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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of April 2, 2022 No. 572

About approval of Rules of import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of pathogenic microorganisms and viruses

According to part 7 of article 11 of the Federal law "About Biological Safety in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of pathogenic microorganisms and viruses.

2. This resolution becomes effective since July 1, 2022.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of April 2, 2022 No. 572

Rules of import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of pathogenic microorganisms and viruses

1. These rules establish procedure for import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of pathogenic microorganisms and viruses, except for the pathogenic microorganisms and viruses which are subject to export control according to the List of microorganisms, toxins, the equipment and technologies, subject to the export control approved by the Presidential decree of the Russian Federation of August 20, 2007 No. 1083 "About approval of the List of the microorganisms, toxins, the equipment and technologies which are subject to export control" and also the biological materials received when performing clinical trial of medicine for medical application (further - import (export) of pathogenic microorganisms and viruses).

2. Import (export) of pathogenic microorganisms and viruses is performed for the purpose of:

a) carrying out basic and applied scientific research in the field of biological safety, including studying of properties of the pathogenic microorganisms and viruses creating threat of origin and spread of infectious and parasitic diseases;

b) developments and deployments of means and methods of indication and identification of pathogenic microorganisms and viruses;

c) developments and deployments of methods, means and technologies of prevention, diagnostics and treatment of infectious and parasitic diseases;

d) depositions of strains in collections of pathogenic microorganisms and viruses, including obligatory deposition in collections of pathogenic microorganisms and viruses of the strains used in case of production of the medicines registered in accordance with the established procedure and allowed to the address in the territory of the Russian Federation for medical application and veterinary application, and also medical products.

3. Import (export) of pathogenic microorganisms and viruses is performed by legal entities and individual entrepreneurs who provide creation, replenishment, maintaining and use of collections of pathogenic microorganisms and viruses, the research organizations, the medical organizations and the laboratory and diagnostic organizations (organizations) which perform researches in the field of veterinary science, and also production of medicines (further - applicants), on the basis:

a) import permits (export) of pathogenic microorganisms and the I-IV viruses of groups of pathogenicity - causative agents of infectious diseases of the person and animals issued by the Chief state health officer of the Russian Federation;

b) import permits (export) of pathogenic microorganisms and viruses - causative agents of infectious and parasitic diseases of animals and plants which are not carried to the I-IV groups of pathogenicity, issued by Federal Service for Veterinary and Phytosanitary Surveillance.

4. The import permit (export) of pathogenic microorganisms and the I-IV viruses of groups of pathogenicity - causative agents of infectious diseases of the person and animals and the import permit (export) of microorganisms and viruses - causative agents of infectious and parasitic diseases of animals and plants which are not carried to the I-IV groups of pathogenicity (further - permission) are issued in the forms approved respectively by Federal Service for the Oversight of Consumer Protection and Welfare and Federal Service for Veterinary and Phytosanitary Surveillance (further - authorized bodies).

5. For receipt of permission the applicant submits the application for import (export) of pathogenic microorganisms and viruses in authorized bodies (further - the statement for import (export) containing the following data:

a) name of pathogenic microorganisms and viruses;

b) purpose of import (export) of pathogenic microorganisms and viruses;

c) full name, the location address of the applicant, its primary state registration number of the legal entity (concerning the legal entities registered in accordance with the legislation of the Russian Federation) and identification taxpayer number (concerning the legal entities obliged to stay on the registry in tax authorities in accordance with the legislation of the Russian Federation), the name and the location address of the consignee, and also the import state (in case of export implementation);

d) form of release (storage) and type of packaging of pathogenic microorganisms or viruses;

e) quantity of samples of pathogenic microorganisms and viruses;

e) terms of import (export) of pathogenic microorganisms and viruses;

g) the country from which (in which) import (export) of pathogenic microorganisms and viruses is performed;

h) mode of transport which is supposed to be used for import (export) of pathogenic microorganisms and viruses, or method of their sending;

i) the expected place and time of movement through frontier of the Russian Federation of pathogenic microorganisms and viruses.

6. The applicant along with the statement for import (export) represents, including in electronic form, the following documents (their verified copies):

a) the document confirming the power of the person which signed the application for import (export);

b) license 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 or the license for implementation of medical activities in case of import (export) of pathogenic microorganisms and the I-IV viruses of groups of pathogenicity;

c) the sanitary and epidemiologic conclusion about compliance of conditions of performance of works with biological substances, biological and microbiological organisms and their toxins to sanitary and epidemiologic rules and regulations.

7. If the submitted documents (their verified copies) are constituted in foreign language, notarized transfer into Russian is applied to them.

8. Authorized bodies in time, not exceeding 15 working days from the date of receipt of the statement for import (export) and the documents specified in Item 6 of these rules make the decision on issue or on refusal in issue of permission.

9. The basis for refusal in issue of permission are:

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