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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 22, 2011 No. 1081

About licensing of pharmaceutical activities

(as amended on 28-11-2020)

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:

Item of 2 changes which are made to acts of the Government of the Russian Federation concerning licensing of the separate types of activity approved by the order of the Government of the Russian Federation of April 7, 2008 N 241 (The Russian Federation Code, 2008, N 15, by the Art. 1551);

Item 2 of the order of the Government of the Russian Federation of May 18, 2009 N 426 "About introduction of amendments to some acts of the Government of the Russian Federation concerning licensing of pharmaceutical activities" (The Russian Federation Code, 2009, N 21, the Art. 2575);

Item of 7 changes which are made to orders of the Government of the Russian Federation on the questions connected with enhancement of state regulation of the prices of vital and major medicines approved by the order of the Government of the Russian Federation of August 8, 2009 N 654 (The Russian Federation Code, 2009, N 33, by the Art. 4086);

Item of 14 changes which are made to acts of the Government of the Russian Federation concerning the state control (supervision), Pravitels    of tv of the Russian Federation approved by the resolution of April 21, 2010 N 268 (The Russian Federation Code, 2010, N 19, by the Art. 2316);

Item of 16 changes which are made to orders of the Government of the Russian Federation concerning the state fee, approved by the order of the Government of the Russian Federation of September 24, 2010 N 749 (The Russian Federation Code, 2010, N 40, the Art. 5076);

the order of the Government of the Russian Federation of November 13, 2010 N 903 "About modification of the Regulations on licensing of pharmaceutical activities" (The Russian Federation Code, 2010, N 47, the Art. 6126);

the order of the Government of the Russian Federation of July 28, 2011 N 622 "About modification of item 4 of the Regulations on licensing of pharmaceutical activities" (The Russian Federation Code, 2011, N 32, the Art. 4823).

Russian Prime Minister

V. Putin

Approved by the Order of the Government of the Russian Federation of December 22, 2011 No. 1081

Regulations on licensing of pharmaceutical activities

1. This Provision establishes procedure for licensing of the pharmaceutical activities performed by 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 (the centers (departments) of general medical (family) practice, out-patient clinic, medical assistant's and medical and obstetrical centers) 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.

1(1). Licensing of the pharmaceutical activities performed in the territory of the international medical cluster by foreign legal entities - project participants of the international medical cluster, is performed according to this Provision taking into account the features established by the Federal Law "About the International Medical Cluster and Modification of Separate Legal Acts of the Russian Federation".

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 licensed control (except for the licensees who submitted applications for renewal of licenses), powers on suspension, renewal of action and cancellation of licenses;

b) executive bodies of subjects of the Russian Federation - regarding implementation of activities in the field of drug circulation for medical application (regarding provision and renewal of licenses, provision of statements from the register of licenses, implementation of licensed control concerning job seekers of the licenses and licensees who submitted applications for renewal 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 and renewal of licenses, approvals of forms of notifications, statements from the specified registers of licenses 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 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 required information), performed is obtained:

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 - project participants of the international medical cluster;

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 for implementation of pharmaceutical activities shall conform to the following licensed requirements:

a) availability of the rooms and the equipment belonging to it on the property right or on other legal cause necessary for performance of works (services) which constitute pharmaceutical activities, conforming to the established requirements (except for the medical organizations and separate divisions of the medical organizations);

b) availability at the medical organization - the license applicant of the license for implementation of medical activities;

c) availability at the head of the organization (except for the medical organizations) whose activities are directly connected with wholesale trade by medicines, their storage, transportation and (or) retail trade by medicines, their leave, storage, transportation and production:

for implementation of pharmaceutical activities in the field of drug circulation for medical application - the higher pharmaceutical education and length of service in at least 3 years or secondary pharmaceutical education and length of service in at least 5 years, the certificate of the specialist;

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