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Rosselkhoznadzor Inspects Animal Drug Manufacturers in China and France for GMP Compliance

Rosselkhoznadzor experts are conducting inspections of animal drug manufacturing facilities in China’s Zhejiang province and the Alsace region in France, the service said.

Rosselkhoznadzor Inspects Animal Drug Manufacturers in China and France for GMP Compliance
Photo by Ivan Lukianov /V&L

“If inspections are successful, the companies will be able to supply a number of veterinary drugs for pets and farm animals to the Russian market. French supplies of anti-inflammatory and antiparasitic drugs for cats and dogs may resume. Additionally, there is a possibility of Chinese vaccines against avian infectious bronchitis, porcine circovirus infection, and swine pneumonia appearing on the Russian market,” the service said in a statement.

Rosselkhoznadzor inspectors are visiting the production facilities of Ceva Animal Health Technology in China and Elanco France SAS in France. The latter may be allowed to supply Credelio for cats, Milbemax for dogs, Milbemaz for cats, and Onsior to the Russian market, the service’s press office told Veterinary Medicine and Life.

Manufacturers from China and France are ready to confirm the compliance of their products with Russian requirements of good manufacturing practice (GMP).

GMP is a system of regulations and requirements ensuring products are manufactured, tested, and stored in accordance with quality standards. If a company fails to comply with GMP requirements, its products can’t be sold in Russia.

Reminder: The new law (No. 317-FZ of July 2, 2021) on the introduction of veterinary drugs into the Russian commercial market came into force on September 1, 2023. According to this law, all domestic and foreign production sites require a Russian certificate of GMP compliance.

Prior to that, only Russian manufacturers had to be GMP-certified. The new law equalized the position of domestic and foreign companies in the Russian pharmaceutical market. 

In addition, under the new law, all veterinary immunobiological products, including animal vaccines, must obtain authorization from the Rosselkhoznadzor in order to be sold on the Russian commercial market.

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English version, 16 Apr 2024 01:47
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