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

According to subitems 51) and 94) article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve:

1) regulations, marginal forming of prices and markup on medicines according to appendix 1 to this order;

2) regulations, marginal forming of prices and markup on medical products within the guaranteed amount of free medical care and (or) in system of compulsory social medical insurance according to appendix 2 to this order.

2. Recognize invalid:

1) the order of the acting minister of health care of the Republic of Kazakhstan of April 19, 2019 No. KR DSM-42 "About approval of Regulations of the prices of medicines" (it is registered in the Register of state registration of regulatory legal acts at No. 18573, it is published on May 03, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan);

2) the order of the acting minister of health care of the Republic of Kazakhstan of June 17, 2020 No. KR DSM-68/2020 "About modification of the order of the acting minister of health care of the Republic of Kazakhstan of April 19, 2019 No. KR DSM-42 "About approval of Regulations of the prices of medicines" (it is registered in the Register of state registration of regulatory legal acts at No. 20871, it is published on June 22, 2020 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.

"Is approved" Agency on protection and development of the competition of the Republic of Kazakhstan

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of December 11, 2020 No. KR DSM-247/2020

Regulations, marginal forming of prices and markup on medicines

Chapter 1. General provisions

1. These rules of regulation, marginal forming of prices and markup on medicines (further - LS) 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).

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

1) biosimilar medicine (bioanalogue, biosimilar medicine, biosimilyar) - 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, LS included in the list, 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 LS, 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 appeal of LS and medical products (further - MI), qualities of rendering medical services (help);

8) the state expert organization in the sphere of the appeal of LS 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 LS and MI;

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

10) 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, including in the LS producer country in case of its realization, and also the actual price of deliveries to the Republic of Kazakhstan;

11) 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;

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 LS 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 LS;

Marginal 15) the price for the trade name HP for retail sale - the price of the trade name HP, LS included in the list, 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 LS;

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. 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;

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 medicine of LS included in the list which are subject to price regulation according to Regulations of the prices of LS 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 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, 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;

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 price of LS within GOBMP and (or) in the OSMS system;

Marginal 26) the price for the international non-proprietary name HP within GOBMP and (or) in the OSMS system - the price of the international non-proprietary name HP, registered in the Republic of Kazakhstan above which the purchase within GOBMP and (or) in the OSMS system cannot be made;

27) the registered price within GOBMP and (or) 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 (or) in the OSMS system, consisting of the price of the producer, expenses on quality evaluation, and for the imported LS - transportation expenses from the producer to border of the Republic of Kazakhstan and customs payments;

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

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

30) the digital signature (further - the EDS) - set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content.

31) 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.

Chapter 2. Procedure for price regulation on medicines

3. State regulation of the prices of medicines is performed based on marginal forming of prices and markup on medicines.

4. The state expert organization performs:

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

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

3) forming of the ceiling project of prices for the trade name HP for wholesale and retail sale;

4) forming of the ceiling project of prices for the trade name HP within GOBMP and (or) in the OSMS system;

5) forming of the ceiling project of prices for the international non-proprietary name HP within GOBMP and (or) in the OSMS system;

6) forming of the draft of the list of LS which are subject to price regulation for wholesale and retail sale;

7) the withdrawal of the registered prices of LS is performed based on the court resolutions which took legal effect and according to the address of the applicant in any form;

8) the state service to applicants (uslugopoluchatel) according to these rules.

5. Price regulation includes the following stages and (or) actions:

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

forming of the draft of the list of LS which are subject to price regulation for wholesale and retail sale;

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

forming of wholesale markups;

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

forming of retail markups;

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

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

2) for LS intended for rendering GOBMP and (or) in the OSMS system:

issue of the conclusion about the registered price of the trade name HP within GOBMP and (or) in the OSMS system;

forming of markups within GOBMP and (or) in the OSMS system;

ceiling forming of prices for the trade name HP within GOBMP and (or) in the OSMS system;

ceiling forming of prices for the international non-proprietary name HP within GOBMP and (or) in the OSMS system;

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

ceiling approval of prices for the international non-proprietary name HP within GOBMP and (or) in the OSMS system.

6. Registration of the price or re-registration of the registered prices and ceiling approval of prices for the trade name HP is performed in national currency of the Republic of Kazakhstan (further – tenge).

Marginal forming of prices and markups, including reference pricing on LS is performed by the state expert organization on contractual basis.

7. When converting foreign currency of the prices in the statement, and also in the documents confirming the actual price of deliveries, copies of invoice (delivery note) or the invoice and also in the contract or the agreement on acquisition of LS in national currency of the Republic of Kazakhstan 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.

