Safety and quality evaluation

The safety and quality evaluation of medicines, medical devices and medical equipment registered in the Republic of Kazakhstan (hereinafter – safety and quality evaluation), is carried out according to the “Rules of the safety and quality evaluation of medicines, medical devices and equipment registered in the Republic of Kazakhstan”, approved by order of the Minister of health and social development of the Republic of Kazakhstan, 26 November 2014, #269 (hereinafter – Regulation).

Safety and quality evaluation is a part of state monopoly and is carried out by National center for medicines, medical devices and medical equipment expertise (hereinafter - NCED), Ministry of health and social development of the Republic of Kazakhstan, and its branches,  which is a state expertise enterprise in the field of medicines, medical devices and medical equipment marketing. NCED has test laboratories accredited according to the legislation of the Republic of Kazakhstan.

Evaluation of safety and quality is carried out to:

• Allow marketing of imported and produced medicines, medical devices in the Republic of Kazakhstan
• If in doubt, confirm the safety and quality of medicines, medical devices registered in the Republic of Kazakhstan, including seized products, as well as to detect counterfeit products.

Payment for the evaluation of safety and quality is made by marketing body through the organization in accordance with the prices set by the authorized body’s Price List.

Evaluation of safety and quality is carried out prior to the release of drugs and medical devices onto the market, as well as during the placement in the pharmaceutical market of the Republic of Kazakhstan. Medicines and medical products imported into the Republic of Kazakhstan and produced in the territory of the Republic of Kazakhstan medicines and medical products are subjected to the evaluation of safety and quality.

Evaluation of safety and quality, excluding immunobiological and orphan drugs produced in accordance with GMP requirements, is done by one of the following ways:

1. Continuous assessment of the safety and quality of drugs produced in accordance with the GMP requirements of the Republic of Kazakhstan, the European Union or GMP or GMP United States of America (hereinafter - GMP Kazakhstan, EU GMP, GMP USA) or the recognition of the results of evaluation of the conditions of production, held during state registration not later than three years, with the list of products registered in the Republic of Kazakhstan on the production line subjected to the assessment of production;
2.  The assessment of the safety and quality of each batch (lot) drugs manufactured not in accordance with the GMP requirements of Kazakhstan, EU GMP, GMP USA;
3. The assessment of the safety and quality of each batch (lot) of drugs that have not undergone a serial assessment of safety and quality in accordance with subparagraph 1) of this paragraph.

Evaluation of the safety and quality of medical devices as specified in Annex 1of the Regulation is done by one of the following ways through:

1. Continuous assessment of the safety and quality of drugs produced in accordance with the requirements of international standard ISO EN 13485 or the recognition of the results of evaluation of the conditions of production, held during state registration not later than three years, with the list of products registered in the Republic of Kazakhstan on the production line subjected to the assessment of production;
2. The assessment of the safety and quality of each batch (lot) drugs manufactured not in accordance with requirements of international standard ISO EN 13485;
3. The assessment of the safety and quality of each batch (lot) of medical devices that have not undergone a serial assessment of safety and quality in accordance with subparagraph 1) of this paragraph.

The evaluation of the safety and quality of immunobiological and orphan drugs, medical devices produced in accordance with the GMP requirements, not stated in Annex 2 of the Regulation includes:

1. Submission of an application form for evaluation of safety and quality according to Annex 2 of the Regulation;
2. Signing the contract for works on the assessment of safety and quality;
3. Assessment of documents, stated in paragraph 16 of the Regulation;
4. Sample assessment on compliance of the product to the following parameters of specification: “Description”, “Packaging”, “Labeling” (with the subsequent return of the medicine), “Packaging”, “Labeling” for medical products – the scanned image of the front, back, side, bottom and the upper sides of the medical device;

If several applicants’ lots of the same batch is accepted by customs warehouse for customs clearance, the first applicant’s lot is taken for the evaluation of the safety and quality. For subsequent applicants who have submitted an application for assessment of safety and quality within twelve months after the issuance of the first certificate, certificate is issued without testing of product samples in a period not exceeding ten working days from the date of application for the assessment of safety and quality.

Sampling to evaluate the safety and quality of product is carried out within two business days after the submission of application with the requirements of the current pharmacopoeia in the Republic of Kazakhstan and specifications for specific products.                                          

Duration of test is provided by the specifications.

The test results are provided according to Annex 6 of the Regulation.

Relying on the work carried out, expert organization prepares a statement of the safety and quality of the product in accordance with Annex 7 of the regulation. In case of negative results, expert organization prepares  a statement refusing to issue a statement on the evaluation of the quality and safety, within two working days since receiving test protocol.

The validity of statements on the evaluation of the safety and quality of each series (lot) is set up to the expiration date of products, but not more than three years.

Prior to the expiration date of products the extension of the statement on the safety and quality is allowed.

Copy of the statement on the safety and quality of products in the prescribed form in accordance with Annex 10 to the Regulation can be provided at the request of the applicant to accompany the products or supply the product consumer with the statement.

The duplicate of the statement on the safety and quality is given by expert organization in case of loss (damage) of the original document by the applicant. In this case, the applicant shall send to the expert organization an application with an indication of the circumstances of the loss (damage).