According to Ksenia Iuranova, an expert in GR & Risk at Baikal Lobridge, the proposed simplified procedure for introducing domestically produced veterinary immunobiological products into circulation could help Russian manufacturers speed up both registration and market launch of new medicines.
“Introducing a notification-based approach for market entry would allow producers to bypass testing in overloaded state laboratories at the early stage of production launch, without compromising quality control, as this function would be carried out by accredited independent centers,” the expert notes.
Russia’s Ministry of Agriculture has prepared a draft government resolution introducing amendments to the decree adopted on March 12, 2022. The document proposes introducing a notification procedure for placing the first two production batches of veterinary immunobiological medicines — manufactured in Russia for the first time — into civil circulation.
Under the proposed rules, manufacturers would be required to notify Federal Service for Veterinary and Phytosanitary Surveillance within five days after the company’s authorized representative confirms that the product complies with state registration requirements.
If the product is a domestically developed veterinary immunobiological medicine created as part of import substitution efforts, manufacturers will also have to provide sample testing protocols.
The initiative is aimed at accelerating import substitution in the vaccines and sera segment, which remains highly dependent on foreign suppliers.