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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 23, 2013 No. 839

About state registration of the gene engineering modified organisms intended for release to the environment and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation

(as amended on 01-10-2018)

According to article 7 of the Federal law "About State Regulation in the field of Genetically Engineered Activities" Government of the Russian Federation decides:

1. Approve the enclosed Rules of state registration of the gene engineering modified organisms intended for release to the environment and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation.

2. To provide to the Ministry of Agriculture of the Russian Federation and Federal Service for the Oversight of Consumer Protection and Welfare transfer to the Ministry of Health of the Russian Federation of the available data on the modified organisms registered before entry into force of this resolution gene engineering and products received with use of such organisms, for their inclusion in the summary state register of the gene engineering modified organisms, and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation.

3. To the Ministry of Education and Science of the Russian Federation to approve:

a) till January 1, 2014. All-Russian qualifier of transformational events;

b) till May 1, 2014 in coordination with the Ministry of Health of the Russian Federation, the Ministry of Agriculture of the Russian Federation and Federal Service for the Oversight of Consumer Protection and Welfare:

form of the certificate on state registration of the gene engineering modified organisms intended for release to the environment;

form of the certificate on state registration of the products received using the gene engineering modified organisms or containing such organisms.

4. Determine that issued before entry into force of the Rules of the certificate on state registration of the gene engineering modified organism or the certificate on state registration of products received with use of the gene engineering modified organisms approved by this resolution are effective before the expiration of the term specified in them.

5. Determine that the Federal Service for the Oversight of Consumer Protection and Welfare and Federal Service for Veterinary and Phytosanitary Surveillance perform according to spheres of maintaining impact monitoring per capita and the environment of the gene engineering modified organisms and the products received using such organisms or containing such organisms, and also control of release of the gene engineering modified organisms to the environment and send information on results of the carried-out monitoring and control to the Ministry of Health of the Russian Federation.

6. Ceased to be valid according to the Order of the Government of the Russian Federation of 29.06.2017 No. 770

7. To the Ministry of Health of the Russian Federation in coordination with the Ministry of Telecom and Mass Communications of the Russian Federation, the Ministry of Education and Science of the Russian Federation, the Ministry of Agriculture of the Russian Federation and Federal Service for the Oversight of Consumer Protection and Welfare to approve till January 1, 2014 procedure for maintaining the summary state register of the gene engineering modified organisms, and also the products received using such organisms or containing such organisms.

8. Determine that the powers provided by this resolution are implemented within the number of workers of the corresponding federal executive bodies and budgetary appropriations provided in the federal budget on management and management in the field of the established functions established by the Government of the limiting Russian Federation.

9. Recognize invalid:

the order of the Government of the Russian Federation of February 16, 2001 No. 120 "About state registration of the gene engineering modified organisms" (The Russian Federation Code, 2001, No. 9, the Art. 860);

the order of the Government of the Russian Federation of January 18, 2002 No. 26 "About state registration of the forages received from the gene engineering modified organisms" (The Russian Federation Code, 2002, No. 4, the Art. 323);

the order of the Government of the Russian Federation of July 14, 2006 No. 422 "About modification of the order of the Government of the Russian Federation of January 18, 2002 No. 26" (The Russian Federation Code, 2006, No. 30, the Art. 3389).

10. This resolution becomes effective since July 1, 2017, except for Items 3, 6 and 7.

Russian Prime Minister

D. Medvedev

 

Approved by the Order of the Government of the Russian Federation of September 23, 2013 No. 839

Rules of state registration of the gene engineering modified organisms intended for release to the environment and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation

I. General provisions

1. These rules establish procedure for state registration of the gene engineering modified organisms intended for release to the environment and also the products received using such organisms or containing such organisms including the specified products imported on the territory of the Russian Federation (further respectively - the modified organisms, products).

2. Are not subject to state registration:

the modified organisms used when conducting examinations and research works according to the established health regulations and regulations;

the modified organisms not intended for release to the environment;

products received by combination, processing or conversion of the registered products containing the modified organisms if such processing and conversion does not lead to change of genetic material of products.

3. State registration is performed by the following federal executive bodies (further - registering bodies):

The Ministry of Health of the Russian Federation - concerning the modified organisms used for production of medicines for medical application, and also the medicines for medical application received using the modified organisms or containing such organisms;

The Federal Service on supervision in the field of health care - concerning the modified organisms used for production of medical products, and also the medical products received using the modified organisms or containing such organisms;

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