishment of the shelf life and re-inspection of medicines, medical products and medical equipment shall be approved by the authorized body.

      4. Manufacture drugs, medical devices and medical equipment shall be prohibited if they:

      1) have not passed state registration in the Republic of Kazakhstan, with the exception of medicines, medical products and medical equipment intended for carrying out an expertise at their state registration, in debugging and launching equipment and technological processes, preclinical (non-clinical) tests, clinical researches, contractual production of medicines, medical products and medical equipment, medicinal substances, produced in conditions of appropriate production practice;

      2) without a license for production of medications, medical devices and medical equipment;

      3) in violation of production Rules and quality control of drugs, medical devices and medical equipment.

      5. Produced and imported medicines, medical products:

      1) should not contain in its composition dyes and auxiliary substances prohibited for the use in the Republic of Kazakhstan, the list of which shall be approved by the authorized body;

      2) should be subject to control in accordance with the normative document for the control of the quality and safety of medicines, medical products.

      6. Production and sale of patented medications, medical devices and medical equipment shall be performed in accordance with the legislation of the Republic of Kazakhstan in intellectual property area.

      7. Production of medical devices and medical equipment, designed for diagnostics or treatment must ensure their safety, provide their use in accordance with functional purposes and eliminate the risk of errors when interpreting the results of diagnostics or treatment.

      Footnote. Article 67, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (for the procedure of enactment see Art. 2).

Article 68. Manufacture of medicines and medical products

      Manufacture of medicines and medical products shall be carried out by the subjects in the sphere of circulation of medicines, medical products, having the appropriate license for the manufacture of medicines and medical products in accordance with the rules, approved by the authorized body. Manufactured medicines shall be subject to intra-pharmacovigilance in accordance with the procedure approved by the authorized body.

      Footnote. Article 68 as amended by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 69. Wholesale and retail trade of pharmaceuticals, medical devices and medical equipment

      1. Wholesale trade of drugs, medical devices and medical equipment shall be performed by the subjects involved in circulation of drugs, medical devices and medical equipment, and obtained the appropriate license for wholesale trade in pharmacy depots or have notified about working in the order, defined by the Law of the Republic of Kazakhstan "On administrative procedures".

      2. Retail trade of pharmaceuticals, medical devices and medical equipment shall be carried out by the subjects that are involved in circulation of drugs, medical devices and medical equipment, and have obtained the appropriate license for retail trade in pharmacies, drugstores, mobile pharmacy stations, or have notified on beginning of activity in the order, established by the Law of the Republic of Kazakhstan "On administrative procedures."

      3. Wholesale and retail trade of medicines, medical products and medical equipment shall be carried out in the manner determined by the authorized body.

      Subjects in the sphere of circulation of medicines, medical products and medical equipment, carrying out wholesale sale of medicines shall be obliged to comply with the requirements of the proper distribution practice (GDP), and those, who carry out the retail trade of medicines, with the requirements of proper pharmacy practice (GPP).

      The subjects in the sphere of circulation of medicines, medical products and medical equipment, having received a license or notified of the commencement of activities in accordance with the procedure determined by the legislation of the Republic of Kazakhstan, shall be allowed to perform wholesale and retail trade of goods, not related to medicines, medical products and medical equipment in accordance with the list approved by the authorized body.

      4. Wholesale and retail trade of drugs, medical devices and medical equipment shall be prohibited:

      1) if they have not passed the state registration in the Republic of Kazakhstan, except for the drug substances, produced under the Good Manufacturing Practice;

      2) if their quality has not been confirmed by a conclusion on safety and quality in accordance with the order, defined by the legislature of the Republic of Kazakhstan;

      3) if they do not meet the requirements of the legislation of the Republic of Kazakhstan;

      4) if they are expired;

      5) to the healthcare workers in healthcare organizations, except for the cases, provided in paragraph 6 of this Article;

      6) through temporary storage of medications, medical devices and medical equipment.

      5. Non-prescription sale of medicines, intended for the sale with the prescription of a doctor shall be forbidden.

      The rules for assigning medicines to a prescription sale, rules for prescribing, recording and storing prescriptions shall be approved by the authorized body.

      6. In remote settlements from the regional center, where there are no pharmacies, the sale of medicines and medical products may be carried out by individuals and legal entities through pharmacies in healthcare organizations, providing primary health care, counseling and diagnostic assistance, and through mobile pharmacies.

      In the absence of pharmacy points, retail trade of medicines and medical products can be carried out through healthcare organizations, providing primary health care, counseling and diagnostic assistance.

      In the absence of specialists with pharmaceutical education, specialists with medical education, who have been trained for their realization, shall be allowed to carry out retail trade of medicines and medical products.

      7. The medications, medical supplies and medical equipment, imported and produced in the territory of the Republic of Kazakhstan, shall be used, handled and operated on the territory of the Republic of Kazakhstan without restrictions before the expiration of the registration certificate.

      Footnote. Article 69, as amended by the Laws of the Republic of Kazakhstan dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 10.07.2012 No 34-V (shall be enforced from the date of its first official publication); dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication.); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (for the procedure of enactment see Art. 2); dated 29. 03. 2016 No. 479-V (shall be enforced from 01.01.2017).

Chapter 14. CIRCULATION OF DRUGS, MEDICAL DEVICES AND MEDICAL EQUIPMENT

Article 70. Development of drugs, medical devices and medical equipment

      1. The goal of developing drugs, medical devices and medical equipment shall be to create safe, effective and qualitative drugs, medical devices and medical equipment.

      2. The rights of a developer of drug products, medical devices and medical equipment shall be protected by the legislation of the Republic of Kazakhstan on intellectual property.

      3. The developer of drugs, medical devices and medical equipment must comply with the national standards’ requirements.

      4. The order of approving the names of the original drug shall be defined by the authorized body.

      Footnote. Article 70, as amended by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 31-V (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 71. The state registration, re-registration and amendments to the registration dossier of drugs, medical devices and medical equipment

      1. The state registration of drugs, medical devices and medical equipment - the procedure, aimed at estimation of lawfulness of presence at the pharmaceutical market, safety, efficacy and quality of drugs, medical devices and medical equipment, and introduction of the drug, medical devices and medical equipment to the State register of drugs, medical devices and medical equipment for a specified period of time, performed in the order, defined by the authorized body.

      2. The state re-registration of drugs, medical devices and medical equipment - the extension of validity of the state registration for a specified period of time, accompanied by the issuance of a new registration certificate under the same registration number as well as the introduction of the corresponding entry in the State Register of drugs, medical devices and medical equipment, performed in the order, established by the authorized body.

      3. Amendments to the registration dossier - the changes, made by an applicant to the registration dossier during the currency of the registration certificate, that do not affect safety, efficacy and quality of drugs, medical devices and medical equipment, and are subject to examination in the order, established by the authorized body.

      4. Medicines, medical products and medical equipment, produced in the Republic of Kazakhstan, as well as those, imported on its territory, shall be subjects to registration and re-registration, including:

      1) medicines under the trade names, indicating drug formulation, dosage, and packaging;

      2) original medicine;

      3) bulk products of medicines, medical products;

      4) new combinations of medicines previously registered in the Republic of Kazakhstan, indicating the drug formulation, dosage, packaging;

      5) medicines, registered earlier in the Republic of Kazakhstan, but produced by other producer organizations, in other drug formulations, with a new dosage, and packaging, other composition of auxiliary substances and name;

      6) medicinal substances not manufactured in good manufacturing practice;

      7) medicines of one holder of the registration certificate, produced in different countries at different production sites;

      8) medical products, including diagnostic reagents, contact lenses for vision correction, care products, medical equipment, taking into account their classification, depending on the degree of potential risk of medical use;

      9) medical products and medical equipment registered earlier in the Republic of Kazakhstan, but produced by other producer organizations;

      10) medical products and medical equipment registered earlier in the Republic of Kazakhstan, but produced in other modifications, with a new packaging, other composition of components or another name;

      11) medical products and medical equipment manufactured by one manufacturer at production sites, located (placed) in different countries;

      12) consumables for medical products and medical equipment, being medical products, except for those specially designed by the manufacturing organization for use with a medical product and medical equipment capable to function only with this consumable;

      13) medical products and medical equipment that are part of a specialized vehicle for the provision of medical assistance;

      14) sets (kits) of medical products;

      15) laboratory diagnostic devices;

      16) medical products and medical equipment intended for prevention, diagnosis, treatment of diseases, assessment of physiological state of the body, rehabilitation, medical procedures, medical research;

      17) medical products and medical equipment for the replacement and modification of parts of tissues, organs of man, restoration or compensation for impaired or lost physiological functions;

      18) medical products for the control of conceiving.

      5. Trade name of a drug - the name under which the drug shall be registered.

      6. Is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).
      7. Is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      8. Medicines, medical products and medical equipment, registered in the producing country and / or in the country holding the production license and (or) in the country- owner of the registration certificate, except for those intended for the prevention and treatment of socially significant and orphan diseases that are not registered (if justified) in the producing country and (or) in the country holding the production license, and (or) the country- owner of the registration certificate shall be subjects to state registration in the Republic of Kazakhstan.

      8-1. State registration of domestic medicines intended for export under different trade names shall be allowed with the issuance of one registration certificate valid on the territory of the Republic of Kazakhstan, subject to confirmation by the manufacturer of the identity of the composition, technological process, methods and quality control methods of medicines, manufactured for the domestic market of the country.

      For registering domestic medicines abroad, the authorized body shall issue a certificate for a pharmaceutical product (CPP) in accordance with the rules approved by the authorized body.

      9. Upon the decision of the authorized body, medicines, medical products and medical equipment can be registered according to the accelerated procedure for carrying out the expertise. The procedure for accelerated expertise of medicines, medical products and medical equipment shall be determined by the authorized body.

      10. After termination of the state registration, the drugs, medical devices and medical equipment shall be subject to re-registration in the Republic of Kazakhstan in the order, defined by the authorized body.

      11. An obligatory condition for state registration, re-registration, making changes of the registration dossier of medicines, medical products and medical equipment shall be the expertise of a medicine, medical product and medical equipment.

      An assessment of production conditions and quality assurance system shall be carried out by visiting the manufacturing organization at the expense of an applicant's funds at the state registration of a medicine, medical product and medical equipment in the manner determined by the authorized body.

      The expenses, associated with the expertise of a medicine, medical product and medical equipment for their state registration and re-registration shall be covered by the applicants.

      The registration dossier containing the documents, the list of which shall be determined by the authorized body, as well as samples of medicines, medical products, standard samples of medicinal substances and their impurities, in quantities sufficient for triplicate analysis, specific reagents and consumables (in exclusive cases and on the return condition) shall be submitted to an expert organization.

      12. State registration shall not subject to:

      1) medicines manufactured in pharmacies;

      2) medicinal substances produced under good manufacturing practices;

      3) pharmacopoeial medicinal plant raw material;

      4) medical products manufactured in shops of medical equipment and medical products under individual orders;

      5) products of medical optics made in optics shops;

      6) exhibition samples of medicines, medical products and medical equipment for carrying out exhibitions without the right to further realization;

      7) samples of medicines, medical products and medical equipment coming in for preclinical (non-clinical), clinical studies and (or) testing;

      8) scientific research laboratory diagnostic devices;

      9) laboratory instruments not used for the diagnosis of diseases;

      10) components, that are parts of the medical product and medical equipment and are not used as an independent product or device.

      13. An application for state registration and re-registration, amendments to the registration dossier of medicines, medical products and medical equipment shall be submitted by the developer or producer (manufacturer) or their authorized representative.

      Accounting and systematization of documents, submitted by an applicant for state registration, re-registration and amendments to the registration dossier of a medicine, a medical product and medical equipment subject to agreement or approval shall be carried out in the manner determined by the authorized body.

      State registration, re-registration, amendments to the registration dossier of medicines, medical products and medical equipment shall be carried out by the state body in the sphere of circulation of medicines, medical products and medical equipment on the basis of the statement and positive conclusion of the expert organization on the safety, efficiency and quality of a medicine, a medical product and medical equipment, issued on the basis of the expertise results.

      14. Fee shall be charged for the state registration, re-registration and issuance of a duplicate of a registration certificate of drug products, medical devices and medical equipment in the order, defined by the tax legislature of the Republic of Kazakhstan.

      15. The applicant shall be refused a state registration and re-registration and making amendments to the registration dossier of a medicine, medical products and medical equipment in cases of negative conclusion based on the results of the expertise of the state expert organization in the sphere of circulation of medicines, medical products and medical equipment and failure to submit the full package of documents, established in the manner determined by the authorized body.

      16. Upon the results of the state registration and re-registration of drug, medical devices and medical equipment, a state registration certificate shall be issued and its sample shall be specified by the authorized body.

      17. A decision on the state registration of drugs, medical devices and medical equipment may be revoked in the order, defined by the authorized body.

      18. During the validity period of the registration certificate, the manufacturer shall be responsible for the quality of the registered drugs, medical devices and medical equipment, available at the market of the Republic of Kazakhstan, that must comply with the samples, submitted for the state registration, re-registration and characteristics, specified in the registration dossier and be attached with the documents, containing information for a consumer, approved by the authorized body.

      19. The state expert organization in the sphere of circulation of medicines, medical products and medical equipment and the state body in the sphere of circulation of medicines, medical products and medical equipment shall not allow without the consent of an applicant to disclose and use for commercial purposes of medicines provided for state registration, confidential information, contained in the application for state registration, materials of expertise of medicines, as well as in the registration dossier of a medicine, containing new chemical substances, for six years from the date of state registration of the medicine.

      20. The provisions, envisaged in paragraph 19 of this Article, that do not allow the disclosure and use of confidential information for commercial purposes shall not apply to:

      1) individuals or legal entities, that have been issued a compulsory license for using the medicine in accordance with the Patent Law of the Republic of Kazakhstan;

      2) usage, production, import, export or distribution of a medicine for non-commercial purposes.

      21. On the basis of a court decision, the disclosure and use of the information, specified in paragraph 19 of this Article shall be allowed without the consent of an applicant, in the presence of one of the following cases:

      1) if the supply of medicines is insufficient to meet the needs of the population within twelve months from the date of registration in the Republic of Kazakhstan;

      2) the need to protect public health in emergency situations or to ensure national security;

      3) identification of actions, violating the requirements of the legislation of the Republic of Kazakhstan in the field of competition protection.

      Footnote. Article 71, as amended by the Law of the Republic of Kazakhstan; dated on 10.07.2012 No 34-V (shall be enforced from the date of its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 27.10.2015 No. 365-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 72. Preclinical (non-clinical) researches of biologically active substances, pharmacological, medicinal products, medical devices and medical equipment

      1. The purpose of preclinical (non-clinical) researches of biologically active substances, pharmacological, medicinal products, medical devices and medical equipment shall be the receipt of assessments and evidences of pharmacological activity and (or) safety by scientific methods.

      2. The procedure for conducting preclinical researches, requirements for preclinical databases shall be determined by the authorized body.

      Footnote. Article 72 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 73. Technical testing of medical devices and medical equipment

      1. The purpose of technical testing of medical devices and medical equipment is to harmonize technical characteristics of medical devices and medical equipment with the national standards.

      2. Is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).
      Footnote. Article 73, as amended by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 31-V (shall be enforced upon expiration of ten calendar days after its first official publication.); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 74. Clinical researches of pharmacological, medicinal products, medical devices and medical equipment

      1. Clinical researches of pharmacological, medicinal products, medical devices and medical equipment shall be conducted with the participation of a person as a subject to identify or confirm clinical, pharmacological and (or) pharmacodynamic effects of the tested pharmacological or medicinal product, medical device and medical equipment, and ( or) identifying adverse reactions, and (or) for the purpose of studying absorption, distribution, biotransformation and excretion to establish safety and efficiency.

      2. Clinical researches shall be divided into interventional and non-interventional.

      An interventional research is a study involving a person as a subject of the research, in which the doctor, on the basis of the protocol of an interventional clinical research corresponding to the order of conducting clinical studies, determined by the authorized body, shall assign special intervention to the subjects of the research.

      In an interventional research, the subjects of the study shall be subjected to a diagnostic, therapeutic or other type of intervention that can be administered in an accidental or non-random way, with further monitoring of the patients and evaluation of biomedical results and results for health.

      A non-interventional research is a study that is conducted after the state registration of a medicinal product and shall be prescribed in the framework of medical practice in accordance with the instruction for medical use, approved by the authorized body.

      The protocol of a non-interventional clinical research corresponding to the order of conducting clinical studies, determined by the authorized body shall not determine in advance the purpose of the drug to the subject of the research and its inclusion in the study, but describes epidemiological methods for collecting data on the safety and efficacy of the drug. Subjects of the research shall not be subjected to additional diagnostic or monitoring procedures.

      3. The procedure for conducting clinical researches, requirements for clinical databases shall be determined by the authorized body.

      Footnote. Article 74 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 75. Labeling of drug product, medical device and medical equipment

      1. Medicines should come into circulation with the labeling, printed on the consumer packaging (primary and secondary), with a well-read typeface in the Kazakh and Russian languages, and with an instruction for medical use.

      2. Medical devices and medical equipment should come into circulation with the labeling, printed directly to the medical device and medical equipment, and (or) to the consumer packaging, and with an instruction for medical use on a medical device and operational document for a medical equipment.

      The rules for labeling of a medicine, medical devices and medical equipment shall be approved by the authorized body.

      The procedure for preparation and design of instructions for the medical use of medicines and medical products shall be determined by the authorized body.

      3. It shall be allowed to use stickers during importation of the limited number of expensive, rarely used, and orphan drugs.

      Applying of stickers on a consumer package shall be performed in the order, defined by the authorized body.

      Footnote. Article 75, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 76. Purchase of medicines and medical products intended to provide a guaranteed volume of free medical care and additional medical care

      1. Medicines intended to provide a guaranteed volume of free medical care and additional medical assistance shall be purchased under international non-proprietary names, and in the case of individual patient intolerance, under trade names. In the case of purchasing a multicomponent medicine, its composition shall be indicated.

      2. For the purpose of optimal and effective expenditure of budget funds allocated for the purchase of medicines and medical products within the guaranteed volume of free medical care and mandatory social medical insurance, medicines and medical products shall be purchased at prices not exceeding those, specified by the authorized body.

      Footnote. Article 76 is in the wording of the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2017).

Article 77. Single Distributor

      1. A single distributor shall be determined by the Government of the Republic of Kazakhstan.

      The main activity of a single distributor shall be:

      1) selection of suppliers;

      2) concluding of contracts for the supply of medicines and medical products;

      3) concluding of long-term contracts for the supply of medicines, medical devices and (or) storage and transportation of medicinal products, medical devices;

      4) concluding of long-term contracts for the supply of medical equipment from a legal entity that has a certificate of origin of goods for internal circulation in accordance with the legislation of the Republic of Kazakhstan and a document, confirming the production of medical equipment in accordance with the requirements of international standards for the List of Medicines, Medical Devices and Medical Equipment ;

      5) provision of medicinal products and medical devices according to the List of medicines, medical devices and medical equipment;

      6) purchase of medicines and medical products, services for storing and transporting of medicines and medical products;

      6-1) purchase of pharmaceutical services;

      6-2) purchase of services for accounting and sale of medicines and medical products;

      7) organization of purchase of medical equipment within the guaranteed volume of free medical care.

      2. The principles of purchase of medicines and medical products shall be:

      1) providing potential suppliers with equal opportunities to participate in the purchase process;

      2) fair competition among potential suppliers;

      3) publicity and transparency of the purchase process;

      4) support of domestic commodity producers.

      3. A single distributor shall be responsible for non-fulfillment and (or) improper performance of his (her) duties in accordance with the laws of the Republic of Kazakhstan.

      Footnote. Article 77 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 78. Storage and transportation of drugs, medical devices and medical equipment

      1. Medicines, medical devices and medical equipment shall be stored and transported in conditions that ensure their safety, efficiency and quality, in accordance with the rules for storage and transportation of medicines, medical devices and medical equipment approved by the authorized body.

      Subjects in the sphere of circulation of medicines, medical devices and medical equipment, carrying out transportation and storage of medicines shall be obliged to comply with the requirements of proper distribution practice (GDP) or good pharmacy practice (GPP).

      2. It shall be prohibited to extend the shelf-life of drugs, medical devices.

      Footnote. Article 78, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (for the procedure of enactment see Art. 2).

Article 79. Destruction of medicines, medical devices and medical equipment

      Medicines, medical products and medical equipment that have become unusable, falsified, expired, and others that do not meet the requirements of the legislation of the Republic of Kazakhstan shall be considered unfit for realization and medical use and shall be subjects to destruction by entities in the sphere of circulation of medicines, medical devices and the medical equipment at their disposal, in the manner prescribed by the authorized body.

      Footnote. Article 79 is in the wording of the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 80. The order of importation of drugs, medical devices and medical equipment

      1. Import of medicines, medical products and medical equipment to the territory of the Republic of Kazakhstan shall be carried out in accordance with the procedure determined by the authorized body in accordance with the customs legislation of the Eurasian economic union and (or) the Republic of Kazakhstan.

      2. Import of drugs, medical devices and medical equipment into the territory of the Republic of Kazakhstan shall not be permitted if the medicinal products have not passed the state registration in the Republic of Kazakhstan, except for the drug substances, manufactured under the Good Manufacturing Practice, and the cases, referred to in paragraph 3 of this Article, Article 80-2 of this Code.

      3. Import of drugs, medical devices and medical equipment into the territory of the Republic of Kazakhstan, not registered in the Republic of Kazakhstan shall be allowed under a resolution (permission), issued by the authorized body if they are intended for:

      1) organization of clinical research;

      2). expertise of drugs;

      3). the state registration of drugs, medical devices and medical equipment;

      4). medical care for a particular patient for life saving, or medical care for a particular group of patients with rare and (or) the most severe disease;

      5). organization of exhibitions without the right for their further distribution;

      6). prevention and (or) elimination of emergency situations;

      7) equipment of healthcare organizations with the unique medical technology, registered in the Republic of Kazakhstan, as well as the equipment of the medical purpose, related and designed for complement of the unique medical devices;

      8). introduction of innovative medical technologies;

      4. It is prohibited to import to the territory of the Republic of Kazakhstan as a humanitarian aid of medicines, medical devices and medical equipment that have not passed state registration, except for certain cases determined by the authorized body.

