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

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 list 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 which are subject to reference pricing and concerning which extreme wholesale selling prices according to the resolution of the Cabinet of Ministers of Ukraine of April 3, 2019 No. 426 "About reference pricing on some medicines which are bought for budgetary funds" (The Official Bulletin of Ukraine, 2019, No. 43, by the Art. 1483), except those medicines on which due to the lack of the prices of such medicines in the reference countries (the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia, Hungary) and limiting Ukraine wholesale selling prices are not calculated are established;

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;

5) data on the declared change of wholesale selling price on the medicines included in the list of the declared wholesale selling prices on medicines are subject to withdrawal by the Ministry of Health from the specified list in case of establishment with such medicines according to the resolution of the Cabinet of Ministers of Ukraine of April 3, 2019 No. 426 "About reference pricing on some medicines purchased for budgetary funds" (The Official Bulletin of Ukraine, 2019, No. 43, the Art. marginal 1483) wholesale and holiday selling prices. In that case the procedures of purchases of medicines begun before withdrawal of data from the list of the declared wholesale selling prices on medicines come to the end according to requirements of the subitem 2 presents of Item.

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.

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.

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