of February 21, 2023 No. 27
About introduction of amendments to the order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-282/2020 "About approval of rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan"
I ORDER:
1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-282/2020 "About approval of rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 21836) the following changes:
in rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan, approved by appendix 1 to the specified order:
state Item 2 in the following edition:
"2. In these rules the following terms and determinations are used:
1) state body in the field of drug circulation and medical products (further – state body) – the state body performing management in the field of drug circulation and medical products, control of drug circulation and medical products;
2) the state expert organization in the field of drug circulation and medical products (further – the expert organization) – the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products;
3) quality evaluation of medicines and medical products (further – products quality evaluation) – determination of compliance of quality of medicines and medical products to data of the registration file, regulating documents on quality of medicines or documents on quality of medical products based on which they were registered in the Republic of Kazakhstan;
4) the supporting document quality of series of medicine – the document of the producer (the quality certificate / certificate the analysis / certificate of series / the analytical passport / protocol the analysis / test report) confirming compliance of quality of the declared medicine series to the quality indicators established in the regulating document on quality;
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