On approval of the Rules for labeling of medicinal products and medical devices

New Unofficial translation

Order of the Minister of Healthcare of the Republic of Kazakhstan dated January 27, 2021 No. ҚR DSM-11. Registered with the Ministry of Justice of the Republic of Kazakhstan on February 2, 2021 No. 22146

      Unofficial translation

      In accordance with Article 242, paragraph 4 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On people’s health and healthcare system" I hereby ORDER:

      1. To approve:

      1) rules for labeling medicinal products in accordance with Annex 1 to this order;

      2) rules for marking medical devices in accordance with Annex 2 to this order.

      2. To recognize as invalid:

      1) order of the Minister of Healthcare and Social Development of the Republic of Kazakhstan dated April 16, 2015 No. 227 "On approval of the Rules for labeling of medicinal products and medical devices" (registered in the Register of State Registration of Regulatory Legal Acts under No. 11088, published on June 5, 2015 in the information and legal system "Adіlet");

      2) order of the Minister of Healthcare of the Republic of Kazakhstan dated April 22, 2019 No. KR DSM-44 "On introduction of amendments to some orders of the Ministry of Healthcare of the Republic of Kazakhstan and the Ministry of Healthcare and Social Development of the Republic of Kazakhstan" (registered with the Register of State Registration of Regulatory Legal Acts under No. 18582, published on May 2, 2019 in the Reference Control Bank of Regulatory Legal Acts of the Republic of Kazakhstan).

      3. The Committee of medical and pharmaceutical control of the Ministry of Healthcare of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, shall:

      1) ensure the state registration of this order with the Ministry of Justice of the Republic of Kazakhstan;

      2) place this order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication;

      3) within ten working days after the state registration of this order with the Ministry of Justice of the Republic of Kazakhstan, submit to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan of information on the implementation of the measures provided for in subparagraphs 1) and 2) of this paragraph.

      4. Control over the execution of this order shall be entrusted to the supervising Vice-Minister of Healthcare of the Republic of Kazakhstan

      5. This order shall enter into force upon expiry of ten calendar days after the day of its first official publication.

      Minister of Healthcare
of the Republic of Kazakhstan
А. Tsoy

  Annex 1
to the order of the Minister
of Healthcare of the
Republic of Kazakhstan
dated January 27, 2021
№ KR ДСМ-11

Rules for labeling of medical devices

Chapter 1. General provisions

      1. These rules for labeling medical devices (hereinafter referred to as the Rules) have been developed in accordance with Article 242, paragraph 4 of the Code of the Republic of Kazakhstan dated July 7, 2020 " On people’s health and healthcare system " (hereinafter referred to as the Code) and shall determine the procedure for labeling medical devices in the Republic of Kazakhstan.

      2. The following concepts shall be used in these Rules:

      1) bulk product of a medicinal product - a dosed medicinal product that has passed all stages of the technological process with the exception of the final packaging;

      2) packaging of the medicinal product - a product or a complex of products that ensure the process of circulation of medicinal products by protecting them from damage and loss, as well as protecting the environment from pollution.

      Packaging shall consist of primary (internal), intermediate (if any) and secondary (external or consumer) packaging:

      primary (internal) packaging - packaging directly in contact with the medicinal product;

      intermediate packaging - a package in which the primary packaging shall be placed for the purpose of additional protection of the medicinal product or based on the characteristics of the use of the medicinal product;

      secondary (external or consumer) packaging - packaging in which the medicinal product shall be placed in the primary and intermediate packaging;

      3) the state body in the field of circulation of medicinal products and medical devices (hereinafter referred to as the state body) - the state body leading in the field of circulation of medicinal products and medical devices, control over circulation of medicinal products and medical devices;

      4) state expert organization in the field of circulation of medicinal products and medical devices (hereinafter referred to as the expert organization) - a state monopoly entity carrying out production and economic activities in the field of healthcare to ensure the safety, effectiveness and quality of medicinal products and medical devices;

      5) trade name of the medicinal product - the name under which the medicinal product shall be registered;

      6) batch number - a distinctive combination of numbers, letters and (or) symbols that allows you to specifically identify the medicinal product series and determine the complete sequence of production and control operations, as well as track the sale of the medicinal product;

      7) sticker (sticker) - a storage medium on which the marking with information for the consumer in the state and Russian languages ​ ​ shall be applied, attached to the secondary packaging by gluing;

      8) labeling - information applied to the packaging of the medicinal product;

      9) trademark, service mark (hereinafter referred to the trademark) - a designation registered in accordance with the Law of the Republic of Kazakhstan dated July 26, 1999 "On trademarks, service marks and names of goods’ places of origin" or protected without registration by virtue of international treaties in which the Republic of Kazakhstan participates, which serves to distinguish goods (services) of some legal entities or individuals from homogeneous goods (services) of other legal entities or individuals.

