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

of December 24, 2020 No. KR DSM-322/2020

About approval of rules of suspension, prohibition or retirement or restriction of use of medicines and medical products

According to Item 2 of article 259 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 suspension, prohibition or retirement or restriction of use of medicines and medical products 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.

Acting minister of health care of the Republic of Kazakhstan

M. Shoranov

Appendix

to the Order Acting Minister of Health Care of the Republic of Kazakhstan of December 24, 2020 No. KR DSM-322/2020

Rules of suspension, prohibition or retirement or restriction of use of medicines and medical products

Chapter 1. General provisions

1. These rules of suspension, prohibition or retirement or restriction of use of medicines and medical products (further – Rules) are developed according to article 259 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 suspension, prohibition or retirement or restriction of use of medicines and medical products.

2. The basic concepts used in these rules:

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).

3. The authorized body in the field of health care according to Item 1 of article 259 of the Code makes the decision on suspension or will lock applications, realization or productions of medicines and medical products, and also about retirement or restriction of application (further – the decision) in cases:

1) discrepancies of medicines and medical products to requirements of the legislation of the Republic of Kazakhstan in the field of health care;

2) identifications of undesirable reactions of the medicines hazardous to health of the person which are not specified in the instruction on medical application of medicine, or increase in frequency of identification of cases of the serious undesirable reactions specified in the instruction, or low therapeutic performance (lack of therapeutic effect), or availability of information on suspension and (or) response it from the market of other countries in connection with identification of serious undesirable reactions with adverse ratio "advantage risk";

3) detection in the course of the application of medical products of defects of design, the principle of action, production execution influencing safety of their application;

4) violations of the approved production process of medicines and medical products influencing safety, quality and efficiency of their application;

5) availability of data on harming health of the patient or the consumer in connection with use of medicines and medical products;

6) data acquisition about insufficiency of scientific and technical technological level of production and quality control, the medicines providing decrease in level of safety of application and medical products;

7) addresses of the holder of the registration certificate about suspension, about withdrawal of the registration certificate or retirement or restriction of use of medicine and medical product;

8) discrepancies of medicines to requirements proper pharmaceutical the practician of the Republic of Kazakhstan and (or) the Eurasian Economic Union revealed by results of pharmaceutical inspection;

9) default on obligations of pharmakonadzor by the holder of the registration certificate of medicine and the producer of medical product on monitoring of safety, quality and efficiency of medical products.

Chapter 2. Procedure for suspension, prohibition or retirement or restriction of use of medicines and medical products

4. In the presence of data and (or) identification of circumstances, stipulated in Item 3 these rules, the state body within one working day informs on it in written (any) form territorial subdivisions, the holder of the registration certificate of medicines and medical products and the expert organization.

5. In the cases specified in subitems 1), 2), 3) and 5) of Item 3 of these rules, the expert organization within four calendar days after receipt of the notice provides the calculations of amount of samples of medicines and medical products necessary for laboratory testing in territorial subdivisions of state body.

6. Territorial subdivisions of state body in the cases specified in subitems 1), 2), 3) and 5) of Item 3 of these rules within five calendar days from the date of receipt of the notice and according to the calculation provided by the expert organization perform withdrawal of samples of medicine and medical product.

7. Samples of medicines and medical products are withdrawn in the quantities sufficient for conducting single laboratory researches without compensation of cost of these products.

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