I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 16, 2009 No. 711

About approval of Rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment

According to article 69 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Approve Rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment according to appendix 1 to this order.

2. Recognize as the deputies who voided some orders. The Minister of Health of the Republic of Kazakhstan, the Chairman of Committee of pharmacy, the pharmaceutical and medical industry of the Ministry of Health of the Republic of Kazakhstan according to appendix 2 to this order.

3. To provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

4. To department of administrative and legal work (Bismildin F. B.) provide in the procedure established by the legislation official publication of this order in mass media after its state registration.

5. To impose control of execution of this order on the Vice-Minister of Health of the Republic of Kazakhstan Birtanov E. A.

6. This order becomes effective after ten calendar days after its first official publication.

Appendix 1

to the order of the deputy. The Minister of Health of the Republic of Kazakhstan of November 16, 2009 No. 711

Rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment

1. General provisions

1. These rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment (further - Rules) establish procedure for wholesale and retail sale of medicines, products of medical appointment and medical equipment.

2. In these rules the following concepts are used:

1) 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 of medicines, products of medical appointment and medical equipment, performed according to these rules;

2) 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 of medicines, products of medical appointment and medical equipment, performed according to these rules;

3) drug circulation, products of medical appointment and medical equipment - the activities performed in the course of finishing safe, effective and high-quality medicines, products of medical appointment and medical equipment from developer and (or) the producer before application by the consumer;

4) subjects in the field of drug circulation, products of medical appointment and medical equipment - the physical persons or legal entities performing pharmaceutical activities;

5) objects of wholesale of medicines, products of medical appointment and medical equipment - pharmaceutical warehouse, warehouse of medical equipment and products of medical appointment;

6) objects of retail sale of medicines, products of medical appointment and medical equipment - drugstore, the 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, shop of medical equipment and products of medical appointment and shop of optics.

3. Wholesale of medicines, products of medical appointment and medical equipment is performed by the subjects in the field of drug circulation, products of medical appointment and medical equipment who obtained the license for the pharmaceutical activities connected with wholesale of medicines, products of medical appointment and medical equipment and appendix to it on object of wholesale of medicines, products of medical appointment and medical equipment.

4. Retail sale of medicines, products of medical appointment and medical equipment is performed by the subjects in the field of drug circulation, products of medical appointment and medical equipment who obtained the license for the pharmaceutical activities connected with retail sale of medicines, products of medical appointment and medical equipment and appendix to it on object of retail sale of medicines, products of medical appointment and medical equipment.

5. The pharmaceutical warehouse and objects of retail sale of medicines, products of medical appointment and medical equipment shall have the reference books, regulatory legal acts of the Republic of Kazakhstan regulating drug circulation and products of medical appointment.

The warehouse (shop) of products of medical appointment and medical equipment, shop of optics shall have the reference books, regulatory legal acts of the Republic of Kazakhstan regulating the product circulation of medical appointment and medical equipment, prospectuses, catalogs, instructions for application, operation and quality assurance of products of medical appointment and medical equipment.

6. For the purpose of the prevention of intake of low-quality medicines, products of medical appointment and medical equipment and non-admission of decrease in their quality in case of storage and realization are carried out:

1) quality control in case of acceptance and realization of medicines, products of medical appointment and medical equipment;

2) all types of intra pharmaceutical control (in drugstores with the right of production of medicines);

3) the precautionary actions including:

observance of health regulations and regulations;

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