      3. Mockup of labeling of packages, labels and stickers for medicinal products shall be registered by a state body during state registration of the medicinal product in the Republic of Kazakhstan, carried out in accordance with Article 23 of the Code.

      4. Information on the organization accepting claims (proposals) on the quality of medicinal products in the Republic of Kazakhstan shall be indicated in the instructions for medical use of medicinal products.

Chapter 2. Procedure for labeling medicinal products

      5. Labeling of medicinal products shall be applied by the manufacturer (or packaging company) of medicinal products for each packaging unit (primary, intermediate, secondary) in Kazakh and Russian languages.

      The labeling on the packaging shall be the same for each batch of medicinal products.

      Labeling of medicinal products shall not contradict or distort the information contained in the registration dossier documents and shall not be advertising in nature.

      It shall be allowed to apply the following on the packaging of the medicinal product:

      1) holographic and protective signs, duplicate the labeling text using Braille (for persons with visual disabilities), shall place symbols or pictograms that help explain the information to the consumer;

      2) the text of the instructions for medical use for packaging of a medicinal product dispensed without a doctor's prescription;

      3) additionally the text of labeling in other languages, provided that the information shall be fully identical;

      4) barcode (if any).

      The color design of the packaging of a medicinal product of the same dosage form containing different amounts of active substances varies.

      6. The expert organization, when conducting an examination in accordance with the procedure established by paragraph 4 of Article 23 of the Code, shall verify the authenticity of the translation or translation into Kazakh of the general characteristics of the medicinal product, instructions for medical use (leaflet), mock-ups of packaging labeling, labels, stickers with labeling.

      7. The packaging shall be marked with clear, legible, easily visible and indelible letters, a well-readable font and maintained for the entire shelf life of the medicinal product subject to the specified storage conditions.

      8. Labeling of secondary packaging, and in its absence - primary packaging shall include the following information:

      1) trade name of the medicinal product;

      2) international non-proprietary name (if any) in Kazakh, Russian and English;

      3) name of the manufacturer of the medicinal product, address. The name of the manufacturing organization and its address shall be indicated in full or in short (city, country). The trademark shall be indicated if it is granted legal protection in the Republic of Kazakhstan.

      If the manufacturer of the medicinal product shall not be its packer, the name of the packer, the date and time of packaging shall be indicated;

      4) the name of the marketing authorization holder, his address (city, country);

      5) dosage form;

      6) dosage, and/or activity, and/or concentration (if applicable) of the medicinal product substance (s);

      7) amount of the medicinal product in the package by weight, volume or number of dosage units depending on the dosage form and type of package;

      8) information on the composition of the medicinal product;

      9) for medicinal herbal products, which are packaged medicinal herbal raw materials, the mass of medicinal herbal raw materials and/or active pharmaceutical substance of plant origin shall be indicated at their certain humidity;

      10) for medicinal products containing substances subject to control in accordance with the Law of the Republic of Kazakhstan dated July 10, 1998 "On narcotic medicinal products, psychotropic substances, their analogues and precursors and measures to counter their illegal trafficking and abuse" (hereinafter referred to as the Law), the names of these substances and their content in units of weight or percentage shall be indicated.

      In single-component medicinal products, subject to the authenticity of the name of the medicinal product and the active substance and the indication of its dosage, concentration, activity, the composition of the active substance shall not be indicated;

      11) list of excipients:

      The list of all excipients for parenteral, ocular and external medicinal products.

      for infusion solutions, the qualitative and quantitative composition of all excipients shall be indicated;

      for other dosage forms, the list of antimicrobial preservatives, dyes, as well as sugars and ethanol shall be indicated;

      the list of excipients indicated during the labeling of medicinal products for oral administration shall be given in the Annex to these Rules;

      12) for infusion solutions containing more than one active substance, the value of osmolarity and/or osmolality shall be indicated;

      13) the mode of use and depending on the dosage form, the route of administration (the method of use for tablets and capsules intended for oral administration shall not be indicated);

      14) precautions;

      15) warning signs;

      16) storage conditions, storage features and, if necessary, transportation conditions;

      17) conditions of dispensing (on prescription or without a doctor's prescription);

      18) batch number;

      19) production date (if not entered in the batch number);

      20) shelf life: "valid to (day, month, year)" or "(day, month, year)";

      Specify the shelf life "valid to (month, year)" or "(month, year)," while the shelf life is determined until the last day of the specified month inclusive;

      21) registration number of the medicinal product in the form of the designation "RK-MP-";

      22) code (if any).

