Certification

Product safety and quality assessment is carried out in relation to registered medicines and medical devices in the Republic of Kazakhstan before their release into circulation. Medicines and medical devices imported into the Republic of Kazakhstan and manufactured in the territory of the Republic of Kazakhstan are subject to safety and quality assessment.

Product safety and quality assessment is carried out in order to:

Confirmation of product safety and quality in the post-registration period;
Confirmation of the safety and quality of products withdrawn from the market by the state body in the case of complaints about the quality of products;
Confirmation of the safety and quality of products withdrawn from the market by the state body, taking into account the risk-oriented approach;
Confirmation of the safety and quality of products based on the results of pharmacovigilance of medicines and monitoring of the safety, effectiveness and quality of medical products;
Prevention of circulation of counterfeit products on the market of the Republic of Kazakhstan;

In order to assess the quality of products, the applicant, in accordance with the Civil Code of the Republic of Kazakhstan dated December 27, 1994, concludes a contract with an expert organization to conduct work on product quality assessment and provides:

An application for an assessment of the quality of a medicinal product or medical device in accordance with Annex 1 to these Rules;
A copy of the license to engage in pharmaceutical activity with the appropriate appendix (production, wholesale sale) to the license or notification of the start of activity (wholesale sale) in accordance with the Law of the Republic of Kazakhstan dated May 16, 2014 "On Permits and notifications" (hereinafter - the Law), for medical devices, prevention of a license for medical activity with the appropriate an appendix to the license in accordance with the Law;
For imported medicines – a copy of the GMP certificate valid at the time of production and import of products with translation into Kazakh or Russian (if the document is presented in a foreign language), notarized or apostilled in accordance with the requirements of the Hague Convention of October 5, 1961 "List of States recognizing Apostille" (hereinafter – the Hague Convention). language), for medicines manufactured on the territory of the Republic of Kazakhstan – a copy of the document confirming the compliance of the production site with the GMP requirements of the Republic of Kazakhstan (if available);
For imported medical devices – a notarized or apostilled copy of the ISO 13485, ISO 9001 or GMP certificate valid at the time of production and import of products with a notarized translation into Kazakh or Russian (if the document is presented in a foreign language), for domestic manufacturers – if available;
A copy of the document confirming the quality of the product series from the manufacturer with translation into Kazakh or Russian (if the document is presented in a foreign language). For immunobiological medicines (vaccines, serums, bacteriophages, anatoxins, allergens and blood products) imported into the Republic of Kazakhstan, a copy of the quality certificate of the series issued by the laboratory of the country of origin or other official laboratory authorized by regulatory authorities to carry out quality control in order to release the series to the market is additionally provided;
A copy of the document of origin of the goods certifying the country of origin of the goods and issued by an authorized organization in accordance with the legislation of this state or the state of export, if the certificate is issued in the state of export on the basis of information received from the country of origin of the goods;
A copy of the invoice, invoice or invoice, for medicines and medical products manufactured in the territory of the Republic of Kazakhstan, a certificate (any form) is provided on the availability of ready-to-sell medicines, medical products specified in the application;
A copy of the customs declaration for products (electronic), with the exception of products provided for in the List of goods for which conditional release is not allowed, approved by the Decree of the Government of the Republic of Kazakhstan dated July 21, 2018 No. 441. When importing products manufactured and (or) imported from the member states of the Eurasian Economic Union, a copy of the document confirming the crossing of the border of the EAEU member states is provided;