Foreign companies that are members of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM) are interested in working on the Russian market, they continue to undergo Russian inspections for compliance with GMP requirements, the association said in a statement citing its executive director Semyon Zhavoronkov. According to finmarket.ru, the association commented on the message of the Rosselkhoznadzor that a number of foreign manufacturers of veterinary drugs withdrew applications for inspections of their production sites by the Rosselkhoznadzor. This may lead to a cessation of supplies, since from September 1, 2023, the products of companies that have not passed the Good Manufacturing Practice (GMP) test will not be able to be supplied to Russia. ignores the number of new applications filed.” “The current rules of law do not provide for the possibility of postponing the inspection within the framework of the current application, therefore, applicants are periodically forced to withdraw applications and submit new ones. So, although 9 applications have been withdrawn since January 2023, currently 7 new ones have already been submitted instead of them,” he said. According to him, AVPHARM members produce products at more than 50 foreign production sites. Over the past 6 years, companies have passed 74 inspections, continue to pass them and apply for new ones. In 2022, more than 80% of foreign inspections completed with a refusal to issue a GMP certificate. Based on the results of unsuccessful inspections, the members of the association make the necessary changes to the production and control processes and then submit new applications for inspection. ”According to statistics, in order to obtain a Russian GMP certificate, foreign companies need to make 3-4 attempts, each of which only takes from 200 working days and paid separately,” he said. In addition, the situation was complicated by restrictions related to COVID-19, and the applicants’ requests for remote inspections were in most cases not approved by Rosselkhoznadzor. “As a result, today more than 80% of registered foreign drugs are not covered by GMP certificates,” he said.
According to Zhavoronkov, inspections of 33 foreign enterprises are planned in the inspection schedule for 2023. “The time remaining until September 1, 2023 is clearly not enough to complete the required number of inspections,” he said. “If the entry into force of the requirement for the mandatory presence of a Russian GMP certificate when entering into civilian circulation is not postponed, then foreign manufacturers will not be able to continue deliveries, and the market will lose about 80% of the range of familiar and popular drugs.” At the same time, he noted that imported products are most in demand by highly efficient livestock and poultry farms, and its shortage can lead to the emergence of gray schemes for importing into the Russian Federation, the development of a “black market” for veterinary drugs.
AVPHARM unites four of the world’s largest manufacturers of vaccines and pharmaceuticals for animals, which are the main suppliers of veterinary drugs imported to Russia: Boehringer Ingelheim, Elanco, MSD Animal Health, Zoetis.