ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of July 7, 2021 No. KR DSM-58

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

According to subitem 132-1) of Item 16 of the Regulations on the Ministry of Health of the Republic of Kazakhstan approved by the order of the Government of the Republic of Kazakhstan of February 17, 2017 No. 71, I ORDER:

1. Approve the enclosed Health regulations "Sanitary and epidemiologic requirements to objects in the sphere of drug circulation and medical products" according to appendix 1 to this order.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix 2 to this order.

3. To provide to committee of sanitary and epidemiologic control 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;

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) and 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 after day of its first official publication.

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of July 7, 2021 No. KR DSM-58

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 objects in the sphere of drug circulation and medical products" (further – Health regulations) are developed according to Item 1 of article 95 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code), and 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, the sewerage, lighting and ventilation, implementation of production supervision on objects in the sphere of drug circulation and medical products.

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. 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) akvadistillyator (distiller) - the device for water purification by distillation method;

3) aseptic complex – set of rooms consisting washing, sterilizing ware, assistant, packing with lock, zakatochny, sterilizing dosage forms;

4) 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;

5) 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;

6) 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;

7) medicine – the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

8) quality of medicine – the set of properties and characteristics of pharmaceutical substance (active pharmaceutical substance) and medicine providing their compliance to purpose;

9) objects in the sphere of drug circulation and medical products – the drugstore including enabling the realization on the Internet, pharmaceutical Item in the organizations of health care, the mobile pharmaceutical unit for the remote rural zones organized from drugstore, 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;

10) shop of medical products – object in the sphere of drug circulation and medical products for providing the population with medical products;

11) warehouse of medical products – 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;

12) medical products – products of medical appointment and medical equipment;

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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