ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of July 3, 2023 No. 124

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 (further – HP) approved by appendix 1 to the specified order:

state Item 2 in the following edition:

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

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

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

3) 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 4) the price for the trade name HP for retail sale – the price of the trade name HP, included in the list of the medicines which are subject to price regulation 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 HP, used for ceiling forming 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 (further – MNN);

9) 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, drug circulation and medical products (further – MI), qualities of rendering medical services (help);

10) 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;

11) 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;

12) 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";

13) 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;

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 wholesale – the price of the trade name HP, included in the list of the medicines which are subject to price regulation above which its wholesale 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 of medicine 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 of the medicines which are subject to price regulation according to Regulations of the prices of medicines and also on medical products 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 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 22) 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;

23) 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;

Marginal 24) 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;

25) 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 HP – transportation expenses from the producer to border of the Republic of Kazakhstan and customs payments;

26) markup within GOBMP and (or) in the OSMS system – the allowance to the registered price within GOBMP and (or) in the HP OSMS system on descending scale, the including profit and expenses connected with acquisition, storage, transportation, realization of HP 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;

27) 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.";

add item 4 with the subitem 7) of the following content:

"7) the withdrawal of the registered prices of medicines is performed based on acts of the law enforcement agencies and court resolutions which took legal effect.";

state Item 11 in the following edition:

"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 approval 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.";

state Item 13-1 in the following edition:

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

The state expert organization directs the draft of the list of the HP which are subject to price regulation in authorized body for review with antimonopoly authority and approvals, in time not later than 40 days before approval by authorized body of the list of the HP 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.";

add with Item 13-2 of the following content:

"13-2 Antimonopoly authority is approved by the draft of the list of the HP 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.";

state Item 18 in the following edition:

"18. The following documents are enclosed to the application:

For domestic manufacturers:

1) the document confirming the right of the applicant to perform registration of the price or re-registration of the registered price for wholesale retail realization (the power of attorney, the agreement, the letter on authorization, etc.);

2) information on actually incurred expenses for wholesale and retail sale on the letterhead of the applicant certified by the authorized signature in form according to appendix 2 to these rules which includes:

expenses on quality evaluation;

expenses on marketing;

3) for HP which effective period of the registration certificate at the time of filing of application expired, the HP made in the territory of the Republic of Kazakhstan before expiration of the registration certificate, the documents confirming production of HP are provided;

4) for the HP given on state registration the documents confirming giving on state registration – the statement on state registration of HP are provided.

For foreign producers:

1) the document confirming the right of the applicant to perform registration of the price or re-registration of the registered price for wholesale retail realization (the power of attorney, the agreement, the letter on authorization, etc.) including the right to provide price information Ex-works in the reference countries and about the prices of the actual deliveries;

2) the copy of the document confirming the HP price (the copy of invoice (delivery note), the invoice) for the last 12 months (in the presence of the actual deliveries), except as specified import to the territory of the Republic of Kazakhstan HP on the bases provided by the subitem 4) of article 252 of the Code.

In the absence of the actual deliveries for the last 12 months, copies of documents for previous period of 12 months are provided.

In the absence of the actual deliveries for the specified period, the applicant confirms lack of import on the letterhead of the applicant certified by the authorized signature of the applicant;

3) copy of the customs declaration;

4) the copy of the contract or the agreement on acquisition of HP existing at the time of filing of application on registration or re-registration of the registered HP price with HP price information;

5) information on actually incurred expenses for wholesale and retail sale of HP is submitted on the letterhead of the applicant certified by the authorized signature in form according to appendix 2 to these rules:

transportation expenses from the producer to border of the Republic of Kazakhstan;

customs payments;

expenses on quality evaluation;

expenses on marketing;

6) for HP which effective period of the registration certificate at the time of filing of application expired, the HP imported in the territory of the Republic of Kazakhstan before expiration of the registration certificate, the documents confirming import of HP are provided: copy of the conclusion about goods quality, and also copy of the customs declaration;

7) for the HP given on state registration the documents confirming giving on state registration – the statement on state registration of HP are provided.";

24, of 25, of 26, 27 to state Items in the following edition:

24. By results of reference pricing on the trade name HP, the state expert organization registers the price or will re-register the registered price for wholesale and retail sale in case of compliance to the following criteria:

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