      Medicines, medical devices and medical equipment (including unregistered ones) intended for humanitarian assistance or assistance in emergency situations shall be imported into the Republic of Kazakhstan on the basis of a conclusion (authorization document), issued in accordance with the procedure determined by the authorized body.

      5. The drugs, medical devices and medical equipment, imported into the territory of the Republic of Kazakhstan, not complying with the legislation of the Republic of Kazakhstan on healthcare, shall be confiscated and destroyed.

      Footnote: Article 80 is in the wording of the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 80-1. The persons, entitled to import drugs, medical devices and medical equipment to the Republic of Kazakhstan

      Import of medicines, medical devices and medical equipment to the territory of the Republic of Kazakhstan in the manner determined by the authorized body may be carried out:

      1) by producer-organizations, licensed to manufacture drugs, medical devices and medical equipment;

      2) by individuals or legal entities, licensed for wholesale trade of drugs or included in the register of healthcare subjects, engaged in wholesale trade of medical devices and medical equipment, according to the notice of the commencement of business;

      3) by research organizations, laboratories for development and state registration of drugs, medical devices and medical equipment in accordance with this Code;

      4) by foreign manufactures of drugs, medical devices and medical equipment, their authorized representatives (affiliates) or their authorized individuals and legal entities for examination in the state registration, clinical testing, and (or) research, and for participation in exhibitions of manufacturers of drugs, medical devices and medical equipment in the Republic of Kazakhstan;

      5) by healthcare organizations for providing medical activities.

      Footnote. The Code shall be supplemented by Article 80-1 in accordance with the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 29 .09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 80-2. Import of medicines, medical devices and medical equipment, as well as biologically active substances, pharmacological agents and biological material of preclinical (non-clinical) and clinical studies, standard samples of medicinal substances and their impurities for the personal use and other non-commercial purposes

      Footnote. Title of Article 80-2 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      1. Drugs, medical devices and medical equipment shall be imported with a permission of the authorized body if they are intended for:

      1). personal use of the individuals, representatives of the diplomatic missions and international organizations;

      2) treatment of passengers and crew members of vehicles, train crews and drivers of vehicles arriving in the customs territory of the Eurasian Economic Union;

      3). treatment of the participants of cultural and sports events, and the members of international expeditions;

      2. In the cases, specified by paragraph 1 of this Article, importation of drugs, medical devices and medical equipment, not registered in the Republic of Kazakhstan, shall be permitted.

      3. Biologically active substances, pharmacological agents, biological material of preclinical (non-clinical) and clinical studies, standard samples of medicinal substances and their impurities shall be imported without the permission of the authorized body.

      4. Import to the territory of the Republic of Kazakhstan of biologically active substances, pharmacological agents, biological material of preclinical (non-clinical) and clinical studies, standard samples of medicinal substances and their impurities shall be carried out by:

      1) manufacturing organizations that have a license to produce medicines and medical products;

      2) foreign organizations - manufacturers of medicines and medical products, their authorized representative offices (branches) or their authorized individuals and legal entities;

      3) scientific research organizations, laboratories in the field of healthcare, education and science.

      Footnote. The Code shall be supplemented by Article 80-2 in accordance with the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 80-3. Interaction of the authorized body and the authorized body in the sphere of customs affairs

      1. When moving across the customs border of the Eurasian economic union, coinciding with the State border of the Republic of Kazakhstan of medicines, medical devices and medical equipment, the authorized body in the field of customs affairs shall be provided with information, confirmed by the authorized body on the state registration of each of the imported medicines, medical products and medical equipment with the indication of the date and number of state registration, except for the cases, stipulated by paragraphs 3 and 4 of Article 80, Article 80-2 of this Code.

      2. The authorized body in the field of customs affairs shall submit information to the authorized body on the importation into the territory of the Republic of Kazakhstan across the customs border of the Eurasian economic union, coinciding with the State border of the Republic of Kazakhstan, and export from the territory of the Republic of Kazakhstan across the customs border of the Eurasian economic union, Republic of Kazakhstan of medicines, medical products and medical equipment.

      Footnote. The Code is supplemented by Article 80-3 in accordance with the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); is in the wording of the Law of the Republic of Kazakhstan dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 81. The procedure for removal of medicines, medical products and medical equipment, as well as biologically active substances, pharmacological and biological materials of preclinical (nonclinical) and clinical studies, standard samples of medicinal substances and impurities

      Footnote. Title of Article 81 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after the day of its first official publication).

      1. Export of medicines, medical products and medical equipment from the territory of the Republic of Kazakhstan shall be carried out in the manner approved by the authorized body.

      2. Medicines, medical products and medical equipment may be exported from the territory of the Republic of Kazakhstan without an approval of the authorized body:

      1) for personal use in the amount required for a course of treatment, by the individuals, leaving the territory of the Republic of Kazakhstan;

      2) in the first-aid kits of a vehicle, leaving the territory of the Republic of Kazakhstan, for treatment of passengers.

      3) exhibition samples, imported at the permission of the authorized body for exhibitions;

      4) medical equipment, imported for preclinical (non-clinical) or clinical studies.

      3. Export of drugs, medical devices and medical equipment from the territory of the Republic of Kazakhstan as part of material and technical devices of medical and rescue organizations and groups, leaving the territory of the Republic of Kazakhstan to liquidate emergency situations, shall be performed in the order, established by the Government of the Republic of Kazakhstan.

      3. Export of medicines, medical products and medical equipment from the territory of the Republic of Kazakhstan as part of material and technical devices of medical and rescue organizations and groups, leaving the territory of the Republic of Kazakhstan to participate in the liquidation of emergency situations shall be carried out in the manner, determined by the authorized body .

      4. Biologically active substances, pharmacological agents and biological materials of preclinical (non-clinical) and clinical studies, standard samples of medicinal substances and their impurities can be exported from the territory of the Republic of Kazakhstan without the permission of the authorized body.

      5. Export from the territory of the Republic of Kazakhstan of biologically active substances, pharmacological agents, biological material of preclinical (non-clinical) and clinical studies, standard samples of medicinal substances and their impurities shall be carried out by:

      1) manufacturing organizations, having a license to produce medicines and medical products;

      2) foreign organizations, producing medicines and medical products, their authorized representative offices (branches) or their trusted individuals and legal entities;

      3) scientific research organizations, laboratories in the field of healthcare, education and science.

      Footnote. Article 81, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 12. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 15. GENERAL SAFETY REQUIREMENTS TO DRUGS, MEDICAL DEVICES AND MEDICAL EQUIPMENT

Article 82. Installation, repair, technical and metrological maintenance of medical devices and medical equipment

      1. Installation, repair, technical and metrological maintenance of medical equipment and in some cases medical products shall be performed by individuals or legal entities, entitled to conduct these works in accordance with the legislation of the Republic of Kazakhstan.

      2. The level of security of medical devices and medical equipment after the repair should not be below the level of safety, established by the technical certificate of medical devices and medical equipment.

      3. The organization of metrological support of measuring instruments of medical purpose, operated in healthcare organizations, shall be regulated in accordance with the legislation of the Republic of Kazakhstan in the field of technical regulation.

      4. Medical technology, which is a means of measurement, shall be registered in the Registrar of the state traceability system of the Republic of Kazakhstan and shall be allowed for use in accordance with the legislation of the Republic of Kazakhstan on uniformity of measurements.

      The list of medical equipment, being a means of measurement, shall be approved by the authorized body in coordination with the authorized body in the scope of technical regulation.

      Footnote. Article 82 as amended by the Law of the Republic of Kazakhstan dated 29. 10. 2015 No. 376-V (shall be enforced from 01.01.2016).

Article 83. Safety classification and safety reclassification of medical devices and medical equipment, depending on the potential risk degree

      1. Medical devices and medical equipment, used in the Republic of Kazakhstan, shall be divided into the safety classes, depending on the potential risk degree of making harm to patients, staff, operating medical devices and medical equipment, and other persons.

      Each safety class shall include the groups and types of medical products and medical equipment, meeting certain technical regulations. Medical devices and medical equipment may not simultaneously belong to several safety classes.

      2. The rules of safety classification of medical devices and medical technology shall be approved by the authorized body in coordination with the competent authorized body for technical regulation.

      3. Classification principles of medical devices and medical equipment shall take into account:

      1) the duration of use;

      2) invasiveness;

      3) presence of contact with an organism or interaction with it;

      4) a mode of administration into the body;

      5) application for the vital organs;

      6) the use of energy sources.

      4. Affiliation to the safety classes of medical products, medical devices and medical equipment shall be defined by the authorized body during their state registration.

      5. A manufacturer shall be entitled to conduct reclassification, at least in two years after the state registration if there are grounds for the safety re-classification of the registered medical products, medical devices and medical equipment, in the order, established by legislation of the Republic of Kazakhstan in healthcare.

      6. The authorized body may introduce changes in classification, taking into account the principles, characteristics, medical techniques, used for the work of medical devices and medical equipment.

Article 84. Prohibition, suspension or withdrawal from circulation or restriction of the use of medicines, medical devices and medical equipment

      Footnote. Title of Article 84 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      1. The authorized body may prohibit or suspend the use, sale or production of medicines, medical devices and medical equipment, as well as to make a decision to withdraw from circulation or restrict application in the following cases:

      1) non-compliance of medicines, medical devices and medical equipment with the requirements of the legislation of the Republic of Kazakhstan on safety, efficiency and quality of medicines, medical devices and medical equipment;

      2) revealing of side effects of drugs that are hazardous to human health, not specified in the instructions for medical use of the medicine, or increasing the frequency of detection of serious side effects, specified in the instructions, or low therapeutic effectiveness (lack of therapeutic effect), or in the presence of information on its suspension and / or withdrawal from the market of other countries in connection with identification of serious side effects with an unfavorable ratio of benefit and risk;

      3) detection of defects in design, mode of operation, production performance, affecting their safety when applying medical devices or medical equipment;

      4) violation of the approved process of production of drugs, medical devices and medical equipment, affecting their quality, safety and efficiency;

      5) the available data on harming the health of a patient or a consumer, caused by the use of drugs, medical devices and medical equipment;

      6) obtaining the data on insufficiency of scientific and technological level of production technology and quality control, reducing the safety level of drugs, medical devices and medical equipment.

      7) obtaining a substantiation of the owner of the registration certificate on suspension, withdrawal of the registration certificate or withdrawal from circulation or restriction of the use of medicines, medical devices and medical equipment.

      2. The rules for prohibition, suspension, withdrawal or restriction from circulation of medicines, medical devices and medical equipment shall be approved by the authorized body.

      Footnote. Article 84, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 84-1. Falsified medicines, medical devices and medical equipment

      1. Production, import, storage, use and sale of falsified medicines, medical devices and medical equipment on the territory of the Republic of Kazakhstan shall be prohibited.

      2. Falsified medicines, medical devices and medical equipment shall be destroyed in the manner determined by the authorized body.

      3. Persons and subjects, involved in the circulation of medicines, medical devices and medical equipment for the production, storage, distribution, sale of falsified medicines, medical devices and medical equipment shall be liable in accordance with the laws of the Republic of Kazakhstan.

      4. Falsification of medicines, medical devices and medical equipment (presentation of unreliable information about characteristics and (or) origin) also includes accessories, parts and materials, manufactured and intended for the production of falsified products, as well as documents, related to the product or its production and (or) distribution.

      5. Prevention and combating of falsification of medicines, medical devices and medical equipment shall be carried out by the authorized body with interested state bodies, manufacturing organizations, healthcare subjects, public organizations.

      6. The authorized body shall carry out international cooperation in the fight against falsified medicines, medical devices and medical equipment.

      Footnote. Chapter 15 is supplemented with Article 84-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 85. Pharmacovigilance of medicines and monitoring of side effects of medicines, medical devices and medical equipment

      1. The authorized body shall conduct pharmacovigilance of medicines on the territory of the Republic of Kazakhstan.

      2. The procedure for pharmacovigilance of medicines and monitoring of side effects of drugs, medical devices and medical equipment shall be determined by the authorized body.

      3. Subjects of healthcare shall be obliged to inform the authorized body about the facts of special interaction of a medicine with other medicines and side effects, including those not specified in the instruction for the use of the medicine, medical device and the manual for the operation of medical equipment.

      Footnote. Article 85 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 86. Information on medicines, medical devices and medical equipment

      Footnote. Title of Article 86 as amended by the Law of the Republic of Kazakhstan dated 6. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      Information on medicines, medical devices and medical equipment approved for the use on the territory of the Republic of Kazakhstan, on medicines that have not passed state registration, not meeting the requirements of the legislation of the Republic of Kazakhstan in the field of healthcare, on recalling the decision on state registration, as well as on the drugs, released by doctor’s prescription shall be provided in specialized printed publications, intended for medical and pharmaceutical workers.

      Footnote. Article 86 as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

SECTION 5. PROTECTION OF PUBLIC HEALTH
Chapter 16. RIGHTS AND RESPONSIBILITIES IN HEALTHCARE AND WARRANTIES OF THEIR SECURITY

Article 87. Guarantees of rights security in healthcare

      The state shall guarantee the citizens of the Republic of Kazakhstan:

      1) the right for health care;

      2) provision of the guaranteed volume of free medical care;

      3) equal access to medical care;

      4) quality of health care;

      5) the availability, quality, effectiveness and safety of drugs;

      6) taking of measures to prevent diseases, promote healthy lifestyles and healthy eating;

      7) privacy, preservation of information, which is a part of doctor-patient confidentiality;

      8) freedom of reproductive choice, protection of reproductive health and observance of reproductive rights;

      9) healthcare-epidemiological, environmental welfare and radiation safety.

Article 88. The citizens’ rights

      1. Citizens of the Republic of Kazakhstan shall have the right to:

      1) the guaranteed volume of free medical care in accordance with the list, approved by the Government of the Republic of Kazakhstan;

      2) the drugs and medical devices in the frames of the guaranteed volume of free medical care, including provision of the certain categories of people with certain diseases (statuses) with free or the reduced-price drugs and specialized medical products on an outpatient basis in accordance with the list, approved by the authorized body;

      3) free choice of a medical organization, qualitative and timely medical assistance;

      4) additional medical services in excess of the guaranteed volume of free medical care at the expense of own funds, funds of the organizations, voluntary health insurance system and other non-prohibited sources;

      5) receiving medical assistance abroad at the expense of budgetary funds in the presence of evidences in the manner determined by the authorized body;

      6) compensation for the harm, caused to the health by wrong assignment and use of drugs, medical devices and medical equipment by the health workers;

      7) certification of temporary disability with the issuance of a temporary disability leave or a temporary disability certificate;

      8) receive reliable information on prevention, diagnosis, treatment and rehabilitation, clinical studies, factors, affecting health, including the environment, working conditions, living and recreation, healthy food and food safety, including the conclusions of healthcare-epidemiological expertise from the state bodies, organizations and attending physician within their competence;

      9) receive information on safety, efficacy and quality of drugs sold, medical devices and medical equipment from the state bodies, independent expert organizations and subjects, involved in circulation of drugs, medical devices and medical equipment;

      10) appeal the actions (or inaction) of medical and pharmaceutical personnel in healthcare organization, higher authority and (or) in a judicial procedure;

      11) an application for attracting independent experts in case of disagreement with the findings of the state medical expertise.

      12) voluntary will for the possibility of withdrawing after death of tissues (parts of tissue) and (or) organs (parts of organs) for the purpose of transplantation.

      2. A woman has the right to resolve an issue on motherhood and the free choice of modern methods of unwanted pregnancy prevention for family planning and protection of her health.

      The right of citizens to protection of maternity shall be provided by:

      1) a medical examination within the frames of the guaranteed volume of free medical care, dynamic screening and health improvement of women of reproductive age;

      2) medical treatment of major diseases, directly affecting women's reproductive health and child’s health, when being hospitalized for care for a sick child.

      Working hours, maternity leave and working conditions of pregnant women and nursing mothers shall be established in accordance with the labor legislation of the Republic of Kazakhstan.

      3. Persons with sexual identity disorders, except for the persons with mental disorders (diseases), shall have the right to change their gender.


      The rules for medical examination and sex change for the persons with sexual identity disorders shall be established by the authorized body.

      4. Citizens, whose freedom is limited, as well as the persons, serving sentence on the verdict of the court in places of deprivation of liberty, placed in special institutions, shall receive medical assistance in the manner determined by the bodies of the penal system, in agreement with the authorized body. These persons shall enjoy all the above rights of citizens of the Republic of Kazakhstan when they receive medical assistance.

      5. Foreigners and stateless persons permanently residing on the territory of the Republic of Kazakhstan shall be entitled to receive a guaranteed volume of free medical care on an equal basis with the citizens of the Republic of Kazakhstan.

      Foreigners and stateless persons temporarily residing on the Republic of Kazakhstan shall have the right to receive a guaranteed volume of free medical care for acute diseases that are dangerous to others, in accordance with the list, determined by the authorized body, unless otherwise stipulated by laws and international treaties ratified by the Republic Kazakhstan.

      5-1. Refugees, as well as asylum seekers, shall be provided with preventive, diagnostic and therapeutic medical services that have the greatest proven effectiveness, in the manner and in the volume, determined by the authorized body;

      6. Is excluded by the Law of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).
      Footnote. Article 88, as amended by the Laws of the Republic of Kazakhstan dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 08.01.2013 No 64-V (shall be enforced from 01.01.2013); dated on 15.04.2013 No 89-V (shall be enforced upon expiration of thirty calendar days after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016); dated 30.06.2017 No. 80-VI (shall be enforced from 01.01.2018).
     

Article 89. Children's rights

      1. Every child shall have the right to:

      1) use modern and effective healthcare services and devices for medical treatment and health rehabilitation;

      2) get education in healthcare protection;

      3) medical examinations and case follow-ups, treatment, drug supply and health improvement in the frames of the guaranteed volume of free medical care.

      2. When hospitalized the children:

      1) under three years old, and very sick older children, who, according to the doctors, need additional care, the mother (father) or any other person, taking care of the child, shall have the opportunity to be with him in the medical organization with the issuance of a temporary disability leave;

      2) a nursing mother with a child under one year of age shall be provided with free meals in a medical organization for the whole period of a child’s hospitalization.

      3. School-age children during their inpatient, rehabilitation treatment shall have the right for regular training in the hospital, rehabilitation centerand sanatorium.

      Patients of the children's inpatient departments and specialized children’s inpatient medical organizations shall have the necessary conditions for games, recreation and educational work.

      4. The children with disabilities, as well as HIV-infected, and AIDS patients shall have the right for a free medical and educational support in education and healthcare organizations, in accordance with the legislation of the Republic of Kazakhstan in healthcare.

      The HIV-infected children shall have a right to stay in orphanages and other medical and educational institutions for general purpose.

      5. The list of medical contraindications to place children in the orphanage and education organizations, organizations for orphans and children left without parental care shall be approved by the authorized body.

Article 90. Duties of citizens, individual entrepreneurs and legal entities

      1. Citizens shall be obliged to:

      1) preserve their health;

      1-1) pay contributions to compulsory social health insurance in accordance with the Law of the Republic of Kazakhstan "On Compulsory Social Health Insurance";

      2) observe the regime, acting in healthcare organizations;

      3) undergo preventive medical examinations in accordance with the legislature of the Republic of Kazakhstan in healthcare;

      4) observe the requirements of medical workers, bodies and healthcare organizations, related to the individual and public health;

      5) observe precautions to protect their own health and the health of others, to pass screening and treatment on demand of healthcare organizations, to inform medical staff about the disease in infectious diseases and the diseases, posing threat to others.

      In case of evasion from medical examination and treatment, the citizens, the patients with the diseases, dangerous to others, shall be subject to mandatory examination and treatment in accordance with this Code and other laws of the Republic of Kazakhstan.

      The grounds and procedure for sending the people, suffering from diseases dangerous to others, to mandatory treatment, shall be regulated by this Code;

      6) observe the legislation of the Republic of Kazakhstan in healthcare.

      2. Pregnant women up to twelve weeks of pregnancy shall have to start the medical records.

      3. Foreigners and stateless persons, residing in the territory of the Republic of Kazakhstan, shall have the same duties in healthcare area as the citizens of the Republic of Kazakhstan.

      4. In accordance with their activities, the individual entrepreneurs and legal entities shall:

      1) conduct sanitary and anti-epidemic and sanitary-preventive measures;

      2) comply with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of population and hygienic standards, as well as acts and sanitary and epidemiological conclusions of officials, performing state sanitary and epidemiological control and supervision;

      3) ensure safety and quality of works performed, services and products in its production, transportation, storage and sale;

      4) conduct a production control in accordance with the legislation of the Republic of Kazakhstan;

      5) inform timely the state healthcare-epidemiological services on emergencies, suspension of productions, violations of technological processes, threatening the healthcare-epidemiological welfare of the population, in cases of mass and group infectious and parasitic, occupational diseases and poisoning;

      6) inform promptly the authorized body on the side-effects of drugs and medical devices in case of their detection;

      7) ensure hygienic training of employees, working in the service sector, which poses a threat to infect others with the infectious and parasitic diseases; 8) allow the officials of state healthcare-epidemiological services to conduct sampling of products, raw materials, goods, work environment for laboratory testing in accordance with their competence;

      9) prevent persons from the work, who do not have a document, certifying the passage of medical examination, hygienic training, as well as to exclude from work those with infectious and parasitic diseases and carriers of infectious and parasitic pathogens, identified by healthcare organizations;

      10) not allow to sell goods, products, raw materials if they do not meet the requirements of normative legal acts in healthcare and epidemiological welfare of the population and health standards, as well as to make a decision on their use or disposal;

      11) excluded by the Law of the Republic of Kazakhstan; dated on 15.07.2011 No 461-IV (shall be enforced from 30.01.2012).

