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Kazakhstan

The Republic of Kazakhstan is one of the largest post-Soviet countries with a population of about 18 million people. The county is a member of the Eurasian Economic Union (EAEU) along with Russia, Belarus, Armenia and Kyrgyzstan. Membership of Kazakhstan in EAEU significantly influences regulatory policy of the state: currently Applicants can choose between “national” and “unified” registration procedure for medicinal products and medical devices.

Food products for special purposes (food supplements, baby food, sport food, medical nutrition etc.) and cosmetic products pass registration procedure according to unified EAEU Technical Regulations only.

Kazakhstan is characterized by the most transparent market for foreign manufacturers of pharmaceutical products from the point of view of legislation. Medicinal products of foreign companies occupy dominant position in rapidly growing pharmaceutical market of the country: the imported pharmaceutical products share in the market of Kazakhstan is about 88%.

The central executive authority implementing state health care policy is the Ministry of Health and Social Development of the Republic of Kazakhstan (website: https://www.enbek.gov.kz/).

The Ministry of Health and Social Development of the Republic of Kazakhstan provides marketing authorization (state registration) of finished medicinal products and active pharmaceutical ingredients, medical devices and medical equipment based on expert examination carried out by the National Center for Expert Evaluation of Medicinal Products, Medical devices and Medical Equipment (website: http://www.dari.kz/).

The authorized body for registration of food products and supplements in Kazakhstan is the State Institution “Committee for Regulation of Natural Monopolies, Protection of Competition and Consumer Rights of the Ministry of National Economy of the Republic of Kazakhstan” (link to the website: http://economy.gov.kz/).

Importation and sales of medicinal products, medical devices, medical equipment, food products and supplements and cosmetics are allowed only after obtaining marketing authorization.

 

Medicinal products

According to the Code of the Republic of Kazakhstan “On the Public Health and the Health Care System”, importation and sales of medicinal products in Kazakhstan are allowed only after state registration (or renewal).  Until 31 December 2020 registration of medicinal products can be performed under the “national” procedure or under the “unified” procedure. After 31 December 2020 EAEU unified procedure can be applied only.

Expert evaluation of finished medicinal products is performed by the “National Center for Expert Evaluation of Medicinal Products, Medical devices and Medical Equipment” of the Ministry of Health and Social Development of the Republic of Kazakhstan (hereinafter the National Center) Website: http://www.dari.kz.

Kazakhstan is the country with high standards of regulation of marketed medicinal products. Inconsistencies between approved and actual packaging artworks, instructions for medical use (package leaflets), certificates of analysis may cause withdrawal of medicinal product and temporary or permanent prohibition of sales.

Marketing authorization holder may be both resident and non-resident of the Republic of Kazakhstan. Marketing authorization holder is not obliged to establish a representative office or a legal entity in the territory of Kazakhstan. At the same time Applicant (a person performing submission of documentation and negotiations with competent authorities) must be a resident.

According to local regulations it is required to indicate name and address of the entity accepting claims (proposals) to quality of medicinal products and responsible for post-marketing pharmacovigilance activities for the products in their instruction for medical use (package leaflet).

Registration dossier is accepted in CTD format. However, for submission of the dossier specific national documents should be developed, namely:

  • Application form for registration of a medicinal product.
  • Normative document that includes composition of finished product, specification for release and shelf life, quality control methods, information on storage conditions, information about manufacturers etc.
  • Instruction for medical use.
  • Artworks of primary and secondary packaging.

The dossier is submitted in electronic and paper forms.  

Part of administrative documentation should be properly legalized.

Part of the documents should be translated into Russian or Kazakh language. Package labeling and instructions for medical use are submitted and approved in Russian and Kazakh languages.

Registration procedure is performed in accordance with the Order of the Minister of Health of the Republic of Kazakhstan No. 736 “On Approval of the Rules for expert examination of Medicinal Products, Medical Devices and Medical Equipment” dated 18 October 2009. The duration of expert examination for state registration of medicinal product is 7 months (not more than 210 calendar days, excluding timelines for Applicant to reply to deficiency letters and observations obtained during the expert examination; for organization of inspection of manufacturing facilities and quality assurance system; conducting preclinical and clinical studies, pharmacovigilance system, reconciliation of final documents).

