ORDER OF THE MINISTER OF NATIONAL ECONOMY OF THE REPUBLIC OF KAZAKHSTAN

of March 19, 2015 No. 232

Health regulations "Sanitary and epidemiologic requirements to objects in the sphere of drug circulation and medical products"

According to Item 6 of article 144 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 Health regulations "Sanitary and epidemiologic requirements to objects in the sphere of drug circulation and medical products".

2. To provide to committee on consumer protection of the Ministry of national economy 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 its direction on official publication in periodic printing editions and in information system of law of Ad_let;

3) placement of this order on official Internet resource of the Ministry of national economy of the Republic of Kazakhstan.

3. To impose control of execution of this order on the supervising vice-minister of national economy of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days from the date of its first official publication.

Approved by the Order of the Minister of national economy of the Republic of Kazakhstan of March 19, 2015 No. 232

Health regulations "Sanitary and epidemiologic requirements to objects in the sphere of drug circulation and medical products"

Chapter 1. General provisions

1. These Health regulations "Sanitary and epidemiologic requirements to content and operation of objects in the sphere of drug circulation and medical products" (further - Health regulations) are developed according to Item 6 of article 144 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and to health care system" (further - the Code) sanitary and epidemiologic requirements to rooms and the equipment, designing, construction of buildings, working conditions, consumer services, to conditions of carrying out sterilization and disinfection, water supply, the sewerage, lighting and ventilation, implementation of production supervision on objects in the sphere of drug circulation and medical products establish.

2. These Health regulations extend to all objects of the sphere of drug circulation and medical products in the territory of the Republic of Kazakhstan.

3. It is excluded according to the Order of the deputy. The Minister of Health of the Republic of Kazakhstan of 03.09.2018 No. KR DSM-9

4. In these Health regulations the following concepts are used:

1) aseptic conditions - the conditions of production of sterile medicines excluding hit in ready-made product of microorganisms or mechanical particles at all stages of engineering procedure;

2) air lock - the closed space between rooms with two or several doors obstructing traffic of air flow between rooms of various purity for prevention of penetration of microorganisms or mechanical particles into the rooms requiring special purity;

3) pharmaceutical Item in the organizations of health care giving primary medical and sanitary, consulting and diagnostic help (further - pharmaceutical Item) - the object in the sphere of drug circulation and medical products relating to health care system for providing the population with medicines and medical products;

4) drugstore - the object in the sphere of drug circulation and medical products relating to health care system for providing the population and the organizations of health care with medicines with medical products;

5) medicines - the means representing or containing pharmacological the active agents intended for prevention, diagnostics and treatment of diseases, and also change of condition and functions of organism: medicinal substance, medicinal raw materials of natural origin, medicinal angro-and balk-products, medicines, medical immunobiological supplies, parapharmaceutics;

6) quality of medicine and medical products - set of the properties and characteristics of medicine and medical products influencing their capability to be effective to destination;

7) objects in the sphere of drug circulation and medical products - drugstore, pharmaceutical Item in the organizations of health care giving primary medical and sanitary, consulting and diagnostic help, mobile pharmaceutical unit for the remote rural zones, pharmaceutical warehouse, warehouse of temporary storage of medicines and medical products, shop of optics, shop of medical products, warehouse of medical products, the organizations for production of medicines, medical products functioning according to the standard provisions approved by the Government of the Republic of Kazakhstan;

8) 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 the rules approved by authorized body in the field of health care;

9) 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 the rules approved by authorized body in the field of health care;

10) pharmaceutical warehouse - the object in the sphere of drug circulation and medical products relating to health care system and enabling wholesale of medicines and medical products;

11) shop medical products (further - shop) - object in the sphere of drug circulation and medical products for providing the population with medical products;

12) warehouse of medical products (further - warehouse) - the object in the sphere of drug circulation and medical products enabling wholesale of medical products for ensuring subjects of pharmaceutical activities and the organizations of health care;

13) the isolated block - complex (set) of rooms isolated metal, plastic by materials or glass blocks from other rooms in architectural structure of the building with separate entrance;

14) the isolated room - the room isolated from other rooms metal, plastic by materials or glass blocks in structure of the main building;

15) shop of optics - the object in the sphere of drug circulation and medical products enabling production and (or) retail sale of products of medical optics for the purpose of providing the population with products of medical optics;

16) sanitary clothes - set of the protective clothes of personnel intended for protection of raw materials, auxiliary materials and ready-made product against pollution by mechanical particles, microorganisms;

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