      9. The primary packaging enclosed in the secondary packaging shall include:

      1) trade name of the medicinal product, indicating dosage, activity or concentration;

      2) international non-proprietary name (if any) in the state, Russian and English languages;

      3) the name of the manufacturer of the medicinal product and (or) its trademark;

      4) batch number;

      5) expiry date "month, year" or "day, month, year."

      Additional information identical to the information printed on the secondary package shall be posted.

      Intermediate packaging, which does not allow reading the information on the primary packaging without violating its integrity, repeats the information indicated on the primary packaging.

      10. When marking a primary package of small size (the area of one side does not exceed 10 sm²) embedded in a secondary package (on an ampoule, an insulin vial, a syringe tube, a tube dropper, a cartridge, a syringe pen), in accordance with paragraph 40 of the Technical Regulations "Product Labeling Requirements," approved by the Order of the Minister of Investment and Development of the Republic of Kazakhstan dated October 15, 2016 No. 724, shall specify:

      1) trade name of the medicinal product, indicating dosage, activity or concentration;

      2) weight or volume;

      3) batch number;

      4) shelf life "month, year."

      11. The composition of homeopathic medicinal products shall be indicated according to the terminology adopted in homeopathy: the names of homeopathic pharmaceutical substances shall be given in Latin with an indication of the scale and degree of their dilution, the names of excipients, shall be given according to the registration dossier documents.

      12. For medicinal herbal products, which are packaged medicinal herbal raw materials, the composition shall be indicated only for collections and the procedure for preparing aqueous extracts is given, indicating the storage conditions and shelf life of the aqueous extraction.

      13. Ampoules containing narcotic medicinal products, psychotropic substances listed in Table II of the List of narcotic medicinal products and psychotropic substances, used for medical purposes and under strict control, specified in the Law of the Republic of Kazakhstan dated July 10, 1998 No. 279 "On narcotic medicinal products, psychotropic substances, their counterparts and precursors and measures to counter their illicit trafficking and abuse, "have a clearly visible double red stripe on the capillary.

      14. When labeling a bulk product of a medicinal product manufactured by foreign manufacturing organizations and packaged in packaging (primary, secondary) by the manufacturing organization of the Republic of Kazakhstan, the following shall be additionally indicated on the primary packaging:

      1) name, trademark of a foreign manufacturer, country of the bulk product of the medicinal product;

      2) batch number of the packaged medicinal product, assigned by the manufacturer who performed the packaging, taking into account the date of manufacture of the bulk product of the medicinal product;

      3) shelf life, which shall be calculated from the date of manufacture of the bulk product of the medicinal product.

      15. When labeling a set of medicinal product with a solvent on the secondary packaging, the name, volume, concentration, composition, and batch number of the solvent should be additionally indicated. The shelf life shall be indicated by the shortest shelf life of the component (medicinal product, solvent) included in the kit.

      16. The following inscriptions shall be applied on the packaging (secondary and/or primary) of the medicinal product:

      1) "For children" - for medicinal products intended for children;

      2) "Homeopathic remedy" - for homeopathic medicinal products;

      3) "The products have passed radiation control and are safe" - for medicinal plant raw materials;

      4) "The medicinal product has passed control and is safe in relation to viruses transmitted by parenteral route, including human immunodeficiency viruses (types 1 and 2) and hepatitis B and C" - for medicinal products obtained from human organs and (or) tissues;

      5) "Parapharmaceuticals" - for parapharmaceuticals.

      17. Medicinal products derived from genetically modified sources have corresponding labels: "Genetically modified" or "Based on genetically modified sources," or "Containing components derived from genetically modified sources."

