ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of January 17, 2012 No. 91

About approval of Health regulations "Sanitary and epidemiologic requirements to objects in the sphere of drug circulation, products of medical appointment and medical equipment"

According to the subitem 2) of article 6 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Health regulations "Sanitary and epidemiologic requirements to objects in the sphere of drug circulation, products of medical appointment and medical equipment".

2. This resolution becomes effective after ten calendar days from the date of the first official publication.

Approved by the order of the Government of the Republic of Kazakhstan of January 17, 2012 No. 91

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

1. General provisions

1. These Health regulations "Sanitary and epidemiologic requirements to content and operation of objects in the sphere of drug circulation, products of medical appointment and medical equipment" (further - Health regulations) establish 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, channeling, lighting and ventilation, implementation of production supervision on objects in the sphere of drug circulation, products of medical appointment and medical equipment.

2. These Health regulations extend to all objects, engaged in pharmaceutical activities in the territory of the Republic of Kazakhstan.

3. Operation of objects in the sphere of drug circulation, products of medical appointment and medical equipment is allowed after coordination and receipt of the positive conclusion of bodies of the state sanitary and epidemiological surveillance.

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

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

2) 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;

3) 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;

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

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, products of medical appointment and medical equipment - set of the properties and characteristics of medicine, product of medical appointment and medical equipment influencing their capability to be effective to destination;

7) objects in the sphere of drug circulation, products of medical appointment and medical equipment - 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, products of medical appointment and medical equipment, shop of optics, shop of medical equipment and products of medical appointment, the warehouse of medical equipment and products of medical appointment, the organization for production of medicines, products of medical appointment and medical equipment functioning according to the standard provisions approved by the Government of the Republic of Kazakhstan;

8) wholesale of medicines, products of medical appointment and medical equipment - the pharmaceutical activities connected with purchase, storage, import, export, realization (except for realization of medicines to the population) without restriction of amounts, destruction, performed according to the rules approved by the Government of the Republic of Kazakhstan;

9) retail sale of medicines, products of medical appointment and medical equipment - the pharmaceutical activities connected with acquisition (except import), storage, distribution, realization (except export) to the final consumer, destruction, performed according to the rules approved by the Government of the Republic of Kazakhstan;

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

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

12) warehouse of medical equipment and products of medical appointment (further - warehouse) - the object in the sphere of drug circulation, products of medical appointment and medical equipment enabling wholesale of medical equipment and products of medical appointment 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, products of medical appointment and medical equipment enabling production and (or) retail sale of products of medical optics for the purpose of providing the population with products of medical optics;

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