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

of January 26, 2015 No. 32

About approval of Rules of use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan

According to Item 1 of article 16 of the Law of the Republic of Kazakhstan of July 10, 1998 "About drugs, psychotropic substances, their analogs and precursors and measures of counteraction to their illicit trafficking and abuse of them" I ORDER:

1. Approve the enclosed Rules of use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan.

2. To provide to committee of control of medical and pharmaceutical activities:

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 from the date of its first official publication.

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of January 26, 2015 No. 32

Rules of use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of use in the medical purposes of the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan (further – Rules), are developed according to the Law of the Republic of Kazakhstan "About drugs, psychotropic substances, their analogs and precursors and measures of counteraction to their illicit trafficking and abuse of them" and establish procedure for use in the medical purposes of the drugs, psychotropic substances and their precursors included in the List of the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan, No. 470 approved by the order of the Government of the Republic of Kazakhstan of July 3, 2019 (further – the List).

2. In these rules the following basic concepts are used:

1) state body in the field of drug circulation and medical products – the state body performing management in the field of drug circulation and medical products, control of drug circulation and medical products;

2) the standard rate of consumption of drugs, psychotropic substances and their precursors (further – the standard rate of consumption) - the amount of certain drugs, psychotropic substances and their precursors necessary for consumption for particular legal entities declared in authorized state body in the field of health care according to the legislation of the Republic of Kazakhstan;

3) drug trafficking, psychotropic substances and their precursors – the types of activity permitted and controlled according to the legislation of the Republic of Kazakhstan connected with cultivation, collection and procurement of narkotikosoderzhashchy plants, development, production, conversion, import, export, en route, transportation, transfer, acquisition, storage, distribution, realization, use, destruction of drugs, psychotropic substances and precursors;

4) drug circulation – the activities including processes of development, preclinical (not clinical) researches, testing, clinical trials, examinations, registration, pharmakonadzor, quality control, production, production, storage, transportation, import and export, leave, realization, transfer, application, destruction of medicines;

5) the Table II of the List – the list of the drugs and psychotropic substances used in the medical purposes and which are under strict control;

6) the Table III of the List – the list of the drugs and psychotropic substances used in the medical purposes and which are under control;

7) 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);

8) the authorized state body in the field of drug trafficking, psychotropic substances, their analogs and precursors – body which within the competence provided to it creates and coordinates implementation of state policy in the field of drug trafficking, psychotropic substances, their analogs and precursors;

9) 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;

10) pharmaceutical activities – the activities performed in the field of health care on production and (or) production, and (or) wholesale and (or) retail sale of medicines and medical products, connected with purchase (acquisition), storage, import, export, transportation, quality control, registration, distribution, use and destruction of medicines and medical products, and also ensuring their safety, quality and efficiency.

3. Use of drugs, psychotropic substances, and also their precursors in the medical purposes is performed in the organizations of health care having the license in the field of drug trafficking, psychotropic substances and precursors issued according to the Law of the Republic of Kazakhstan "About permissions and notifications".

In the organizations of health care all medicines containing drugs, psychotropic substances, and also their precursors are subject to accounting in paper and (or) electronic type.

Chapter 2. Procedure for use in the medical purposes of the drugs, psychotropic substances and their precursors which are subject to control in the Republic of Kazakhstan

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