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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 20, 2021 No. 1983

About approval of the Regulations on the state control (supervision) of realization of subjects of the Russian Federation of powers by executive bodies in the sphere of drug circulation for medical application

According to part 5 of article 9.2 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on the state control (supervision) of realization of subjects of the Russian Federation of powers by executive bodies in the sphere of drug circulation for medical application.

2. Realization of the powers of Federal Antimonopoly Service provided by this resolution is performed within the established number of staff and the salary fund of employees of central office of Federal Antimonopoly Service, and also budgetary appropriations provided to Federal Antimonopoly Service by the Federal Law on the federal budget for the corresponding financial year and planning period on management and management in the sphere of the established functions.

3. This resolution becomes effective from the date of its official publication.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of November 20, 2021 No. 1983

Regulations on the state control (supervision) of realization of subjects of the Russian Federation of powers by executive bodies in the sphere of drug circulation for medical application

1. This Provision establishes procedure for the organization and implementation of the state control (supervision) of realization of subjects of the Russian Federation of powers by executive bodies in the sphere of drug circulation for medical application (further - the state control (supervision).

2. The state control (supervision) is exercised by Federal Antimonopoly Service.

3. The organization and implementation of the state control (supervision) are regulated by the Federal Law "About the General Principles of the Organization of Legislative (Representative) and Executive Bodies of the Government of Subjects of the Russian Federation".

4. Subject of the state control (supervision) is observance of the executive authority of subjects of the Russian Federation by authorized bodies (further - subjects of control) techniques of limiting establishment of the sizes of wholesale allowances and the extreme sizes of retail allowances to the actual selling prices established by producers of medicines on the medicines included in the list of vital and essential drugs.

5. Officials of Federal Antimonopoly Service, representatives on decision making about holding control (supervising) actions, are the head of Federal Antimonopoly Service or deputy managers of Federal Antimonopoly Service under whose authority questions of the state control (supervision) are.

6. The officials of Federal Antimonopoly Service exercising the state control (supervision) are:

a) head of Federal Antimonopoly Service;

b) deputy managers of Federal Antimonopoly Service under whose authority questions of the state control (supervision) are;

c) chiefs of structural divisions of Federal Antimonopoly Service and their deputies under whose authority questions of the state control (supervision) are;

d) chiefs of departments of structural divisions of Federal Antimonopoly Service and their deputies under whose authority questions of the state control (supervision), the chief state inspectors, the chief state inspectors and the state inspectors of departments of structural divisions of Federal Antimonopoly Service under whose authority questions of the state control (supervision) are are;

e) the federal government civil servants of the leading and senior groups of positions of category "specialists" of departments of structural divisions of Federal Antimonopoly Service who are not specified in the subitem "g" of this Item under whose authority questions of the state control (supervision) are.

7. When implementing the state control (supervision) the following types of actions are carried out (further - checks):

a) documentary check;

b) exit check.

8. Are performed on planned and unplanned basis.

9. Scheduled inspections are carried out based on the annual consolidating plan of the conducting checks created according to item 4 of article 29.2 of the Federal law "About the General Principles of the Organization of Legislative (Representative) and Executive Bodies of the Government of Subjects of the Russian Federation".

10. In the decision on conducting check are specified:

a) date, time and place of decision making;

b) who makes the decision;

c) basis of conducting check;

d) check subject;

e) type of the state control (supervision);

e) surnames, names, middle names (in the presence) the officials of Federal Antimonopoly Service exercising the state control (supervision);

g) the name and the address of the subject of control concerning which it is performed;

h) check type;

i) date and term of conducting check.

11. Scheduled inspections are carried out not more often than once in 2 years.

12. The basis of carrying out unscheduled inspections are:

a) the decision of the head of Federal Antimonopoly Service or deputy managers of Federal Antimonopoly Service under which authority questions of the state control (supervision) are accepted based on addresses of citizens, the organizations and information on the facts of violation of the law of the Russian Federation received from state bodies, local government bodies which attract or can entail threat of life and to health of citizens, and also mass violations of the rights of citizens;

b) orders of the President of the Russian Federation, the Government of the Russian Federation, the requirement of the Prosecutor General of the Russian Federation, prosecutor of the subject of the Russian Federation about carrying out unscheduled inspection within supervision of execution of the laws on the materials and addresses which arrived in bodies of prosecutor's office, and also for the purpose of control of execution of earlier issued instruction about elimination of violation of mandatory requirements.

13. On the basis specified in the subitem "an" of Item 12 of this provision are performed in coordination with prosecutor's office of the subject of the Russian Federation.

14. During checks officials of Federal Antimonopoly Service, representatives on conducting checks, request from subjects of control on paper and (or) electronically the documents and other materials relating to check subject and also explanations in oral and written form of employees of the subject of control on the questions relating to check subject.

15. Representation by the subject of control of the documents requested by Federal Antimonopoly Service on paper and (or) electronically and other materials is performed within 10 working days from the date of sending an inquiry.

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