The registration procedure may be presented by the following stages:

  • Making  contract with the National Center for expert examination.
  • Obtaining and payment of invoice for the expert examination.
  • Obtaining permission to import samples of medicinal product and required standards.
  • Filing of registration dossier and samples to the National Center for Expert Evaluation.
  • Expert examination:
    • Primary expert examination.
    • Analytical expert examination.
    • Specialized expert examination.
  • Inspection at manufacturing site if necessary.
  • Reconciliation of final documents.
  • Obtaining a conclusion on safety, efficacy and quality of medicinal product.
  • Submission of Application form for registration of medicinal product to the Ministry of Health.
  • Payment of state fee for registration.
  • Issuing an order of Ministry of Health, obtaining a Registration Certificate.

During registration the National Center has the right to request Applicant to provide additional documents related to quality, safety and efficacy of medicinal product. The Applicant has 30 days to respond to the National Center queries or to justify timelines necessary to provide replies. In the event when Applicant does not provide the requested data or provides them incomplete the registration materials are withdrawn from examination and payments are not returned.

Registration Certificate (Marketing Authorization) consists of several documents:

  • Registration Certificate itself.
  • Approved text of instructions for medical use.
  • Approved color artworks of primary and secondary packaging.
  • Agreed normative document (that includes composition of product, specification for release and shelf-life, quality control methods, etc.).

Validity period of Registration Certificate is 5 years. As After following renewal validity of Registration Certificate is set as unlimited. Medicinal products imported to the country during period of the Registration Certificate validity are allowed to be marketed until their expiry date.

 

Renewal

Application form for renewal should be submitted before expiry date of Registration certificate but not later than 6 months after Registration Certificate expiration. Renewal procedure is similar to new product registration procedure in Kazakhstan.

During renewal examination the National Center may assign laboratory control of registration sample in case if changes in specifications and/or methods of quality control of the finished product take place. The National Center may assign inspection of manufacturing site during renewal procedure as well.

The set duration of expert examination is not more than 120 calendar days excluding timelines for Applicant to reply to deficiency letters and observations obtained during the expert examination; for organization of inspection of manufacturing facilities and quality assurance system; conducting preclinical and clinical studies, pharmacovigilance system, reconciliation of final documents.

Based on the results of renewal Registration Certificate is issued for a period of validity of five years (or unlimited).

 

Variations

Application form for variations should be submitted within two months from the date of their approval by authorized body of country of manufacturing site (if the relevant variations passes approval procedure).

Variations to registration dossier of medicinal products are classified as follows:

  • Type I variations (divided into variations of type IA and type IB) to registration dossier of medicinal product which do not require new registration:
    • Minor changes related to correction of registration dossier content during validity period of Registration Certificate of medicinal product.
    • Urgent temporary restrictions related to safety of medicinal product which implemented by Applicant in the event of identification of a risk to human health during administration of registered medicinal product; and which should be urgently reported to state authority for making a decision on their implementation. In case of the state authority positive decision Applicant should provide the relevant package of documents for variation procedure not later than in fifteen working days from the date of implementation of safety restrictions.
  • Type II variations which require new state registration of medicinal product and which are accompanied by significant changes in characteristics of medicinal product.

Notifications about changes to registration dossier are not provided according to legislation of Kazakhstan.

All types of variations should be officially approved by the competent authority.

Duration of expert examination of variation procedures is:

  • For type IA variations the duration is not more than 30 calendar days excluding timelines for reconciliation of final documents.
  • For type IB and II variations (without laboratory control) the duration is not more than 60 calendar days excluding timelines for Applicant to reply to deficiency letters and observations obtained during the expert examination; for organization of inspection of manufacturing facilities and quality assurance system; conducting preclinical and clinical studies, pharmacovigilance system, reconciliation of final documents.
  • For type IB and II variations (accompanied by laboratory control) the duration is not more than 90 calendar days excluding timelines for Applicant to reply to deficiency letters and observations obtained during the expert examination; for organization of inspection of manufacturing facilities and quality assurance system; conducting preclinical and clinical studies, pharmacovigilance system, reconciliation of final documents.

