I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 24, 2020 No. KR DSM-323/2020

About approval of rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach

According to the subitem 20) article 10 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach.

2. 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.

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

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

Appendix

to the Order of the Acting minister of health care of the Republic of Kazakhstan of December 24, 2020 No. KR DSM-323/2020

Rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach

Chapter 1. General provisions

1. These rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach (further – Rules) are developed according to the subitem 20) of article 10 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code) and establish procedure for selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach (further – sampling).

2. For the purposes of these rules the following terms and determinations are applied:

1) 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;

2) 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;

3) authorized body in the field of health care (further – authorized body) – the central executive body performing management and cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);

4) 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. Sampling is made annually by specialists of the expert organization performing quality evaluation of medicines and medical products according to the procedure, stipulated in Item 1 article 241 of the Code.

4. The expert organization annually till November 1 creates and approves the plan of sampling for quality evaluation, the medicines which are in circulation in the territory of the Republic of Kazakhstan and medical products the next calendar year (further - the plan), and also posts it in open entry on the official site of the expert organization.

The expert organization concludes with the producer (the holder of registration certificates of medicines, the authorized representative of the producer of medical products) or his authorized representatives (further - the producer) the products included in the contract for carrying out testing of product samples in the plan, selected from the market taking into account risk - the oriented approach, within 15 working days from the moment of the appeal of producer.

From the moment of the conclusion of the contract for carrying out testing of product samples, selected from the market taking into account risk - the oriented approach, the expert organization within 10 working days creates the schedule of sampling of products and sends it for approval to the producer.

The producer approves the schedule of sampling of products within 30 calendar days from the date of its obtaining. In the absence of coordination by the producer within 30 calendar days from the date of receipt of request from the expert organization, the expert organization within 10 calendar days sends the notification (in any form) to state body about acceptance of adequate measures.

Review or entering of adjustments into the schedule of sampling of products is performed by the expert organization within 10 working days after receipt of the written request (in any form) from the producer.

Following the results of calendar year the expert organization sends to state body information (in any form) about products included in the plan, but not last selection, in connection with not conclusion the producer of the contract for carrying out testing of product samples, selected from the market taking into account risk - the oriented approach, for decision making about suspension of the existing certificates of conformity of products issued according 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" (it is registered in the Register of state registration of regulatory legal acts at No. 21836).

5. Are subject to inclusion in the plan:

1) the medicines requiring special storage conditions (which are stored at temperature up to +15 ° (degrees Celsius));

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