      12) submit records and reporting documentation on healthcare and epidemiological welfare to the state healthcare-epidemiological services for review;

      13) suspend business and (or) any other activity in case if they pose threat to life or health of population;

      14) ensure unhindered access of officials, exercising the state healthcare-epidemiological supervision to the objects in order to verify their compliance with the regulations in healthcare and epidemiological safety and health standards;

      15) conduct disinfection, disinfestation and deratization activities upon epidemiological indications and regulations, and decrees of officials of healthcare-epidemiological services at their own expense.

      16) provide complete and reliable information about the medicines they sell;

      17) pay deductions and (or) contributions to compulsory social health insurance in accordance with the Law of the Republic of Kazakhstan "On compulsory social health insurance".

      Footnote. Article 90, as amended by the Laws of the Republic of Kazakhstan dated on 06.01.2011 No 378-IV (shall be enforced upon expiration often calendar days after its first official publication); dated on 15.07.2011 No 461-IV (shall be enforced from 30.01.2012); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 16.11.2015 No. 406-V (shall be enforced from 01.07.2017).

Article 91. Patients’ rights

      1. In addition to the rights, specified in Article 88 of this Code, a patient shall have the following rights:

      1) a decent treatment during diagnostics, medical treatment and care, respect for his cultural and personal values;

      2) a medical care in the order, determined solely on the basis of medical criteria, without the influence of any discriminatory factors;

      3) choice or replacement of a doctor or medical organization, including a foreign doctor, working in healthcare organizations of the Republic of Kazakhstan, providing medical assistance within the guaranteed volume of free medical care;

      3-1) notification that audio and (or) video surveillance and recording shall be conducted in the medical organization;

      4) support of his family, relatives and friends, as well as the members of religious communities;

      5) relief of suffering to the extent that is provided by the current level of medical technologies;

      6) to receive an independent opinion on his health status and have a consultation;

      7) other rights, provided by the laws of the Republic of Kazakhstan.

      2. The patient shall have the right to receive information about his rights and responsibilities, the services provided, the cost of paid services, the order of their provision, taking into account the availability for people with visual impairment and (or) hearing. Information on the rights of the patient should be placed in the places of visual agitation of medical organizations.

      When being hospitalized, a patient should be provided with the information about the names and professional status of those who shall provide medical services, as well as the internal rules of the medical organization.

      3. Medical assistance should be provided after receiving informed oral or written voluntary consent from the patient. Written voluntary consent of the patient for invasive interventions shall be made in the form approved by the authorized body.

      4. When a patient receives medical care, he shall have a right to be fully informed about his health status, including information about the risks and benefits of the proposed and alternative treatments, information about the possible consequences of refusing the treatment, information on diagnosis, prognosis and plan of remedial measures in an accessible form, as well as an explanation of his discharge from the hospital or transfer to another medical institution.

      5. A patient may appoint a person to whom the information on his health status should be provided. The patient's refusal from obtaining the information shall be made in a written form and included in the medical record.

      6. Information may be hidden from the patient in the cases where there are reasonable grounds to believe that the medical information shall not do good for him and cause serious harm to him. In this case, this information shall be reported to the spouse (wife) of the patient, his relatives or legal representatives.

      7. The patients receiving medical care in the clinical educational institutions in healthcare shall have the right to refuse to participate in the teaching process, as well as the presence of the third parties during therapeutic and diagnostic procedures.

      8. The patients’ rights shall be protected by the healthcare bodies, healthcare organizations, as well as public organizations within their jurisdiction.

      9. When receiving medical care a patient shall have a right to be fully informed about the prescribed drugs.

      10. Citizens, who are getting married, shall have a right to health and medical genetic examination.

      Footnote. Article 91 as amended by the laws of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 03.12.2015 No. 433-V (shall be enforced from 01.01.2016).

Article 92. Responsibilities of patients

      1. In addition to the duties, specified in Article 90 of this Code, the patient shall:

      1) take measures to preserve and strengthen his health;

      2) communicate with health care workers respectfully;

      3) tell a doctor all the information, required for diagnosis and treatment, after giving a consent for medical intervention to comply strictly with all the requirements of a doctor;

      4) observe the internal rules and take good care of the property of the medical organization, to cooperate with the medical staff when obtaining medical care;

      5) inform health professionals about the changes in his health status during the diagnosis and treatment, as well as in the cases of diseases, dangerous to others, or their possibility on time;

      6) not commit acts, violating the rights of other patients;

      7) perform other duties, provided by the Laws of the Republic of Kazakhstan;

      8) perform all instructions prescribed when receiving medical and medicinal assistance at an outpatient level, in accordance with the contract concluded with the medical organization.

      2. Duties of the patients referred to in subparagraphs 2) - 4) of paragraph 1 of this Article shall be applied to the parents or other persons, directly involved in a hospital care for a sick child.

      Footnote. Article 92 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 93. The right to refuse medical treatment

      1. A patient or his legal representative shall have the right to refuse medical treatment, except for the cases, provided for in Article 94 of this Code.

      2. In case of refusal from medical care, form the patient or his legal representative shall be informed about the possible consequences in an easily-accessible.

      3. Refusal from medical treatment, providing of information about the possible consequences shall be recorded in medical records and signed by the patient or his legal representative, as well as by a medical worker.

      In case of refusal to sign by the patient or his legal representative the refusal from medical care, a relevant entry about this shall be made in the medical record and signed by a medical professional.

      4. Upon refusal of legal representatives of a minor or an incapacitated person from medical care, required to save the lives of these persons, a medical organization shall have the right to apply to the guardianship authority and (or) to the court to protect their interests.

Article 94. Providing medical care without the consent of the citizens

      1. Medical care without consent shall be provided to the persons:

      1) in shock, coma, not allowing them to express their will;

      2) suffering from diseases dangerous to others;

      3) severe mental disorders (diseases);

      4) mental disorders (diseases) and those, who committed socially dangerous act.

      2. The consent for medical care for minors and citizens, declared incompetent by a court shall be given by their legal representatives. In the absence of the legal representatives, a decision on medical assistance shall be taken by the concilium, and if it is impossible to gather a concilium - by a medical professional with the notification of the officials of the medical organization and legal representatives.

      3. Medical care without the consent of the citizens shall go on until elimination of grounds, provided for in paragraph 1 of this Article.

      Footnote. Article 3, as amended by the Law of the Republic of Kazakhstan dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 95. Medical secrecy

      1. Information on seeking medical advice, the health status of a citizen, his diagnosis and other information, received during his examination and (or) treatment, shall be the medical secrecy.

      2. Disclosure of information, which is a part of a patient’s confidentiality shall not be allowed to the persons who have learnt it during training, professional performance, service and other obligations, except for the cases, defined by paragraphs 3 and 4 of this Article.

      3. With the consent of a patient or his legal representative, the information constituting a medical secret may be transferred to other individuals and (or) legal entities for the benefit of examination and treatment of the patient, for research, teaching process and for other purposes.

      4. Presentation of information, constituting a medical secret, without the consent of the patient or his legal representative shall be allowed in the following cases:

      1) for the purposes of examination and treatment of a citizen, unable to express his will because of his condition;

      2) when there is a threat of spreading of diseases that pose a danger to others, including the blood donation and its components;

      3) at the request of inquiry and preliminary investigation bodies, prosecutor, lawyer, and (or) a court in view of investigation or prosecution;

      4) when providing medical care to a minor or an incapable person to inform his legal representatives;

      5) if there are grounds to believe that the injury, caused to the citizen is a result of illegal acts;

      6) when a citizen has a mental disability and a tendency to sexual violence.

      4-1. It is not a matter of disclosure of a medical secret to transfer a reserve copy of an electronic information resource for storage to a single platform for the backup storage of electronic information resources in accordance with the procedure and terms determined by the authorized body in the field of information security, unless such electronic information resources contain information related to reconnaissance, counterintelligence activities and security measures to ensure the safety of protected persons and objects, the transfer of which shall be carried out in accordance with the legislation of the Republic of Kazakhstan on state secrets.

      5. Collection and processing of personal data relating to their private life shall not be allowed without the permission of individuals (patients) to form electronic information resources, containing personal data of individuals (patients), except for cases related to the donation of blood and its components.

      It is not allowed to connect electronic information resources, containing personal data of individuals (patients) to telecommunications networks connecting them to other databases without the permission of individuals (patients), when using personal data concerning their private life, except for cases related to donation blood and its components, as well as requests by law enforcement, special state and other bodies for the provision of information in the form of an electronic document constituting a medical secret, on the state at dispensary records of people, suffering from dangerous to society disorders and diseases, including persistent mental disorders, alcohol, drug and other addictions, the propensity to commit aggression and violent actions.

      For illegal collection and processing of personal data concerning the private life of individuals (patients), officials shall be liable under the laws of the Republic of Kazakhstan.


      Footnote. Article 95 as amended by the Law of the Republic of Kazakhstan dated on 21.05.2013 No. 95-V (shall be enforced upon expiration of six months after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 24.11.2015 No. 419-V (shall be enforced from 01.01.2016); dated 09.04.2016, No. 501-V (shall be enforced from 01.01.2018); dated 28. 12. 2017 No. 128-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 17. PROTECTION OF REPRODUCTIVE RIGHTS

Article 96. The rights and duties of citizens in ??reproductive rights area

      1. Citizens, shall have the right to:

      1) free reproductive choice;

      2) receive services for protection of reproductive health and family planning;

      3) receive reliable and complete information about their reproductive health status;

      4) treatment of infertility, including the use of modern auxiliary reproductive techniques and technologies, allowed in the Republic of Kazakhstan;

      5) donation of germ cells, tissues of reproductive organs;

      6) use and free choice of contraceptive methods;

      7) surgical sterilization;

      8) abortion;

      9) protection of their reproductive rights;

      10) take a free decision on the number of their children and time of their birth within wedlock or out of it, the periods between their birth, necessary to reserve mother’s and child’s health;

      11) storage of germ cells, tissues of reproductive organs, embryos.

      2. The minors shall have the right to protection of reproductive health, and for moral and sexual education.

      3. The citizens shall be obliged to respect the rights, freedoms and legitimate interests of other citizens when exercising their reproductive rights.

      Footnote. Article 96 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 97. Protection of women’s health during pregnancy, delivery and postpartum

      1. A woman shall have the right to health protection and care during pregnancy, in childbirth and after childbirth, including premature one, defined by the international criteria of live birth and stillbirth fetus, using the methods, permitted in the territory of the Republic of Kazakhstan.

      2. Medical, consultative assistance to pregnant women, women in childbirth and new mothers in healthcare organization shall be provided within the guaranteed volume of free medical care.

      3. During pregnancy, the examination, treatment and medical intervention may be performed only with the consent of the woman or her legal representative.

      In cases when delay of screening, treatment and medical intervention threatens the life of a woman and a child (fetus), the decision on screening, treatment and medical intervention shall be taken by a doctor or a medical commission.

Article 98. Treatment of infertility

      1. The individuals shall have the right to infertility treatment in healthcare organizations, private medical practitioners, applying safe and effective methods, including the use of auxiliary reproductive techniques and technologies, allowed at the territory of the Republic of Kazakhstan by the authorized body in accordance with legislation of the Republic of Kazakhstan in healthcare area, with the obligatory provision of complete and comprehensive information on their effectiveness, optimal time frames for their appliance, the possible complications, medical and legal implications, and other information, related to their effects on the body.

      2. Is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).
      Footnote. Article 98 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 99. The auxiliary reproductive techniques and technologies, cloning

      1. A woman and a man, both married and unmarried, shall have the right to use assisted reproductive methods and technologies if they have mutual informed voluntary consent to medical intervention. A single woman also shall have the right to use assisted reproductive methods and technologies if she has her informed voluntary written consent for medical intervention.

      2. The order and conditions of the auxiliary reproductive techniques and technologies shall be defined by the authorized body.

      3. When using the auxiliary reproductive techniques and technologies, the prenatal sex selection shall not be allowed, unless the possibility of inheritance of diseases related to sex.

      4. The human embryo cannot be used for commercial, military and industrial purposes.

      5. Human cloning - reproduction of genetically identical individuals shall be prohibited in the Republic of Kazakhstan.

      6. Export from the Republic of Kazakhstan of sex cells, human embryos for commercial, military or industrial purposes shall not be allowed.

      Footnote. Article 99 as amended by the laws of the Republic of Kazakhstan dated 03.07.2014 No. 227-V (shall be enforced from 01.01.2015); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 100. Health care for surrogacy

      1. Surrogate motherhood - bearing and birth of a child (children), including cases of premature birth, under a contract between a surrogate mother and spouses with payment of remuneration.

      2. A surrogate mother may be a woman of twenty-thirty five years old, received a medical conclusion on a satisfactory state of mental, physical and reproductive health, including the results of medical and genetic testing.

      3. The rights and duties of a surrogate mother, the perspective parents, the rights of the child and the order for concluding an agreement shall be regulated by the legislation of the Republic of Kazakhstan on marriage (marriage) and family.

      Footnote. Article 100 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 101. Donation of sexual cells, tissues of reproductive organs

      1. Citizens between the ages of eighteen and thirty-five years old, physically and mentally healthy, who have undergone a medical genetic examination, shall have the right to be donors of sex cells, tissues of reproductive organs.

      2. Donors shall have no right to information about the future fate of their donor sex cells, the tissue of reproductive organs.

      3. The procedure and conditions for carrying out the donation of germ cells, tissues of reproductive organs shall be determined by the authorized body.

      Footnote. Article 101 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 102. The use of contraception

      1. Citizens shall have the right to choose contraception methods and means, including medical one, and to refuse them.

      2. The citizens receive a medical assistance on individual selection of suitable contraception methods, taking into account their health status, age and individual characteristics.

Article 103. Surgical sterilization

      1. Surgical sterilization as a method of preventing unwanted pregnancy may be conducted to the citizens of not less than thirty-five years old, or those, who at least have two children, and for medical reasons, and with the consent of the full-aged citizen - regardless of his age and presence of children.

      2. Surgical sterilization shall be carried out only upon a written agreement of a patient in the healthcare organizations, by the private medical practitioners, licensed for this activity, with the obligatory prior notification of the patient on irreversibility of the operation.

      3. The procedure and conditions for the surgical sterilization shall be established by the authorized body.

Article 103-1. Chemical castration

      1. Chemical castration - taking drugs that reduce sexual desire, carried out on the basis of a court decision by a medical organization.

      2. The type of the used medicinal product, the frequency of its introduction within the period of validity of criminal-legal effect, 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 and the Ministry of Internal Affairs of the Republic of Kazakhstan.

      Footnote. Chapter 17 is supplemented by Article 103-1 in accordance with the Law of the Republic of Kazakhstan dated 09.04.2016 No. 501-V (shall be enforced from 01.01.2018).

Article 104. Abortions

      1. A woman shall have the right to abortion.

      In order to prevent abortion, the doctors shall have to conduct interviews to explain ethical, psychological and physiological adverse effects and possible complications.

      2. Abortions shall be performed at a woman's request if pregnancy is up to twelve weeks, for social reasons - for the pregnancies up to twenty-two weeks, and in medical indications, threatening the life of a pregnant woman and (or) a fetus (in the presence of mono-gene genetic diseases, not-corrective congenital malformations and fatal fetal conditions) - regardless of the gestational age.

      3. Abortions to the minors shall be performed with the consent of their parents or other legal representatives.

      4. In medical and preventive treatment institutions at a woman’s request, medical-social counseling shall be held before and after abortion, including individual choice of methods and means of contraception.

      5. The procedure and conditions for abortion shall be established by the authorized body.

Chapter 18. MEDICAL AND SOCIAL CARE FOR TUBERCULOSIS PATIENTS

Article 105. Medical care for tuberculosis patients

      1. Tuberculosis patients shall be subject to mandatory medical care and treatment and shall be provided with the necessary drugs within the guaranteed volume of free medical care.

      2. The patients with infectious tuberculosis shall be subject to mandatory hospitalization, treatment and rehabilitation.

Article 106. The procedure for recognizing a citizen as a contagious TB patient

      1. Recognizing a citizen as an infectious tuberculosis patient shall be performed taking into account a medical conclusion of a healthcare organization, the results of laboratory and instrumental testing.

      2. The order of medical examination for recognizing a citizen as an infectious tuberculosis patient shall be established by the authorized body.

      3. The citizen, recognized the infectious tuberculosis patient, may appeal the decision of the healthcare organization to a higher authority, and (or) to the court.

Article 107. Grounds and procedure for sending citizens suffering from tuberculosis to compulsory treatment

      1. Forced treatment of citizens with tuberculosis, shall include anti-tuberculosis and symptomatic treatment with isolation of patients in specialized anti-tuberculosis organizations.

      2. The grounds for compulsory treatment of patients, suffering tuberculosis shall be their refusal of treatment prescribed by a doctor, as well as unauthorized leave and violation of the treatment regimen in anti-tuberculosis organizations and primary healthcare organizations, recorded in medical documentation.

      3. The decision on compulsory treatment of citizens, suffering from tuberculosis and evading treatment shall be taken by the court on the recommendation of healthcare organizations.

      4. Materials on direction to compulsory treatment shall be considered by the court within five working days from the date of receipt of medical documentation and with the participation of a representative of healthcare organization.

      5. The enforcement of the court's decision to direct a citizen, suffering from tuberculosis to compulsory treatment shall be entrusted to enforcement agencies.

      Footnote. Article 107 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 31. 10. 2015 No. 378-V (shall be enforced from 01.01.2016).

Article 108. Rights of patients with tuberculosis, being under compulsory treatment

      Footnote. Title of Article 108 as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      1. Patients, suffering from tuberculosis, being under compulsory treatment shall enjoy all the rights of citizens of the Republic of Kazakhstan with restrictions related to the need to adhere the regime of stay in a specialized anti-tuberculosis organization.

      2. Sending to compulsory treatment in a specialized anti-TB organization shall not entail a criminal record.

      3. The place of work shall be saved for a person, suffering from tuberculosis, directed on compulsory treatment.

      4. The duration of stay for compulsory treatment shall not interrupt the labor experience and shall be included in the general seniority.

      5. Housing shall be remained for the patients, suffering from tuberculosis, directed to compulsory treatment, living in a dwelling of the public housing stock, for the period of stay in treatment.

      Footnote. Article 108 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 109. Treatment and maintenance of tuberculosis patients in specialized anti-tuberculosis organizations

      Footnote. Title of Article 109 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      1. Treatment and maintenance of tuberculosis patients in specialized anti-tuberculosis organizations for compulsory treatment shall be carried out at the expense of budgetary funds.

      2. Organization of compulsory treatment, as well as the rules of stay in the specialized anti-TB institutions shall be performed in the order, approved by the authorized body.

      3. Forced treatment of tuberculosis patients in specialized anti-tuberculosis organizations and their discharge shall be carried out in the manner determined by the authorized body.

      Footnote. Article 109 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 110. Medical supervision and treatment of patients with tuberculosis after the end of compulsory treatment

      Footnote. Title of Article 110 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      Patients with tuberculosis, undergoing forced treatment after being discharged from a specialized anti-tuberculosis organization shall be required to register in an anti-tuberculosis organization at their place of residence and receive treatment that excludes the relapse of the disease by tuberculosis, in accordance with the procedure established by the authorized body.

      Footnote. Article 110 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 111. Social assistance to the patients, suffering from tuberculosis

      Footnote. Title of Article 111 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      Local executive bodies shall assist patients with tuberculosis, discharged from a specialized anti-tuberculosis medical organization after the end of compulsory treatment, in their work and household arrangements.

      Footnote. Article 111 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 19. MEDICAL AND SOCIAL ASSISTANCE TO THE HIV and AIDS- INFECTED PATIENTS

Article 112. State guarantees in prevention, diagnosis, and treatment of HIV and AIDS

      The state shall guarantee to the HIV-infected and AIDS-patients:

      1) availability and quality of confidential medical examinations on a free basis, provision of dynamic surveillance, psychosocial, legal and medical consultations;

      2) medical care and drug supply within the guaranteed volume of free medical care;

      3) social and legal protection;

      4) prevention of any form of discrimination due to the nature of the disease;

      5) fulfillment of preventive measures to reduce the risk of transmission of HIV infection from mother to fetus.

      Footnote. Article 112 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 113. Social protection of the HIV-infected or AIDS patients

      1. The children, infected with HIV or suffering from AIDS, shall take training in schools and other educational institutions.

      2. Dismissal from work, refusal to hire, non-admission to kindergartens and schools, as well as the infringement of other rights and legitimate interests of the persons, infected with HIV or AIDS, as well as infringement of housing and other rights of their relatives shall not be allowed.

      Medical workers infected with HIV, performing medical manipulations, associated with a breach of the integrity of the skin or mucous membranes shall be transferred to other work, not associated with a violation of the integrity of the skin or mucous membranes.

      3. The persons, infected with HIV or AIDS in the result of improper execution of duties by health professionals and consumer services workers, shall be entitled to receive compensation for the damage, caused to life or health, in accordance with the legislation of the Republic of Kazakhstan.

      Footnote. Article 113 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 114. HIV Prevention

      HIV prevention measures shall include:

      1) development and implementation of target prevention and education programs for various population groups;

      2) provision of information on epidemic situation of HIV infection and preventive measures through the media;

      3) development and distribution of information materials for various groups of population;

      4) implementation of programs on protection from HIV infection through sex and blood;

      5) opening of the trust points, anonymous testing, psychological, legal and medical counseling;

      6) safety and security arrangements when providing the services, related to the skin penetration.

Article 115. Testing for HIV

      1. Citizens of the Republic of Kazakhstan and repatriates shall have the right to voluntary anonymous and (or) confidential medical examination and counseling on HIV-infection on a free basis in the manner determined by the authorized body.

      2. The following individuals shall be subject to mandatory confidential medical examination for HIV infection:

      1) donors and recipients of blood, its components, tissue and (or) organs (parts of organs), germ cells;

      2) persons on the basis of requests of the prosecutor's office, investigation and court;

      3) persons for clinical and epidemiological indications in accordance with the rules approved by the authorized body.

      3. Foreigners and stateless persons, residing in the territory of the Republic of Kazakhstan, in case of avoiding a medical HIV testing shall be deported from the Republic of Kazakhstan.