      18. The labeling on the packaging of the medicinal product (secondary and, if necessary, primary), requiring special conditions for storage, handling and use, shall include the following warning labels:

      Keep out of reach of children;

      "Sterile" - for sterile medicinal products;

      "No antibodies to human immunodeficiency virus" "No antibodies to hepatitis viruses" - for medicinal products obtained from human blood;

      on the inclusion of bags (tablets) with a desiccant in the primary packaging of the medicinal product;

      for parenteral medicinal products, the method (route) of administration ("Intravenous," "Intramuscular," "For infusions," "Subcutaneous") shall be indicated, if the medicinal product is administered by three or more methods it is allowed to indicate "For injections."

      On the primary packaging, the method (route) of administration shall be indicated in abbreviations ("Intravenous (IV)," "Intramuscular (IM)," "Subcutaneous (SC)," "For injection (F/I)" - if three or more routes of administration are allowed for the medicinal product);

      explaining safety requirements, precautions for transportation, storage and use:

      "Before use, shake"; "Handle with care"; "Keep away from fire," "Do not freeze" (if necessary).

      If bags (or tablets) with a desiccant are present in the intermediate or secondary packaging of the medicinal product, warning marking of the corresponding content shall be applied to them.

      19. For radiopharmaceutical medicinal products, the packaging (primary and secondary) shall be marked in accordance with the Laws of the Republic of Kazakhstan dated April 23, 1998 "On Radiation safety of the population," dated January 12, 2016 "On the use of atomic energy" and shall meet the following requirements:

      1) the labeling on the protective container further explains the coding given on the primary packaging, indicates the number of units of radioactivity in a dose or in the primary packaging for a given time period and date, as well as the number of units of the dosage form (capsules) or the volume of the liquid dosage form in milliliters;

      2) labeling of primary packaging shall contain the following information:

      the trade name or code of the medicinal product, including the name or chemical symbol of the radionuclide;

      batch number and shelf life;

      international symbol of radioactivity;

      name and address of the manufacturer of the medicinal product;

      number of radioactivity units in accordance with the approved regulatory document.

      20. The labeling of medical immunobiological preparations, in addition to the information specified in paragraphs 8, 9, 10 of these Rules, has the following additional information characterizing this immunobiological preparation:

      1) for immune sera, shall indicate:

      group name (e.g. serum, immunoglobulin) with specificity;

      species origin (human or animal species used for production);

      production technology (e.g. purified, concentrated);

      physical condition (liquid, dry);

      dosage;

      shelf life ("number, month, year" shall be indicated), shall not be indicated on primary packaging with a volume of 1 milliliter and less, embedded in secondary packaging;

      for multi-dose packages - conditions and period of use after the first opening;

      the name and dose of any antimicrobial preservative or other adjuvant contained in the immune serum;

      the name of the excipient capable of causing a side reaction;

      contraindications when used;

      2) for freeze-dried immune sera:

      the name or composition and the amount of solvent required;

      indication of the need for immediate use after dilution or conditions and period of use after rehydration;

      3) for vaccines:

      group name indicating the word "Vaccine" and specificity;

      production technology (e.g. culture, allantoic, recombinant, purified, concentrated, adsorbed);

      biological state (living, inactivated);

      physical condition (liquid, dry);

      name and amount of antimicrobial preservative (if necessary);

      the name of the antibiotic, adjuvant, flavor or stabilizer present in the vaccine;

      the name of the excipient capable of causing any adverse reaction and contraindications when used;

      for multi-dose primary packages - conditions and period of use after the first opening;

      4) for lyophilized vaccines, in addition to the information specified in subparagraph 3) of this paragraph, shall indicate:

      the name (or composition) and volume of the liquid or liquid components of the complex vaccine added to the lyophilizate;

      conditions and period of administration of the vaccine after dissolution;

      5) for allergenic medicinal products:

      biological activity and/or protein content and/or extract concentration;

      name and amount of antimicrobial preservative added;

      for multi-dose primary packages - conditions and period of use after the first opening;

      6) for lyophilized allergenic preparations, in addition to the information specified in subparagraph 5) of this paragraph, shall indicate:

      name, composition and volume of liquid added for rehydration;

      storage conditions and the period of time during which the product shall be used after rehydration;

      sterility information (for non-sterile products not specified);

      the name and quantity of the adsorbent;

      7) for treatment and prophylactic phages:

      name, composition and activity of phages;

      for multi-dose primary packages - conditions and period of use after the first opening;

      for multicomponent medicinal products - specificity and activity of each phage;

      8) for diagnostic immunobiological products: group name (for example, diagnosticum, antigen, diagnostic serum);

      indications for use, indicating the infection, causative agent or antigen, for the diagnosis of which and with the help of which methods (methods) shall be used;

      the nature and technology of producing the active ingredient;

      designation of antigens, antibodies, phages in the composition;

      physical condition (liquid, dry);

      for serum, the following is additionally indicated: species, group, monoclonal, polyvalent.

