Russian manufacturers have one month left for simplified registration of veterinary drugs

The Cabinet of Ministers introduced an accelerated registration regime for Russian veterinary drugs in May last year, when foreign companies began to suspend supplies of animal drugs to our country.

The registration period has been reduced to 60 working days by waiving the quality assessment of the drug, provided that the company provides a conclusion on the compliance of production with GMP (Good Manufacturing Practice) requirements. Previously, the registration procedure took up to 160 working days. The period for state registration of reproduced veterinary drugs has also been reduced.

In addition, the government introduced an accelerated procedure for examining samples of the first two batches of the drug for compliance with regulatory requirements. For immunobiological drugs, the maximum period for conducting the examination was 35 working days, for the rest - no more than 10.

Let us recall that such examination is carried out by the All-Russian State Center for Quality and Standardization of Veterinary Medicines and Feed (FSBI VGNKI), which is subordinate to ROSSELKHOZNADZOR.

Russian manufacturers of veterinary drugs were also allowed to import pharmaceutical substances for veterinary use into RUSSIA that are not included in the state register until September 1, 2023. Until September 1, this can be done by notification, but only for the production of registered drugs.

Earlier, Veterinary Science and Life reported that Russian manufacturers called on the government to extend the accelerated registration regime for animal drugs.