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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of January 25, 2022 No. 46

About licensing of activities in the field of use of causative agents of infectious diseases of the person and animals (except for case if the specified activities are performed in the medical purposes) and the gene engineering modified organisms III and IV degrees of the potential danger performed in the closed systems

The government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of activities in the field of use of causative agents of infectious diseases of the person and animals (except for case if the specified activities are performed in the medical purposes) and the gene engineering modified organisms III and IV degrees of the potential danger performed in the closed systems.

2. Recognize invalid:

the order of the Government of the Russian Federation of April 16, 2012 No. 317 "About licensing of activities in the field of use of causative agents of infectious diseases of the person and animals (except for case if the specified activities are performed in the medical purposes) and the gene engineering modified organisms III and IV degrees of the potential danger performed in the closed systems" (The Russian Federation Code, 2012, No. 17, the Art. 1991);

Item 24 of the order of the Government of the Russian Federation of March 6, 2015 No. 201 "About introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2015, No. 11, the Art. 1607).

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

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of January 25, 2022 No. 46

Regulations on licensing of activities in the field of use of causative agents of infectious diseases of the person and animals (except for case if the specified activities are performed in the medical purposes) and the gene engineering modified organisms III and IV degrees of the potential danger performed in the closed systems

1. This Provision establishes procedure for licensing of activities in the field of use of causative agents of infectious diseases of the person and animals (except for case if the specified activities are performed in the medical purposes) and the gene engineering modified organisms III and IV degrees of the potential danger performed in the closed systems (further - activities).

2. Licensing of activities and federal state licensed control (supervision) of activities (further - licensed control) are exercised by Federal Service for the Oversight of Consumer Protection and Welfare and its territorial authorities (further - the licensing body).

3. The licensed activities include works and services in the list according to appendix.

4. The licensed requirements imposed to the license applicant (licensee) on implementation of the licensed activities are:

a) availability on the property right or other legal cause of production facilities in the place of implementation of the licensed type of activity, the technical means, the equipment necessary for performance of works (rendering services) according to Items 1 - the 5th appendices to this Provision, constituting the licensed type of activity and Articles meeting the requirements 20, 22 and 24 - 26 Federal Law "About Sanitary and Epidemiologic Wellbeing of the Population" and article 11 of the Federal law "About Biological Safety in the Russian Federation";

b) availability on the property right or other legal cause of production facilities in the place of implementation of the licensed type of activity, the technical means, the equipment necessary for performance of works (rendering services) according to Items 6 - the 9th appendices to this Provision, constituting the licensed type of activity and Articles meeting the requirements 20, 22, 24 - 26 and 29 Federal Law "About Sanitary and Epidemiologic Wellbeing of the Population", article 11 of the Federal law "About Biological Safety in the Russian Federation" and articles 7 and 8 of the Federal law "About State Regulation in the field of Genetically Engineered Activities";

c) availability at the head of the legal entity or his deputy or the head of the structural unit responsible for implementation of the licensed activities, the individual entrepreneur of the higher education or secondary professional education and additional professional education according to programs of advanced training in volume of at least 72 hours in "bacteriology", "virology", "parasitology" or "microbiology" meeting the requirements and nature of the declared works (services), and length of service in at least 3 years;

d) availability in staff of the specialists having the higher education or secondary professional education and additional professional education according to programs of advanced training in volume of at least 72 hours in "bacteriology", "virology", "parasitology" or "microbiology", meeting the requirements and nature of the declared works (services).

5. The licensee when implementing of the licensed activities shall provide carrying out advanced training of persons specified in subitems "v" and "g" of item 4 of this provision, at least once in 5 years.

6. Gross violation of licensed requirements is the non-compliance with requirements by the licensee, stipulated in Item 4 this provision which entailed the effects established by part 10 of article 19.2 of the Federal law "About Licensing of Separate Types of Activity".

7. For receipt of the license the license applicant sends to the licensing body according to the procedure, established by the legislation of the Russian Federation on the organization of provision of the state and municipal services, the statement for provision of the license, and also:

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