In case of lack of the official rate of currencies in the list of foreign currencies approved by the resolution of Board of National Bank of the Republic of Kazakhstan of August 24, 2012 No. 242 "About approval of Rules of establishment of the official rate of national currency of the Republic of Kazakhstan to foreign currencies" (it is registered in the Register of state registration of regulatory legal acts at No. 7977), price information in the reference countries 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 https://treasury.un.org.

8. In case of monthly change of the exchange rate of tenge to foreign currencies for 10 or more percent and (or) excesses of the actual annual inflation of the upper bound of target corridor more than in time 1,5, marginal prices are created according to the trade name on medicines by price increment of the producer of the percentage value provided by authorized body.

9. In case of monthly change of the exchange rate of tenge to foreign currencies for 10 or more percent and (or) reduction of the actual annual inflation of the upper bound of target corridor more than in time 1,5, marginal prices are created according to the trade name on medicines by deduction from the price of the producer of the percentage value provided by authorized body.

10. In case of registration or re-registration of the registered price the currency price adjustment in national currency of the Republic of Kazakhstan, according to the price specified in the documents confirming the actual price of deliveries and contracts or agreements on acquisition of LS corresponding to difference of average currency rates at the time of import, date of the contract or contracts on acquisition of LS and for date of filing of application for registration or re-registration of the registered price in the month preceding date of filing of application on registration or re-registration of the registered price is made.

11. Information provided by the applicant for registration of the price or re-registration of the registered price is confidential, except as specified its provisions of the state expert organization, to authorized body, law enforcement agencies, and also antimonopoly authority in case of ceiling coordination of prices for the trade name HP for wholesale and retail sale, and also within GOBMP and (or) in the OSMS system.

Persons having access to confidential information owing to post, provision or accomplishment of obligations including when carrying out audit, keep and take measures for its protection.

12. During restrictive actions, including quarantine, introduction of emergency state, emergence of emergency situations of social, natural and technogenic nature in the territory of the Republic of Kazakhstan, the special procedure for ceiling forming of prices for LS for wholesale and retail sale, and also within GOBMP and (or) in the OSMS system is performed (further – special procedure).

In case of special procedure the authorized body sends to the state expert organization the LS list on MNN for ceiling forming of prices for the trade name HP for wholesale and retail sale, and also within GOBMP and (or) in the OSMS system, according to descending scale of the markups established by Items 30, 35 and 59, of these rules and also exception of marketing expense for wholesale and retail sale.

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

Chapter 3. Procedure for forming of the draft of the list of the medicines which are subject to price regulation for wholesale and retail sale, marginal prices and markups on medicines for wholesale and retail sale

Paragraph 1. Forming of the draft of the list of the medicines which are subject to price regulation for wholesale and retail sale, registration or re-registration of the price for wholesale and retail sale for the trade name of medicines

13-1. The state expert organization creates the draft of the list of LS which are subject to price regulation for wholesale and retail sale (further - the draft of the list), on the basis of the registered LS and also having the registration certificate within the Eurasian Economic Union as of January 15 and on July 15 the current year.

In the draft of the list are subject to inclusion of LS:

1) prescription;

2) the nonprescription, having no more than two trade names HP within one MNN and (or) the having no more than two producers of trade names HP within one MNN;

3) the nonprescription, included in the list LS and MI which are purchased from the single distributor and (or) in the list of LS and MI for free and (or) preferential out-patient ensuring separate categories of citizens with certain diseases (conditions).

The state expert organization directs the draft of the list of LS which are subject to price regulation in authorized body for review with antimonopoly authority and approvals, in time not later than 40 calendar days before approval by authorized body of the list of LS which are subject to price regulation according to Item 1 of article 245 of the Code in form according to appendix 1 to these rules.

13-2. The antimonopoly authority is approved by the draft of the list of LS which are subject to price regulation for wholesale and retail sale, registration or re-registration of the price for wholesale and retail sale for the trade name of medicines created on the basis of data of the state expert organization.

14. The prices of LS for wholesale and retail sale are registered or will be re-registered for consumer packaging, separately on each trade name taking into account dosage form, dosage, concentration, amount and packing of LS.

15. For registration or re-registration of the registered price for wholesale and retail sale for the trade name HP in the Republic of Kazakhstan the applicant provides in the state expert organization the statement for registration of the price or re-registration of the registered price for wholesale and retail sale (further – the statement) during the period no later than April 10 or on October 10 the current year in form, according to appendix 1-1 to these rules. Data on LS are specified in the statement according to the registration certificate for LS.

16. If within one registration certificate several options of consumer packagings, dosages, dosage forms and packing of LS are registered, the applicant provides the statement separately for each of options.

17. The electronic application form moves on the website of the state expert organization (www.ndda.kz) on the Portal in online the mode with further provision of paper documents.

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