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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of July 28, 2021 No. 854

Some questions of reimbursation of medicines according to the program of the state guarantees of medical attendance of the population

According to part seven of Article 9 and Item 5 of the Section IV "Final and transitional provisions" of the Law of Ukraine "About the state financial guarantees of medical attendance of the population", to articles 5 and 13 of the Law of Ukraine "About the prices and pricing" the Cabinet of Ministers of Ukraine decides:

1. Approve enclosed:

Limiting procedure of payments of wholesale selling prices on medicines;

Procedure for reimbursation of medicines.

2. Determine that:

The limiting register of wholesale selling prices on medicines which are subject to reimbursation according to the program of the state guarantees of medical attendance of the population regarding medicines which reimbursation is performed according to the program of the state guarantees of medical attendance of the population since October 1, 2021, is created in August, 2021 according to the limiting Procedure of payments of wholesale selling prices on medicines approved by this resolution;

The register of the medicines which are subject to reimbursation according to the program of the state guarantees of medical attendance of the population as of October 1, 2021 is created and will be promulgated in September, 2021 according to the Procedure for reimbursation of medicines approved by this resolution and becomes effective on October 1, 2021;

created in July, 2021. The limiting register of wholesale selling prices on medicines which are subject to reimbursation according to the program of the state guarantees of medical attendance of the population is supplemented with medicines which reimbursation according to the program of the state guarantees of medical attendance of the population begins since October 1, 2021, and will be promulgated till August 20, 2021;

created in August, 2021. The register of the medicines which are subject to reimbursation according to the program of the state guarantees of medical attendance of the population is supplemented with medicines which reimbursation according to the program of the state guarantees of medical attendance of the population begins since October 1, 2021, will be promulgated in September, 2021 and becomes effective on October 1, 2021.

3. Make changes which are applied to resolutions of the Cabinet of Ministers of Ukraine.

4. Recognize invalid resolutions of the Cabinet of Ministers of Ukraine according to the list which is attached.

5. To the Ministry of Health till October 1, 2021 to develop and approve the regulatory legal acts necessary for accomplishment of this resolution.

6. This resolution becomes effective from the date of its publication, except:

Items 2, 3, 5, 6, the paragraph of the fourth subitem 3 Items 7, Items 9 and 10 of the changes approved by this resolution, Items 1 - 6, 8 - 10, 12 - 14, 16 - 18, 20 - 22 lists of resolutions of the Cabinet of Ministers of Ukraine, invalid, approved by this resolution which become effective since October 1, 2021;

the subitem 2, paragraphs of third, the sixth - the seventeenth subitem 3 of Item 7 of the changes approved by this resolution which become effective since January 1, 2022.

Prime Minister of Ukraine

D. Shmygal

Approved by the Resolution of the Cabinet of Ministers of Ukraine of July 28, 2021 , No. 854

Limiting procedure of payments of wholesale selling prices on medicines

1. This Procedure determines the mechanism of limiting calculation of wholesale selling prices on medicines which are subject to reimbursation according to the program of the state guarantees of medical attendance of the population (further - the program of medical guarantees), the procedure of forming and maintaining the limiting Register of wholesale selling prices on medicines which are subject to reimbursation according to the program of medical guarantees (further - the limiting Register of wholesale selling prices on medicines).

2. In this Procedure terms are used in such value:

Limiting 1) wholesale selling price of medicine (except insulin drugs) - the maximum cost of daily dose of medicine (except insulin drugs) which is subject to reimbursation, the corresponding form of release, calculated on the basis of external reference pricing according to this Procedure without supplying and sales and trade (retail) allowances and the value added tax;

Limiting 2) wholesale selling price of drug of insulin - the maximum cost of primary package of drug of insulin which is subject to reimbursation, established within the corresponding reference group, calculated on the basis of external reference pricing for one international unit of drug of insulin and quantities of the international units in primary package according to this Procedure without supplying and sales and trade (retail) allowances and the value added tax;

3) daily dose of medicine - the fixed medicine consumption unit (except insulin drugs) which is used for basic purpose for treatment of adults, the recommended WHO and WHO calculated by the Center of cooperation for methodology of statistics of medicines;

4) external reference pricing - limiting calculation of wholesale selling price on the basis of the wholesale selling prices established in the reference countries according to this Procedure;

5) the international unit (IU) - the unit of measure of force of effect of drug of insulin based on its biological activity;

6) the reference countries - the countries determined in appendix 1, data on stated prices on medicines in which are used for external reference pricing for medicines.

Other terms are used in the value given in Bases of the legislation of Ukraine on health care, the Laws of Ukraine "About the state financial guarantees of medical attendance of the population", "About medicines", the Procedure for reimbursation of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of July 28, 2021 No. 854 "Some questions of reimbursation of medicines according to the program of the state guarantees of medical attendance of the population".

3. Action of this Procedure extends to the finished pharmaceutical products registered in Ukraine which are subject to reimbursation agrees to the list of conditions and the international unlicensed names of medicines determined by the program of medical guarantees for the corresponding year (further - the list of the international unlicensed names).

4. The reference prices of medicines are determined on the basis of the last published information on the registered prices by date received from official sources of authorized state bodies of the reference countries.

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