      Members of diplomatic, representative and consular institutions of foreign states and other persons in the Republic of Kazakhstan, who enjoy diplomatic privileges and immunities, shall pass a HIV infection testing only with their consent. The offer on the need to pass medical examinations shall be coordinated by the authorized body and the Ministry of Foreign Affairs of the Republic of Kazakhstan.

      4. Examination of minors and incapable persons shall be performed with the consent of their legal representatives or at their request.

      5. Healthcare organizations that revealed the fact of HIV infection in a medical examination, shall notify the patient of the results obtained, inform on the need to observe precaution measures, aimed at protecting his own health and the health of others, and also inform about administrative and criminal liability for failure to treat the infection and contamination of other individuals.

      Footnote. Article 115, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 20. MEDICAL AND SOCIAL ASSISTANCE TO THE PERSONS WITH MENTAL DISORDERS (DISEASES)

Article 116. Voluntariness of mental health seeking behavior

      1. Mental health care shall include prevention of mental disorders (diseases), examination of mental health, diagnosis of mental disorders, treatment and care, medical and social rehabilitation of those, suffering from mental disorders (diseases).

      2. Psychiatric care shall be provided after the voluntary request of the person with his or her written consent, except for the cases provided for in this Code.

      3. The minors, as well as the person, recognized incapable by the court, shall receive the psychiatric care with the consent of their legal representatives in the order, stipulated by this Code.

Article 117. Restriction of certain types of professional activity

      1. A citizen may be found unfit for a while with the right of re-examination because of a mental disorder (illness), to perform certain professional activities, as well as the work, related to the extra-hazardous source.

      Recognition of unfitness shall be made by the decision of a medical commission created in a specialized psychiatric medical organization that has a license for the relevant expertise.

      In case of disagreement with the commission’s decision, it may be appealed to the court.

      2. The list of medical psychiatric contraindications for the implementation of certain types of professional activity, as well as works, related to a source of increased danger, shall be approved by the authorized body and reviewed, taking into account the accumulated experience and scientific achievements, at least once every five years.

Article 118. Protecting the rights and interests of the citizens, receiving psychiatric care

      1. A citizen, when receiving psychiatric care, shall have the right to invite a representative to protect his legitimate rights and interests. Registration of a representative shall be made in the order, defined by the Criminal Procedure Code of the Republic of Kazakhstan and the Civil Procedure Code of the Republic of Kazakhstan.

      2. The legitimate interests of a minor or a person, recognized incompetent by a court, in receiving the psychiatric care shall be protected by their legal representatives.

      3. The rights and legitimate interests of a citizen, receiving psychiatric care shall be protected by an attorney or a legal representative. The organization’s administration, providing mental health care, shall ensure the possibility of inviting a lawyer, except for the cases, provided in the part 2 of paragraph 3 of Article 97 and paragraph 5 of Article 123 of this Code.

      Footnote. Article 117 as amended by the laws of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 09. 2016 No. 479-V (shall be enforced from 01.01.2017).

Article 119. Diagnostics and treatment of mental disorders (diseases)

      1. Psychiatric care shall be provided by a psychiatrist.

      2. The diagnosis of mental disorder (disease) shall be made by a psychiatrist in accordance with the clinical manifestations, laboratory data and objective information. A person, who was forcibly hospitalized, shall be diagnosed by a commission of psychiatrists. The diagnosis may not be based on disagreement of the citizens with the accepted moral, cultural, political, and religious values, or on other reasons, not related to the mental health status of the person.

      3. For diagnosis and treatment of persons suffering from mental disorder (diseases), the medical devices and methods shall be used, allowed by the legislation of the Republic of Kazakhstan in healthcare area.

      4. Medical devices and techniques shall be used for diagnostic and therapeutic purposes only in accordance with the nature of disorders and shall be prohibited for use in the form of punishing a person.

      5. Within forty-eight hours from the time of a psychiatric examination, a physician shall provide a person, suffering from a mental disorder (illness), if he can correctly perceive the provided information, or his legal representative, with the written information on the nature of the mental disorder (disease), the purposes and methods of treatment, and well as the duration of the recommended treatment, possible pains, side effects and the expected results. A special entry shall be made in the medical records on the information provided. In other cases, the information may be provided in accordance with the paragraph 4 of Article 95 of this Code.

      6. Treatment of a person, suffering from a mental disorder (disease) shall be conducted after the receipt of his consent or his legal representatives, except for the cases, provided in paragraph 7 of this Article.

      7. The treatment may be provided without the consent of a person, suffering from a mental disorder (illness), or without the consent of his legal representative only if compulsory medical treatment is applied on the grounds, established by the legislation of the Republic of Kazakhstan, as well as for compulsory hospitalization, taking into account the grounds, specified in paragraph 1 of Article 94 of this Code. In these cases, except for the emergency hospitalization, the treatment shall be provided under the decision of the commission of psychiatrists. During a compulsory hospitalization of a person, a decision on the order of treatment must be taken by the commission of psychiatrists within forty-eight hours since his hospitalization to a psychiatric organization.

      8. A person, suffering from a mental disorder (disease) or his legal representative shall have the right to refuse the proposed treatment or stop it, except for the cases, provided in paragraph 7 of this article.

      9. The person, refused the treatment, or his legal representative shall be explained the possible consequences of stopping the treatment. Refusal of treatment with notification of the possible consequences shall be registered in the medical record and signed by the person with a mental disorder (disease) or his legal representative and a psychiatrist.

      Footnote. Article 119, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 120. The rights of persons with mental disorders (diseases)

      1. The persons, suffering from mental disorders (diseases), shall have all the rights and freedoms of the citizens, provided by the Constitution of the Republic of Kazakhstan.

      Restriction of the rights and freedoms of citizens, associated with a mental disorder (disease) shall be allowed only in the cases provided by the Laws of the Republic of Kazakhstan.

      2. Every person suffering from mental disorders (diseases), when receiving mental health care shall be entitled to:

      1) receive mental health care at the place of residence, and at the location if necessary;

      2) to refuse from the use of medical devices and methods, scientific research or training, photo, video or filming in any phase of treatment;

      3) invite a specialist, involved in the mental health care provision (with the consent of the latter), to join the medical commission on the issues, regulated by this Code;

      4) study an education program of a secondary or a special school for children with mental development disorder, if the patient is under eighteen years of age;

      5) correspond, send and receive parcels, packages, money, use a telephone, receive visitors, subscribe to periodicals;

      6) possess and purchase daily necessities, and wear his own clothes.

      3. The persons suffering from mental disorders (diseases), who are subject to the compulsory medical treatment in the state specialized mental institutions with intensive supervision, in addition to the rights, specified in paragraphs 1 and 2 of this Article, shall have the rights to:

      1) the acquisition of extra meals;

      2) receipt of additional medical services in excess of the guaranteed volume of free medical care;

      3) the acquisition of soft furniture, clothing, and footwear;

      4) the use of long-distance telephone service;

      5) the use of the cash control account.

      These rights shall be exercised at the expense of the person to whom they are provided.

Article 121. Compulsory medical treatment for the persons with mental disorders (diseases)

      1. Compulsory medical measures shall be applied upon the court decision to the persons, suffering from mental disorders (diseases), who committed socially dangerous acts, on the grounds and in the order, defined by the legislation of the Republic of Kazakhstan.

      2. Compulsory medical measures shall be implemented in mental health organizations in the form of:

      1) mandatory outpatient supervision and treatment by a psychiatrist;

      2) compulsory treatment in a mental hospital of common type;

      3) compulsory treatment in a specialized psychiatric hospital;

      4) compulsory treatment in a specialized psychiatric hospital with intensive supervision.

      3. The individuals, hospitalized in a psychiatric hospital for compulsory medical treatment, shall be recognized incapable for the entire period of their stay in a psychiatric hospital.

      4. The money of individuals and legal entities, including pension allowances and the state social benefits shall be credited to the cash control account of the state psychiatric specialized institution with intensive supervision (hereinafter - the institution) to be used by the patients, receiving compulsory treatment in the institution.

      5. The procedure for using money shall be determined by the authorized body.

      6. Accounting and reporting on the money use of the cash control account of the institution, as well as the control over their use shall be performed in accordance with the legislation of the Republic of Kazakhstan.

      Footnote. Article 121 as amended by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 122. Mental health care and social protection, guaranteed by the state

      1. The state shall guarantee:

      1) emergency and routine mental health care;

      2) psychiatric examination and assessment of temporary incapability;

      3) social help and support in employment of the persons, suffering from mental disorders (diseases), including people with disabilities - in accordance with the individual rehabilitation program.

      2. In order to provide the persons, suffering from mental disorders (diseases), with mental health care and social protection, the state shall:

      1) organize provision of mental health care;

      2) organize general and vocational training of juveniles with mental disorders, including the people with disabilities - in accordance with the individual rehabilitation program;

      3) establish occupational therapy organizations, as well as special productions, workshops or areas with the sheltered employment for occupational therapy, development of new skills for employment of the persons with mental disorders (diseases), including the disabled in these organizations.

Article 123. Psychiatric examination

      1. Psychiatric examination shall be conducted in order to reveal mental disorders (diseases) in an examined person, define the need for mental health care and its types, as well as to address the issues of custody and assessment of temporary incapability.

      2. Psychiatric examination, as well as routine examinations shall be conducted at the request or with the written consent of the examined person or with the written request of his legal representatives, indicating the reasons for examination; as for a minor or an incompetent person - at the request or with the written consent of their legal representatives.

      The results of a psychiatric examination and a conclusion on mental health of the examined person shall be recorded in the medical record, indicating the reasons for coming to a psychiatrist and medical recommendations.

      3. In case of objection or if an examined person or a minor does not have a legal representative, the examination shall be performed upon the decision of the guardianship authority, which can be appealed in the court.

      4. The physician conducting the psychiatric examination shall have to introduce himself to the examined person and his legal representative, as a psychiatrist, except for the cases, provided in subparagraph 1) of paragraph 5 of this Article.

      5. Psychiatric examination of a person may be held without his consent or without the consent of his legal representative in the case when the examined person conducts actions, giving a reason to believe that he has a severe mental disorder (disease), causing:

      1) a direct danger to himself or others;

      2) his helplessness, the inability to independently satisfy the survival needs in the absence of proper care;

      3) substantial harm to his health as a result of deteriorating mental condition if a person is left without mental health care.

      6. Psychiatric examination of a person may be held without the consent of his legal representative, if the examined person is under the dynamic supervision, in the order, provided by paragraph 2 of Article 124 of this Code.

      7. Different types of psychiatric expertise and psychiatric examination of a person shall be made in accordance with the legislation of the Republic of Kazakhstan in healthcare area.

      8. In the cases, specified in paragraph 5 of this Article, the decision on psychiatric examination shall be taken by a commission of psychiatrists with notification of the legal representative of the patient.

      9. The decision on psychiatric examination of a person without his consent or without the consent of his legal representative, except for the cases, specified in paragraph 6 of this Article, shall be taken by a psychiatrist at the request, containing the grounds for such an examination, listed in paragraph 5 of this Article.

      10. excluded by the Law of the Republic of Kazakhstan,dated on 29.12.2010 No 375-IV (shall be enforced upon expiration often calendar days after its first official publication.)
      11. excluded by the Law of the Republic of Kazakhstan,dated on 29.12.2010 No 375-IV (shall be enforced upon expiration often calendar days after its first official publication.)

      12. An application for a psychiatric examination must be in a written form and contain the detailed information, supporting the need for such an examination, and the data on the person’s refusal (or his legal representative) from visiting a psychiatrist. The psychiatrist may request additional information necessary for a decision making. Having established that the application has no circumstances, specified in paragraph 5 of this Article, a psychiatrist, in a written form, shall reasonably refuse to conduct a psychiatric examination.

      Footnote. Article 123, as amended by the Law of the Republic of Kazakhstandated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 124. Dynamic monitoring of the persons with mentaldisorders (diseases)

      1. Dynamic monitoring may be set independently from the consent of a person with a mental disorder (disease), or his legal representative in the cases, specified in paragraph 2 of this Article, and shall include monitoring of the person’s mental health via regular examinations by a psychiatrist and provision of necessary medical and social assistance.

      2. Dynamic monitoring may be set for the person, suffering from chronic disease with severe, persistent, recrudescent symptoms of illness.

      3. The decision on the need to set a dynamic monitoring and its termination shall be taken by a commission of psychiatrists, appointed by the administration of mental health organization, providing outpatient mental health care, or by a commission of psychiatrists, appointed by the healthcare authority, in the amount of no less than three doctors.

      4. A reasoned decision of the commission of psychiatrists shall be recorded in the medical records. The decision on establishment or termination of the dynamic monitoring may be appealed in the order, defined by this Code.

      5. The previously established dynamic monitoring shall stop in recovery or significant and persistent improvement of mental state of the person, suffering from mental disorders (diseases). After the termination of the dynamic monitoring, at the request or with the consent of the person or at the request or with the consent of the legal representative, the psychiatric care shall be provided in the form of counseling and treatment. If mental state of a person with a mental disorder (illness) is changing, the person may be examined without his consent or without the consent of his legal representative on the grounds and in the order, defined in Article 123 of this Code. Dynamic monitoring of mental disorders (diseases) may be resumed in such cases upon the decision of the commission of psychiatrists.

      6. Consideration of termination of dynamic monitoring may be performed in the order, defined by paragraph 3 of this Article, at the initiative of the person, suffering from a mental disorder, as well as at the initiative of his legal representative.

Footnote. Article 124, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 125. Hospitalization in a psychiatric clinic

      1. The reason for hospitalization in a psychiatric hospital shall be the presence of a mental disorder (disease) and the decision of the psychiatrist on the need for examination or treatment in a hospital.

      1-1. Mandatory hospitalization to a psychiatric hospital shall be allowed on the basis of the court decision.

      Mandatory hospitalization to a psychiatric hospital before taking a court decision shall be allowed only in order to prevent the consequences, specified in subparagraphs 2), 3) and 4) of paragraph 1 of Article 94 of this Code.

      For each case of mandatory hospitalization without a court decision, within forty-eight hours after the hospitalization to a psychiatric hospital, the hospital’s administration shall send a written notice to the prosecutor.

      If there is information about a spouse, close relatives and (or) legal representatives, within forty-eight hours after hospitalization to the psychiatric hospital, the hospital’s administration shall inform them about it.

      2. Hospitalization to a psychiatric hospital shall be conditioned by the need to conduct a psychiatric examination in the order, defined by the legislation of the Republic of Kazakhstan in healthcare area.

      3. Hospitalization of a person to a psychiatric hospital shall be voluntary at his request or with his written consent, except for the cases, specified in Article 94 of this Code.

      4. A minor shall be hospitalized to a psychiatric hospital with the written consent of his parents or other legal representative.

      5. excluded by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration often calendar days after its first official publication.)

      6. In case of objection or absence of a legal representative, a minor’s hospitalization to a psychiatric hospital shall be conducted upon the decision of the guardianship authority, which may be appealed to the court, with a written notification of the prosecutor within twenty-four hours since the decision on hospitalization shall be taken.

      7. The obtained consent of a person for hospitalization shall be recorded in the medical record, and signed by the person or his legal representative and by a psychiatrist.

      8. The person’s mandatory stay in a psychiatric hospital shall last until the grounds for hospitalization maintain.

      9. The person, hospitalized in a psychiatric hospital forcedly, within the first six months of the stay, not less than once a month shall be examined by a commission of psychiatrists to resolve the issue on prolongation of hospitalization. Prolongation of hospitalization for more than six months shall be carried out by a court decision on the basis of a statement of a psychiatric hospital on the need to extend the period of compulsory hospitalization and treatment, where the conclusion of the commission of psychiatrists shall be attached.

      10. An extraordinary examination of a forcedly hospitalized person may be performed at the request of the patient or his legal representative, a lawyer.

      A person, hospitalized to a psychiatric hospital on the grounds, specified in paragraph 1 of Article 94 of this Code, shall be subject to mandatory examination within forty-eight hours since hospitalization, by the commission of psychiatrists of the mental health organization, which takes a decision on reasonability of hospitalization. In the cases when hospitalization is considered unreasonable and the hospitalized person does not want to stay in a psychiatric hospital, it is subject to immediate discharge from the hospital.

      11. In case of disagreement with the forced hospitalization, the person, suffering from mental disorders (diseases), or his legal representative shall be entitled to appeal to the court.

      Footnote. Article 125, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.); dated 31.10.2015 No. 378-V (shall be enforced from 01.01.2016).

Article 126. Examination of a minor or a person, recognized incapable by a court,placed in a psychiatric hospital at the request or with the consent of their legal representatives

      1. A minor or a person, recognized incapable by the court, placed in a psychiatric hospital shallbe subject to mandatory examination by a commission of psychiatrists of a mental health organization in the order, specified by Article 123 of this Code.

      2. During the first six months, a minor or a person, recognized incapable by the court shall be subject to examination by a commission of psychiatrists at least once a month to resolve the issue on prolongation of hospitalization. The decision on prolongation of the hospitalization for more than six months shall be made by the court at the request of the commission of psychiatrists in the order, defined by the legislation of the Republic of Kazakhstan in healthcare area.

      3. In case if the commission of psychiatrists or the psychiatric hospital’s administration shall find out violations, committed during hospitalization by the legal representatives of a minor or a person, recognized incapable by a court, within twenty-four hours since revealing the said circumstances, the psychiatric hospital’s administration shall notify about it the prosecutor and the guardianship authority at the place of residence of the patient.

      Footnote. Article 126, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 127. Security measures in providing psychiatric care

      1. Inpatient mental health care shall be provided in the least restrictive conditions, ensuring safety of the hospitalized person and other persons, and observance of his rights and legitimate interests by the medical staff.

      2. Measures of physical restraint and isolation in the forced hospitalization and stay in a psychiatric hospital shall be applied in the cases, forms and time, when, according to a psychiatrist, other methods shall not be able to prevent the actions of the hospitalized person, dangerous to him or others and shall be performed under the permanent supervision of medical personnel. The forms and time of applying the physical restraints or isolation shall be recorded in the medical record with the notice of his legal representative.

      3. Law enforcement officials shall be obliged to assist medical staff in implementing compulsory examination,mandatory hospitalization, provide safe access to the hospitalized person for his examination and also in the cases, when the hospitalized person (the person subject to hospitalization) threatens life and health of others.

      Footnote. Article 127, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 № 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 128. Discharge from the psychiatrichospital

      1. Discharge from the psychiatric hospital shall be made upon the patient’s recovery or improvement of his mental state, when further inpatient treatment shall not be required, and after completion of examination or expertise, which were the grounds for hospitalization.

      2. Discharge of the patient, voluntarily staying in a psychiatric hospital shall be made at his personal application, a request of his legal representative or under the decision of his attending physician.

      3. Discharge of the patient, hospitalized in a psychiatric hospital by force shall be made upon the conclusion of the commission of psychiatrists, court decision or prosecutor’s resolution.

      4. The patient to whom mandatory medical measures were applied under the court decision shall be discharged from the hospital under the court's ruling only.

      5. The patient, hospitalized in a psychiatric hospital voluntarily, may be refused to be discharged from the hospital, if the commission of psychiatrists of a mental health organization will find out the grounds for mandatory hospitalization, specified in paragraph 1 of Article 94 of this Code. In this case, the issues about his stay in the hospital, prolongation of hospitalization and discharge from the hospital shall be resolved in the order, defined by paragraphs 8 – 10 of Article 125, paragraph 3 of this Article.

      Footnote. Article 128, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 129. Reasons for hospitalization to the psycho-neurological organization

      1. The reason for hospitalization of a minor to the psycho-neurological organization shall be the conclusion of the psychological, medical and educational counseling; for the person, declared incompetent by the court - a decision of the guardianship authority, based on the conclusion of the medical commission with participation of a psychiatrist.

      Hospitalization of an adult with a mental disorder (disease) to the psycho-neurological organization, who is not recognized as incapable shall be performed under the court decision.

      The conclusion should confirm the presence of a mental disorder (disease), depriving the person of the opportunity to be in a non-specialized organization for social welfare, and for the person’s legal capacity - the data on absence of the grounds for raising the issue on recognizing him incapable in the court.

      2. Guardianship authorities shall be obliged to take measures to protect property interests of the persons, hospitalized to a psycho-neurological organization.

      3. The ground for sending a minor to a psycho-neurological organization for special education shall be the presence of a mental disorder (disease). Sending shall be made at the request of the parents or his legal representative and shall be based on the conclusion of republican, regional or urban psychological, medical and educational consultations. The conclusion should contain the ground for training the minor in a special school for the children with mental development disorder.

      4. The ground for transfer of a person, suffering from a mental disorder (disease), from a psycho-neurological organization or a special mental school to the similar organization of common type shall be the conclusion of the medical commission with participation of a psychiatrist, psychological, medical and educational consultation on absence of medical indications for living or training in a specialized psycho-neurological organization.

      5. Discharge from a psycho-neurological organization or a special education school shall be made:

      1) at the personal request of the person with a mental disorder (disease), with the presence of a conclusion of the medical commission with participation of a psychiatrist, confirming that the person is able to live independently;

      2) at the request of the parents, other relatives or a legal representative, ready to take care of the discharged minor or of the person, recognized incapable by the court.

      Footnote. Article 129, as amended by the Law of the Republic of Kazakhstan, dated on 29.12.2010 No 375-IV (shall be enforced upon expiration of ten calendar days after its first official publication.)

Chapter 21. MEDICAL AND SOCIAL ASSISTANCE TO THE PATIENTS, SUFFERING FROM ALCOHOL, DRUG ADDICTION AND SUBSTANCE ABUSE

Article 130. Medical care for the patients, suffering from alcoholism, drug addiction and substance abuse

      1. The state shall provide a system of measures for prevention and treatment of alcohol, drug addiction and substance abuse.

      2. Compulsory measures of a medical nature shall be applied by a court decision in respect of persons who have committed criminal offenses found to be in need of treatment for alcoholism or drug addiction or substance abuse, as well as for the persons, committed an administrative offense and have been found to be ill with chronic alcoholism or drug abuse or substance abuse and evading voluntary treatment.

