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

of October 27, 2020 No. KR DSM-155/2020

About approval of Rules of destruction of the medicines and medical products which became useless the expired, counterfeited and other medicines and medical products which are not conforming to requirements of the legislation of the Republic of Kazakhstan

According to item 4 of article 250 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Rules of destruction by subjects in the sphere of drug circulation and which medical products the medicines and medical products which became useless, expired, counterfeited medicines and medical products and others, the legislations of the Republic of Kazakhstan which are not conforming to requirements are at the disposal.

2. Recognize invalid:

1) the order of the Minister of health and social development of the Republic of Kazakhstan of August 26, 2015 No. 687 "About approval of Rules of destruction of the medicines and medical products which became useless, counterfeited, expired" (it is registered in the Register of state registration of regulatory legal acts at No. 12122, it is published on October 6, 2015 in information system of law of Ad_let);

2) Item 9 of the List of some orders of the Ministry of Health of the Republic of Kazakhstan and the Ministry of health and social development of the Republic of Kazakhstan to which changes are made the Minister of Health of the Republic of Kazakhstan approved by the order of April 22, 2019 No. KR DSM-44 "About introduction of amendments to some orders of the Ministry of Health of the Republic of Kazakhstan and the Ministry of health and social development of the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 18582, it is published on May 2, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

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.

No. KR DSM-155/2020 are approved by the Order of the Acting minister of health care of the Republic of Kazakhstan of October 27, 2020

Rules of destruction of the medicines and medical products which became useless the expired, counterfeited and other medicines and medical products which are not conforming to requirements of the legislation of the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of destruction of the medicines and medical products which became useless of the expired, counterfeited and other medicines and medical products which are not conforming to requirements of the legislation of the Republic of Kazakhstan (further – Rules) are developed according to item 4 of article 250 of the Code of the Republic of Kazakhstan "About health of the people and health care system" and determine procedure for destruction of the medicines and medical products which became useless for the expired, counterfeited and other medicines and medical products which are not conforming to requirements of the legislation of the Republic of Kazakhstan.

2. In these rules the following concepts are used:

1) destruction of medicines and medical products – the procedure of impact (thermal, chemical, mechanical or other) on the medicine and medical product excluding possibility of their further use;

2) subjects in the sphere of drug circulation and medical products (further – subjects) – the physical persons or legal entities performing pharmaceutical activities;

3) medicine expiration date – date after which expiration medicine are not subject to application;

4) counterfeited medicines and medical products – medicines, medical products, illegally and purposely supplied with unreliable information about their structure or picking and (or) the producer, and also about deliveries, including the records and documents mentioning the used supply channels;

5) the medicines and medical products, unsuitable to realization and medical application, which - became useless, expired, counterfeited and others, the legislations of the Republic of Kazakhstan which are not conforming to requirements, medicines and medical products which application constitutes danger of life and to health of the person.

Chapter 2. Procedure for destruction by subjects in the sphere of drug circulation and medical products of the become useless, expired, counterfeited and other medicines and medical products which are not conforming to requirements of the legislation of the Republic of Kazakhstan

3. Destruction unsuitable to realization and medical application of medicines and medical products (scrap, expiry date) and destruction of the medical products which became useless (physical and obsolescence, as a result of natural disasters and accidents, breakdown with impossible recovery) is performed directly by subjects with observance of requirements of the legislation of the Republic of Kazakhstan in the field of environmental protection and sanitary and epidemiologic wellbeing of the population.

Destruction of medicines and medical products is performed by the permanent commission which structure affirms the subject's head (further – the commission) and includes at least 3 members of the commission.

Destruction unsuitable to realization and medical application of medicines and medical products in number of over 300 packagings (pieces) is carried out through the organization performing destruction of medicines and medical products based on the relevant agreement, with observance of requirements of the legislation of the Republic of Kazakhstan in the field of environmental protection and sanitary and epidemiologic wellbeing of the population.

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