A new procedure for the introduction of veterinary drugs into civil circulation will come into force in Russia on September 1, 2023. Rosselkhoznadzor has developed updated rules, FV reports with reference to the corresponding project.
“Manufacturers will be obliged to provide the Service with information about each batch and lot of veterinary drugs produced in Russia or imported. The information will be published on the official website of the Service within five working days after data submission. Manufacturers or importers of medicines for veterinary use will need to submit to Rosselkhoznadzor a report on a test held in an accredited laboratory of one series of each trade name of the drug that entered civil circulation during the year. The data must be submitted no later than February 1,” the publication writes.
Quality confirmation for veterinary drugs series has not been regulated since 2019, and this is the argument that the authors of the project provide for the new rules. According to the regulator, the project will guarantee ongoing quality control.
The rules for the introduction of imported drugs into civil circulation will also change. This procedure will now require an opinion on the conformity of production with GMP rules. Foreign manufacturers are also required to provide drug test reports and conduct certification of the registration certificate holder. Importers previously received certificates only for medicines registered after the introduction of the GMP standard in Russia.