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The document ceased to be valid since August 6, 2020 according to Item 1 of the Order of the deputy. The Minister of Health of the Republic of Kazakhstan of May 22, 2019 No. KR DSM-84

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

of June 29, 2015 No. 535

About approval of standard provisions of objects in the sphere of drug circulation, products of medical appointment and medical equipment

According to the subitem 23) Item 1 of article 1 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve:

1) Standard regulations on drugstore according to appendix 1 to this order;

2) Standard regulations on pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help;

3) Standard regulations on the mobile pharmaceutical unit for the remote rural zones organized from drugstore according to appendix 3 to this order;

4) Standard regulations on pharmaceutical warehouse according to appendix 4 to this order;

5) Standard regulations on warehouse of temporary storage of medicines, products of medical appointment and medical equipment according to appendix 5 to this order;

6) Standard regulations on shop of optics according to appendix 6 to this order;

7) Standard regulations on shop of medical equipment and products of medical appointment according to appendix 7 to this order;

8) Standard regulations on warehouse of medical equipment and products of medical appointment according to appendix 8 to this order;

9) Standard regulations on the organization for production of medicines, products of medical appointment and medical equipment according to appendix 9 to this order.

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 in the procedure established by the legislation:

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 L. V.

4. This order becomes effective after day of its first official publication.

Minister

T. Duysenova

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of June 29, 2015 No. 535

Standard regulations on drugstore

1. General provisions

1. This provision is developed according to the subitem 23) of Item 1 of article 1 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 determines the status of drugstore.

2. The drugstore is the object in the sphere of drug circulation, products of medical appointment and medical equipment enabling retail sale of medicines, products of medical appointment and medical equipment, production of medicines.

3. Retail sale of medicines, products of medical appointment and medical equipment, production of medicines in drugstores is performed in the presence of the license for pharmaceutical activities and appendices to the license for retail sale of medicines, products of medical appointment and medical equipment, production of the medicines issued according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications" (further - the Law on permissions).

4. The drugstore acquires and realizes medicines and the products of medical appointment, medical equipment which underwent state registration in the Republic of Kazakhstan, assessment of safety and quality, according to the order of the Minister of Health of the Republic of Kazakhstan of November 18, 2009 No. 735 "About approval of Rules of state registration, re-registration and modification of the registration file of medicine, products of medical appointment and medical equipment" (it is registered in the Register of state registration of regulatory legal acts for No. 5935 of November 26, 2009), the order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269 "About approval of Rules of evaluating safety and quality of medicines and products of medical appointment, registered in the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts for No. 10003 of November 25, 2014), metrological certification of measuring instruments according to the Law of the Republic of Kazakhstan of June 7, 2000 "About ensuring unity of measurements" (further - the Law on measurements).

5. According to the subitem 1 of Item 12 of article 71 of the Code the medicines made in drugstores are not subject to state registration.

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