ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of April 16, 2015 No. 227

About approval of Rules of marking of medicines and medical products

According to article 75 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve:

1) Rules of marking of medicines according to appendix 1 to this order;

2) Rules of marking of medical products according to appendix 2 to this order.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

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 in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

3. To impose control of execution of this order on the Vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A.B.

4. This order becomes effective from the date of its first official publication.

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of April 16, 2015 No. 227

Rules of marking of medicines

Chapter 1. General provisions

1. These rules of marking of medicines (further - Rules) are developed according to Items 1 and 3 of article 75 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for marking of medicines in the Republic of Kazakhstan.

2. Prototypes of marking of packagings, labels and stickers on medicines affirm state body as the sphere of drug circulation and medical products (further - state body) in case of state registration of medicine in the Republic of Kazakhstan which is carried out according to article 71 of the Code.

3. According to Item 3 of article 75 of the Code use of stickers when importing limited amount of the expensive, seldom applied, orphan medicines is allowed.

4. Information on the organization, the accepting claim (offer) on quality of medicines in the territory of the Republic of Kazakhstan, is specified in the instruction on medical application.

5. In these rules the following concepts are used:

1) medicinal angro-product - the medicine made and realized in large packing, and also used for further production processing for the purpose of production (production) of ready medicines;

2) medicine balk-product - the dosed medicine which passed all stages of engineering procedure except for of final packaging;

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