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

of April 19, 2019 No. KR DSM-42

About approval of Regulations of the prices of medicines

According to the subitem 112) Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Regulations of the prices of medicines according to appendix 1, to this order (dalee-Pravila).

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 pharmacy 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) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" the Ministries of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) within ten calendar days after state registration of this order the direction it the copy on official publication in periodic printing editions;

4) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

5) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), 3) and 4) of this Item.

4. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Nadyrov K. T.

5. This order becomes effective after ten calendar days after day of its first official publication.

Acting minister of health care of the Republic of Kazakhstan

L. Aktayeva

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of April 19, 2019 No. KR DSM-42

Regulations of the prices of medicines

Chapter 1. General provisions

1. These rules establish procedure for price regulation on medicines (further - LS).

2. State regulation of the prices is performed by authorized body in the field of health care by forming and marginal approval of prices and markups.

3. In these rules the following basic concepts are used:

1) the register of the prices - system of accounting and systematization of information in electronic form on ceiling prices for the trade name HP for wholesale and retail sale, in chronological procedure, taking into account the made changes and preserving the previous versions, with provision of possibility of open access to these data on the Internet resource of the state expert organization;

2) fixed price - the price of LS determined by results of purchase at which the supplier shall deliver LS to the single distributor;

3) biosimilar medicine (bioanalogue, biosimilar medicine, biosimilyar) - biological medicine which contains the version of active ingredient of the registered biological original medicine or reference medicine and on which similarity (similarity) on the basis of comparative researches on indicators of quality, biological activity, safety and efficiency is shown;

Marginal 4) the price for the trade name HP for retail sale - the price of the trade name HP above which its retail sale cannot be enabled;

5) retail markup - the allowance to the ceiling price for the trade name HP for wholesale on descending scale including the profit and expenses connected with implementation of retail sale of LS, used for ceiling calculation of price for the trade name HP for retail sale;

6) descending scale of retail markup - scale of retail markup in percentage expression, dependent on the ceiling size of price for the trade name HP for wholesale;

7) original medicine - medicine with new active ingredient which was registered and placed by the first in the world pharmaceutical market, based on the file containing results of the complete preclinical (not clinical) and clinical trials confirming its safety, quality and efficiency;

8) the international non-proprietary name of medicine - the name HP recommended by the World Health Organization;

9) authorized body in the field of health care (further - authorized body) - the state body performing management in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, the appeal of LS, and medical products (further - MI), control of quality of medical services;

10) the state expert organization in the sphere of the appeal of LS and MI (further - the state expert organization) - the republican state company on the right of economic maintaining performing production economic activity in the field of health care on safety, efficiency and qualities of LS and also scientific research in the field of development of new original LS, pharmacy, pharmacology;

11) the state register of LS and MI - the information resource containing data about LS and MI registered and allowed for medical application in the Republic of Kazakhstan;

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