      Footnote. Article 130 as amended by the Law of the Republic of Kazakhstan dated 03.07.2014 No. 227-V (shall be enforced from 01.01.2015).

Article 131. Treatment of patients, suffering from alcohol, drug addiction and substance abuse in medical institutions and those, needing medical and social rehabilitation

      1. Medical and social rehabilitation of the persons, suffering from alcoholism, drug addiction and substance abuse, shall be voluntary when seeking medical care in health care organizations, providing drug treatment and, at the request of the patient, it can be anonymous.

      2. A minor, suffering from alcoholism, drug addiction and substance abuse, and a drug addict, acknowledged by a court to be legally incapable, shall receive a medico-social rehabilitation with the consent of their legal representatives.

Article 132. A procedure for recognizing a person as alcohol, drug addict and substance abuser

      1. Recognition of a person as an alcohol, drug addict and substance abuser shall be performed by the state healthcare organizations after proper medical examination and in the order, defined by the authorized body.

      2. In case of disagreement of the person with recognizing him an alcohol, drug addicted and substance abuser, such a decision may be appealed to a higher healthcare governing body and (or) to the court.

Article 133. The rights of the persons suffering from alcoholism, drug addiction and substance abuse

      1. The persons, suffering from alcohol, drug addiction and substance abuse shall be entitled to:

      1) receive qualitative medical care;

      2) choose a drug treatment organization;

      3) receive information about their rights, the nature of their substance abuse disorders, the methods of treatment, medical and social rehabilitation;

      4) receive medical and social rehabilitation at the place of residence, and at the location if necessary.

      2. A drug addict or his legal representative shall have the right to refuse the proposed medical and social rehabilitation at any stage.

      3. The person, refused medical and social rehabilitation, or his legal representative shall be explained the possible consequences of rejection from the medical and social rehabilitation. Refusal of the medical and social rehabilitation and explanation of the possible consequences are recorded in the medical record and signed by the drug addict or his legal representative and by the addiction psychiatrist.

      4. It shall be prohibited to restrict the rights and freedoms of drug addicts, just by virtue of having the diagnosis of drug addiction, the fact of being under dynamic supervision of a drug treatment organization, except for the cases, provided by the Laws of the Republic of Kazakhstan.

Article 134. Record and surveillance of the alcohol and drug addicts and substance abusers

      The persons, recognized as suffering from alcohol, drug addiction and substance abuse, shall be subject to registration and supervision in health care organizations at the place of residence and receive supportive treatment there in the order, defined by the authorized body.

Chapter 22. MEDICAL ASSISTANCE TO CERTAIN CATEGORIES OF CITIZENS

Article 135. Provision of medical assistance to military men, candidates for cosmonauts, astronauts, employees of special state and law enforcement bodies, members of their families and recipients of pension payments for long service

      For military men, candidates for cosmonauts, astronauts, employees of special state and law enforcement agencies, members of their families and recipients of pension payments for long service years, medical assistance shall be provided in accordance with the laws of the Republic of Kazakhstan.

      Footnote. Article 135 is in the wording of the Law No. 80-VI dated 30. 06. 2017 (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 135-1. Provision of medical assistance to certain categories of civil servants and citizens

      Provision of medical assistance to certain categories of civil servants and citizens shall be carried out in accordance with the list approved by the Office of the President of the Republic of Kazakhstan in agreement with the Administration of the President of the Republic of Kazakhstan.

      Footnote. Chapter 22 is supplemented by Article 135-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten days after its first official publication).

Article 136. Medical assistance to the citizens, who were exposed to ionizing radiation

      1. The citizens, exposed to ionizing radiation, shall receive medical care in accordance with the Laws of the Republic of Kazakhstan.

      2. The procedure for collection, storage and use of blood and tissues of citizens exposed to ionizing radiation shall be established by the authorized body.

      Footnote. Article 136 as amended by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 136-1. Rendering medical assistance to disabled people

      Healthcare organizations shall form the conditions for adapting health facilities for their accessibility to the people with disabilities and other low-mobility groups.

      Footnote. Chapter 22 is supplemented with Article 136-1 in accordance with the Law of the Republic of Kazakhstan dated 03.12.2015 No. 433-V (shall be enforced from 01.01.2016).

Article 137. Medical assistance to the citizens, injured by environmental disaster

      1. The citizens - victims of ecological disaster - the categories of persons, specified by the Laws of the Republic of Kazakhstan.

      2. The citizens, who were the victims of environmental disasters, shall receive medical care in accordance with the Laws of the Republic of Kazakhstan.

Article 138. Medical assistance to the citizens, whose freedom is limited

      Freedom limited and persons serving a sentence in prison and placed in special institutions, shall receive the medical care in the order, defined by the authorized body and other state bodies within their competence, established by the Laws of the Republic of Kazakhstan.

Article 138-1. Rendering medical assistance to athletes and coaches

      1. Medical support and medical assistance to athletes and coaches shall be carried out in accordance with the procedure approved by the authorized body in the field of physical culture and sports, in agreement with the authorized body.

      2. Athletes who do not undergo medical examination in accordance with the procedure established by the authorized body in the field of physical culture and sports in agreement with the authorized body shall not be allowed to participate in sports competitions.

      Footnote. Chapter 22 is supplemented with Article 138-1 in accordance with the Law of the Republic of Kazakhstan dated 03.07.2014 No. 229-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 23. REGULATION OF CERTAIN RELATIONSHIPS IN HEALTHCARE SYSTEM

Article 139. The procedure of surgery, blood transfusions, its components and application of invasive diagnostic techniques

      1. Surgery, blood transfusion, its components and appliance of invasive diagnostic techniques shall be used with the written consent of the patients.

      People, suffering from mental disorders (diseases), recognized by the court as legally incapable, and the minors shall receive surgery, blood transfusion and its components, invasive diagnostic methods with the written consent of their legal representatives.

      2. The consent may be withdrawn, except for the cases when for the health reasons the medical professionals have already started surgery and its termination is impossible because of the threat to the life and health of the patient.

      3. In the cases when a delay of a surgery, blood transfusion and its components, invasive diagnostic techniques threaten the patient's life, and to obtain the consent of the patient or his legal representative is impossible, the decision shall be taken by a doctor or a concilium, followed by informing the patient or his legal representatives on the measures taken.

Article 140. Confirmation of biological death. Conditions for termination of artificial life sustaining measures

      1. Biological death - the cessation of functioning of a body when its vital functions have failed irreversibly.

      2. Biological death shall be ascertained by a medical professional taking into account all the following symptoms:

      1) cardiac arrest;

      2) respiratory arrest;

      3) termination of the functions of the central nervous system.

      3. Artificial life-support measures may be terminated only if:

      1) biological death is pronounced;

      2) irreversible death of the brain recorded by the concilium, subject to a written unanimous consent of close relatives and (or) legal representatives in the manner determined by the authorized body.

      Footnote. Article 140 as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 141. Euthanasia

      Implementation of euthanasia shall be prohibited.

Article 142. Anatomical gift

      1. Anatomical gift - a voluntary donation of tissues and (or) organs (parts of organs) by a capable person both in life and after his death, performed by a person under the duly settled contract or a last will.

      2. Information about the anatomical gift shall not be disclosed.

      3. As an anatomical gift, in addition to the willed tissues and (or) organs (parts of organs) shall be recognized the corpses, that were not identified and claimed within forty-five days from the date of their detection.

      4. Anatomical gift may be used in scientific, research and practice and training purposes to conduct biomedical research.

      5. The procedure and conditions for the commission and transfer of anatomical gift to healthcare organizations shall be determined by the authorized body.

      Footnote. Article 142 as amended by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

SECTION 6. ACTIVITIES IN HEALTHCARE AND EPIDEMIOLOGICAL WELFARE AND PROTECTION OF PUBLIC HEALTH
Chapter 24. ACTIVITIES IN HEALTHCARE AND EPIDEMIOLOGICAL WELFARE OF THE POPULATION

Article 143. The system of state Healthcare and epidemiological service

      The unified system of the state healthcare-epidemiological service shall include:

      1) the state body for healthcare and epidemiological welfare of the population;

      2) structural units of other state bodies, working in healthcare and epidemiological welfare of the population;

      3) the state organizations, working in healthcare and epidemiological welfare of the population.

Article 144. State healthcare-epidemiological regulation

      1. State healthcare-epidemiological regulation - the activity of healthcare-epidemiological service, which includes:

      1) development of uniform standards for improvement of healthcare epidemiological regulation and control over their development;

      2) development (improvement), examination, approval and publication of documents of healthcare and epidemiological regulation;

      3) research, generalization of application practice, control over application of the documents on healthcare and epidemiological regulation;

      4) formation and keeping of a single data bank of the documents on healthcare and epidemiological regulation;

      5) harmonization of healthcare and epidemiological regulation documents with the generally accepted international standards.

      2. The documents on the state healthcare-epidemiological regulation shall be the healthcare rules and hygienic standards, instructions, guidelines, procedures, orders, technical regulations, rules and standards.

      3. The procedure for development and approval of documents of the state system of sanitary and epidemiological regulation shall be approved by the state body in the field of sanitary and epidemiological welfare of population.

      4. Healthcare regulations shall be the regulatory legal acts for healthcare and epidemiological welfare of the population, establishing the healthcare and epidemiological requirements (including the safety criteria, and (or) the safety of environmental factors, business and other activities, products, works and services to the people), violation of which shall pose a threat to human life or health, as well as the threat of emergence and spread of diseases.

      5. Health standard - the established by researches, permissible maximal or minimal quantitative and (or) qualitative value of an indicator on a particular environmental factor from the perspective of its safety and (or) harmlessness to the people.

      6. Normative legal acts in the sphere of sanitary and epidemiological welfare of population, hygienic standards shall be approved by the state body in the field of sanitary and epidemiological welfare of the population and shall be obligatory for execution by all individuals and legal entities, located on the territory of the Republic of Kazakhstan.

      7. State bodies when developing and approving normative legal acts, concerning issues in the sphere of sanitary and epidemiological welfare of population shall be obliged to coordinate them with the state body in the field of sanitary and epidemiological welfare of population.

      Footnote. Article 144, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 145. Sanitary and epidemiological requirements

      1. The basis of sanitary and epidemiological requirements shall be sanitary rules and hygienic standards, which shall be established for objects and products subject to state sanitary and epidemiological supervision.

      2. Sanitary rules shall establish sanitary and epidemiological requirements for facilities subject to state sanitary and epidemiological supervision, and shall contain requirements for:

      1) the choice of land for the construction of the facility;

      2) design, construction, reconstruction, repair and commissioning of facilities;

      3) maintenance and operation of industrial, public, residential and other premises, buildings, structures, equipment, vehicles;

      4) water supply, sanitation, heat supply, lighting, ventilation, air conditioning of facilities;

      5) reception, storage, recycling (processing) of raw materials;

      6) conditions of production, packaging, transportation, storage, sale, disposal and destruction of food products;

      7) iodization of table salt and enrichment (fortification) of food products;

      8) conditions of production, packaging, transportation, storage, sale, disposal and destruction of medical immunobiological preparations;

      9) application and use of potentially hazardous 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), disposal, transportation, storage, burial and working conditions with them;

      10) working conditions with sources of physical factors, affecting the person;

      11) conditions of industrial production of medicines;

      12) production for technical purposes;

      13) goods for household and hygienic purposes and technologies for their production;

      14) conditions for upbringing, education, living and working practices, physical development, labor, recreation, nutrition, water supply and medical care for various groups of the population;

      15) training and workload and the mode of study in educational organizations;

      16) conditions for sterilization and disinfection of medical devices;

      17) organization of specialized (children's, dietary and dietary preventive), medical and preventive, public catering services;

      18) water sources (water intake points for household and drinking purposes), domestic and drinking water supply and places of cultural and domestic water use and safety of water objects;

      19) collection, use, application, neutralization, transportation, storage and disposal of production and consumption wastes;

      20) organization and implementation of works and services, including development, testing, production, manufacture, storage, transportation, sale, use of disinfection and disinfestation, equipment, materials, maintenance and operation of disinfection objects, as well as control of the efficiency and safety of operations and services;

      21) the conditions for transportation of passengers;

      22) liquidation, conservation, re-profiling of objects;

      23) implementation of production control;

      24) working conditions, consumer services, medical support, specialized dietary curative and dietary preventive nutrition;

      25) hygienic education and training of the population;

      26) organization and conduct of sanitary and anti-epidemic and sanitary-preventive measures, including implementation of sanitary protection of the territory of the Republic of Kazakhstan, introduction of restrictive measures, including quarantine, against patients with infectious and parasitic diseases, medical examinations, and preventive vaccinations of the population;

      27) zones of sanitary protection and sanitary-protective zones.

      3. Hygienic standards shall establish standards for the maximum permissible concentrations of harmful substances (chemical, biological), physical effects, permissible levels of radiation exposure, compliance with which shall provide a person life-friendly and safe conditions for life.

      Hygienic standards shall be established to:

      1) microclimate, air exchange, air of the working area, physical factors of industrial, residential and other premises, the territory of residential development;

      2) radiation, chemical, microbiological, toxicological, parasitological safety of products (goods) and the environment;

      3) atmospheric air in urban and rural settlements, on the territories of industrial organizations;

      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 145 as amended by the Law of the Republic of Kazakhstan dated 29.12.2014 No. 269-V (shall be enforced from 01.01.2015).

Article 146. State registration of products, having a harmful effect on human health

      1. State registration in the state body in the field of sanitary and epidemiological welfare of population shall be subject to products, having a harmful effect on human health, in accordance with the list and in accordance with the procedure determined by the state body in the field of sanitary and epidemiological welfare of population.

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

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

      2) sanitary and epidemiological expertise for compliance with regulatory legal acts in the field of sanitary and epidemiological welfare of the population and hygienic standards for the content of substances and individual components of the product;

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

      3. The costs, associated with the conduct of sanitary and epidemiological expertise and scientific justification of products subject to state registration shall be covered by the applicants.

      4. A single register of certificates of state registration shall be placed on the Internet resource of the state body in the field of sanitary and epidemiological welfare of the population.

      5. The procedure for state registration and withdrawal of a decision on state registration of products, having a harmful effect on human health shall be established by the state body in the field of sanitary and epidemiological welfare of the population.

      Footnote. Article 146 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 147. Healthcare-epidemiological monitoring

      1. Healthcare-epidemiological monitoring - the state system for supervising the public health and the environment, their analysis, evaluation and prognosis, as well as the establishment of cause-and-effect relationship between the health status of the population and the impact of environmental factors.

      2. Sanitary-epidemiological monitoring shall be carried out by state bodies and organizations of sanitary-epidemiological service in the manner determined by the state body in the field of sanitary-epidemiological welfare of the population.

      Footnote. Article 147 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 148. Sanitary and anti-epidemic and sanitary-preventive measures

      Footnote. Title of Article 148 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      1. In order to prevent the emergence and spread of infectious and parasitic diseases, poisonings of the population, sanitary and anti-epidemic and sanitary-preventive measures, stipulated by the documents of the state system of sanitary and epidemiological regulation, shall be carried out, including implementation of sanitary protection of the territory of the Republic of Kazakhstan, introduction of restrictive measures, including number of quarantine, for implementation of production control in relation to patients with infectious and parasitic bubbled diseases, conduct of medical examinations, preventive vaccinations, hygiene education of persons of decreed groups and individuals, engaged in heavy work, work with harmful and (or) dangerous working conditions, underground works.

      2. Sanitary-anti-epidemic and sanitary-preventive measures shall be included in the developed documents of the System of state planning of the Republic of Kazakhstan.

      3. The patients with infectious and parasitic diseases, the persons, suspected of infectious and parasitic diseases, bacilli-carriers shall be subject to isolation and treatment, and those, who communicated with them – to the medical supervision and isolation and treatment if necessary.

      4. The patients with chronic infectious and parasitic diseases, chronic bacilli-carriers, dangerous to others, shall be subject to temporarily suspension from work in accordance with the labor legislation of the Republic of Kazakhstan.

      5. Hygienic training shall be conducted in order to prevent infectious and parasitic diseases of the decreed population in accordance with the procedure and programs of hygienic training, approved by the state body in the field of sanitary and epidemiological welfare of population.

      Footnote. Article 148 as amended by the Law of the Republic of Kazakhstan dated on 03.07.2013 No. 124-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 148-1. Radiation сontrol in the sphere of sanitary and epidemiological welfare of population

      1. Radiation control shall be carried out by the state bodies of sanitary and epidemiological service, shall includes monitoring of compliance with sanitary and epidemiological requirements to ensure radiation safety of population.

      2. Radiation control shall be carried out in the form of an audit, conducted in accordance with the Entrepreneurial Code of the Republic of Kazakhstan.

      Footnote. Chapter 24 is supplemented with Article 148-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 29.10.2015 No. 376-V (shall be enforced from 01.01.2016).

Article 149. Healthcare protection of the territories of the Republic Kazakhstan

      1. At the checkpoints across the State border of the Republic of Kazakhstan, coinciding with the customs border of the Eurasian economic union, with the exception of automobile checkpoints, sanitary quarantine points shall be set up to carry out sanitary and quarantine supervision of passengers, crews, train staffs, vehicles, posing a danger to public health.

      2. Sanitary and quarantine supervision at the checkpoints (sanitary quarantine points) across the State border of the Republic of Kazakhstan shall be carried out by territorial divisions of the state body in the sphere of sanitary and epidemiological welfare of population.

      At automobile checkpoints across the State border of the Republic of Kazakhstan, sanitary and quarantine supervision shall be conducted by the state revenue bodies of the Republic of Kazakhstan.

      3. It shall not be permitted to import dangerous cargos and goods into the territory of the Republic of Kazakhstan, prohibited for importation, as well as the cargos and goods in respect of which the healthcare and quarantine supervision found out that their importation to the territory of the Republic of Kazakhstan would cause the emergence and spread of infectious diseases or mass noncommunicable diseases and poisoning.

      Footnote. Article 149, as amended by the Laws of the Republic of Kazakhstan dated on 30.06.2010 No 297-IV (the order of enforcement see Article 2); dated on 06.01.2011 No 378-IV (shall be enforced upon expiration often calendar days after its first official publication); dated 07.11.2014 No. 248-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 150. Terms for introduction of restrictive measures, including quarantine, in case of a threat of emergence of epidemics of infectious diseases

      1. In case of a threat of import and spread of infectious and parasitic diseases, the state body in the sphere of sanitary and epidemiological welfare of the population at the checkpoints across the State border of the Republic of Kazakhstan, coinciding with the customs border of the Eurasian economic union, and in the relevant territories shall impose restrictive measures, including quarantine, with special conditions of entrepreneurial and (or) other activity and life of the population.

      2. Operational guidelines for coordination of central and local executive bodies, individuals and legal entities in the cases of introducing the restrictive measures, including quarantine, shall be entrusted to the state inter-departmental commission for prevention and elimination of emergency situations and the territorial emergency commissions.

      3. Restrictive measures, including quarantine, at certain objects shall be introduced (canceled) by the decision of the chief state sanitary doctor of the relevant territory (transport) or his deputies, as well as at departmental objects by the head of structural divisions of other state bodies engaged in activities in the sphere of sanitary and epidemiological welfare of population.

      4. The procedure for implementing restrictive measures, including quarantine, and a list of infectious diseases, in case of a threat of occurrence and distribution of which restrictive measures, including quarantine, are introduced, shall be established by the state body in the field of sanitary and epidemiological welfare of population.

      Footnote. Article 150, as amended by the Law of the Republic of Kazakhstan, dated on 30.06.2010 No 297-IV (shall be enforced from 01.07.2011); dated 29.09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 151. Registration and investigation of cases of infectious and parasitic, occupational diseases and poisonings

      1. All cases of infectious and parasitic diseases, occupational diseases and poisonings shall be subject to registration by healthcare organizations at the place of their detection, state registration and reporting by state bodies and organizations of sanitary-epidemiological service. The procedure for registering, keeping records of these cases of diseases and poisonings, as well as the procedure for keeping records on them, shall be determined by the state body in the field of sanitary and epidemiological welfare of the population.

      2. Cases of infectious and parasitic diseases, occupational diseases and poisonings of the population shall be investigated by specialists of sanitary and epidemiological service in the manner determined by the state body in the field of sanitary and epidemiological welfare of population.

      Footnote. Article 151 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 152. Disinfection, disinfestation and deratization actions

      1. In order to prevent the emergence, spread of infectious and parasitic diseases, the individual entrepreneurs, individuals and legal entities shall be required to conduct a set of measures to eliminate infectious and parasitic diseases (disinfection), insects and other arthropods (pest control), and deratization (extermination of rodents) at their own expense and upon the epidemiological indications, regulations, and instructions of the officials of healthcare-epidemiological service.

      2. In case of epidemic emergencies at the expense of budget funds, the extraordinary compulsory disinfection, disinfestation and deratization measures shall be taken under the decision of local executive bodies of regions, city of republican significance and the capital upon the recommendation of the state bodies of the healthcare-epidemiological service.

      2-1. Preventive disinsection and deratization (with the exception of disinsection and deratization on the territory of natural foci of infectious diseases, as well as in the foci of infectious diseases) shall be carried out by local executive bodies of oblasts, cities of republican significance, the capital, the district, the city of regional significance.

      3. Focal disinfection, disinfestation, deratization on the foci of infectious and parasitic diseases of man and natural foci of infectious and parasitic diseases shall be carried out by the organizations of sanitary and epidemiological service and medical organizations for the purpose of preventing and (or) eliminating infectious and parasitic diseases.

      Footnote. Article 152 as amended by the laws of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 25. PROTECTION OF PUBLIC HEALTH

Article 153. The purpose and types of disease prevention

      1. To prevent disease is to prevent occurrence or progression of diseases, as well as their effects and complications.

      2. Disease prevention shall be divided into primary, secondary and tertiary preventions.

      Primary prevention of diseases (mass and individual) shall be aimed at creation of favorable living conditions in order to prevent the occurrence of diseases.

