ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 29, 2021 No. 1049

About federal state control (supervision) in the field of drug circulation

According to the Federal Law "About Drug Circulation" and Item 1 of part 2 of article 3 of the Federal law "About the State Control (Supervision) and Municipal Control in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on federal state control (supervision) in the field of drug circulation.

2. Recognize invalid acts and separate provisions of acts of the Government of the Russian Federation according to the list according to appendix.

3. Determine that from the date of entry into force of this resolution the planned inspections of legal entities and individual entrepreneurs included in the annual plan of conducting planned inspections for federal state supervision in the field of drug circulation for 2021, planned and unplanned control (supervising) actions within the state control (supervision) in the field of drug circulation, the decision on which conducting is made before entry into force of this resolution, and also the control (supervising) actions directed to check of execution of instructions about elimination of the revealed violations of the mandatory requirements issued before entry into force of this resolution within licensed control in the field of pharmaceutical activities and federal state supervision in the field of drug circulation are carried out according to the Provision approved by this resolution.

3(1). Determine that the subitem "d" of Item 2 of the Provision approved by this resolution is effective till September 1, 2029.

4. This resolution becomes effective since July 1, 2021.

Approved by the Order of the Government of the Russian Federation of June 29, 2021 No. 1049

Regulations on federal state control (supervision) in the field of drug circulation

I. General provisions

1. This Provision establishes procedure for the organization and implementation of federal state control (supervision) in the field of drug circulation.

2. Subject of federal state control (supervision) in the field of drug circulation are:

a) observance by the legal entities and individual entrepreneurs performing activities in the field of drug circulation (further - controlled persons) mandatory requirements in the field of drug circulation (further - mandatory requirements), including:

observance of requirements to preclinical researches of medicines, to clinical trials of medicines, production, storage, transportation, import to the Russian Federation, to leave, realization, transfer, sale of medicines, use of medicines, destruction of medicines, establishment by producers of medicines of the prices of the medicines included in the list of vital and essential drugs;

compliance of the medicines which are in circulation, to the indicators of quality, efficiency and safety established according to the Federal Law "About Drug Circulation";

b) observance by controlled persons of the requirements specified regarding 1 article 67.1 of the Federal law "About Drug Circulation" the restrictions set by articles 67.1 and 67.2 of the Federal law "About Drug Circulation";

c) observance of licensed requirements to implementation of pharmaceutical activities;

d) observance by controlled persons of requirements to provision of information on medicines and (or) medicines provided by Articles 9. 1, 52. 1, 52.2 and 64 Federal Laws "About Drug Circulation";

e) observance of the stipulated in Article 55.2 Federal Laws "About Drug Circulation" of requirements to carrying out experiment on implementation of retail trade by medicines for medical application with use of mobile pharmaceutical units. In this Provision the concept "mobile pharmaceutical unit" is applied in the value provided by the Federal Law "About Drug Circulation".

3. Federal state control (supervision) in the field of drug circulation for medical application is exercised by the Federal Service on supervision in the field of health care and its territorial authorities.

Federal state control (supervision) in the field of drug circulation for veterinary application is exercised by Federal Service for Veterinary and Phytosanitary Surveillance and its territorial authorities.

4. The officials authorized on implementation of federal state control (supervision) in the field of drug circulation for medical application are:

a) the head (deputy manager) of the Federal Service on supervision in the field of health care (territorial authority of the Federal Service on supervision in the field of health care);

b) officials of the Federal Service on supervision in the field of health care (territorial authority of the Federal Service on supervision in the field of health care) whose job responsibilities according to official regulations or the job description include implementation of powers on implementation of federal state control (supervision) in the field of drug circulation for medical application, including holding preventive actions and control (supervising) actions.

5. The officials authorized on implementation of federal state control (supervision) in the field of drug circulation for veterinary application are:

a) head (deputy manager) of Federal Service for Veterinary and Phytosanitary Surveillance (territorial authority of Federal Service for Veterinary and Phytosanitary Surveillance);

b) officials of Federal Service for Veterinary and Phytosanitary Surveillance (territorial authority of Federal Service for Veterinary and Phytosanitary Surveillance) whose job responsibilities according to official regulations or the job description include implementation of powers on implementation of federal state control (supervision) in the field of drug circulation for veterinary application, including holding preventive actions and control (supervising) actions.

6. The officials authorized on decision making about holding control (supervising) actions concerning medicines for medical application are:

a) the head of the Federal Service on supervision in the field of health care (territorial authority of the Federal Service on supervision in the field of health care);

b) the deputy manager of the Federal Service on supervision in the field of health care (territorial authority of the Federal Service on supervision in the field of health care) (in case of availability at it appropriate authority according to job responsibilities, the official regulations or distribution of obligations).

7. The officials authorized on decision making about holding control (supervising) actions concerning medicines for veterinary application are:

a) Head of the Federal Service for Veterinary and Phytosanitary Surveillance (territorial authority of Federal Service for Veterinary and Phytosanitary Surveillance);

b) the deputy manager of Federal Service for Veterinary and Phytosanitary Surveillance (territorial authority of Federal Service for Veterinary and Phytosanitary Surveillance) (in case of availability at it appropriate authority according to job responsibilities, the official regulations or distribution of obligations).

8. The officials exercising federal state control (supervision) in the field of drug circulation when holding control (supervising) action within the powers and in volume of the carried-out control (supervising) actions have the rights established by part 2 of article 29 of the Federal law "About the State Control (Supervision) and Municipal Control in the Russian Federation".

9. Provisions of the Federal Law "About the State Control (Supervision) and Municipal Control in the Russian Federation" are applied to the relations connected with implementation of federal state control (supervision) in the field of drug circulation.

II. Objects of federal state control (supervision) in the field of drug circulation

10. The Federal Service on supervision in the field of health care and its territorial authorities exercise federal state control (supervision) in the field of drug circulation for medical application, and the Federal Service for Veterinary and Phytosanitary Surveillance and its territorial authorities exercise federal state control (supervision) in the field of drug circulation for veterinary application (further - state control bodies) behind the following objects (further - objects of the state control):

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