RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of July 28, 2021 No. 854

Some questions of reimbursation of medicines and medical products 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 and medical products;

Procedure for reimbursation of medicines and medical products.

1-1. Determine that for action of warlike situation of the requirement of the Procedure for use of the means provided in the government budget on program implementation of the state guarantees of medical attendance of the population approved by this resolution concerning reports of suppliers of medical services on the rendered medical services and pharmaceutical institutions about the allotted medicines are not applied.

Determine that for action of warlike situation registration in bodies of the Public treasurer service of budget obligations and budget financial liabilities for payment of medical services in agreements is performed based on the budget obligations of managers (receivers) of budgetary funds and the Register of budget financial liabilities of managers (receivers) of budgetary funds submitted National service of health of the Register which forms are determined according to the procedure of registration and accounting of budget obligations of managers of budgetary funds and receivers of budgetary funds in bodies of the Public treasurer service of Ukraine, No. approved by the order of the Ministry of Finance of March 2, 2012 309, without submission of supporting documents (the summary register of agreements by form according to appendix 1 and the summary register of reports (accounts) of suppliers of medical services on amount of the rendered services in form according to appendix 2).

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.

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 subject to extraordinary updating no later than September, 2022.

2-1. Determine that in the period of warlike situation in the territories of active fighting or temporarily occupied by the Russian Federation which are included in the list of the territories in which are conducted fighting (was conducted) or temporarily occupied by the Russian Federation, the Ministry of questions of reintegration of temporarily occupied territories approved by the order (further - the list), from the date of entry into force of such order (or modification of it) in case of lack of technical capability of writing out of electronic recipes on the medicines and/or medical products which are subject to reimbursation, writing out of recipes it can be performed in paper form according to the rules of writing out of recipes on medicines and medical products approved by the order of the Ministry of Health of July 19, 2005 No. 360.

Repayment of such recipes is performed:

for all medicines and/or medical products which are subject to reimbursation - pharmaceutical institutions which are located in the territories in which are conducted conducted) fighting or temporarily occupied by the Russian Federation which are included in the list;

for the narcotic (psychotropic) medicines which are subject to reimbursation - pharmaceutical institutions which are located in the territories of active fighting, the territories of active fighting in which the state electronic information resources function, or temporarily occupied by the Russian Federation which are included in the list.

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.

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 and medical products

1. This Procedure determines the mechanism of limiting calculation of the wholesale selling prices on medicines and medical products 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 list of the wholesale selling prices on medicines which are subject to reimbursation according to the program of medical guarantees (further - the limiting list of wholesale selling prices on medicines), and the limiting list of the wholesale selling prices on medical products which are subject to reimbursation according to the program of medical guarantees (further - the limiting list of wholesale selling prices on medical products).

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

Limiting 1) wholesale selling price of medicine (except drugs of insulin and the combined medicines) - the maximum cost of daily dose of the medicine (except drugs of insulin and the combined medicines) 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;

1-1) extreme wholesale selling prices of medical product - the maximum cost of unit of the medical product which is subject to reimbursation, 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;

2-1) extreme wholesale selling price of medicine, except drugs of insulin which contains two either more active ingredients, or medicine for which the daily dose recommended to WHO is not established (further - the combined medicine), - the maximum cost:

the combined medicine which is subject to reimbursation, the corresponding form of release - for tablets, capsules and tablets with the modified release;

primary package of medicinal means - for granules, liquid, powders, powders for inhalations, inhalations in cylinders, nebulizers, the thaw ear and eye, oculentum, is 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;

3) daily dose of medicine - the fixed medicine consumption unit (except drugs of insulin and the combined medicines) 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, and the countries determined in appendix 3, data of rather stated prices on medical products in which are used for external reference pricing for medical products.

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