Ecolex Logo
The gateway to
environmental law
Search results » Legislation

Order No. 169 of the Ministry of Agriculture validating the Methodology for the performance of molecular genetic research of genetically modified organisms used for the production of medicines for veterinary use.

Country/Territory
Russian Federation
Document type
Regulation
Date
2019
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Genetically modified organism (GMO) Research
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
Abstract

This Order establishes the procedure for the performance of molecular genetic research of genetically modified organisms used for the production of medicines for veterinary use. The following tests shall be carried out within the framework of the research: (a) verification (validation) of the GMO identification methods, including the assessment of sensitivity and specificity of this method in accordance with the efficiency criteria specified in Table 1 of the Annex to this Methodology; (b) confirmation of the presence (absence) of the declared genetic modification in the GMO genome; (c) confirmation of the presence (absence) of marker and selective genes in the GMO genome specified in Table 2 of the Annex to this Methodology; and (d) full genomic GMO sequencing, which is contained in the product in a viable form (in case of failure of the applicant to provide GMO data of full genomic GMO sequencing, which is a plasmid, virus (bacteriophage), bacterium or unicellular protozoa, animal, fungus), conducted using the method of full genomic sequencing, meeting the criteria of effectiveness specified in Table 3 of the Annex to this Methodology.

Full text
Russian
Website
pravo.gov.ru

References - Legislation

Implements

Ministerial Decree No. 839 validating the Regulation “On state registration of genetically modified organisms destined for release into environment, and also produce obtained from or containing such organisms.

Legislation | Russian Federation | 2013

Keyword: Genetically modified organism (GMO), Consumer protection, Registration, Animal feed/feedstuffs, Plant production, Biotechnology, Wild fauna, Wild flora, Ranching/captive breeding

Source: FAO, FAOLEX