      21. Medicinal products manufactured in a pharmacy shall be dispensed to the population in primary packaging with an appropriate label containing information for the consumer in the state and Russian languages ​ ​ and a decorated medical emblem (snake bowl) in accordance with 23 - 31 of these Rules.

      22. Each label shall have a corresponding designation depending on the method of use of the medicinal product. Labels with corresponding inscriptions shall be divided into:

      1) labels for medicinal forms of internal use: "Internal," "Internal children's";

      2) labels for medicinal forms of external use: "External";

      3) labels for parenteral dosage forms: "For injection";

      4) labels for eye medicinal products: "Eye drops," "Eye ointment."

      23. To reduce the risk of errors when dispensing the medicinal product on the label, signal colors in the form of a colored stripe on a white background shall be used:

      1) on labels for internal medicinal forms - green;

      2) on labels for dosage forms of external use - orange;

      3) on labels for eye medicinal products - pink;

      4) on the labels for parenteral dosage forms - blue.

      24. Depending on the dosage form, labels for internal or external use shall be divided into the following types: "Mixture," "Drops," "Powders," "Ointment," "Nasal drops," "Eye drops," "For injection."

      25. The following information shall be indicated on the labels for the design of individual medicinal products:

      1) name of the pharmacy;

      2) location (legal address) of the pharmacy;

      3) prescription number;

      4) Full name (if any) of the patient;

      5) designation depending on the dosage form and method of use in accordance with paragraphs 23, 26 and 27 of these Rules;

      6) detailed method of application:

      for mixtures: " ___ spoon ____ times a day ____ meal";

      for internal drops: "__ drops ___ times a day ___ meal ";

      for powders: "___ powder ____ times a day ____ meal ";

      for eye drops: "___ drops ___ times a day eye ____";

      for other dosage forms, as well as those used externally, space shall be left to indicate the method of use;

      7) date of manufacture;

      8) shelf life (number of days);

      9) price;

      10) warning inscription "Protect from children."

      The labels for the design of mixture, drops for internal use, ointments, eye drops, eye ointments, in addition to the listed designations, indicate the designations given in paragraphs 23, 27 as well as the corresponding warning signs given in paragraphs 26, 30 of these Rules.

      26. The following information shall be additionally indicated on the labels of various types of dosage forms:

      1) intended for injection - the route of administration of the medicinal product: "Intravenous," "Intravenous (drip)," "Intramuscular," "Subcutaneous";

      2) intended for therapeutic enemas: "For enemas";

      3) intended for disinfection: "For disinfection," "To Handle with care";

      4) intended for children: "Children's";

      5) intended for newborns: "For newborns";

      6) series.

      27. In addition to the information specified in paragraphs 25 and 26 of these Rules, the labels for registration of medicinal products manufactured for medical organizations shall indicate:

      1) the name of the medical organization for which they are intended;

      2) name of the department;

      3) signature of the person who prepared, checked and released the medicinal product ("prepared ______"; "checked ______"; "dispensed _____");

      4) analysis number;

      5) composition of the dosage form.

      28. All pharmacy labels shall be printed with warning labels corresponding to each dosage form:

      1) for mixtures: "Store in a cool and keep away from sunlight," "Shake before use";

      2) for ointments, eye ointments and eye drops, suppository: "Store in a cool place and keep away from sunlight";

      3) for injections and infusions: "Sterile";

      4) requiring special conditions of storage, handling and use are formalized with additional labels "Handle with care"; "Keep out."

      29. Dosage forms containing poisonous substances (mercury dichloride, mercury cyanide, mercury oxyanide) shall be issued with a black warning label with an image of a skull and crossed bones and with an inscription in white in the font "Poison" and "Handle with care" The label shall indicate the name of the poisonous substance and its concentration.

