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The document ceased to be valid since October 3, 2020 according to Item 2 of the Order of the Minister of Health of the Republic of Kazakhstan of September 17, 2020 No. KR DSM-104/2020

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

of September 14, 2015 No. 713

About approval of Rules of wholesale and retail sale of medicines and medical products

(as amended on 16-03-2020)

According to article 69 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed Rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment (further - Rules).

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;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

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, except for Item 5 of Rules which becomes effective since January 1, 2018.

Minister of health and social development of the Republic of Kazakhstan

T. Duysenova

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of September 14, 2015 No. 713

Rules of wholesale and retail sale of medicines and medical products

Chapter 1. General provisions

1. These rules of wholesale and retail sale of medicines and medical products (further - Rules) are developed according to article 69 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for wholesale and retail sale of medicines and medical products.

2. In these rules the following concepts are used:

1) retail sale of medicines and medical products - the pharmaceutical activities connected with acquisition (except import), storage, distribution, realization (except export) to the final consumer, destruction of medicines and medical products, performed according to Rules;

2) wholesale of medicines and medical products (distribution) - the pharmaceutical activities connected with purchase (acquisition), storage, import (import), export (export), realization (except for realization to the population) without restriction of amounts, transportation and destruction of medicines and medical products, performed according to Rules;

3) 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;

4) the address of medical products - designing, development, creation of prototypes, carrying out technical testing, researches (testing) of assessment of biological effect of medical products, clinical trials, examinations of safety, quality and efficiency of medical products, registration, production (production), storage, transportation, realization, installation, adjustment, application (operation), maintenance, repair and utilization of medical products;

5) subjects in the field of drug circulation and medical products - the physical persons or legal entities performing pharmaceutical activities;

6) objects of wholesale of medicines, medical products - pharmaceutical (distributor) warehouse, warehouse of medical products;

7) objects of retail sale of medicines, medical products - drugstore, pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help, the mobile pharmaceutical unit for the remote rural zones organized from drugstore, shop of optics, shop of medical products.

Chapter 2. Procedure for wholesale and retail sale of medicines and medical products

3. Wholesale of medicines and medical products is performed by the subjects in the field of drug circulation and medical products who obtained the corresponding license for wholesale in pharmaceutical warehouses or notified on the beginning of activities through warehouse of medical products according to the procedure established by the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications" (further - the Law on permissions and notifications).

4. Retail sale of medicines and medical products is performed by the subjects in the field of drug circulation and medical products who obtained the corresponding license for retail sale in drugstores, pharmaceutical Items, mobile pharmaceutical units or notified on the beginning of activities through shops of optics and medical products according to the procedure established by the Law on permissions and notifications.

5. No. KR DSM-17/2020 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 16.03.2020

6. The subjects in the field of drug circulation and medical products enabling wholesale of medicines observe requirements of proper distributor practice (GDP).

7. The subjects in the field of drug circulation and medical products enabling retail sale of medicines observe requirements of proper pharmaceutical practice (GPP).

8. With subjects of wholesale and retail sale it is provided:

1) sign availability with indication of the name of the subject of pharmaceutical activities, its form of business and operating mode in the state and Russian languages;

2) placement in the place, convenient for acquaintance:

copies of the license for pharmaceutical activities and appendices to it or the document (including the printed-out copy of the electronic document) informing on the beginning or the termination of implementation of activities or certain actions;

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