Assessment of the quality of medicines registered in the Republic of Kazakhstan is carried out by determining the compliance of the quality of medicines with the data of the registration dossier, regulatory documents on the quality of medicines, on the basis of which they were registered in the Republic of Kazakhstan and is carried out in accordance with the requirements of the Rules for assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 No. KR DSM-282/2020.
The service is provided in accordance with the annual plan for sampling to assess the quality of medicines and medical devices in circulation on the territory of the Republic of Kazakhstan.
Product quality assessment is carried out for the purpose of:
1) determining the quality of registered products;
2) determining the quality of products selected from the market taking into account the risk-based approach;
3) preventing the circulation of counterfeit products on the market of the Republic of Kazakhstan.
Quality assessment is carried out for each series (batch) of products produced and imported into the Republic of Kazakhstan during the period of validity of the registration certificate, including those registered in accordance with the Rules for registration and examination of medicinal products for medical use, approved by the decision of the Council of the Eurasian Economic Commission dated November 3, 2016 year No. 78 and the Rules for registration and examination of the safety, quality and effectiveness of medical devices, approved by decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46
The test results are documented in a test report in the form in accordance with Appendix 5 to these Rules.