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;

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