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The document ceased to be valid since  February 13, 2016 according to Item 1 of the Order of the Government of the Republic of Kazakhstan of January 27, 2016 No. 31

ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 30, 2011 No. 1693

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

(as amended on 30-11-2013)

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" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment.

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

Prime Minister of the Republic of Kazakhstan

K. Masimov

Approved by the Order of the Government of the Republic of Kazakhstan of December 30, 2011 No. 1693

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) are developed according to the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determine 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 (further - subjects) - the physical persons or legal entities performing pharmaceutical activities;

5) objects of wholesale of medicines, products of medical appointment and medical equipment (further - objects of wholesale) - 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 (further - objects of retail sale) - 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, 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 having the license for pharmaceutical activities and appendix to the license for wholesale of medicines, products of medical appointment and medical equipment, or the coupon about acceptance of the notification with mark of state body or service center of the population or the coupon in electronic form on wholesale of products of medical appointment and the medical equipment issued according to the legislation of the Republic of Kazakhstan.

4. Retail sale of medicines, products of medical appointment and medical equipment is performed by the subjects having the license for pharmaceutical activities and appendix to the license for retail sale of medicines, products of medical appointment and medical equipment, or the coupon about acceptance of the notification with mark of state body or service center of the population or the coupon in electronic form on retail sale of products of medical appointment and the medical equipment issued according to the legislation of the Republic of Kazakhstan.

5. 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 by specialists of objects of wholesale and retail sale are carried out:

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

2) the precautionary actions including:

providing and observance of rules and storage durations of medicines, products of medical appointment and medical equipment;

accounting of medicines, products of medical appointment and medical equipment with limited expiration date;

ensuring compliance of the registered doses, regulations of one-time leave, check of correctness of writing out of recipes, term of its action, compatibility of the written-out medicines;

ensuring operability and accuracy of weight measuring devices;

3) in drugstores with the right of production of medicines it is in addition provided:

all types of intra pharmaceutical control;

observance of manufacturing techniques of dosage forms.

6. Objects of wholesale and retail sale provide sign availability with indication of in the state and Russian languages of the name of the subject, its form of business and operating mode.

In objects of wholesale and retail sale in the place, convenient for acquaintance, take place:

1) copies of licenses for pharmaceutical activities and the corresponding appendix to it, or the coupon about acceptance of the notification with mark of state body or service center of the population or the coupon in electronic form on wholesale and (or) retail sale of products of medical appointment and the medical equipment issued according to the legislation of the Republic of Kazakhstan;

2) information on phones and addresses of territorial subdivisions of state body in the field of drug circulation, products of medical appointment and medical equipment;

3) visitors book;

4) information on phone numbers of service pharmaceutical desk;

5) besides, in objects of retail sale take place: information of the following nature: "Medicines to children are not provided", "Nonprescription realization of the medicines intended for leave according to the recipe of the doctor" is forbidden, "Medicines are not subject to return and exchange";

information on storage durations of the medicines produced in drugstore (for drugstores with the production right);

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