Russia approves the rules for the import and export of pathogenic microorganisms and viruses

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The Government of the Russian Federation has approved import and export rules for pathogenic microorganisms and viruses. They come into force on July 1. The corresponding resolution is published on the official Internet portal of legal information.

“These rules establish the procedure for the import into the Russian Federation and export outside its territory of pathogenic microorganisms and viruses, with the exception of those that are listed as microorganisms, toxins, equipment, and technologies subject to export control,” the document says.

In accordance with the resolution, pathogenic microorganisms and viruses may be imported or exported  to the Russian Federation for fundamental and applied research in the field of biological safety, including the study of the properties of pathogenic microorganisms and viruses that create a threat of the spread of infectious and parasitic diseases;  development and implementation of facilities and methods for indication and identification of such viruses, and also, the development and implementation of methods, tools, and technologies for the prevention, diagnosis and treatment of infectious and parasitic diseases.

In addition, such procedures are allowed for depositing strains in collections of pathogenic microorganisms and viruses, including those used in the production of medicines registered in accordance with the established procedure and approved for circulation in the Russian Federation for medical and veterinary use, as well as medical products.

It is stated that pathogenic microorganisms and viruses may be exported and imported by legal entities and individual entrepreneurs who ensure the creation, replenishment, maintenance, and use of collections of pathogenic microorganisms and viruses by research, medical, and laboratory diagnostic organizations involved in research in veterinary medicine,  as well as the production of medicines under permits issued by the head of Rospotrebnadzor (Federal State Agency for Health and Consumer Rights) or by Rosselkhoznadzor (Federal Service for Veterinary and Phytosanitary Surveillance).

The new rules do not apply to pathogenic microorganisms and viruses subject to export control.

The Government of the Russian Federation has also decided to simplify the procedure for state registration of medical devices.