Chapter 3. Procedure for medicinal product sticker

      30. Labeling on stickers shall comply with the requirements of these Rules and shall be approved during state registration of a medicinal product in the Republic of Kazakhstan.

      31. Application of stickers on the package shall be carried out by the manufacturer of the medicinal product for each unit of the package (if there is a control of the first opening only on the secondary package) in Kazakh and Russian.

      32. The sticker shall be placed on the package, leaving open the trade and/or international non-proprietary name and dosage of the medicinal product of the original label.

      33. The application of stickers on the packaging of medicinal products unregistered in the Republic of Kazakhstan and imported in accordance with the procedure provided for in paragraph 1 of Article 251 of the Code shall be carried out by the manufacturer of the medicinal product or a subject of the pharmaceutical market that imports unregistered medicinal products.

      Labels on stickers of medicinal products unregistered in the Republic of Kazakhstan shall be placed in Kazakh and Russian.

  Annex to
Rules for labeling
medicinal products

List of auxiliary substances for the labeling of oral medicinal products

Name of the auxiliary substances

Substance code

Minimum content

Azo dyes:



sunny sunset yellow

Е110

0

azorubine (carmuazine)

Е122

punz (ponso 4R, cochineal red A)

Е124

diamond black BN (black shiny BN, black PN)

Е151

Peanut butter


0

Aspartame

Е951

0

Galactose


0

Glucose (dextrose)


0

Glycerol (glycerol)


10 g/dose

Isomalt (isomaltite)

Е953

0

Potassium-containing compounds


39 mg/dose

Polyethoxylated castor oils (macrogol glycerylricinoleate, macrogol glyceryl hydroxystearate)


0

Preservatives


0

Xylitol (xylitol)


10 g

Gingelly oil


0

Lactitol (Lactitol)

Е966

0

Lactose


0

Latex (natural rubber)


0

Maltitol (maltitol)

Е965

0

Mannitol (mannitol)

Е421

10 г

Urea


0

Sodium-containing compounds


23 mg/dose

Propylene glycol and its esters


400 mg/kg for adults
200 mg/kg for children

Wheat starch


0

Invert sugar


0

Sucrose


0

Soybean oil


0

Sorbitol (sorbit)

Е420

0

Phenylalanine


0

Formaldehyde


0

Fructose


0

Ethanol* (ethyl alcohol)


0

  Annex 2 to order
of the Minister of Healthcare
of the Republic of Kazakhstan
dated January 27, 2021
№ RK ДСМ-11

Rules for labeling medical devices

      1. These rules for labeling medical devices (hereinafter referred to as the Rules) have been developed in accordance with paragraph 4 of Article 242 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On People’s Health and Healthcare System" (hereinafter referred to as the Code) and shall determine the procedure for labeling medical devices in the Republic of Kazakhstan.

      2. The following concepts shall be used in these Rules:

      1) the state body in the field of circulation of medicinal products and medical devices (hereinafter referred to as the state body) - the state body leading in the field of circulation of medicinal products and medical devices, control over circulation of medicinal products and medical devices;

      2) state expert organization in the field of circulation of medicinal products and medical devices (hereinafter referred to as the expert organization) - a state monopoly entity carrying out production and economic activities in the field of healthcare to ensure the safety, effectiveness and quality of medicinal products and medical devices;

      3) operational document of a medical device - a document developed by the manufacturer of a medical device for consumers, containing information about the design, principle of operation, parameters, characteristics (properties) of the medical device, its components; instructions required for correct and safe operation of the medical device (intended use, maintenance, storage and transportation); information on disposal; information about the manufacturer, supplier of the product and their warranty obligations;

      4) labeling - information applied to the packaging of a medical device.

      3. Labeling of medical devices shall be approved by the state body during the state registration of medical devices in the Republic of Kazakhstan, carried out in accordance with Article 23 of the Code.

      4. Information for the consumer (operational document of a medical device, instructions for medical use of medical devices) shall contain complete and reliable information that does not mislead them regarding the composition, properties, nature of origin, method of manufacture (production) and use, as well as other information that directly or indirectly characterize the quality and safety of medical devices.

      Information on the organization accepting claims (proposals) on the quality of medical devices in the territory of the Republic of Kazakhstan shall be indicated in the instructions for medical use of the medical device and the operational document of the medical device.

Chapter 2. Procedure for labeling medical devices

      5. Labeling shall be applied by the medical device manufacturing organization directly to each medical device unit, package (container), label (mark, container), stated in a compressed form, complete enough to transfer the necessary and reliable information to the consumer.