During  variation procedure the National Center may assign laboratory control of samples in case  if changes to specifications and/or methods of quality control of finished product have occurred. The National Center may assign inspection of manufacturing site (for example, in case of transfer of manufacturing process to another manufacturing site) during variation procedure as well.

 

Pharmacovigilance

The fundamentals of pharmacovigilance system in the Republic of Kazakhstan are established by Article 85 of the Code of the Republic of Kazakhstan “On the Public Health and the Health Care System”.

Marketing Authorization Holders as well as health care and pharmaceutical professionals are obliged to submit information on identified adverse reactions, in the order determined by the Ministry of Health of the Republic of Kazakhstan.

Marketing Authorization Holders of medicinal products are obliged to implement, assure and guarantee organization and functioning of pharmacovigilance system in accordance with requirements of Regulations on Pharmacovigilance of medicinal products and monitoring of adverse reactions of medicinal products, medical devices and medical equipment approved by order of the Minister of Health and Social Development of the Republic of Kazakhstan.

 

Competent state authority on pharmacovigilance system in Kazakhstan is the “National Center for Expert Evaluation of Medicinal Products, Medical devices and Medical Equipment” of the Ministry of Health and Social Development of the Republic of Kazakhstan (hereinafter, the National Center). Website: http://www.dari.kz/.

To assure functioning of pharmacovigilance system Authorized person for pharmacovigilance should be appointed in the territory of Kazakhstan by marketing authorization holder. The pharmacovigilance system of marketing authorization holder is a subject to control by the competent authority.

Manufacturing authorisation holders should submit the following information to the competent authority:

  • About location of master file of pharmacovigilance system.
  • About specialist responsible for pharmacovigilance activities in the territory of Kazakhstan.
  • About any prohibitions or restrictions in use  implemented in other countries related to medicinal product registered in Kazakhstan.
  • About all cases of adverse reactions identified in the territory of the Republic of Kazakhstan.
  • About cases of serious unexpected adverse reactions identified in other countries.

 

Medical devices and equipment

Medical devices and medical equipment of foreign production may be imported and sold in the territory of the Republic of Kazakhstan after state registration. At present Application form for state registration may be submitted both under the “national” Kazakh and under the “unified” procedure of the EAEU.

Below is a description of the national procedure. Procedure for registration of medical devices according to Eurasian Economic Union regulations is described on a separate page of our website.

Registration is performed based on the national legislation: Order of the Minister of Health of the Republic of Kazakhstan No. 735 dated 18 November 2009, Order of the Minister of Health of the Republic of Kazakhstan No. 736 dated 18 November 2009, etc.

Registration Certificate is issued for a period of 5 years and it is valid only for Kazakhstan.

A non-resident manufacturing site should appoint its authorized representative in the territory of Kazakhstan. The authorized representative should be a resident legal entity and it should take responsibilities for quality and safety of medical device as well as to be a facility for  storage of documentation and act as a point of contact with the manufacturing site.

It is necessary to appoint a local specialist for pharmacovigilance activities related to  adverse reaction (events) reporting.

Registration dossier may be submitted in English with translation of certain sections into Russian. The required languages of package labeling and instructions for use (user manual) text are Russian and Kazakh.

Prior to submission of Application form for registration, medical device and medical equipment should pass expert examination for its safety, efficiency and quality in the state expert organization. Examination of medical devices and medical equipment during state registration/renewal consists of the following stages:

  • Initial expert examination.
  • Analytical expert examination (for medical devices).
  • Specialized expert examination.
  • Issuing conclusions on safety, efficacy and quality of medical device or medical equipment.

Expert activities are carried out by the National Center for Expert Evaluation of Medicinal Products, Medical devices and Medical Equipment.

Renewal of medical devices and medical equipment is performed in the event of Registration Certificate expiration.

Application form for renewal should be submitted before expiry date of Registration Certificate. After completion of renewal procedure for medical devices and medical equipment produced in accordance with ISO 13485 requirements, Registration Certificate is issued for unlimited period.

During validity of Registration Certificate variations procedure can be provided if necessary. The list of variations to registration dossier of medical device which do not require new registration is following:

  • Change of the name of manufacturing site.
  • Change of the name of th medical device or medical equipment.
  • Changes in accessories, and/or components, and/or consumables.
  • Removal/addition of indications for use, intended use, contraindications, side effects.
  • Change of manufacturer(s) of medical device.
  • Increase/decrease of shelf-life of medical device.
  • Change in storage conditions of medical device.
  • Change in quality control procedure for finished medical device.
  • Change of packaging of medical device.
  • Change of imprints, primers or other marking used for labeling.

