The Government of the Russian Federation has decided to significantly reduce administrative barriers for the market launch of new Russian-made immunobiological products intended for veterinary use. The relevant Decree No. 417, dated April 15, 2026, signed by Mikhail Mishustin, has officially entered into force.
Permit Abolition: 5 Days to Notify Rosselkhoznadzor
The new document amends Government Decree No. 353 of March 12, 2022. Until a specific federal law is adopted, an exception to the general rules will apply in Russia for veterinary vaccines produced within the country for the first time.
Under the updated procedure, the requirement to obtain a permit for entry into civil circulation is completely waived for the first two batches of a new immunobiological medicinal product. Instead, a fast-track notification format is introduced:
- The manufacturer must submit a notification to Rosselkhoznadzor within 5 calendar days;
- The period starts from the moment the authorized person at the production site confirms the batch complies with state registration requirements.
Requirement for Import Substitution Programs:
For vaccines developed under import substitution programs, the notification procedure also applies, but the manufacturer is additionally required to provide the agency with laboratory test protocols for product samples.
Rules for Subsequent Batches
The simplification of procedures extends to later stages as well. After the successful launch of the first two batches, the third batch of the drug also does not require a separate primary permit for circulation (valid for 3 years). The condition remains the same: submitting an official notification within a 5-day period after quality confirmation.
It is expected that the transition to a notification-based format will significantly accelerate access for livestock enterprises, poultry farms, and veterinary clinics to new Russian vaccines during the active replacement of imported analogs.
