The Ministry of Agriculture of the Russian Federation has developed a draft document that significantly reduces administrative barriers for Russian manufacturers of veterinary medicines. The department proposes to simplify the procedure for introducing the first batches of immunobiological drugs (vaccines) into civil circulation, replacing lengthy state trials with quality confirmation from the manufacturer.
Essence of the Regulatory Maneuver
The Ministry of Agriculture intends to amend Government Decree No. 353 dated March 12, 2022, “On the specifics of permitting activities in the Russian Federation.” The draft amendments adjust the permitting rules for 2025. The key innovation concerns the first and second series of immunobiological medicinal products manufactured in Russia. The draft resolution is currently undergoing public discussion until February 4.
Currently, releasing such batches into circulation requires a test protocol issued exclusively by accredited testing laboratories (centers) of Rosselkhoznadzor or state institutions subordinate to the Ministry of Agriculture.
The new mechanism proposes an alternative:
- Market entry is carried out on the basis of a manufacturer’s document confirming quality (Quality Passport);
- Additionally, a test protocol from any accredited testing laboratory is required (removing the strict restriction to the Rosselkhoznadzor system).
“The adoption of the draft will reduce the time required to introduce immunobiological medicinal products for veterinary use into civil circulation, as well as reduce the financial burden on their manufacturers.”
— From the explanatory note to the document
Time Horizon and Goals
The proposed measure is a regulatory experiment and will remain in effect until September 1, 2030. The initiative is aimed at accelerating import substitution in the vaccine and serum segment, where dependence on foreign supplies has historically been high.
The simplified procedure will allow domestic pharmaceutical companies to bring new developments to market faster, bypassing the “bottleneck” of overloaded state laboratories at the start of production, while maintaining mandatory quality control through accredited centers.
Document Status
At the moment, the initiative is undergoing public discussion on the federal portal of draft regulatory legal acts. The new rules are expected to enter into force in 2025, becoming part of a package of measures to support the technological sovereignty of the agro-industrial complex.
Source: Veterinary and Life