Introduction of other changes to medical device or equipment leads to new registration procedure.

Register of approved medical equipment and medical devices of the Republic of Kazakhstan is available in electronic format: http://www.dari.kz/category/gos_reestr_excel

 

Food products for special purpose

Special purpose food products are listed below:

  • Food supplements.
  • Sport products.
  • Food products for nutrition of pregnant and breast-feeding women.
  • Food products for baby nutrition.
  • Food products for dietary therapeutic and dietary preventive nutrition.
  • Mineral natural, therapeutic-table, therapeutic mineral water with mineralization over 1 mg/dm3 or with less mineralization, containing biologically active substances in an amount not lower than balneological norms.

Food products and supplements are subjected to state registration under “unified” procedure, according to the EAEU Technical Regulations. The authorized body for registration of food products and supplements in Kazakhstan is the State Institution “Committee for Regulation of Natural Monopolies, Protection of Competition and Consumer Rights of the Ministry of National Economy of the Republic of Kazakhstan” (hereinafter, the Committee). Link to the website is http://economy.gov.kz/.

State registration of food products and supplements is valid for an unlimited period the territory of all countries - members of EAEU: Kazakhstan, Belarus, Russia, Armenia and Kyrgyzstan.

State registration of food products and supplements of foreign production is performed prior to importation of the products to the customs territory of EAEU.

Prior to registration procedure, it is necessary to testing samples of food products and supplements in an accredited testing laboratory in the territory of Kazakhstan or another EAEU country. Therefore, the state registration procedure may be presented as the following stages:

  1. Testing of samples in an accredited testing laboratory.
  2. Expert examination of Application form, results of testing and other necessary documents that confirm safety and conformity of the products to the requirements of EAEU Technical Regulations.
  3. Entering data to the unified register of food products and supplements.

The unified register of food products and supplements is updated on a daily basis and is available at this link. The national register is also maintained on the website of the Public Health Protection Committee of the Ministry of Health of the Republic of Kazakhstan (link:  http://www.rep.nca.kz/index.php?mode=r3).

Documentation for registration should be provided in Russian or Kazakh languages.

Prior to registration it may be necessary to check composition of a product as well as quality, safety and labeling requirements for compliance with requirements of the EAEU Technical Regulations, for example:

  • For all food products and supplements it is recommended to check the compliance with:
    • Technical Regulations 021/2011 "On Food Products Safety", and in particular Annex 7 “List of Plants and Products of Their Processing, Objects of Animal Origin, Microorganisms, Fungi and Biologically Active Substances forbidden for Use as Components of Food Supplements”.
    • Technical Regulations of Customs Union 029/2012 “Safety Requirements for Food Supplements, Flavors and Technological Excipients”.
    • Technical Regulations 022/2011 “Food Products in Terms of Labeling”.
  • If a food product are indicated for use in children it is also recommended to check the compliance with:
  • Annex 8 TR TS 021/2011 “Types of Plant Raw Materials for Use in the Production of Food Supplements for Children from 3 to 14 Years and Baby Herbal Teas (Tea Drinks) for Young Children”.
  • Annex 9 TR TS 021/2011 “Vitamins and Mineral Salts Used in Production of Baby Food”.
  • Annex 10 TR TS 021/2011 “Pesticides Forbidden for Use in Production of Food (Nutritional) Raw Materials Intended for Production of Baby Food”.
  • If a food product contains oils and/or fats, it is also advisable to check its compliance with TR TS 024/2011 “Technical Regulations for Fat and Oil Products”.

 

Labeling requirements

When registering and subsequently marketing food product, special attention should be given to the issue of labeling. An obligatory element of labeling is the unified sign of the products circulation on the market of the EAEU member states. For bulk products (in-bulk) unified mark is indicated in the accompanying documents.    

