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Governmental Decree No. 46 validating the Regulation on licensing of activities in the field of the use of pathogens of infectious diseases in humans and animals (except for the case if the specified activity is carried out for medical purposes) and genetically modified organisms of III and IV degrees of potential danger, carried out in closed systems.

Country/Territory
Russian Federation
Document type
Regulation
Date
2022
Source
FAO, FAOLEX
Subject
Livestock, General
Keyword
Public health Genetically modified organism (GMO) Authorization/permit Enforcement/compliance
Geographical area
Arctic, Asia and the Pacific, Black Sea, Caspian Sea, CIS (Commonwealth of Independent States), Eastern Europe, Europe, Europe and Central Asia, North Pacific, North-West Pacific
Entry into force notes
This Governmental Decree enters into force on 1 September 2022.
Abstract

This Regulation establishes the procedure for licensing of activities in the field of the use of agents of infectious diseases of humans and animals (except for cases of activities carried out for medical purposes) and genetically modified organisms of III and IV degrees of potential danger, carried out in closed systems. Licensing of activities and federal state licensing control (supervision) over activities is carried out by the Federal Service for Supervision in the Sphere of Protection of Consumer Rights and Human Well-being and its territorial bodies. The licensed activities include works and services according to the list contained in the Annex. This Regulation lists required documentation for obtaining license. Assessment of compliance by the license applicant (licensee) with licensing requirements is carried out in the form of: (a) assessing the compliance of the license applicant (licensee) with the licensing requirements carried out in accordance with Article 19 (1) of the Federal Law "On Licensing Certain Types of Activities"; (b) license control carried out in relation to the licensee; and (c) periodic confirmation of compliance of the licensee with licensing requirements conducted in accordance with Article 19 (3) Federal Law "On Licensing Certain Types of Activities".

Full text
Russian
Website
publication.pravo.gov.ru