      Secondary prevention shall be aimed at prevention of diseases’ progression in the early stages and their consequences.

      Tertiary prevention shall be aimed at controlling of the already developed complications, damage of organs and tissues.

Article 154. Promotion of a healthy lifestyle

      1. A healthy lifestyle shall include promotion of healthy lifestyles, healthy food and disease prevention through information management, hygienic education in improving health and prevention of diseases, related to the lifestyle.

      2. A healthy lifestyle shall be promoted by healthcare organizations, coordinated and guided by the authorized body together with other government agencies, with participation of international and public organizations.

Article 155. Medical examinations

      1. The main goals of medical examinations shall provide timely medical examination, aimed at improvement of health, detection and prevention of a disease spread, including occupational diseases, poisoning, accidents, and ensure labor safety and health protection of employees of organizations, and the persons, conducting economic and (or) production activities.

      2. Medical examinations may be mandatory and preventive.

      3. Mandatory medical examinations shall be divided into preliminary, periodic and pre-shift.

      Preliminary mandatory medical examinations shall be conducted for admission to work or school to assess fitness for work or studies, as well as prevention of general, occupational and non-infectious and parasitic diseases.

      Mandatory periodic medical examinations shall be conducted to ensure a dynamic monitoring of the health status of employees, the timely detection of initial symptoms of diseases, prevention of general, occupational and non-infectious and parasitic diseases.

      Pre-shift mandatory medical examinations shall be carried out in order to establish or confirm the presence or absence of a person's illness, determine the state of health, as well as temporary incapacity for work, professional suitability for work in the intervening shift.

      4. The list of harmful factors of production, occupations in which mandatory medical examinations are conducted, as well as the procedure and frequency of these inspections shall be established by the state body in the field of sanitary and epidemiological welfare of the population in agreement with the authorized body.

      5. The employers, at their own expense, shall arrange timely mandatory periodic medical examinations for workers, subject to the examinations, in accordance with the legislation of the Republic of Kazakhstan in healthcare area.

      6. Medical examinations shall be divided into mass and selective.

      Mass medical examinations shall be conducted via a continuous method to the target population groups in order to detect diseases at the early stages and prevent development of diseases, risk factors, causing emergence of diseases, formation and improvement of public health.

      Selective medical examinations shall be carried out for a dynamic monitoring, implementation of a set of measures for treatment and rehabilitation of those, suffering from certain diseases or at risk.

      7. Target groups, subject to preventive medical check-ups, as well as the order and frequency of these examinations shall be established by the authorized body, taking into account the proven scientific data on their efficacy, safety and cost-effectiveness.

      8. Employers shall create conditions for taking preventive medical examinations for the persons, subject to the examinations, in accordance with the list of the guaranteed volume of free medical care, approved by the Government of the Republic of Kazakhstan.

      9. The employers shall not admit to work persons, who have not undergone mandatory medical examinations or are found unfit to work for health reasons, as well as preventive medical examinations within the guaranteed volume of free medical care.

      10. The procedure for issuing, registering and maintaining personal medical cards shall be determined by the state body in the field of sanitary and epidemiological welfare of population.

      11. Timeliness of mandatory and preventive medical examinations shall be controlled by the state bodies, working in healthcare and epidemiological welfare of the population, provision health services, and the state labor inspectors of the authorized body for labor.

      Footnote. Article 155, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 12. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 156. Preventive vaccination

      1. Individuals on the territory of the Republic of Kazakhstan shall be entitled to receive preventive vaccinations against infectious and parasitic diseases within the guaranteed volume of free medical care.

      1-1. Before the introduction of a preventive vaccination, a medical worker shall examine the vaccinated person. The medical worker shall provide him or his legal representative with complete and objective information about preventive vaccination, possible side effects, the consequences of abandoning them, possible post-vaccination complications.

      The condition for carrying out a preventive vaccination shall be the availability of consent or refusal in written form..

      2. The list of diseases against which vaccinations shall be held, the order, time-frames and population groups, subject to routine immunization, shall be defined by the Government of the Republic of Kazakhstan.

      3. Storage, transportation and use of preventive (immunobiological, diagnostic, disinfectant) drugs should be carried out in the order established by the state body in the field of sanitary and epidemiological welfare of population.

      4. Is excluded by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).
      Footnote. Article 156, as amended by the Law of the Republic of Kazakhstan, dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated 29. 12. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 157. Prevention of non-communicable diseases, including occupational diseases and injuries

      1. Prevention of non-communicable diseases, including occupational, shall include:

      1) prevention of behavioral risk factors for diseases and improvement of medical literacy through:

      promotion of a healthy lifestyle and healthy eating;

      informing of the population through the media, educational programs on prevention of diseases;

      organization of health schools to train the necessary self-help techniques to those, suffering from chronic non-communicable diseases;

      2) monitoring of disease risk factors of the attached population by the primary health care specialists, occupational diseases of workers – by the specialists of the state bodies, working in healthcare and epidemiological welfare of the population;

      3) minimization of impact of industrial disease risk factors by the state bodies within their powers, other agencies and organizations, as well as individual entrepreneurs;

      4) detection of those, suffering from chronic non-communicable diseases, including occupational, via conduction of medical examinations and motivation of earlier ambulation;

      5) dynamic monitoring and timely rehabilitation of the persons with chronic diseases, including occupational, including outpatient drug supply of certain categories of citizens, rehabilitation treatment, and medical and social rehabilitation;

      6) temporary transfer to an easier job for health reasons for the period of time, specified in the medical certificate, in accordance with the order, approved by the authorized body.

      2. Injury prevention shall be performed at the inter-sectorial level by the state bodies within their powers, by the individuals and legal entities.

Article 158. Prevention of substance abuse

      1. Prevention of substance abuse shall include:

      1) promotion of information about the danger of substance abuse, as well as medical, social and legal aspects of their use;

      2) prohibition of advertising in hallucinogenic drug circulation area, promotion of the ways, methods of development, manufacturing and use, the places for purchase of psychoactive substances, as well as limiting of advertising the samples of pharmaceuticals, containing narcotic drugs, psychotropic substances and precursors in the specialized medical publications;

      3) preventive monitoring and registration of risk individuals with mental and behavioral disorders (diseases), caused by the psychoactive substances use;

      4) voluntary, anonymous treatment of the persons, addicted to psychoactive substances;

      5) voluntary medical and social rehabilitation of drug addicts.

      2. Prevention of substance abuse shall be performed by all individual and legal entities within their competence.

Article 159. Prevention and restriction of tobacco products and alcohol consumption

      Footnote. Title of Article 159 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

      1. Prevention and restriction of tobacco products and alcohol consumption shall be aimed at protecting the health of the population, introducing age limit for the persons, eligible to purchase tobacco, alcohol products, forming the attitude of the population towards consumption of tobacco products and alcohol as a factor of increased risk to life and health, conducting agreed measures to prevent the spread of tobacco products and alcohol consumption.

      2. Sale of tobacco products shall be prohibited:

      1) to the persons and by the persons under the age of eighteen years;

      2) from open packets of tobacco products or unit sales;

      3) without the direct involvement of a seller, through vending machines, electronic or other mechanical devices;

      4) in buildings and on the territories of healthcare organizations, education, physical culture and sports;

      5) without the appropriate documents, certifying the quality of products;

      6) without excise stamps or accounting and control marks;

      7) if a pack of tobacco products contains less than twenty cigarettes;

      8) without the information on the composition, the level of tar content, nicotine and at least three harmful compounds - systemic poisons, carcinogenic and mutagenic substances, applied to a pack of tobacco products, packaging of a tobacco product.

      The procedure for placing information on the composition, level of tar content, nicotine and systemic poisons, carcinogenic and mutagenic substances on a pack of tobacco products, packaging of a tobacco product, shall be approved by the authorized body;

      9) without a warning of the harm of tobacco consumption printed on a pack of tobacco products;

      10) without the printed information on prohibition to sell the tobacco products to the persons under eighteen years of age;

      11) on a pack of tobacco products, on a package of tobacco products containing the words "low in tar," "light," "very light" or "soft," or other phrases, including in foreign languages, creating a false impression about the less harmfulness of a tobacco product, compared to others and causing associations with fruits, berries, confectionery;

      12) from self-service shelves;

      13) as part of sets with other products;

      14) in the trade organizations, selling goods for children.

      3. In the places where the sale of tobacco products is carried out, an inscription "The sale of tobacco products to persons and by persons under the age of eighteen is prohibited" should be placed in a conspicuous place, as well as a warning on the harmful use of tobacco products, approved by the authorized body.

      4. When selling tobacco products to the persons, whose age, judging by their appearance, is less than eighteen years of age, the persons, selling the tobacco products shall:

      1) require an ID, to know the actual age of the buyer;

      2) refuse to sell tobacco products in case if an ID was not shown.

      5. Consumption of tobacco products shall be prohibited in:

      1) education institutions, and recreation organizations for the minors;

      2) health care organizations;

      3) foodservice outlets;

      4) cinemas, theaters, circuses, concerts, exposition and exhibition halls, sports arenas and other indoor facilities, designed for public recreation, including in night clubs and discos;

      5) museums, libraries and lecture halls;

      6) unestablished places in local and long-distance trains, marine and river vessels;

      6-1) on aircrafts, buses and mini-vans, transporting passengers, taxis and municipal electric transport;

      7) buildings of airports, railway, auto and water stations;

      8) the state bodies and organizations;

      9) the rooms, that are the working places;

      10) porches of houses.

      6. The norms provided for in subparagraphs 3), 6), 7) of paragraph 5 of this article shall not be applied in cases, if special equipped places are allotted for the consumption of tobacco products.

      7. Places, allotted specifically for the consumption of tobacco products should be equipped in accordance with the requirements, established by the state body in the field of sanitary and epidemiological welfare of the population.

      8. The manufacturer and importer of tobacco products shall be obliged to submit reports on the results of laboratory studies on the maximum allowable content of nicotine and tarry substances in all brands of tobacco and tobacco products, the ingredients of tobacco products that they produced, in accordance with the procedure approved by the authorized body, by February 1st, or intend to produce, sell or otherwise distribute in the previous twelve months on the territory of the Republic of Kazakhstan.

      9. Examination of nicotine, tar and other harmful compounds - systemic poisons, carcinogenic and mutagenic substances in tobacco products shall be performed by a manufacturer, an importer of tobacco products at their own expense in the laboratories, accredited in accordance with the legislation of the Republic of Kazakhstan.

      10. It shall be prohibited to import, manufacture, sell and distribute tobacco products, exceeding the maximum permissible levels of nicotine and tar content determined by the state body in the field of sanitary and epidemiological welfare of the population, as well as tobacco products for which sanitary and epidemiological requirements have not been established.

      11. Manufacturing, sale and distribution of the goods, imitating tobacco products shall be prohibited.

      12. Signs, prohibiting the consumption of tobacco products should be placed in the places, banned for the consumption of tobacco products.

      13. A pack of tobacco products, a package of tobacco products should contain a warning about the harmful use of tobacco products, approved by the authorized body and meet the following requirements:

      1) to occupy not less than forty percent of each larger area of ​​a pack of tobacco products, packaging of a tobacco product;

      2) should not be printed on a transparent wrapping film or any other outer wrapping material;

      3) to be made in the form of a picture (pictograms, graphics) and inscriptions.

      14. Retail sales shall be prohibited:

      1) of alcohol products to the persons under the age of twenty-one;

      2) alcohol products, except for sale in restaurants, bars and cafes:

      from 23 to 8 o'clock the next day;

      with a volume fraction of ethyl alcohol exceeding thirty percent from 21p.m. to 12 a.m. the following day;

      3) in other cases, provided by the legislation of the Republic of Kazakhstan.

      15. Sponsorship of tobacco, tobacco products and advertising of products, simulating alcoholic beverages shall be prohibited.

      It is allowed to render charitable assistance in the order, established by the legislation of the Republic of Kazakhstan, by individuals and legal entities, carrying out importation, production, sale and distribution of tobacco.

      Footnote. Article 159, as amended by the Law of the Republic of Kazakhstan dated on 05.07.2011 No 452-IV (shall be enforced from 13.10.2011); dated on 04.07.2013 No 132-V (shall be enforced upon expiration of ten calendar days after its first official publication); dated 18. 06. 2014 No. 210-V (shall be enforced upon expiry of twenty-one calendar days after its first official publication); dated 03.07.2014 No. 229-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 No. 299-V (for the procedure of enactment see Article 2).

Article 160. Prevention of iron deficiency

      1. Iron deficiency anemia - a pathological process of the body, caused by insufficient intake and absorption of iron in the body, the increased iron losses in certain chronic diseases of gastrointestinal, genitourinary systems and the blood system, the increased iron requirements.

      2. The preventive measures for iron deficiency shall be based on the following principles:

      1) liability of state bodies, individuals and legal entities for compliance with the requirements for production, import, export, sale and movement in the other stages of the fortified foods turnover in the Republic of Kazakhstan;

      2) provision of preventive iron-containing medications for the target population groups;

      3) accessibility to health care in healthcare organizations for the persons, suffering from iron deficiency anemia;

      4) fortification of flour and other food products with iron-containing vitamins, minerals and other substances.

      3. Extra and first grade wheat flour, sold in the territory of the Republic of Kazakhstan, shall be subject to mandatory fortification with iron-containing vitamins, minerals and other substances.

      The order of enriching (fortification) of food products shall be determined by the state body in the field of sanitary and epidemiological welfare of population.

      Footnote. Article 160 as amended by the Law of the Republic of Kazakhstan dated 29. 09. 2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 161. Prevention of iodine deficiency disorders

      1. Prevention of iodine deficiency disorders shall be based on the following principles of:

      1) responsibility of the state bodies, individuals and legal entities for compliance with the requirements for production, import, export, sale of iodized edible and fodder salt in the Republic of Kazakhstan;

      2) accessibility of medical assistance in health care organizations to the persons, suffering from iodine deficiency disorders;

      3) protection of the citizens’ rights in case of loss of health, caused by the harmful effects of iodized salt and other food products, fortified with iodine.

      2. Iodization of food, fodder salt and other food products subject to mandatory enrichment shall be carried out in accordance with the legislation of the Republic of Kazakhstan on the prevention of iodine deficiency diseases.

      Footnote. Article 161 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

SECTION 7. DONATION AND TRANSPLANTATION
Chapter 26. DONATION OF BLOOD AND ITS COMPONENTS

Article 162. Donation, banking of blood, its components and preparations

      1. Donation of blood and its components (hereinafter- donation) – a voluntary participation of donors in protecting the health of citizens by donating blood and its components for medical purposes.

      2. Donation shall include a set of measures on medical examination of a donor, banking of his blood, recovery and storage of blood components.

      3. The process of blood collecting and its components shall include:

      1) donation of blood - a one-time extraction of blood given by the donor;

      2) donation of plasma - a one-time extraction of plasma by plasmapheresis method.

      Depending on the immune characteristics of the received plasma, the following shall be distinguished:

      isoimmune plasma, containing a specific concentration of specific protein structures (isoimmune antibodies), used for the production of blood preparations and diagnostic reagents;

      immune plasma, containing a certain concentration of specific protein structures (immune antibodies) of natural or artificial origin, possessing the property of purposeful medical interaction on certain types of pathogens. Immune plasma shall be used for transfusion to the recipient or for production of blood products;

      3) donation of cells - a one-time extraction of donor blood cells by the method of cypheresis.

      4. In the process of blood banking and processing, the following components shall be received:

      1) blood components – the blood components, derived from it in the form of cells and cell-free medium;

      2) blood products – the medicines, obtained during processing of blood components.

      5. The nomenclature, the rules of banking, processing, storage, sale of blood, its components, and the rules of storage, transfusion of blood, its components, and products shall be approved by the authorized body.

      Footnote. Article 162 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 163. Healthcare and other organizations, working in the field of organ donation, banking of blood, its components and preparations

      1. Banking, processing, storage and sale of blood and its components shall be carried out by the licensed state healthcare organizations.

      2. Blood products shall be produced by the organizations having a relevant license.

      3. Healthcare and other organizations, working in the field of organ donation, banking of blood, its components and preparations shall be responsible for their quality in the order, defined by the Laws of the Republic of Kazakhstan.

      4. In case of emergency or martial law in the territory of the Republic of Kazakhstan, the donorship shall be organized in accordance with the legislation of the Republic of Kazakhstan.

Article 164. Ensuring the safety and quality of donor blood, its components and preparations

      1. The safety of donated blood, its components and preparations shall be ensured by observing the established requirements for medical examination of donors, laboratory screening of donor blood, collection of blood and its components, receiving blood components using the methods of quarantinization, leukofiltration, virusinactivation, radiation exposure and other methods, permitted in the Republic of Kazakhstan.

      2. The donated blood and its components shall be subject to quality control in the order, specified by the authorized body.

      3. It shall be prohibited to use and sell the donated blood, its components, and preparations without proper labeling.

      4. Healthcare organizations and medical personnel, making transfusion of blood and its components and preparations shall be required to ensure compliance with the requirements for their safe use.

      Footnote. Article 164 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 165. The donor, his rights and obligations

      1. A donor shall be an individual, reaching the age of eighteen, who has undergone the appropriate medical examination and having no contraindications, expressing a voluntary desire to donate blood and its components for medical purposes.

      2. The donor shall have the right to:

      1) donate blood and its components free of charge;

      2) donate blood and its components for a fee in the amounts, established by the authorized body;

      3) review the results of the medical examination;

      4) be encouraged in compliance with this Code.

      3. The donor shall be obliged to inform the information known to him about all existing or previous diseases, as well as about the use of narcotic drugs, psychotropic substances, their analogues and precursors.

      Footnote. Article 165 as amended by the laws of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 03. 07. 2014 No. 227-V (shall be enforced from 01.01.2015); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 166. Medical examination of the donor

      1. Before the donation of blood and its components, the donor shall undergo mandatory free medical examination in the manner determined by the authorized body.

      2. Health certificates for implementation of donor functions shall be given in public healthcare institutions for free.

      Footnote. Article 166 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 167. The guarantees, provided to the donor

      1. During the days of medical examination and donation of blood and its components, an employee who is a donor shall be released from work by the employer with the preservation of an average wage.

      The donor, performing the donor function, shall receive an additional one day of rest without compensation, with the preservation of an average wage.

      2. If, by agreement with the employer, an employee who is a donor, commenced work on the days of donation of blood and its components, he shall be provided at his request another day off with preservation of his average salary, or this day may be attached to the annual work holiday.

      3. It shall not be allowed to employ an employee who is a donor on the days of donating blood and its components to night work, overtime, hard work, work with harmful and (or) dangerous working conditions.

      4. A military man, who is a donor, shall be released from carrying out orders, duty watches and other forms of service during the donation of blood and its components.

      5. Students, pupils who are donors, shall be released from educational process during the donation of blood and its components.

      6. The system of encouraging donors shall be approved by the authorized body.

      Additional incentive measures, provided to the donor, taking into account the total amount of blood and its components donation, shall be determined by normative legal acts of the Republic of Kazakhstan.

      7. A donor, performing a donor function free of charge, in order to replenish the volume of his blood and energy costs of the body after donating blood and its components, shall receive free food or its monetary equivalent in the amount established by the authorized body.

      8. A donor, performing a donor function on a paid basis, the healthcare organization that carries out activities in the field of blood and its components procurement, shall be paid in the manner and amounts established by the authorized body.

      Footnote. Article 167 as amended by the laws of the Republic of Kazakhstan dated 29.09.2014 No. 239-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 30.06.2017 No. 80-VI (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 168. Responsibilities of employers and leaders of organizations to create conditions for donorship development

      1. Employers and heads of organizations, in order to create conditions for donorship development shall:

      1) support local state healthcare management bodies, public healthcare organizations to attract people to donorship;

      2) provide the necessary facilities and create conditions for sampling blood and blood components;

      3) unhindered free the employee, who is a donor, from work on the day of examination and donation of blood and its components;

      4) provide the employee, who is the donor, with the guarantees, established by this Code.

      2. Employers and managers of organizations shall have the right to provide extra encouragement of donors.

      Footnote. Article 168 as amended by the Law of the Republic of Kazakhstan dated 06. 04. 2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Chapter 27. Transplantation of tissues (parts of tissue) and (or) organs (parts of organs)

      Footnote. Chapter 27 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 169. Transplantation of tissues (parts of tissue) and (or) organs (parts of organs) and conditions for their removal

      1. Donors for the transplantation of tissues (parts of tissue) and (or) organs (parts of organs) may be a person, a human corpse or an animal.

      2. Forced removal of tissues (parts of tissue) and (or) organs (parts of organs) of a person and their transplantation shall be prohibited.

      3. The purchase and sale of tissues (parts of tissue) and (or) organs (parts of organs) of a person shall be prohibited.

      4. A living transplant donor can be a person who is in a genetic relationship with the recipient or has a tissue compatibility with it (the immunological property of organic tissues that promotes their engraftment to the tissues of another organism).

      5. A live donor must undergo a comprehensive medical examination and receive a conclusion of a concilium about the possibility for recuperation of his tissue (part of the tissue) and (or) organs (parts of organs).

      6. Recuperation of tissues (parts of tissue) and (or) organs (parts of organs) from a person who is a minor or incapable person shall be possible only if the following conditions are simultaneously observed, along with those specified in this article:

      1) written notarized consent of his/her legal representatives, who received the necessary information on the state of health in accordance with Article 91 of this Code;

      2) absence of another compatible donor who is able to give appropriate consent;

      3) the recipient is the donor's brother or sister;

      4) transplantation is designed to preserve the life of the recipient;

      5) the potential donor does not object to the recuperation.

      7. The consent of legal representatives of minors or incapable persons may be withdrawn at any time before the beginning of medical intervention.

      8. The recuperation of tissues (parts of tissue) and (or) organs (parts of organs) from a person can be carried out only with his written notarized consent, with the exception of hematopoietic stem cells.

      9. For transplantation, only one of the paired organs, part of the organ or tissue may be recuperated, the absence of which does not entail an irreversible health disorder.