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Requirements for labeling of food products and supplements are specified in Technical Regulation of the Customs Union 022/2011 “Food Products in Terms of Labeling”. The labeling of the consumer packaging of food products should contain the following information:

  • Name.
  • Composition.
  • Quantity (volume, weight, number of units).
  • Date of manufacture.
  • Shelf life (expiry date).
  • Storage conditions that are specified by the manufacturer or are stipulated in the technical regulations of the EAEU.
  • Storage conditions after opening the package if necessary.
  • Name and location of the manufacturer of food products.
  • If the manufacturer is a non-resident of the EAEU countries, it is necessary to indicate the name and location of the person authorized by the manufacturer, the name and location of the importing organization.
  • Recommendations and (or) restrictions on use, including preparation of food products if necessary.
  • Nutritional values, based on 100 g, 100 ml or one portion, including:
    • Energy value (caloric content).
    • Amount of proteins, fats, carbohydrates.
    • Amount of vitamins and minerals.
  • Information on the presence of components obtained using genetically modified organisms (GMOs) in the food products.
  • Unified sign of the products circulation on the market of the EAEU member states.

If applicable (when necessary) the labeling must also contain:

  • When flavors are present the labeling of the composition should have the word “flavor(s)”.
  • When the components that can cause allergic reactions or are contraindicated in certain types of diseases are present, it is necessary to indicate them in the composition, regardless of their quantity.
  • For food products obtained using GMOs, including those that do not contain DNA and protein, it is necessary to indicate “genetically modified products”, or “products derived from genetically modified organisms”, or “products contain components of genetically modified organisms”.
  • In the event that genetically modified organisms are not used in production (0.9% or less), then the labeling of such food products does not indicate the presence of GMOs.
  • If there is a food additive in the food product, it is obligatory indicate the purpose (for example, acidity regulator, stabilizer, emulsifier) and the name that may be replaced by the index according to the International Digital System (INS) or the European Digital System (E).

Components of the food product are listed in descending order of their mass fraction at the time of production. The header “Composition” should be placed before the list these components.

Labeling is reconciled in Russian and Kazakh languages.

 

Perfume and cosmetic products

Perfume and cosmetic products (PCP) are the products intended to be applied directly to the outer surface of the human body (skin, scalp, nails, lips and external genital organs) or to the teeth and mucous membrane of the oral cavity with the sole or primary purpose of cleansing, appearance modification, odorization, protection, physiological state maintenance, and/or care.

Perfume and cosmetic products are subject to the “centralized” authorization by means of conformity assessment (in the form of declaration or state registration with the Registration Certificate issue).

The authorized bodies for authorization of perfume and cosmetics in Kazakhstan are the certification authorities accredited under the Technical Regulations of the Eurasian Economic Union (EAEU).

The state authorization of perfume and cosmetic products is indefinite (or until changes are made to the name and/or composition of products), and is valid in the territory of all EAEU member countries: Kazakhstan, Belarus, Russia, Armenia and Kyrgyzstan.

State authorization of perfume and cosmetic products of foreign manufacture is performed before the products are imported into the customs territory of the EAEU.

Applicant for the procedure for authorizing perfume and cosmetics products can only be a legal entity registered in the territory of the EAEU (manufacturer, authorized representative of the manufacturer or importer).

The Applicant must assign and place information about the organization authorized to receive claims from consumers and its location (legal address) on the labeling. The functions of such organization may be performed by the authorized representative of the manufacturer or importer (the organization registered in the territory of the EAEU).

Documentation for registration is provided in Russian or Kazakh languages. In case of providing original documentation of a foreign manufacturer, it is necessary to provide translations of all documents into Russian or Kazakh languages (translations must be notarized or signed by an interpreter with confirmation of his/her qualification).

Prior to the authorization procedure, it is advisable to check the documentation for the product for compliance with the requirements of the Technical Regulations of the EAEU, namely:

  1. Requirements for the composition.
  2. Requirements for physicochemical parameters.
  3. Requirements for microbiological parameters.
  4. Requirements for the content of toxic elements.
  5. Requirements for toxicological parameters.
  6. Requirements for clinical (clinical and laboratory) parameters.
  7. Requirements for manufacture.
  8. Requirements for consumer packaging.
  9. Labelling requirements.

