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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

(as amended on 19-11-2020)

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 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 gene inzhenernomodifitsirovannykh 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 October 29, 2007 No. 720 "About modification of Item 5 of the Regulations on licensing of the activities connected with use of causative agents of infectious diseases" (The Russian Federation Code, 2007, No. 45, the Art. 5502);

Item of 34 changes which are made to acts of the Government of the Russian Federation concerning the state control (supervision), approved by the order of the Government of the Russian Federation of April 21, 2010 No. 268 (The Russian Federation Code, 2010, No. 19, the Art. 2316);

Item of 33 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 No. 749 (The Russian Federation Code, 2010, No. 40, the Art. 5076).

 

Russian Prime Minister

V. Putin

Approved by the Order of the Government of the Russian Federation of April 16, 2012 No. 317

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 gene inzhenernomodifitsirovannykh organisms III and IV degrees of the potential danger performed in the closed systems by legal entities and individual entrepreneurs in the territory of the Russian Federation (further - activities).

2. Licensing of activities is performed by Federal Service for the Oversight of Consumer Protection and Welfare (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 on implementation of the licensed activities (further - the license), are:

a) availability at the license applicant assuming performance of works according to Items 1 - the 5th appendices to this Provision, belonging to it on the property right or on other legal cause of the buildings, rooms, the equipment and material equipment necessary for implementation of the licensed activities and meeting the requirements of the Federal Law "About Sanitary and Epidemiologic Wellbeing of the Population";

b) availability at the license applicant assuming performance of works according to Items 6 - the 9th appendices to this Provision, belonging to it on the property right or on other legal cause of the buildings, rooms, the equipment and material equipment necessary for implementation of the licensed activities and meeting requirements of the Federal Law "About Sanitary and Epidemiologic Wellbeing of the Population" and 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 higher 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, and length of service in at least 3 years;

d) availability in staff of the license applicant of the specialists having the higher 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;

e) availability at the individual entrepreneur of the higher 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, and length of service in at least 3 years.

5. The licensee when implementing of the licensed activities shall meet the following licensed requirements:

a) availability at the licensee performing works according to Items 1 - the 5th appendices to this Provision, belonging to it on the property right or on other legal cause of the buildings, rooms, the equipment and material equipment necessary for implementation of the licensed activities and meeting the requirements of the Federal Law "About Sanitary and Epidemiologic Wellbeing of the Population";

b) availability at the licensee performing works according to Items 6 - the 9th appendices to this Provision, belonging to it on the property right or on other legal cause of the buildings, rooms, the equipment and material equipment necessary for implementation of the licensed activities and meeting requirements of the Federal Law "About Sanitary and Epidemiologic Wellbeing of the Population" and the Federal Law "About State Regulation in the field of Genetically Engineered Activities";

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