      6. Labeling of medical devices containing information in accordance with the instructions for medical use of the medical device or the operational document of the medical device approved during state registration, in the form of text, individual graphic, color signs (symbols) and (or) pattern and their combinations, shall be applied directly to the medical device, package (container) or label (sticker), label, container.

      When applying graphic signs, the following requirements must be observed:

      signs are easily recognizable and understood, different from other signs;

      the same signs applied to a medical device have the same meaning regardless of their functions or purpose and type of application;

      symbols and designations used in labeling are deciphered in the instructions for medical use of the medical device and in the operating document of the medical device.

      7. Labeling shall be unified for each series (batch) of medical device and shall be indicated in the state and Russian languages.

      The expert organization, when conducting an examination in accordance with the procedure established by paragraph 4 of Article 23 of the Code, shall verify the authenticity of the translation or translation into Kazakh of labeling of mock-ups of packages, labels, stickers, instructions for medical use, as well as the requirements of these Rules.

      8. The labeling of the medical device shall be clearly and intelligibly executed, and shall be also distinguished or placed against a background contrasting with the color of the surface on which it is located.

      9. Labeling shall be maintained during the entire permissible period of application (operation) of the medical device, methods of application and manufacture of labels (signs), marks, containers take into account the features of the medical device and ensure the necessary image quality.

      10. Safety requirements for storage, transportation, sale, use, disposal (recycling), destruction of medical devices shall be highlighted from the rest of the information for the consumer in another font, color.

      11. If the package (container) in which the medical devices are embedded is placed in an additional package, then the external package does not interfere with the internal label (sticker) of the package for reading, or a similar label (sticker) is applied to the external package.

      If it is impossible to apply the necessary labeling text on the package (container), label (sticker), label, small-size container (the area of ​ ​ one side does not exceed 50 sm²), then the marking is placed on the group package (container).

      12. The labeling means in contact with the medical device ensure the stability of the applied information during their storage, transportation, sale, use and impact of climatic factors, without affecting the safety and quality of the medical device.

      13. The safety of the labeling used in the conditions of active exposure to the environment or in special conditions (high or low temperature, aggressive environment and other similar conditions) shall be ensured by one of the following methods or their combination:

      1) application of a material-carrier resistant to action (moisture-resistant, heat-resistant);

      2) application of the appropriate application method (extrusion, etching);

      3) application of a resistant shell (transparent film, bag, box).

      14. The labeling for consumers, applied directly to the medical device, package (container), label (sticker), label (tag), container, contains the following data:

      1) name of the medical device (if the size of the label is less than 50 cm ², it is possible to indicate the name in Latin letters or in the manufacturer's language);

      2) the name of the country-manufacturer;

      3) name and/or trademark of the manufacturer (if any);

      4) name and location (legal address) of the manufacturer and/or license holder, if the medical device is manufactured under a license;

      5) the main properties and characteristics that are specified in the metric system of measures (International System of Units): indication of mass (net, gross), basic dimensions, volume and capacity;

      6) information necessary for the user to identify a medical device: if possible, a bar code identifying medical devices placed in a place convenient for reading by scanning devices;

      7) shelf life (month, year) and/or operation up to which safe use of a medical device is allowed;

      8) the year of manufacture of the active medical device (in accordance with the state standards of the Republic of Kazakhstan). The production year is indicated together with the batch number or serial number;

      9) special conditions for storage and (or) use (operation): for example, indication of temperature and light modes;

      10) indication of sterility (for sterile medical devices);

      11) batch number (batch) and/or batch code, and/or symbol;

      12) information that the medical device is intended for disposable use, in the form of an inscription: "For disposable use";

      13) on a medical device made to order, the inscription: "Made to order";

      14) on a medical device intended for clinical studies, indication ("Only for clinical research");

      15) precautions to be taken during storage, transportation, sale, operation, use;

      16) trademark (if any).

      15. The labeling of medical devices shall not contradict or distort the information contained in the registration dossier documents and is not advertising in nature.

      It is allowed to apply the following on the medical device packaging:

      1) holographic and protective signs, duplicate the labeling text using Braille (for persons with visual disabilities), shall place symbols or pictograms that help explain the information to the consumer;

      2) in addition, the labeling text in other languages, provided that the information is fully identical.

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