“Last Friday, September 22, after business hours, a representative of Boehringer Ingelheim LLC informed the Russian service of the inability to conduct an inspection of the Boehringer Ingelheim Animal Health France production site (located at 69210 Lentili, Chemy de Cruzols, France), which was scheduled for September 26 – 28, due to the lack of official confirmation from the French authorities,” the Rosselkhoznadzor said in a statement.
The inspectors' flight scheduled for September 25 was cancelled.
“Rosselkhoznadzor considers these actions an unfriendly position on the part of the French authorities,” said the service.
The products submitted for inspection included feline vaccines (Purevax RCP, Purevax RCPCh, and Purevax FeLV), an Aviffa PTI vaccine against avian infectious bronchitis, Newcastle disease, avian metapneumovirus, and swollen head syndrome in chickens, and a Dindoral vaccine against hemorrhagic enteritis in turkeys and marble spleen disease in pheasants.
Reminder: The new law (No. 317-FZ) on the introduction of veterinary drugs into the Russian commercial market came into force on September 1, 2023. According to this new law, all domestic and foreign production sites require a certificate of GMP (Good Manufacturing Practice) compliance. Without it, veterinary medicines can’t be introduced into the commercial market in Russia.
GMP is a set of regulations and requirements ensuring that products are produced, tested, and stored according to quality standards.
Previously, only Russian manufacturers had to be GMP-certified. The new law equalized the position of domestic and foreign companies in the Russian pharmaceutical market. According to Rosselkhoznadzor, 39 foreign manufacturers, producing more than 200 animal health products, are GMP-certified. “Another 22 inspections of production sites are scheduled for 2023-2024. Nineteen foreign sites have refused to undergo GMP inspections,” said the representatives of the service.