      10. Recuperation of tissues and (or) organs (parts of organs) from a corpse shall not be allowed, if the healthcare organization at the time of recuperation is informed that during the life the person or his spouse, close relatives or legal representative stated their disagreement on the recuperation of his/her tissues and (or) organs (parts of organs) after the death for transplantation to the recipient.

      Tissues and (or) organs (parts of organs) can be recuperated from the corpse for transplantation, if there is indisputable evidence of death recorded by the concilium.

      The certification of the death shall be given on the basis of a statement of biological death or irreversible death of the brain (brain death) in the manner determined by the authorized body.

      11. The participation of persons, ensuring the recuperation of tissues (parts of the tissue) and (or) organs (parts of organs) for subsequent transplantation, in ascertaining biological death or irreversible death of the brain shall be prohibited.

      12. To ensure the transplantation of tissues (parts of tissue) and (or) organs (parts of organs), registers of tissue recipients (tissue parts) and (or) organs (parts of organs), as well as donors of tissue (tissue part) and (or) organs (parts of organs) shall be formed.

      The procedure for the formation and maintenance of registers of tissue recipients (tissue parts) and (or) organs (parts of organs), as well as tissue donors (tissue parts) and (or) organs (parts of organs) shall be determined by the authorized body.

Article 170. The order of transplantation of tissues (parts of tissue) and (or) organs (parts of organs)

      1. The medical conclusion on the need for transplantation of tissues (parts of the tissue) and (or) organs (parts of organs) shall be given by the consilium of the relevant healthcare organization.

      2. Transplantation of tissues (parts of tissue) and (or) organs (parts of organs) to a recipient who is not capable of making a conscious decision due to his/her state of health shall be performed with the consent of his/her spouse or one of his/her close relatives or legal representatives.

      In exceptional cases, when the delay in the transplantation threatens the life of the recipient, and the persons indicated in this paragraph are not available or their location cannot be established, the decision to conduct the transplantation shall be taken by the doctors' concilium, and if it is impossible to assemble it, by the transplant doctor, with the record in the medical documentation and the subsequent notification of this to the officials of healthcare organization within 24 hours.

      3. A recipient or legal representative of a minor recipient or recipient recognized as legally incapable by the court should be warned about the possible complications for the recipient's health in connection with the forthcoming transplantation.

      4. Transplantation of infected tissues (parts of tissues) and (or) organs (parts of organs) shall be prohibited.

      5. Recuperation, conservation, collection, storage, transportation of tissue (part of the tissue) and (or) organs (parts of organs) and transplantation of tissues (parts of tissue) or organs (parts of organs) from a living donor shall be carried out in healthcare organizations included in the List of healthcare organizations in the manner determined by the authorized body and obtained a license for the relevant specialty in accordance with the legislation of the Republic of Kazakhstan.

      The list of healthcare organizations for recuperation, collection, storage, conservation, transportation of tissues (parts of tissue) and (or) organs (parts of organs) and tissue transplantation (parts of tissue) or organs (parts of organs) shall be formed in the manner determined by the authorized body.

      6. The recuperation and conservation of tissues and (or) organs (parts of organs) from corpses for transplantation shall be performed in healthcare organizations in the manner determined by the authorized body.

      7. The order and conditions for recuperation, collection, storage, preservation, transportation, transplantation of tissues (parts of tissue) and (or) organs (parts of organs) from donor to recipient shall be determined by the authorized body.

      8. The effect of this Article shall not apply to tissues (tissue parts) and (or) organs (parts of organs) that are related to the process of human reproduction, including reproductive tissues (sex cells), as well as blood and its components.

Article 171. Rights of the donor and the recipient

      1. A donor, in addition to the rights provided for in Article 165 of this Code, shall have the right to:

      1) demand full information about possible complications to his health in connection with the forthcoming surgical intervention on recuperation of tissues (part of the tissue) and (or) organs (parts of organs) from the healthcare organizations;

      2) receive treatment, including medicament, in the healthcare organization in connection with the surgical intervention on recuperation of tissues (tissue part) and (or) organs (parts of organs) within the guaranteed volume of free medical care.

      2. A recipient shall have the right to:

      1) demand full information about possible complications to his health in connection with the forthcoming surgical intervention on transplantation of tissues (part of the tissue) and (or) organs (parts of organs) from the healthcare organizations;

      2) receive treatment, including medicament, in the healthcare organization in connection with the surgical intervention on recuperation of tissues (tissue part) and (or) organs (parts of organs) within the guaranteed volume of free medical care.

      3. Medical and other employees of healthcare organizations shall be prohibited from disclosing information about the donor and the recipient.

Chapter 28. IMPORT, EXPORT OF HUMAN TISSUES AND (OR) ORGANS (PARTS OF ORGANS), HEMATOPOIETIC STEM CELLS, BONE MARROW, BLOOD AND ITS COMPONENTS, SAMPLES OF CELLS, TISSUES, BIOLOGICAL FLUIDS AND HUMAN SECRETIONS

      Footnote. The title of Article 28 is in the wording of the Law of the Republic of Kazakhstan dated on 21.06.2013 No 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication).

Article 172. Grounds for import, export of organs (parts of organs)and (or)human tissues, hematopoietic stem cells, bone marrow of a human being

      1. Importation of organs (parts of organs) and (or) human tissues, hematopoietic stem cells, bone marrow of a human being to the territory of the Republic of Kazakhstan shall be performed for:

      1) transplantation in public healthcare organizations;

      2) diagnostic studies in the territory of the Republic of Kazakhstan;

      3) joint scientific researches.

      2. Export of organs (parts of organs) and (or) human tissues, hematopoietic stem cells, bone marrow of a human being from the Republic of Kazakhstan shall be performed for:

      1) providing medical assistance to the citizen of the Republic of Kazakhstan, located abroad;

      2) providing medical assistance to the close relatives and spouses of the citizens of the Republic of Kazakhstan, who are located out of the Republic of Kazakhstan;

      3) diagnostic researches;

      4) joint scientific researches;

      5) in the cases, provided for in international treaties, ratified by the Republic of Kazakhstan.

      6) transplantation of hematopoietic stem cells, bone marrow of a human being from a donor, residing in the territory of the Republic of Kazakhstan to a recipient, residing abroad.

      3. The license to import into the territory of the Republic of Kazakhstan from countries that are not members of the Eurasian Economic Union and the export from the territory of the Republic of Kazakhstan to these countries of organs (parts of organs), human tissues in the cases provided for by subparagraph 1) of paragraph 1 and subparagraphs 1), 2) and 5) of paragraph 2 of this article shall be issued by the authorized body upon the application of healthcare organizations, carrying out activities on the specialty "transplantology", "hematology" in accordance with the license for medical activities.

      4. Import and export of hematopoietic stem cells, bone marrow of a human being from and to the territory of the Republic of Kazakhstan shall be performed for unrelated transplantation under the resolution (permission), issued by the authorized body.

      5. Import and export of organs and (or) human tissues by individuals shall be prohibited.

      6. The order of examination for biological safety, conservation and transportation of human tissues and (or) organs (parts of organs), intended for import and export, shall be defined by the authorized body.

      Footnote: Article 172 is in the wording of the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 173. Grounds for import, export of blood and blood components, samples of cells, tissues, biological fluids and human secretions

      Footnote. The title of Article 173 is in the wording of the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication).

      1. Import of blood and blood components to the territory of the Republic of Kazakhstan shall be performed for:

      1) providing medical assistance in the territory of the Republic of Kazakhstan;

      2) diagnostic studies in the territory of the Republic of Kazakhstan;

      3) joint scientific researches;

      4) necessity to conduct laboratory studies on the NLA system to confirm the tissue compatibility of the donor living abroad and the recipient living in the Republic of Kazakhstan, as well as the immunostimulation of the recipient within the framework of hematopoietic stem cell transplantation.

      2. Export of blood and blood components from the Republic of Kazakhstan shall be performed for:

      1) providing medical assistance to the citizen of the Republic of Kazakhstan, located abroad;

      2) providing medical assistance to close relatives and spouses of citizens of the Republic of Kazakhstan, who are outside the Republic of Kazakhstan;

      3) diagnostic researches;

      4) joint scientific researches;

      5) in the cases, provided for in international treaties, ratified by the Republic of Kazakhstan.

      6) when sending blood components abroad for production of plasma blood preparations at the plants of foreign producers from the blood components, banked at the state healthcare organizations, engaged in blood banking services of the Republic of Kazakhstan, in order to provide Kazakhstan population with blood preparations (contract fractionation);

      7) if it is necessary to carry out laboratory studies on the system-NLA confirming the tissue compatibility of the donor living in the Republic of Kazakhstan and the recipient living abroad, as well as the immunostimulation of the recipient within the framework of hematopoietic stem cell transplantation.

      3. Apart from the cases, provided for in paragraphs 1 and 2 of this Article, the import and export of blood and its components may be performed by way of exchange. This exchange shall be carried out only in the cases when the blood and its components with the required biological properties shall be not available.

      4. A license on importation into the territory of the Republic of Kazakhstan from countries that are not members of the Eurasian Economic Union and export from the territory of the Republic of Kazakhstan to these countries of blood and its components in the cases provided for by subparagraph 1) of paragraph 1 and subparagraphs 1), 2) and 5 ) of paragraph 2 of this article shall be issued by the authorized body upon the application of healthcare organizations, carrying out activities on the specialty "blood collection" in accordance with the license for medical activity.

      5. Import and export of samples of cells, tissues, body fluids and secretions, including the products of human activity, physiological and pathological secretions, smears, scrapings, swabs, intended for diagnostic and research purposes, or received during biomedical research, shall be performed under the resolution (permission), issued by the authorized body.

      6. Import and export of blood and its components by individuals shall be prohibited.

      Footnote. Article 173 as amended by the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication); dated 26. 12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

Article 174. The order of import, export of human tissues and (or) organs (parts of organs), blood and blood components

      1. Import to the territory of the Republic of Kazakhstan from countries that are not members of the Eurasian economic union, and export from the territory of the Republic of Kazakhstan to these countries of organs (parts of organs) and (or) tissues of man, blood and its components by healthcare organizations specified in paragraph 3 of article 172 and paragraph 4 of Article 173 of this Code shall be carried out on the basis of a license, issued in accordance with the procedure, established by international treaties in the field of licensing foreign trade of goods that have been ratified by the Republic of Kazakhstan and the Law of the Republic of Kazakhstan "About permits and notifications".

      2. Within three working days, the authorized body shall make a decision on issuance or rejection to issue a license for import and export of human tissues, blood and its components, and within one working day – for import and export of human organs.

      Footnote. Article 174 is in the wording of the Law of the Republic of Kazakhstan dated on 21.06.2013 No. 107-V (shall be enforced upon expiration of thirty calendar days after its first official publication); as amended by the Law of the Republic of Kazakhstan dated 16. 05. 2014 No. 203-V (shall be enforced upon expiry of six months after its first official publication); dated 26.12. 2017 No. 124-VI (shall be enforced from 01.01.2018).

SECTION 8. EDUCATIONAL AND SCIENTIFIC ACTIVITY IN HEALTHCARE AREA
Chapter 29. EDUCATIONAL ACTIVITIES IN HEALTHCARE

Article 175. Educational activities in healthcare

      1. The educational goals in healthcare shall be the professional training of the teaching, medical and pharmaceutical personnel for the healthcare system, their training and retraining.

      2. Educational activities in the field of healthcare shall be carried out in organizations of medical and pharmaceutical education and at medical and pharmaceutical faculties of educational organizations, implementing technical and professional, post-secondary, higher, postgraduate and additional education programs in accordance with the legislation of the Republic of Kazakhstan in the field of education. An indispensable condition for the implementation of medical education programs shall be the formation of an integrated academic system based on the integration of education, science and practice, by concluding contracts with scientific centers and clinics.

      3. State compulsory standards and standard professional training programs for medical and pharmaceutical specialties, as well as regulations on the clinical bases of education organizations in the field of healthcare and the requirements imposed on them, shall be approved by the authorized body.

      4. For the persons, who have mastered the educational programs of technical and professional, post-secondary, higher, postgraduate and additional education, the basis for holding positions in medical organizations shall be the education diploma of the state sample, and for clinical specialties also the certificate of a specialist, with the exception of students of the residency.

      5. Post-graduate medical and pharmaceutical education includes residency, master and doctoral studies. The regulation on residency shall be approved by the authorized body.

      6. Additional education shall be provided in medical organizations of education and science, implementing educational curricula of additional training.

      The main forms of additional education shall be advanced training and retraining of medical and pharmaceutical personnel. The procedure for qualification development and retraining of medical and pharmaceutical personnel, as well as qualification requirements for organizations, implementing programs for additional medical and pharmaceutical training, shall be determined by the authorized body.

      7. Training of medical and pharmaceutical personnel shall be performed by the authorized body, as well as by the local public healthcare management bodies within their powers, taking into account the needs of the branch.

      Footnote. Article 175 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 176. Certification of specialists in the field of healthcare

      1. Certification of specialists in the field of healthcare shall be conducted in order to determine the readiness of individuals with secondary (technical and vocational), post-secondary, higher medical education, as well as persons, who have been retrained and (or) acquired postgraduate education, to carry out medical activities and admit them to clinical practice (work with patients) with the issuance of a specialist certificate.

      Certification of specialists in the field of healthcare shall be carried out on the basis of an assessment of professional preparedness, confirmation of the conformity of specialists’qualifications in the field of healthcare, conducted by organizations, that assess professional preparedness and confirm the conformity of specialists’ qualifications in the field of healthcare, accredited by the authorized body in the manner, determined by the authorized body.

      2. An individual without an appropriate specialist’s certificate shall be forbidden to engage in clinical practice, with the exception of residency students, who are admitted to clinical practice (working with patients) under the supervision of a specialist, having the appropriate certificate.

      Deprivation of the certificate of a specialist in the field of healthcare shall be carried out in accordance with the Code of the Republic of Kazakhstan on administrative offenses.

      3. The procedure and terms for certification of specialists in the field of healthcare, as well as the procedure for assessing professional preparedness and confirming the conformity of specialists’ qualifications in the field of healthcare shall be determined by the authorized body.

      4. The procedure and conditions for admission to certification of specialists in the field of healthcare of persons, having received medical education outside the Republic of Kazakhstan shall be determined by the authorized body.

      5. A document, giving the right to engage in medical activities or certifying the assignment of a qualification category obtained by foreign specialists abroad, invited in accordance with the legislation of the Republic of Kazakhstan to carry out medical activities, shall be equivalent to a specialist’s certificate.

      Footnote. Article 176 is in the wording of the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of six months after its first official publication).

Article 176-1. Assignment and withdrawal of qualification categories

      1. The assignment of qualification category shall be a voluntary procedure, conducted to determine the level of qualification of specialists with medical and pharmaceutical education, with the assignment of the appropriate qualification category, with the issuance of a certificate of qualification for a particular specialty.

      The assignment of the qualification category shall be carried out on the basis of an assessment of professional preparedness and confirmation of the conformity of specialists’qualification in the field of healthcare, organizations, that perform assessment of professional preparedness and confirmation of the compliance of specialists’ qualifications in the field of healthcare, accredited by the authorized body in the manner, determined by the authorized body.

      2. In the presence of a certificate of assignment of a qualification category, issued by an authorized body, a specialist in the field of healthcare shall have the right to obtain a certificate of a specialist.

      3. The list of qualification categories shall be approved by the authorized body.

      4. The procedure, terms of issue and withdrawal of the certificate of a qualification category for the specialists in the field of healthcare, with the exception of specialists in the field of sanitary and epidemiological welfare of the population, shall be determined by the authorized body.

      5. The procedure, terms of issue and withdrawal of the certificate of assignment of a qualification category for the specialists in the field of sanitary and epidemiological welfare of the population shall be determined by the state body in the field of sanitary and epidemiological welfare of population.

      Footnote. Chapter 29 is supplemented by Article 176-1 in accordance with the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of six months after its first official publication).

Article 177. Oath of a doctor of the Republic of Kazakhstan

      Graduates of higher education institutions, who passed training in medical specialties, take the oath of a physician of the Republic of Kazakhstan as follows: "Taking the high title of a doctor, in the face of my teachers and colleagues, I solemnly swear to serve faithfully and loyally to the medicine, fully devoting myself to protection of public health. In my work I swear to be guided only by the interests of the patients, whose health is the supreme value. I swear to provide medical care with equal eagerness and patience to everyone who needs it, regardless of age, gender, nationality, religion, social status or nationality. I swear to keep medical secrets, never use it for personal profit. I swear to improve constantly my knowledge and skills, to be demanding to myself and my disciples, never refuse to provide generous assistance and seek advice from colleagues if the patient’s interests require it. I swear to protect and increase the noble traditions of Kazakhstan medicine, and thank and respect those who taught me the healing art".

Chapter 30. SCIENCE IN HEALTHCARE

Article 178. Subjects of scientific research in healthcare

      1. A scientific organization in healthcare (hereinafter - the research organization) - a legal entity, engaged in scientific and (or) scientific and technical activities, training of scientific personnel in healthcare area.

      2. Scientific organizations shall be divided into research organizations (research institutes, research centers), higher medical and pharmaceutical education organizations and other organizations, engaged in scientific activities.

      3. Scientific organizations may be engaged in medical, pharmaceutical and educational activities in accordance with the legislation of the Republic of Kazakhstan in education and healthcare areas.

Article 179. Coordination of scientific research activities in healthcare

      1. Priorities of scientific research of fundamental and applied nature, coordination of scientific support in healthcare, a concept of medical science shall be developed by the authorized body.

      2. The authorized body shall be the founder of scientific organizations.

      3. The authorized body shall perform a scientific and medical expertise of scientific programs in healthcare.

Article 180. Medico-biological experiments, pre-clinical (non-clinical) and clinical researches, application of new techniques of diagnosis, treatment and medical rehabilitation

      1. The purpose of the medical and biological experiments, pre-clinical (non-clinical) and clinical studies shall be the assessment and receipt of evidence of their safety and effectiveness via scientific methods.

      2. Pre-clinical (non-clinical) studies shall be made on animals.

      3. Clinical research involving people (patients or volunteers), provided that the positive results of pre-clinical (non-clinical) studies were obtained, may be conducted only with the written informed consent.

      4. Clinical studies involving minors may be conducted in parallel with the persons, who reached the age of majority, in order to obtain the data on:

      1) medical technology or pharmaceuticals for healing of children;

      2) the best dosage of the drug for treatment of minors.

      Clinical tests involving minors shall be conducted only with the written informed consent of their legal representatives.

      5. Upon receipt of a consent to participate in a clinical test, a legal representative of a minor, a patient or a volunteer shall be be informed about:

      1) the medical technology, pharmaceuticals or drug, the nature and duration of the clinical test;

      2) the safety and efficacy of medical technology, pharmaceutical of drug, as well the risk to the health;

      3) the actions in case of unforeseen effects of the use of medical technology, pharmaceuticals, drugs to the health status;

      4) the terms of health insurance.

      6. Clinical tests shall be terminated at any stage:

      1) at the request of a minor, his legal representative, a patient or a volunteer, participating in the test;

      2) in case of a threat to life and health of a minor, a patient or a volunteer.

      7. The mandatory requirements for conducting clinical tests shall be the official registration of documents on life and health insurance of patients and volunteers, involved in the tests, as well as the ethical assessment of research materials.

      8. The use of new methods of diagnosis, treatment and medical rehabilitation shall be possible if positive results of clinical tests were received.

      9. Conduction of clinical tests of medical technology, pharmaceuticals and medical products shall be prohibited on:

      1) the minors, who do not have legal representatives;

      2) pregnant women, except for the cases, when the clinically tested medical technologies and medicines are intended for pregnant women, and the necessary information may only be obtained in clinical tests with participation of pregnant women and when the risk of harm to the pregnant woman and the fetus is fully eliminated;

      3) the military servicemen;

      4) the persons, serving sentences in prison, and the persons, kept in temporary detention facility and in detention centers;

      5) the persons, recognized incapable by the court, except for the clinical tests of medical technologies and medicines, intended for treatment of mental disorders (diseases), for the patients with mental disorders (diseases).

      10. Standards for conducting clinical tests (proper clinical practice and research) shall be approved by the authorized body and the state bodies within their competence.

      11. The order of conducting biomedical experiments, pre-clinical (non-clinical) and clinical research, as well as the application of new methods, diagnostics, treatment and medical rehabilitation shall be approved by the authorized body.

      12. Issuance of permits for non-clinical (non-clinical) and clinical test of pharmaceutical and drugs, as well as clinical testing of medical technologies shall be carried out by the authorized body.

      13. Is excluded by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No 36-V (shall be enforced upon expiration often calendar days after its first official publication.)
      Footnote. Article 180, as amended by the Law of the Republic of Kazakhstan, dated on 10.07.2012 No. 36-V (shall be enforced upon expiration of ten calendar days after its first official publication.)

Article 181. Ethics Commissions

      1. Ethics Commissions shall be the independent expert bodies, protecting the rights, safety and welfare of the researched people and the researchers, as well as moral, ethical and legal assessment of the clinical test materials.

      2. The purpose of the Ethics Commissions shall be to protect the rights and dignity of a person in relation to the application of biology and medicine achievements.

      3. The tasks of the Ethics Commissions shall be to:

      1) conduct an independent review of the research documents;

      2) conduct an independent evaluation of safety and observance of human rights in the phase of planning and performing the test;

      3) assess compliance of the clinical research program with the standards of proper clinical practice and research, as well as qualification of researchers and technical equipment of a healthcare organization, conducting the test;

      4) assess observance of the international and national ethical standards when conducting clinical tests;

      5) participate in development of documents on biological and medical ethics.

      4. The ethics commissions may include experts in the areas of health, science, art, law, religious confessions and public associations.

      5. The Central and local Ethics Commissions shall be establishedIn the Republic of Kazakhstan.

      6. The Central Ethics Commission shall be established under the authorized body for independent evaluation of tests, conducted at the international and national levels.

      The structure and the regulation on the Central Ethics Commission shall be approved by the authorized body.

      7. Local Ethics Commissions shall be established under the healthcare organizations for independent evaluation of researches, conducted on the basis of these organizations.

