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.

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.