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ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 5, 2022 No. 1809

About reference pricing with the separate medicines purchased for budgetary funds

According to resolutions of the Cabinet of Ministers of Ukraine of October 4, 2022 No. 1117 "About introduction of amendments to some resolutions of the Cabinet of Ministers of Ukraine of rather reference pricing with the separate medicines purchased for budgetary funds" of April 3, 2019 No. 426 "About reference pricing with the separate medicines purchased for budgetary funds", the paragraph of the forty second subitem 12 of item 4 of the Regulations on the ministry of health protection of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 No. 90), for the purpose of implementation of state regulation of the prices by reference pricing for some medicines which are bought for budgetary funds, PRIKAZYVAYU:

1. Approve limiting Procedure of payments of wholesale selling prices on the separate medicines which are purchased for budgetary funds and subjects to reference pricing which is applied.

2. Determine that:

the register of data about limiting wholesale selling prices on the separate medicines which are purchased for budgetary funds and subjects to reference pricing (further - the Register), affirms the Ministry of Health of Ukraine in October, 2022 based on the limiting calculation of wholesale selling prices on medicines which is carried out according to the Procedure approved by this order, by data about the prices of medicines in the reference countries or Ukraine in case of lack of the prices of medicine to four of five reference countries as of August - September, 2022;

the limiting register of wholesale selling prices as of the August 11, 2022 approved by the order of the Ministry of Health of Ukraine of August 23, 2022 No. 1512, affects the separate medicines which are purchased for budgetary funds before approval of the Register by the Ministry of Health of Ukraine.

3. Make change to Item 14 of the Regulations on the register of wholesale selling prices on medicines and products of medical appointment, procedure for the introduction in it for changes approved by the order of the Ministry of Health of Ukraine of the August 18, 2014 No. 574, registered in the Ministry of Justice of Ukraine on September 09, 2014 for No. 1097/25874, having added it with the new paragraph of the following content:

"Data on the declared change of wholesale selling price on the medicines included in the register of the prices are subject to withdrawal from the specified register in case of establishment with such medicines according to the resolution of the Cabinet of Ministers of Ukraine of April 03, 2019 No. 426 "About reference pricing on the separate medicines purchased for budgetary funds" extreme wholesale selling prices. The Ministry of Health withdraws data on such medicine from the register of the prices within ten working days from the date of establishment on it in the procedure established by the legislation, extreme wholesale selling price.".

4. Recognize invalid:

1) the order of the Ministry of Health of Ukraine of July 11, 2019 No. 1600 "About some questions of reference pricing on the medicines included in the National list of the main medicines which are purchased for budgetary funds", registered in the Ministry of Justice of Ukraine on July 19, 2019 for No. 793/33764;

2) the order of the Ministry of Health of Ukraine of July 29, 2019 No. 1713 "About approval of the List of the medicines included in the National list of the main medicines and on which extreme wholesale selling prices are established", registered in the Ministry of Justice of Ukraine on July 31, 2019 for No. 839/33810.

5. To provide to pharmaceutical management (Ivan Zadvornikh) submission of this order in the procedure established by the legislation on state registration in the Ministry of Justice of Ukraine.

6. I reserve control over the implementation of this order.

7. This order becomes effective from the date of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of October 5, 2022, No. 1809

Limiting procedure of payments of wholesale selling prices on the separate medicines which are purchased for budgetary funds and subjects to reference pricing

1. This Procedure determines the mechanism of limiting calculation of wholesale selling prices on medicines which are registered in Ukraine:

on the basis of the prices of medicines in the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia, Hungary (further - the reference countries) received from official sources of authorized state bodies of these countries (further - external summarizing);

on the basis of the prices of medicines in Ukraine received according to system of research of the market in Ukraine which is used on a contract basis by MZ and/or the state company and treats the sphere of management of MOZ, is attracted for implementation of calculations (further - internal summarizing).

2. Action of this Procedure extends to medicines which are registered in Ukraine, are bought for budgetary funds and:

are included in the National list of the main medicines approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2009 No. 333 (in edition of the resolution of the Cabinet of Ministers of Ukraine of December 23, 2021 No. 1431) (further - the National list);

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