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

of June 23, 2022 No. KR DSM-56

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:

state preamble in the following edition:

"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" I ORDER:";

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 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) and establish procedure for regulation, marginal forming of prices and markup on medicines (further – HP).";

in Item 2:

4) to state the subitem in the following edition:

"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;";

15) to state the subitem in the following edition:

"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;";

19) to state the subitem in the following edition:

"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);";

21) and 22) to state subitems in the following edition:

"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;";

24) to state the subitem in the following edition:

"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;";

6) of item 4 to state the subitem in the following edition:

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

1) of Item 5 to state the subitem in the following edition:

"1) for the HP which are subject to wholesale and retail sale:

forming of the draft of the list of the HP 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;";

state Items 6 and 7 in the following edition:

"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 HP 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 HP 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.";

state Item 10 in the following edition:

"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 HP corresponding to difference of average currency rates at the time of import, date of the contract or contracts on acquisition of HP 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.";

state Item 12 in the following edition:

"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 HP 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 HP 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.";

in Chapter 3:

state heading in the following edition:

"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";

to state heading of paragraph 1 in the following edition:

"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";

add with Item 13-1 of the following content:

"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 HP taking into account dosage form, dosage, concentration, amount as of January 15 and on July 15 the current year.

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

1) prescription;

2) nonprescription:

HP and MI which are purchased from the single distributor and (or) in the list of HP and MI for free and (or) preferential out-patient ensuring separate categories of citizens with certain diseases (conditions) included in the draft of the list;

the having less than 3 trade names HP within one MNN;

the having less than 3 producers of trade names HP within one MNN.

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.";

15, of 16, 17 and 18 to state Items in the following edition:

"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 HP are specified in the statement according to the registration certificate for HP.

16. If within one registration certificate several options of consumer packagings, dosages, dosage forms and packing of HP 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.

In case of not provision of paper documents within 20 working days from the date of filing of application, the state expert organization cancels the submitted application on the website (www.ndda.kz) without its consideration.

If the electronic application form is signed by the digital signature, provision of paper documents is not required.

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.);

Expense information 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 also includes 2):

data on actually incurred expenses on quality evaluation;

data of marketing expense;

3) the copy of the document confirming the operating patent protection of original medicine or biological original medicine on MNN with indication of date of the expiration of action of patent protection or the letter from the manufacturing plant or the holder of the registration certificate confirming originality of medicine on MNN (in the presence);

4) 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;

5) 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 (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 or the customs declaration) 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 in case of availability of remaining balance of HP 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 contract or contract on acquisition of HP with HP price information;

4) expense information for wholesale and retail sale of HP is represented on the letterhead of the applicant certified by the authorized signature in form according to appendix 2 to these rules and includes:

data of actually incurred transportation expenses from the producer to border of the Republic of Kazakhstan;

data of customs expenses;

data of expenses on quality evaluation;

data of marketing expense.

5) the copy of the document confirming the operating patent protection of original medicine or biological original medicine on MNN with indication of date of the expiration of action of patent protection or the letter from the manufacturing plant or the holder of the registration certificate confirming originality of medicine on MNN;

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