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

of August 20, 2024 No. 63

About modification and amendments in the order of the Minister of Health of the Republic of Kazakhstan of December 11, 2020 No. KR DSM-247/2020 "About approval of regulations, marginal forming of prices and markup on medicines, and also medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance"

I ORDER:

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of December 11, 2020 No. KR DSM-247/2020 "About approval of regulations, marginal forming of prices and markup on medicines, and also medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance" (it is registered in the Register of state registration of regulatory legal acts at No. 21766) the following changes and amendments:

in Regulations, marginal forming of the prices and markup on medicines approved by appendix 1 to the specified order:

state Item 1 in the following edition:

"1. These rules of regulation, marginal forming of prices and markup on medicines (further - HP) are developed according to subitems 51) and 94) of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further - the Code), the subitem 1) of article 10 of the Law of the Republic of Kazakhstan "About the state services" (further - the Law) and determine procedure for rendering the state service "Registration of the Price of Medicines and Medical Products" (further - the state service).";

state Item 2 in the following edition:

"2. In these rules the following basic concepts are used:

1) biosimilar medicine (bioanalogue, biosimilar medicine, биосимиляр) - biological medicine which contains the version of active ingredient, 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 2) the price for the trade name HP for wholesale - the price of the trade name HP, included in the list of the HP which are subject to price regulation above which its wholesale cannot be enabled;

3) 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 HP, used for ceiling forming of price for the trade name HP for retail sale;

4) 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;

5) 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;

6) the international non-proprietary name HP - the name HP recommended by the World Health Organization (further - MNN);

7) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, the address of HP and medical products (further - MI), qualities of rendering medical services (help);

8) the state expert organization in the field of the address of HP and MI (further - the state expert organization) - the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of HP and MI;

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

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

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

12) uslugopoluchatel - physical persons and legal entities, except for the central state bodies, foreign institutions of the Republic of Kazakhstan, local executive bodies of areas, the cities of republican value, the capital, areas, the cities of regional value, akims of areas in the city, the cities of district value, settlements, villages, rural districts;

13) the service provider - the central state bodies, foreign institutions of the Republic of Kazakhstan, local executive bodies of areas, cities of republican value, the capital, areas, cities of regional value, akims of areas in the city, the cities of district value, settlements, villages, rural districts, and also the physical persons and legal entities rendering the state services according to the legislation of the Republic of Kazakhstan;

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 HP consisting of marginal price of the producer, expenses on quality evaluation, expenses on marketing, and also transportation expenses from the producer to border of the Republic of Kazakhstan and customs payments for the imported HP;

Marginal 15) the price for the trade name HP for retail sale - the price of the trade name HP, included in the list of the HP which are subject to price regulation above which its retail sale cannot be enabled;

16) wholesale markup - the allowance to the registered price on descending scale including the profit and expenses connected with implementation of wholesale of HP;

17) descending scale of wholesale markup - scale of wholesale markup in percentage expression, dependent on size of the registered price;

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. Different salts, ethers, 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. Different dosage forms for intake with immediate release of substances are recognized within the bioavailability researches the same dosage form;

Marginal 19) price of the producer - the price of the trade name HP provided by the producer, which is the basic price for limiting calculation of the wholesale and retail prices of the trade name of the medicine included in the list by HP, which are subject to price regulation according to Regulations of the prices for HP and also of MI within the guaranteed amount of free medical care (further - GOBMP) and (or) in system of compulsory social medical insurance (further - OSMS);

20) 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 for HP, being 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, and also other subjects in the field of the address of the HP or MI, for HP 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 HP at the time of filing of application expired;

21) the state service - one of the forms of realization of the separate state functions or their set performed according to the address or without address of uslugopoluchatel and directed to realization of their rights, freedoms and legitimate interests, provision of the corresponding material or non-material benefits by it;

22) the portal of reference pricing (further - the Portal) - the automated information system of the state expert organization;

23) the reference countries - the countries of the European and Central Asian region macroeconomically comparable to the Republic of 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, Poland, Russia, Romania, Slovakia, Slovenia, Turkey, Croatia, the Czech Republic, Estonia);

Marginal 24) the price for the trade name HP within GOBMP and (or) in the OSMS system - the price of the trade name HP registered in the Republic of Kazakhstan above which the purchase within GOBMP and (or) in the OSMS system cannot be made;

25) descending scale of markup within GOBMP and (or) in the OSMS-system markup scale within GOBMP and (or) in the OSMS system in percentage expression, dependent on size of the registered HP price within GOBMP and (or) in the OSMS system;

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