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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of July 2, 2014 No. 240

Questions of declaring of change of wholesale selling prices on medicines

(as amended on 28-07-2021)

According to articles 5 and 13 of the Law of Ukraine "About the prices and pricing" the Cabinet of Ministers of Ukraine decides:

1. Determine that:

1) changes of wholesale selling prices net of any taxes are subject to declaring and charges on medicines which are bought and/or cost of which is subject to reimbursation, except narcotic and psychotropic medicines, precursors, active ingredients (substances), medical gases and dosage forms made in drugstores according to recipes of doctors (the main formulas) and by request of treatment and prevention facilities (further - medicines);

2) organization and healthcare institution which are fully or partially financed from state and local budgets, is bought by medicines at the prices which do not exceed the level of the declared changes of wholesale selling prices taking into account taxes and fees, and also limiting supplying and sales and trade (retail) allowances established by the resolution of the Cabinet of Ministers of Ukraine of October 17, 2008 No. 955 "About measures for price stabilization on medicines and products of medical appointment" (The Official Bulletin of Ukraine, 2008, No. 84, of the Art. 2825);

3) the declared changes of wholesale selling prices on the medicines included in the state Register of the medicines which are subject to reimbursation according to the program of the state guarantees of medical attendance of the population which affirms the Ministry of Health cannot exceed the wholesale selling prices established in the limiting procedure determined by the legislation;

4) requirements of this resolution do not extend on:

the medicines included in the list of medicines which are included in the National list of the main medicines and on which extreme wholesale selling prices are established, approved by the Ministry of Health;

medicines which are bought according to agreements of the managed access.

medicines which are bought according to Item 19 parts five of article 3 of the Law of Ukraine "About public purchases" and medicines which are bought by the state company "Medical Purchases of Ukraine" as the receiver of budgetary funds for accomplishment of programs and implementation of centralized actions for health care.

2. Approve the Procedure for declaring of change of wholesale selling prices on medicines which is applied.

3. Declare invalid the resolution of the Cabinet of Ministers of Ukraine of August 13, 2012 No. 794 "Questions of declaring of change of wholesale selling prices on the medicines and products of medical appointment which are purchased at the expense of means state and local budgets" (The Official Bulletin of Ukraine, 2012, No. 65, the Art. 2655).

4. To the Ministry of Health:

To bring 1) in two-month time own regulatory legal acts into accord with this resolution;

To inform 2) producers of the medicines and products of medical appointment about change of pricing to such means and products provided by this resolution;

To approve 3) in two-month time by the joint order of the Ministry of Economic Development and Trade procedure of payments of wholesale selling price on medicine.

Prime Minister of Ukraine

A. Yatsenyuk

Approved by the Resolution of the Cabinet of Ministers of Ukraine of July 2, 2014, No. 240

Procedure for declaring of change of wholesale selling prices on medicines

1. This Procedure determines the mechanism of declaring of change of wholesale selling prices on medicines which are bought and/or the cost of which is compensated for budgetary funds, except narcotic and psychotropic medicines, precursors, active ingredients (substances), medical gases and dosage forms which are made in drugstores according to recipes of doctors (the main formulas) and by request of treatment and prevention facilities (further medicines).

2. Change of wholesale selling price of each dosage form, dosage and consumer packaging of medicine is subject to declaring:

national production - in national currency without the expense accounting, connected with loading, unloading and transportation;

foreign production - in national currency with indication of the official rate of hryvnia to foreign currency established by National Bank for date of submission of the declaration of change of wholesale selling price on medicine.

3. For declaring of change of wholesale selling price on medicine the owner of the registration certificate on medicine or person (applicant) authorized by it in accordance with the established procedure files the following documents to the Ministry of Health:

the statement for declaring of change of wholesale selling price on medicine in the form established by the Ministry of Health;

the power of attorney certifying powers of the authorized person to declare change of wholesale selling price on medicine, issued by the owner of the registration certificate on medicine, with the translation into Ukrainian certified in the procedure established by the legislation or the copy of such power of attorney certified of the procedure established by the legislation.

4. If the applicant is legal entity, the documents specified in Item 3 presents of the Procedure make sure the signature of his head, under seal (in the presence).

Responsibility for unauthenticity of information specified in such documents is conferred on the applicant.

The list of documents specified in Item 3 presents of the Procedure for the procedure of declaring is exhaustive.

5. If the documents specified in Item 3 presents of the Procedure are provided not in full, drawn up with violation of the established requirements, the Ministry of Health reports about it to the applicant in writing within five working days from the date of their registration.

6. On condition of provision in full and properly processed documents the Ministry of Health:

makes the decision on declaring of the wholesale selling price on medicine offered by the applicant and enters data in the register of wholesale selling prices on medicines in time which is not exceeding 10 working days from the date of submission of documents specified in Item 3 presents of the Procedure;

places in two-day time after adoption of the specified decision on the website the relevant information.

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