The introduction of mandatory GMP certification when introducing veterinary drugs into civilian circulation should be postponed for 2-4 years. Such notice Express in an interview with Russian media, Semyon Zhavoronkov, executive director of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM, unites MSD Animal Health, Boehringer Ingelheim, Elanco and Zoetis).
“Still, the civil registration regime with the presence of a GMP certificate (it is necessary) to postpone for a certain number of years – 2-3-4 years. In order to still allow the inspections to take place, let them pass. Because each inspection from the time the application is submitted to its completion often takes more than six months,” Zhavoronkov said.
From September 1, the new requirements of the law “on the circulation of medicinal products” come into force. According to the amendments, the introduction into civil circulation of an imported drug for veterinary use must be carried out if there is a conclusion on the manufacturer’s compliance with the requirements of the rules of good manufacturing practice (GMP).
According to Zhavoronkov, out of 180 sites of foreign manufacturers that supply drugs to Russia, 36 have received a GMP certificate.
“Bridging this gap of more than 100 sites requires at least 5 years of work. At least. We are talking about even shorter periods – well, give 2-3 years for manufacturers from all countries who want to work with Russia to be able to supply these drugs,” he added.
According to AVPHARM, after the introduction of new rules, out of a thousand foreign veterinary drugs currently circulating on the Russian market, nominally 160 items will remain, and in fact – about 60.
Rosselkhoznadzor provides further data. The agency said that out of 890 drugs on the Russian market, 300 items will remain permanently, which are produced by 36 foreign sites. “Twenty other sites are preparing reports on the results of the inspections. Another 23 sites are included in the inspection program,” noted Rosselkhoznadzor.
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