Amendments are introduced to the federal law “On circulation of medicines”. “There is a procedure for the introduction of medicines for human use into the commercial market, but as for veterinary drugs, it is an innovation,” Vasilina Gritsyuk, Deputy Director of the Russian State Center for Animal Feed and Drug Standardization and Quality (FGBI “VGNKI” of Rosselkhoznadzor), told “Veterinary medicine and Life”.
According to the new rules, the manufacturer or importer of a veterinary pharmaceutical must provide Rosselkhoznadzor with a document, confirming its quality. Besides that, a confirmation of its compliance with the requirements stated at official registration received from the authorized person is also required.
Commercial release of immunobiologicals, such as vaccines or serums, will be possible only through authorization, issued by the Rosselkhoznadzor, and based on test results of the first two batches of the drug by an accredited laboratory. The document will be valid throughout the entire sales period of the drug series it has been issued for. Permission for subsequent series will be valid for 3 years.
The introduction of a foreign-made veterinary medicine into the market also requires a certificate of GMP (Good Manufacturing Practice) compliance. This document is issued by Rosselkhoznadzor based on the results of GMP inspection of the corresponding production site. That provides for equal requirements for foreign and local manufacturers, says Anna Babushkina, deputy head of the State Veterinary Supervision Office of Rosselkhoznadzor. In fact, according to the law on the circulation of medicines all Russian manufacturers of animal health products have to confirm their compliance with GMP requirements, while foreign manufacturers must provide those only for products, that were authorized after the introduction of the GMP standard in Russia. As for veterinary drugs that have already been authorized and introduced to the market, they are not currently subject to this requirement, she explained.
Besides that, manufacturers and importers of animal health products are obliged to submit to the Rosselkhoznadzor a test report issued by an accredited laboratory for one batch of each trademark introduced into the Russian market within a year. According to the new law, the document has to be submitted annually, not later than February 1.
Read more on the new veterinary legislation and rules coming into force in 2023.