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ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of February 27, 2015 No. 106

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

(as amended on 16-04-2019)

According to Item 2 of article 84 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed Rules of suspension, prohibition or retirement or restriction of use of medicines and medical products.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

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

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

3. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after ten calendar days from the date of its first official publication.

Minister

T. Duysenova

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of February 27, 2015 No. 106

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) determine procedure for suspension, prohibition or retirement or restriction of use of medicines and medical products.

2. The authorized body in the field of health care (further – authorized body) according to Item 1 of article 84 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - 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 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

3. In the presence of data and (or) identification of circumstances, stipulated in Item 2 these rules, the authorized body within three calendar days from the date of receipt of information makes the decision on application suspension (series and/or batch) medicines and medical products, will lock applications or retirement, or restriction (series and/or batch) use of medicines and medical products.

4. The authorized body within one calendar day from the date of decision making, stipulated in Item 3 these rules, informs on it in written (any) form territorial subdivisions of authorized body (further - territorial subdivisions), the owner of the registration certificate of medicines and medical products and the state expert organization in the sphere of drug circulation and medical products (further - the expert organization).

5. The expert organization in the cases specified in subitems 1) 2), 3) and 5) of Item 2 of these rules within two calendar days after receipt of the notice provides in territorial subdivisions the calculations of amounts of samples of medicines and medical products necessary for conducting examination, including laboratory researches.

All expenses connected with conducting examination of the withdrawn samples of medicine and medical product, including laboratory researches are born by producer of medicine and medical product, the holder of the registration certificate of medicine or the authorized representative of the producer of medical product according to Item 2 of article 63 of the Code.

6. Territorial subdivisions in the cases specified in subitems 1), 2), 3) and 5) of Item 2 of these rules within five calendar days from the date of receipt of the notice, perform withdrawal of samples of medicine and medical product.

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