      The structure and the regulation on the local Ethics Commission shall be approved by the order of the head of the health care organization, where the commission shall be established.

SECTION 9. LEGAL STATUS, SOCIAL PROTECTION OF MEDICAL AND PHARMACEUTICAL SPECIALISTS
Chapter 31. RIGHTS AND DUTIES, LABOR RELATIONS, THE CODE OF HONOR FOR MEDICAL AND PHARMACEUTICAL SPECIALISTS

Article 182. Rights and responsibilities of medical and pharmaceutical specialists

      1. Medical and pharmaceutical specialists shall be entitled to:

      1) have necessary conditions for their professional activity;

      2) perform private medical practice and pharmaceutical services;

      3) improve their qualification level at the expense of budget funds or the employer if they work in private health care organizations not less than once every five years;

      4) pass retraining at the expense of budget funds or the employer in case of layoffs due to downsizing or liquidation of the state healthcare organizations;

      5) receive compensation for the harm, caused to life or health in connection with performance of labor (official) duties;

      6) have smooth and free access to communication facilities, belonging to the organizations or citizens, as well as any available form of vehicle to transport a citizen to the nearest medical institution in the cases, threatening to his life;

      7) receive service housing;

      8) receive reimbursement of travel costs, associated with the itinerant nature of work;

      9) be rewarded for their professional duties at a high qualitative level;

      10) receive protection of their professional honor and dignity;

      11) have professional liability insurance for damage to the health of citizens in the absence of negligence or neglect by healthcare professional.

      2. Training and retraining of the teaching staff of public healthcare organizations shall be carried out at the expense of budget funds, the employer's funds, own funds, as well as at the expense of other non-prohibited sources.

      3. Medical and pharmaceutical specialists of the state healthcare sector, working in rural areas and small towns, shall be provided with the additional social support:

      1) a fringe benefit to the basic salary in the amount, defined by the local representative bodies;

      2) compensation of costs for utilities services and fuel at the expense of budget funds in the amount, set by the local representative bodies of the regions, town of republican significance and the capital;

      3) those, who have livestock in private ownership are provided with fodder, land plots for grazing and hay-making upon the decision of local representative and executive bodies;

      4) in addition to the benefits, provided by the laws of the Republic of Kazakhstan, the healthcare professionals can receive additional benefits at the expense of local budgets, the amounts of which are defined by local representative bodies.

      4. Medical and pharmaceutical specialists of state healthcare organizations, working in rural areas shall be provided with additional social support, prescribed by the Law of the Republic of Kazakhstan "On State Regulation of development of agriculture sector and rural areas".

      5. Infection with HIV of medical and pharmaceutical staff of healthcare organizations, working with the HIV infected materials, when performing their official and professional duties shall be related to the occupational diseases.

      These persons, for the period of temporary disability due to the occupational disease, shall receive a social allowance for temporary disability in accordance with the labor legislation of the Republic of Kazakhstan.

      Medical and other personnel, the official duties of whom may lead to occupational AIDS disease, shall be subject to compulsory social insurance.

      Medical workers, employees and technical personnel directly involved in preventive, diagnostic and scientific-research work related to HIV / AIDS shall have the right to a reduced six-hours day, additional paid leave of twenty-four calendar days, additional pay for occupational hazards in the amount of sixty percent of the official salary.

      6. Medical and pharmaceutical workers shall have to:

      1) perform their professional duties, respect and humanely treat their patients, and be guided by the principles of medical ethics and deontology properly;

      2) promote prevention of disease and improvement of health, provide medical care;

      3) provide emergency medical assistance to the population in case of emergency;

      4) promote health knowledge and healthy lifestyles among the population;

      5) comply with the Code of Honor of medical and pharmaceutical workers, keep patient confidentiality, not to disclose information about diseases, private and family life of citizens;

      6) continuously develop and improve their professional level, including by continuing to improve their qualifications every five years;

      6-1. Medical workers shall be subject to obligatory assessment of professional preparedness and confirmation of compliance of specialists’ qualification in the field of healthcare.

      7. Interference of the state bodies and officials, as well as the citizens in professional activities of medical and pharmaceutical workers shall be prohibited, except for the cases, provided herein.

      8. When performing their professional duties, the medical and pharmaceutical workers shall not be allowed to conduct any actions (inactions) under their religious beliefs, as well as conduction of religious rites and ceremonies, which may cause damage to life and health of individuals.

      Footnote. Article 182, as amended by the Law of the Republic of Kazakhstan, dated on 11.10.2011 No 484-IV (shall be enforced upon expiration of ten calendar days after its first official publication.); dated 06.04.2015 № 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

Article 183. Labor relations of workers of health care organizations

      1. Labor relations of workers of health care organizations shall be regulated by the labor legislation of the Republic of Kazakhstan.

      2. Payment for the labor of employees in public healthcare organizations shall be made in the order, defined by the labor legislation of the Republic of Kazakhstan.

      3. Appointment and dismissal of the heads of subordinate organizations and their deputies, including the institutions of education and science shall be conducted by the authorized body.

Article 184. The Code of Honor of medical and pharmaceutical workers of the Republic of Kazakhstan

      1. The Code of Honor of medical and pharmaceutical workers of the Republic of Kazakhstan (hereinafter - the Code of Honor) shall define the moral responsibility of the medical and pharmaceutical workers for their activities to the citizens and society as a whole.

      2. In their work the medical and pharmaceutical workers shall:

      1) be guided by this Code and the Code of Honor;

      2) help improve the health of citizens of the Republic of Kazakhstan;

      3) take decisions solely in the interests of the patient;

      4) prevent commissioning of acts which may discredit the high title of the medical and pharmaceutical worker of the Republic of Kazakhstan;

      5) perform their duties conscientiously and efficiently;

      6) improve their professional knowledge continuously;

      7) prevent promotion and use of methods and means of prevention and treatment, for their personal profit;

      8) observe strictly the labor discipline;

      9) preserve and take good care of the property of healthcare organizations;

      10) fight corruption;

      11) not allow to use confidential information for financial gain or other personal profit;

      12) promote sustainable and positive moral and psychological climate in the team;

      13) prevent and suppress violations of the norms of the Code of Honor by other medical and pharmaceutical workers;

      14) comply with the established form of clothing during performing their official duties.

      3. In relations with the patients, the medical and pharmaceutical workers shall have to:

      1) respect the rights and dignity of all persons, regardless of age, gender, nationality, religion, nationality, origin, social and property status, or any other circumstances;

      2) provide medical care to everyone who needs it;

      3) constantly remember their duty to preserve human life;

      4) enhance public confidence in the state healthcare system;

      5) prevent fraud and other extortions against patients, make efforts to suppress such actions on the part of their colleagues;

      6) by their actions, not give rise to justified criticism from society, to tolerate it, use constructive criticism to correct deficiencies and improve their professional activities;

      7) explain the principles of joint responsibility for the protection of one's own health.

      4. In relations with the colleagues, the medical and pharmaceutical workers shall have to:

      1) observe generally the accepted ethical standards, be polite and correct;

      2) provide generous support and seek advice from colleagues if the patient’s interests required it;

      3) not question publicly the professional qualifications of other medical and pharmaceutical worker;

      4) multiply the traditions and achievements of Kazakhstan's medicine.

      5. Observance of the Code of Honor by the medical and pharmaceutical workers is their professional duty.

      6. A healthcare organization, upon a decision of its head, may consider non-observance of the Code of Honor by the medical and pharmaceutical worker and make a public reprimand upon the consideration results.

      7. The heads of health care organizations provide placement of the text of the Code of Honor for visual propaganda.

      Footnote. Article 184 as amended by the Law of the Republic of Kazakhstan dated 06.04.2015 No. 299-V (shall be enforced upon expiry of ten calendar days after its first official publication).

SECTION 9-1. Basic provisions of the national preventive mechanism

      Footnote. The Code shall be supplemented by the Section 9-1 in accordance with the Law of the Republic of Kazakhstan dated on 02.07.2013 No. 111-V (shall be enforced upon expiration pf ten calendar days after its first official publication).

Chapter 31-1. The National preventive mechanism

Article 184-1. The National preventive mechanism

      1.The National preventive mechanism shall be in the form of the system preventing tortures and other cruel, inhuman or degrading treatment or punishment, functioning through the work of participants of the national preventive mechanism.

      2. As part of its activities, the members of the national preventive mechanism shall visitorganizations for compulsory treatment (specialized anti-TB organizations, drug addiction treatment organizations for compulsory treatment, psychiatric hospitals for application of compulsory medical measures (a psychiatric hospital of a general type for compulsory treatment, a specialized psychiatric hospital, a specialized psychiatric hospital with intensive supervision) and other organizations, defined by the Laws of the Republic of Kazakhstan to be visited by these participants (hereinafter –the preventive visits).

      3. Participants of the national preventive mechanism shall be the Commissioner for Human Rights, as well as the members of public monitoring commissions and associations, selected by the Coordinating Council and engaged in protection of the rights and interests of citizens, lawyers, social workers and doctors.

      4. Human Rights Commissioner shallcoordinate the activities of the participants in the national preventive mechanism, and in accordance with the Laws of the Republic of Kazakhstan shall take measures to ensure the necessary capacity and professional skills of participants of the national preventive mechanism.

      5. Reimbursement of expenditures to the members of the national preventive mechanism for preventive visits shall be covered by the budget in the order, established by the Government of the Republic of Kazakhstan.

Article 184-2. The Coordinating Council

      1. In order to ensure effective coordination of the work of the national preventive mechanism under the Commissioner for Human Rights, the Coordinating Council shall be established.

      Members of the Coordinating Council, except for the Ombudsman, shall be elected by the commission, created by the Human Rights Ombudsman, from the citizens of the Republic of Kazakhstan.

      2. Commissioner for Human Rights shall approve:

      the regulation on the Coordinating Council under the Commissioner for Human Rights;

      the procedures for selecting the participants of the national preventive mechanism;

      the procedure for formation of groups of participants of the national preventive mechanism for preventive visits;

      recommendations for preventive visits;

      the procedure for preparation of a consolidated on annual report on preventive visits.

      3. The Coordinating Council shall interact with the Subcommittee on Prevention of Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment of the United Nations Committee against Torture.

Article 184-3. Requirements for participants of the national preventive mechanism

      1. Participants of the national preventive mechanism may not be the persons that:

      1) have the unexpunged or unspent convictions;

      2) suspected or accused of committing a criminal offense;3) recognized incapable or partially capable by the court;

      4) judges, lawyers, civil servants and military personnel, as well as the officials of law enforcement and special state bodies;

      5) are registered by a psychiatrist and (or) a narcologist.

      2. Persons, who are exempted from criminal liability under articles 3, 4, 9, 10 and 12 of part one of Article 35 or Article 36 of the Code of Criminal procedure of the Republic of Kazakhstan for committing an intentional crime cannot also participate in the national preventive mechanism; dismissed from the state or military service, from law enforcement and special state bodies, courts or excluded from the bar of advocates for negative reasons; deprived of a license to practice as a lawyer.

      Footnote. Article 184-3 as amended by the Law of the Republic of Kazakhstan dated 04. 07. 2014 No. 233-V (shall be enforced from 01.01.2015).

Article 184-4. Rights of a participant of the national preventivemechanism

      1. A member of the national preventive mechanism shall be entitled to:

      1 ) obtain information about the number of persons, detained in institutions subject to preventive visits, the number of such organizations and their location;

      2) have access to information relating to the treatment of detainees, kept in organizations subject to preventive visits, as well as their conditions of detention;

      3) carry out preventive visits in the prescribed manner in the formed groups;

      4) have talks with persons detained in institutions subject to preventive visits, and (or) their legal representatives, without witnesses, either personally or through an interpreter if necessary, as well as any other person who in the opinion of members of the national preventive mechanism may provide relevant information;

      5) choose and visit organizations subject to preventive visits;

      6) accept reports and complaints of torture and other cruel, inhuman or degrading treatment or punishment.

      2. A member of the national preventive mechanism shall be independent in carrying out lawful activities.

Article 184-5. Responsibilities of participants in the national preventive mechanism

      1. When exercising their powers, the participants of the national preventive mechanism must observe the legislation of the Republic of Kazakhstan.

      2. Intervention of participants of the national preventive mechanism in the work of entities subject to preventive visits shall be prohibited.

      3. If there are circumstances doubting impartiality of a member of the national preventive mechanism in the group on preventive visits, he must refuse to participate in preventive visits.

      4. Participants of the national preventive mechanism shall register the received reports and complaints of torture and other cruel, inhuman or degrading treatment or punishment in the manner, defined by the Commissioner for Human Rights.

      The received messages and complaints shall be submitted to the Ombudsman in the order, defined by the legislation of the Republic of Kazakhstan.

      Information about the received and submitted reports and complaints shall be included in the report upon the results of preventive visits.

      5. Participants of the national preventive mechanism that violated the provisions of this Code shall be liable under the Laws of the Republic of Kazakhstan.

Article 184-6. Termination of the powers of the national preventive mechanism

      Powers of a member of the national preventive mechanism shall terminate for:

      1) violation of the provisions of this Code;

      2) a written statement of resignation;

      3) his death or the entry into force of the 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 force of a judgment of conviction;

      7) occurrence of other cases, stipulated by theLaws of the Republic of Kazakhstan.

Article 184-7. Types and frequency of preventive visits

      1. Preventive visits of the members of the national preventive mechanism shall be divided into:

      1) periodic preventive visits, conducted on a regular basis at least once every four years;

      2) intermediate preventive visits conducted between periodic preventive visits to monitor implementation of the recommendations upon the results of the previous periodic preventive visit, as well as to prevent persecution of persons with whom the participants of the national preventive mechanism had talks, by the administrations of the organizations, subject to preventive visits;

      3) special preventive visits, conducted on the basis of the received reports about torture and other cruel, inhuman or degrading treatment or punishment.

      2. The Coordinating Council shall determine the date and the list of organizations, subject to preventive visits, within the allocated budget.

Article 184-8. The order of preventive visits

      1. Preventive visits shall be made by the groups, formed by the Coordinating Council from the participants of the national preventive mechanism, in accordance with the rules, approved by the Government of the Republic of Kazakhstan in coordination with the Commissioner for Human Rights.

      2. When forming groups for preventive visits, none of the members of the national preventive mechanism shall be subjected to any discrimination for reasons of origin, social and property status, sex, race, nationality, language, attitude to religion, convictions, place of residence or for any other circumstances.

      3. Administrations of organizations, subject to preventive visits, shall ensure safety of participants of the national preventive mechanism. In the case of wrongful acts of the participants of the national preventive mechanism, the head of the administration of the organizations, subject to preventive visits, shall made a written report to the Commissioner for Human Rights.

      4. After each preventive visit on behalf of the group, a written report shall be made in a form approved by the Coordinating Council, which shall be signed by all members of the group, which has carried out the preventive visits. A member of the group having a dissenting opinion shall write it and attach to the report.

Article 184-9. Consolidated on annual report of the participants of the national preventive mechanism

      1. The Coordinating Council shall prepare an annual consolidated on report of the participants of the national preventive mechanism in accordance with their reports upon the results of preventive visits.

      2. The consolidated on annual report of the participants of the national preventive mechanism shall include:

      Recommendations for the authorized state bodies for improvement of conditions for treatment of persons, detained in institutions, subject to preventive visits, and prevention of torture and other cruel, inhuman or degrading treatment or punishment;

      proposals for improving the legislation of the Republic of Kazakhstan.

      The annual consolidated on report of the participants of the national preventive mechanism shall be attached with the financial report for preventive visits, conducted in the past year.

      3. The consolidated on annual report of the participants of the national preventive mechanism shall be sent for consideration to the authorized state bodies and shall be posted on the Internet site of the Ombudsman no later than one month from the date of its approval by the Coordinating Council.

Article 184-10. Privacy

      1. Participants of the national preventive mechanism shall not disclose any information about the private life of individuals that have become known to them during preventive visits, without the consent of that person.

      2. Disclosure of information by the participants of the national preventive mechanism about the private life of a person that became known to them during preventive visits, without the consent of the person, shall entail responsibility, established by the Laws of the Republic of Kazakhstan.

Article 184-11. Interaction of the authorized state bodies with the members of the national preventive mechanism

      1. The state bodies and their officials shall assist participants of the national preventive mechanism in implementing their legitimate activities.

      None state body or official shall be entitled to restrict the rights and freedoms of citizens for informing the participants of the national preventive mechanism about tortures and other cruel, inhuman or degrading treatment or punishment.

      The officials, hampering the legitimate activities of the participants of the national preventive mechanism, shall be liable under the Laws of the Republic of Kazakhstan.

      2. The authorized state bodies, within three months from the date of receipt of the consolidated on annual report of the participants of the national preventive mechanism, in a written form, shall inform the Commissioner for Human Rights on the measures taken after considering the received reports.

      3. Based on the reports of the participants of the national preventive mechanism on the results of preventive visits, in accordance with the legislation of the Republic of Kazakhstan,the Commissioner for Human Rights shall have the right to appeal to the authorized state bodies or officials with a request to initiate disciplinary, administrative or criminal proceedings against the officer that violated the rights and freedoms of a citizen.

SECTION 10. FINAL AND TRANSITIONAL PROVISIONS
Chapter 32. RESPONSIBILITY FOR VIOLATION OF THE LEGISLATION OF THE REPUBLIC OF KAZAKHSTAN IN HEALTHCARE AND THE ORDER FOR ENACTMENT OF THIS CODE

Article 185. Responsibility for violation of the legislation of the Republic of Kazakhstan in healthcare

      Violation of the healthcare legislation of the Republic of Kazakhstan shall entail liability in compliance with the Laws of the Republic of Kazakhstan.

Article 185-1. Transitional Provisions

      To establish that from January 1st , 2022, the first passage of subparagraph 2) of paragraph 2 of Article 34 of this Code shall operate as follows:

      "2) outpatient and polyclinic assistance for socially significant diseases, as well as for the diseases that are dangerous to others, according to the list determined by the authorized body, which includes:"

      Footnote. Chapter 32 is supplemented with Article 185-1 in accordance with the Law of the Republic of Kazakhstan dated 16.11.2015 No. 406-V (shall be enforced from 01.01.2016); as amended by the Law of the Republic of Kazakhstan dated 25. 12. 2017 No. 122-VI (shall be enforced from 01.01.2018).

Article 186. The order of enactment of this Code

      1. This Code shall be enforced upon expiration of ten calendar days after its first official publication, except for the subparagraphs 8), 10), 11) of paragraph 2 and paragraph 13 of Article 159, which shall beenforcedupon expiration of twelve months after the date of enactment of this Code.

      2. The following Laws of the Republic of Kazakhstan shall be declared repealed:

      1) The Law of the Republic of Kazakhstan dated on October 5, 1994 "On prevention and treatment of the HIV and AIDS" (the Bulletin of the Supreme Council of the Republic of Kazakhstan, 1994, No. 16-17, Art. 212; the Bulletin of the Parliament of the Republic of Kazakhstan, 1999, No. 23, Art. 921, 2004, No. 23, Art. 142, 2006, No. 15, Art. 93, 2007, No. 5-6, Art. 40; No. 9, Art. 67);

      2) The Law of the Republic of Kazakhstan,dated on April 1, 1997 "On Psychiatric Care and the Guarantees of the citizens’ rights when providing such care" (the Bulletin of the Parliament of the Republic of Kazakhstan, 1997, No. 8, Art. 86, 2001, No. 17-18, Art. 245, 2004, No. 23, Art. 142);

      3) The Law of the Republic of Kazakhstan,dated on December 10, 1999 "On compulsory treatment of citizens suffering from infectious tuberculosis" (the Bulletin of the Parliament of the Republic of Kazakhstan, 1999, No/ 24, Art. 1071, 2006, No. 15, Art. 92, 2007, No. 5-6, Art. 40);

      4) The Law of the Republic of Kazakhstan,dated on May 27, 2002 "On medical and social rehabilitation of drug addicts" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2002, No. 10, Art. 104, 2004, No. 23, Art. 142);

      5) The Law of the Republic of Kazakhstan, dated on July 10, 2002 "On prevention and limitation of tobacco smoking" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2002, No 15, Art. 149, 2006, No 23, Art. 141, 2007, No 12, Art. 88);

      6) The Law of the Republic of Kazakhstan dated on December 4, 2002 "On healthcare-epidemiological welfare of the population" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2002, No 21, Art. 176, 2004, No 23, Art. 142, 2005, No 7-8, Art. 23, 2006, No 3, Art. 22; No 15, Art. 92, 2007, No 19, Art. 147; No 20, Art. 152, 2008, No 21, Art. 97);

      7) The Law of the Republic of Kazakhstan, dated on June 4, 2003 "On the health care system" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2003, No 11, Art. 70, 2004, No 23, Art. 142, 2006, No 3, Art. 22; No 15, Art. 92; No 24, Art. 148; 2007, No 2, Art. 18; No 9, Art.. 67; No10, Art. 69; No 19, Art. 147; No20, Art. 152, 2008, No 23, Art. 124);

      8) The Law of the Republic of Kazakhstan, dated on January 13, 2004 "On Medicines" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2004, № 2, Art. 8; No 23, Art.142, 2006, No 3, Art. 22; No 15, Art. 92; No 24, Art. 148, 2007, No 2, Art. 18; No 19, Art. 147; No 20, Art. 152, 2008, No 21, Art. 97);

      9) The Law of the Republic of Kazakhstan, dated on 16 June 2004 "On reproductive rights and guarantees of their implementation" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2004, No 13, Art. 73, 2006, No 15, Art. 92, 2007, No 20, Art. 152);

      10) The Law of the Republic of Kazakhstan dated on June 28, 2005 "On donation of blood and its components" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2005, No 12, Art. 45);

      11) The Law of the Republic of Kazakhstan, dated on July 7, 2006 "On protection of public health" (the Bulletin of the Parliament of the Republic of Kazakhstan, 2006, No 14, Art. 91, 2007, No 2, Art. 14).

      The President

      of the Republic of Kazakhstan Nursultan Nazarbayev

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