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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

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 08.12.2021 No. KR DSM-127)

According to the subitem 44) article 7 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan according to appendix 1 to this order.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix 2 to this order.

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after ten calendar days after day of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-282/2020

Rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan (further - Rules) are developed according to the subitem 44) of article 7 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code) and determine procedure for evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan.

2. In these rules the following terms and determinations are used:

1) 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 based on which they were registered in the Republic of Kazakhstan (further - products quality evaluation);

2) products - the medicines and medical products registered according to the procedure, stipulated in Item 3 articles 23 of the Code and allowed for medical application in the Republic of Kazakhstan;

3) the applicant - the physical person or legal entity performing pharmaceutical activities in the Republic of Kazakhstan which provides products for quality evaluation;

4) state body in the sphere of drug circulation and medical products (further - state body) - the state body performing management in the sphere of drug circulation and medical products, control of drug circulation and medical products;

5) the state expert organization in the sphere 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;

6) the registration file - set of the documents and materials represented for examination of medicine, medical product;

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