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Ministry of Justice

Russian Federation 

On July 28, 2014 No. 33318

ORDER OF FEDERAL SERVICE FOR THE OVERSIGHT OF CONSUMER PROTECTION AND WELFARE OF THE RUSSIAN FEDERATION

of May 5, 2014 No. 384

About licensing by Departments of Rospotrebnadzor for subjects of the Russian Federation, on rail transport 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 22-07-2016)

According to the order of the Government of the Russian Federation of 30.06.2004 No. 322 "About approval of the Regulations on Federal Service for the Oversight of Consumer Protection and Welfare" (The Russian Federation Code, 2004, No. 28, Art. 2899; 2006, No. 22, Art. 2337, No. 52, Art. 5587; 2008, No. 40, Art. 4548, No. 46, Art. 5337; 2009, No. 30, Art. 3823; No. 33, Art. 4081; 2011, No. 14, Art. 1935; No. 43, Art. 6079; 2012, No. 27, Art. 3729; 2013, No. 5, Art. 405; No. 22, the Art. 2812), for the purpose of implementation of the order of the Government of the Russian Federation of 16.04.2012 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, 17, of the Art. 1991) I order to No.:

1. Assign to Departments of Rospotrebnadzor for subjects of the Russian Federation, for rail transport:

1.1. The organization and implementation of 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 when implementing by the license applicant of the following performed works and the rendered services constituting 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:

- diagnostic testings, storage of microorganisms, their production, museum strains and the material infected or with suspicion on contamination of the III-IV groups of pathogenicity;

- diagnostic testings, storage of protozoa, their production, museum strains and the material infected or with suspicion on contamination of the III-IV groups of pathogenicity;

- diagnostic testings (except for sampling of products of animal origin for the laboratory researches and obligatory trikhinelloskopiya which are carried out within veterinary and sanitary examination by the organizations subordinated to the executive bodies of subjects of the Russian Federation authorized in the field of veterinary science), storage of helminths, their production, museum strains and the material infected or with suspicion on contamination of the III-IV groups of pathogenicity;

- diagnostic testings, storage of sanitary and indicative microorganisms of the III-IV groups of pathogenicity.

1.2. Maintaining the register of licenses for 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 issued by Department of the Federal Service for the Oversight of Consumer Protection and Welfare for the subject of the Russian Federation, for rail transport.

1.3. Control of observance by the licensees performing 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 licensed requirements established by 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, approved by orders of the Government of the Russian Federation of 16.04.2012 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".

1.4. Carrying out licensed control of observance by the licensees who obtained the license in Federal Service for the Oversight of Consumer Protection and Welfare, performing 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 in the territory of appropriate subject of the Russian Federation, rail transport, the licensed requirements established by 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 the approved order of the Government of the Russian Federation of 16.04.2012 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". Reports on results of licensed control go to Rospotrebnadzor quarterly.

2. Determine that:

2.1. Execution of licenses is performed on the form of the established form which is the protected printed material.

2.2. The register of the granted licenses is kept in the form of the electronic database protected from damage and unauthorized access. Maintaining the Register is performed by means of the specialized software providing storage and exchange of information.

2.3. Provision in the Register of information on the granted licenses (report generation about the granted licenses, preparation and information transfer in the Register) is performed no later than three days from the date of signing of the license in time.

3. Assign to federal budgetary institution of health care "Information and methodical center" of Federal Service for the Oversight of Consumer Protection and Welfare:

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