 

Declaring perfume and cosmetic products

Prior to the declaring procedure, it is necessary to test samples of perfume and cosmetic products in an accredited testing laboratory in the territory of Kazakhstan or another EAEU country. Therefore, the declaring procedure may be presented as the following stages:

  1. Tests of samples in an accredited testing laboratory.
  2. Expert evaluation of the application, results of tests and other necessary documents that confirm the safety and conformity of the products to the requirements of the Technical Regulations of the EAEU.
  3. Registration of the declaration in the accredited body.

The unified register of perfume and cosmetic products completed the declaring procedure is updated daily and is available at the following link (http://www.rep.nca.kz/index.php?mode=r4).

 

Registration of perfume and cosmetic products

List of products subject to registration:

  • Perfume and cosmetic products for artificial tan.
  • Perfume and cosmetic products for whitening/lightening the skin.
  • Perfume and cosmetic products for individual skin protection from the impact of negative workplace factors.
  • Perfumes and cosmetics for chemical dyeing, lightening and styling hair.
  • Perfume and cosmetic products for perming or straightening hair.
  • Perfume and cosmetic products for depilation.
  • Perfume and cosmetic products for peeling.
  • Cosmetics for tattooing (except for tattooing products applied with skin integrity violation).
  • Intimate cosmetics.
  • Baby cosmetics.
  • Fluorinated oral hygiene products (fluorides ≥ 0.15% for hard and soft products, fluorides ≥ 0.05% for liquid products).
  • Products for teeth whitening (with concentration of hydrogen peroxide 0.1-6.0%).
  • Perfume and cosmetic products made with the use of nanomaterials.

Prior to the registration procedure, it is necessary to test samples of perfume and cosmetic products in an accredited testing laboratory in the territory of Kazakhstan or another EAEU country. Therefore, the state registration procedure may be presented as the following stages:

  1. Tests of samples in an accredited testing laboratory.
  2. Expert evaluation of the application, results of tests and other necessary documents that confirm the safety and conformity of the products to the requirements of the Technical Regulations of the EAEU.
  3. Adding information to the unified register of products and the Registration Certificate issue.

The unified register of perfume and cosmetic products completed the registration procedure is updated daily and is available at the following link. A national register is also maintained and accessible at the link http://www.rep.nca.kz/index.php?mode=r3

 

Labeling requirements

When authorizing and subsequently marketing perfume and cosmetic products, special attention should be given to the issue of labeling. An obligatory element of labeling is the unified sign of the products circulation on the market of the EAEU member states, which is indicated on each product unit.

Image result for ЕАС

The requirements for labeling of perfume and cosmetic products are specified in Technical Regulation of the Customs Union 009/2011 “On the Safety of Perfume and Cosmetic Products”. The labeling of the consumer packaging of perfume and cosmetic products should contain the following information:

  • Name of the articles.
  • Name of the product (if available).
  • Product designation (if this does not follow from the product name).
  • Information on how to use the product.
  • List of the product components.
  • Quantity (volume or mass) of the products.
  • Batch number or special code of the product.
  • Expiration date:
    • Date of manufacture (month, year) and shelf life (months, years).
    • Alternatively the end date of the shelf life with the previous heading “best before”/”use before” (month, year).
  • Description of storage conditions (if these conditions differ from standard).
  • Name of the manufacturer and its location (legal address, including country).
  • Country of origin of the product (if the effective address of the manufacturer is different from legal).
  • Name of the organization authorized to assume claims from consumers and its location (legal address).
  • Unified sign of the products circulation on the market of the EAEU member states.

If applicable (when necessary) the labeling must also contain:

  • Information on color and/or tone for makeup and coloring products.
  • Information on the mass fraction of fluoride for oral hygiene products containing fluoride compounds.
  • Information on the use of the product for children, if the product is intended for children.
  • Information on special precautions, if any.

Labeling is reconciled in Russian and Kazakh languages.   

 

The company Cratia offers provision of services for state registration of medicinal products, development and maintenance of pharmacovigilance system, registration of medical devices and medical equipment, food products for special purpose and cosmetics in Kazakhstan.

To start cooperation or get advice, you can contact us:

  • telephone +38 044 361-48-28, +38 044 221-71-29,
  • Skype: maxim.bagreev,
  • WhatsApp, Viber, Telegram +38 067 238-31-37,
  • e-mail info@cratia.ua,
  • or meet us in our office.