ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of March 31, 2022 No. 547

About approval of the Regulations on licensing of pharmaceutical activities

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of pharmaceutical activities.

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

3. This resolution becomes effective since September 1, 2022 and is effective till September 1, 2028.

Approved by the Order of the Government of the Russian Federation of March 31, 2022 No. 547

Regulations on licensing of pharmaceutical activities

1. This Provision establishes procedure for licensing of the pharmaceutical activities performed by legal entities, including foreign legal entities including the organizations of wholesale trade by medicines, the pharmaceutical organizations, the veterinary pharmaceutical organizations, and also the medical organizations and their separate divisions located in rural settlements in which there are no pharmaceutical organizations (further respectively - the medical organizations, separate divisions of the medical organizations), the veterinary organizations and individual entrepreneurs.

2. Pharmaceutical activities include works and services according to appendix.

3. Licensing of pharmaceutical activities is performed by the following licensing authorities:

a) The Federal Service on supervision in the field of health care - regarding the activities performed:

the organizations of wholesale trade by medicines for medical application;

pharmaceutical organizations subordinated to federal executive bodies;

other organizations and individual entrepreneurs performing pharmaceutical activities regarding assessment of observance by licensees of licensed requirements by means of implementation of federal state control (supervision) in the field of drug circulation (except for the licensees who submitted applications for modification of the register of licenses for implementation of pharmaceutical activities (further respectively - licenses, the register of licenses), powers on suspension, renewal of action of licenses, and also the powers connected with cancellation of licenses judicially;

b) executive bodies of subjects of the Russian Federation - regarding implementation of activities in the field of drug circulation for medical application (regarding provision of licenses and modification of the register of licenses, provision of statements from the register of licenses, assessment of conformity of the license applicant, the licensee to licensed requirements - concerning job seekers of the licenses and licensees who submitted applications for modification of the register of licenses, cancellation of licenses, forming and maintaining registers of the subjects of the Russian Federation of licenses presented by public authorities, approvals of forms of statements for provision of licenses, modification of the register of licenses, approval of forms of notifications and other documents used in the course of licensing, and also provision to interested persons of information on questions of licensing including placement of this information on the Internet (further - Internet network) on the official sites of public authorities of subjects of the Russian Federation with indication of e-mail addresses by which inquiries can be sent by users of this information and is obtained required information) performed:

the organizations, except for the organizations of wholesale trade by medicines for the medical application and the pharmaceutical organizations subordinated to federal executive bodies;

individual entrepreneurs;

foreign legal entities;

c) Federal Service for Veterinary and Phytosanitary Surveillance - regarding the activities performed in the field of drug circulation for veterinary application.

4. The license applicant shall conform to the following licensed requirements:

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