of September 17, 2020 No. KR DSM-104/2020
About approval of Rules of wholesale and retail sale of medicines and medical products
According to the subitem 15) article 10 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:
1. Approve Rules of wholesale and retail sale of medicines and medical products according to appendix 1 to this order.
2. Recognize invalid some orders in the field of health care according to appendix 2 to this order.
3. To provide to committee of quality control and safety of goods and services 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), 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 from the date of the first official publication.
Minister of Health of the Republic of Kazakhstan
A. Tsoi
Appendix 1
to the Order of the Minister of Health of the Republic of Kazakhstan of September 17, 2020 No. KR DSM-104/2020
1. These rules of wholesale and retail sale of medicines and medical products (further – Rules) are developed according to the subitem 15) of article 10 of the Code of the Republic of Kazakhstan "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) 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;
2) objects in the field of drug circulation and medical products – the drugstore including enabling the realization via the Internet, pharmaceutical Item in the organizations of health care and mobile pharmaceutical unit for rural settlements, pharmaceutical (distributor) warehouse, warehouse of temporary storage of medicines, medical products, shop of optics, shop of medical products, warehouse of medical products, the organizations for production of medicines and medical products;
3) subjects in the field of drug circulation and medical products (further – subjects) – the physical persons or legal entities performing pharmaceutical activities;
4) 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;
5) wholesale of medicines and medical products – 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;
6) 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;
7) state body in the field of drug circulation and medical products (further – state body) – the state body performing management in the field of drug circulation and medical products, control of drug circulation 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 "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. 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 Kazakh 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;
information on phone number and addresses of territorial subdivision of state body in the field of drug circulation and medical products;
visitors books;
information on phone numbers of service pharmaceutical desk;
3) systematic personnel training, is at least once in five years advanced training and retraining of pharmaceutical (medical) personnel;
4) observance of Rules of marking and traceability of medicines, according to rules of marking and traceability of medicines and markings of the medical products approved by the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-11 "About approval of rules of marking and traceability of medicines and markings of medical products" (it is registered in the Register of state registration of regulatory legal acts No. 22146).
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