The draft order is available for discussion at regulation.gov.ru.
According to the new rules, manufacturers will have to submit to Rosselkhoznadzor the information on each batch and product series for both imported and locally produced veterinary medicinal products.
The information on series and batches of medicinal products introduced into commercial market will be made available within 5 business days via the official website of the Rosselkhoznadzor, the document says.
Besides that, manufacturers and importers of animal health products are to submit to the Rosselkhoznadzor a test report issued by an accredited laboratory for one batch of each trademark, introduced into the market within a year. This has to be done annually, not later than 1 February.
Rosselkhoznadzor officials explained, that since November 2019 there was no legal procedure for the confirmation of the quality of the series of veterinary medicines at their introduction into the commercial market. That is the legal gap to be addressed by the new law. “This regulation will allow verification of the manufacturer’s guarantees in consistent control of the quality of medicinal products for veterinary use,” outlined the experts of the department. The comment is quoted in the summary report to the project.
About the introduction of foreign-made animal health products into commercial market
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. Besides that, foreign manufacturers are subject to certification procedure for the holder of manufacturing authorization for the veterinary medicinal product and provide test report for medicines.
This will provide for equal requirements for foreign and local manufacturers at the introduction of animal health products into the commercial market, the Rosselkhoznadzor officials noted.
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, explained the experts.
Besides that, the experts outlined another issue: since 2010 the mutual recognition procedure for the registration of veterinary drugs is active in the Eurasian Economic Union (EAEU). Which means that the product registered, for example, in Kazakhstan is recognized as registered in Russia.
At the same time, according to the Rosselkhoznadzor, from 2017 to 2022 the sales of more than 840 animal health products (over 15% of the entire EAEU market) were restricted on the territory of the union due to their poor quality, unsafety and inefficiency. “This results from unequal requirements for the introduction of foreign-made and locally produced animal health products to the Russian market. Currently, foreign-made drugs are not subject to some requirements, which apply to locally produced medicines. The lack of proper control over animal health products introduced to the commercial market, including immunobiologicals, that are used for prevention of zoonotic disease outbreaks, may threaten epizootic security of the Russian Federation, and lead to reduction in the number of farm animals,” Rosselkhoznadzor officials explained.
