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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of May 6, 2015 No. 434

About regional state control of use of the prices of the medicines included in the list of vital and essential drugs

(as amended of the Order of the Government of the Russian Federation of 24.09.2020 No. 1541)

According to Item 9 of article 60 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

Approve the enclosed Regulations on regional state control of use of the prices of the medicines included in the list of vital and essential drugs.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of May 6, 2015 No. 434

Regulations on regional state control of use of the prices of the medicines included in the list of vital and essential drugs

1. This Provision establishes procedure executive bodies of subjects of the Russian Federation of regional state control of use of wholesale trade by the organizations by medicines, the pharmaceutical organizations, the individual entrepreneurs having the license for implementation of pharmaceutical activities, the medical organizations having the license for implementation of pharmaceutical activities and their separate divisions (out-patient clinics, medical assistant's and medical and obstetrical centers, the centers (departments) of general medical (family) practice) located in rural settlements in which there are no pharmaceutical organizations, the prices of the medicines included in the list of vital and essential drugs (further respectively - medicines, objects of control, regional state control).

2. Subject of regional state control is observance by object of control in case of realization of medicines of requirements of part 2 of article 63 of the Federal law "About Drug Circulation" for use of the prices which level (excluding tax on value added) shall not exceed the amount of the actual selling price of the producer of medicine which is not exceeding registered or the re-registered marginal selling price of the producer (for date of realization of medicine by the producer), and the size of the wholesale allowance and (or) the size of the retail allowance which are not exceeding the extreme respectively a size of the wholesale allowance and (or) the extreme size of the retail allowance established in the subject of the Russian Federation (further - mandatory requirements).

3. Regional state control in the territory of the subject of the Russian Federation is exercised by executive body of the subject of the Russian Federation, authorized supreme executive body of the government of the subject of the Russian Federation (further - body of regional state control).

4. Regional state control is exercised by means of:

a) organizations and conducting checks of observance by object of control of mandatory requirements;

b) systematic observation of execution by object of control of mandatory requirements;

c) acceptances according to the procedure, established by the legislation of the Russian Federation, measures for suppression of the revealed violations of mandatory requirements and (or) to elimination of effects of such violations, issues of instructions about elimination of the revealed violations of mandatory requirements and taking measures to accountability of persons who made such violations.

5. Officials of body of regional state control when conducting checks observe restrictions and carry out the obligations established by Articles 15 - 18 Federal Laws "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control", and also bear responsibility for improper execution of the powers assigned to them.

6. To the relations connected with implementation of regional state control including the organization and conducting checks of object of control, provisions of the Federal Law "About Protection of the Rights of Legal Entities and Individual Entrepreneurs when Implementing the State Control (Supervision) and Municipal Control" are applied.

7. Decisions and actions (failure to act) of officials of bodies of regional state control can be appealed in administrative and (or) legal process in accordance with the legislation of the Russian Federation.

8. Information on activities of body of regional state control, including on results performed by it, is posted on the official site of body of regional state control on the Internet according to the procedure established by the legislation of the Russian Federation.

 

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