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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of January 27, 2021 No. KR DSM-11

About approval of rules of marking of medicines and medical products

According to item 4 of article 242 of the Code of the Republic of Kazakhstan of July 7, 2020 "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. Recognize invalid:

1) the 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" (it is registered in the Register of state registration of regulatory legal acts at No. 11088, it is published on June 5, 2015 in information system of law of Ad_let);

2) the order of the Minister of Health of the Republic of Kazakhstan of April 22, 2019 No. KR DSM-44 "About introduction of amendments to some orders of the Ministry of Health of the Republic of Kazakhstan and the Ministry of health and social development of the Republic of Kazakhstan" (it is registered the Register of state registration of regulatory legal acts at No. 18582, it is published on May 2, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

3. To provide to committee of medical and pharmaceutical 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 after its official publication;

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.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-11

Rules of marking of medicines

Chapter 1. General provisions

1. These rules of marking of medicines (further - Rules) are developed according to item 4 of article 242 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 determine procedure for marking of medicines in the Republic of Kazakhstan.

2. In these rules the following concepts are used:

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

2) medicine packaging - means or complex of the means providing process of drug circulation by their protection against damages and losses, and also protecting the environment from pollution.

Packaging consists from primary (internal), intermediate (in the presence) and secondary (external or consumer) packagings:

primary (internal) package - the packaging which is directly adjoining to medicine;

intermediate packaging - packaging in which the primary package for the purpose of additional protection of medicine or proceeding from features of use of medicine is located;

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