“The Service rules out the possibility of making amendments to Russian legislation on the initiative of foreign businesses aimed at cancelation of mandatory requirements or postponing their entry into force,” the service said in a statement.
Federal Law #317, setting new rules for the introduction of new veterinary drug products into the commercial market, will come into force on September 1, 2023.
Thus, the introduction of a foreign-made veterinary medicine into the market is possible only in cases when a manufacturer meets the requirements of Good Manufacturing Practice (GMP) and the corresponding certificate is in place. This document is issued by Rosselkhoznadzor.
“A GMP certificate is issued on the basis of a completed GMP inspection of a foreign manufacturer by the experts of FGBI VGNKI,” the agency reported earlier.
Besides that, commercial release of immunobiologicals, such as vaccines, is possible only through authorization, issued by Rosselkhoznadzor and valid within 3 years. Moreover, a test report provided by a certified organization, subordinate to Rosselkhoznadzor or the Ministry of Agriculture of Russian Federation, has to be submitted.
During the meeting, the representatives of Rosselkhoznadzor and AVPHARM discussed the issues of animal health products import and maintaining their presence in the Russian market given the new requirements. The procedure for oversight of the foreign manufacturer’s production sites compliance with GMP regulations has also been discussed.
The Rosselkhoznadzor’s officials underlined that activities of foreign businesses in Russia should be carried out in compliance with the rules set by legislation. “The Service has taken comprehensive measures to maintain the presence of foreign-made drugs on the Russian market. However, the time, allocated for bringing activities of organizations willing to keep their business in Russia in line with mandatory requirements is used irrationally,” the representatives of the service said in a comment.