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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;

12) reference pricing on LS - the analysis system of the prices of the trade name HP based on the ex-works prices of the LS same producer provided by the applicant with the same active agent taking into account dosage form, concentration and dosage in the reference countries, and also the actual price of deliveries to the Republic of Kazakhstan;

13) unit of measure of LS (purchase unit) - unit of the dosed (divided) dosage form or the amount (weight) of not dosed (undivided) dosage form limited to primary package for LS;

14) the registered price for wholesale and retail sale - the estimated basic price for the trade name HP for ceiling forming of price for the trade name HP for wholesale and retail sale of LS consisting of the price of the producer for wholesale and retail sale, expenses on assessment of safety and quality, expenses on marketing and also for the imported LS - transportation expenses from the producer to border of the Republic of Kazakhstan and customs expenses;

Marginal 15) the price for the trade name HP for wholesale - the price of the trade name HP above which its wholesale cannot be enabled;

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

17) descending scale of wholesale markup - scale of wholesale markup in percentage expression, dependent on size of the registered price for wholesale and retail sale of LS;

18) the reproduced medicine (generic) - medicine which has the same quantitative and high-quality composition of active ingredients and the same dosage form, as original medicine and which bioequivalence to original medicine is confirmed by the corresponding researches of bioavailability. Various salts, air, isomers, mixes of isomers, complexes or derivatives of active ingredient are recognized the same active ingredient if their safety and efficiency significantly do not differ. Various dosage forms for intake with immediate release of substances are recognized within the bioavailability researches the same dosage form;

19) the applicant - physical person or legal entity, competent to submit applications, documents and materials for registration of the price or re-registration of the registered price of LS which is the producer, the owner or the holder of the registration certificate or being the authorized representative of the producer, the owner or the holder of the registration certificate based on the power of attorney, and also other subjects in the sphere of the appeal of LS or MI, for LS imported and (or) made in the territory of the Republic of Kazakhstan before expiration of the registration certificate, effective period of the registration certificate of LS at the time of filing of application expired;

20) the reference countries - the countries of the European and Central Asian region macroeconomically comparable to Kazakhstan relating to group of the countries high, above average or below average the income, according to classification of the World Bank by the estimative level of gross national income per capita, from category credited by the International Bank for Reconstruction and Development (Azerbaijan, Belarus, Bulgaria, Hungary, Greece, Latvia, Lithuania, Russia, Poland, Romania, Slovakia, Slovenia, Turkey, Croatia, the Czech Republic, Estonia);

Marginal 21) the price for the trade name HP or MI within the guaranteed amount of free medical care (further - GOBMP) and in system of compulsory social medical insurance (further - OSMS) - the price of the trade name HP or MI above which the purchase within GOBMP and in the OSMS system cannot be made;

22) descending scale of markup within GOBMP and in the OSMS system - markup scale within GOBMP and in the OSMS system in percentage expression, dependent on size of the registered price of LS within GOBMP and in the OSMS system;

Marginal 23) the price for the international non-proprietary name HP or technical characteristic of MI within GOBMP and in the OSMS system - the price of the international non-proprietary name HP or technical characteristic of MI above which the purchase within GOBMP and in the OSMS system cannot be made;

24) the registered price within GOBMP and in the OSMS system - the estimated basic price for the trade name HP for ceiling forming of price for the trade name within GOBMP and in the OSMS system, consisting of the price of the producer within GOBMP and in the OSMS system, expenses on assessment of safety and quality, and also for the imported LS - transportation expenses from the producer to border of the Republic of Kazakhstan and customs expenses;

25) markup within GOBMP and in the OSMS system - the allowance to the registered price within GOBMP and in the LS OSMS system on descending scale, the including profit and expenses connected with acquisition, storage, transportation, realization of LS within GOBMP and in the OSMS system used for ceiling calculation of price for the trade name HP within GOBMP and in the OSMS system;

26) DDP the INCOTERMS 2010 - the international trade term of standard agreement provisions of the international purchase and sale which are developed and determined by International Chamber of Commerce.

4. Price regulation includes the following stages / actions:

1) for LS which are subject to wholesale and retail sale:

registration of the price or re-registration of the registered price for wholesale and retail sale for the trade name HP;

establishment of wholesale markups;

ceiling calculation of prices for the trade name HP for wholesale;

ceiling approval of prices for the trade name HP for wholesale;

establishment of retail markups;

ceiling calculation of prices for the trade name HP for retail sale;

ceiling approval of prices for the trade name HP for retail sale;

ceiling introduction of prices for the trade name HP for wholesale in the register of the prices;

ceiling introduction of prices for the trade name HP for retail sale in the register of the prices;

2) for LS intended for rendering GOBMP and OSMS:

registration of the price or re-registration of the registered price within GOBMP and in the OSMS system on the trade name HP;

establishment of markups within GOBMP and in the OSMS system;

ceiling calculation of prices for the trade name HP within GOBMP and in the OSMS system;

ceiling approval of prices for the trade name HP within GOBMP and in the OSMS system;

ceiling calculation of prices for the international non-proprietary name HP;

ceiling approval of prices for the international non-proprietary name HP.

5. Registration of the price or re-registration of the registered prices and ceiling approval of prices for the trade name HP is performed in tenge. When converting the price of the applicant in national currency the official rates of foreign currencies on average in the month preceding filing of application (the average exchange rate) of National Bank of the Republic of Kazakhstan are used.

6. In the absence of the exchange rate in National Bank of the Republic of Kazakhstan information on the reference price moves in dollars of the United States of America according to settlement rate of the transactions for prior month provided by treasury of the United Nations on the website www.treasury.un.org.

7. Information provided by the applicant for registration of the price or re-registration of the registered price is confidential. Persons having access to confidential information owing to post, provision or accomplishment of obligations including when carrying out audit, keep and take measures to its protection.

8. The price of the medicines made in the conditions of drugstore is determined by management of the pharmaceutical organization.

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