Foreign manufacturers of veterinary medicines had more than 6 years to pass all the necessary checks on the compliance of production sites with the requirements of good manufacturing practice. This was stated in the All-Russian State Center for Quality and Standardization of Medicines and Feed (FGBI VGNKI) subordinate to the Rosselkhoznadzor. Enterprises that have not passed such an inspection will not be able to supply their products to Russia from September 1.
Russian inspectors have been checking foreign manufacturers since January 2017. Foreign manufacturers had more than 6 years to prepare and successfully pass the inspection.
Starting from September 1, 2023, a new law No. 317-FZ on the rules for the introduction of medicinal products for veterinary use will enter into force in Russia.
According to the new law, for the introduction of imported veterinary medicines into civil circulation, an opinion on the conformity of production with GMP requirements will also be required. Such a document is issued by the Rosselkhoznadzor after a GMP inspection of the production site where this drug is produced.
These amendments were adopted back in July 2021.
VGNKI experts provided statistics on the submission of applications for inspection, which proves that after the adoption of the amendments, the number of applicants has not increased.
43 applications were submitted in 2020, 43 in 2021, and 34 in 2022.
Foreign manufacturers of veterinary medicines have previously stated in the media that no inspections were carried out during the pandemic. This information was provided by representatives of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM), which unites 4 foreign companies. However, VGNKI denied this information and reported that remote inspections had been carried out. In 2020, 16 such inspections were conducted, in 2021 - 32, in 2022 – 42.
In early March, the Rosselkhoznadzor reported on the refusal of foreign manufacturers to carry out inspections for production compliance with GMP requirements.
VGNKI experts added that after a refusal, manufacturers can re-apply for an inspection the very next day without hindrance.
"At the moment, the Rosselkhoznadzor's work regarding the organization and conduct of inspections for compliance with GMP requirements is planned and there is no excitement," the center's specialists said.
They cited the experience of foreign countries as an example. For example, in the European Union and the United States, the circulation of medicines that are manufactured on production sites that do not have a valid GMP certificate is prohibited.
Russian inspectors have been checking foreign manufacturers since January 2017. Foreign manufacturers had more than 6 years to prepare and successfully pass the inspection.
Starting from September 1, 2023, a new law No. 317-FZ on the rules for the introduction of medicinal products for veterinary use will enter into force in Russia.
According to the new law, for the introduction of imported veterinary medicines into civil circulation, an opinion on the conformity of production with GMP requirements will also be required. Such a document is issued by the Rosselkhoznadzor after a GMP inspection of the production site where this drug is produced.
These amendments were adopted back in July 2021.
VGNKI experts provided statistics on the submission of applications for inspection, which proves that after the adoption of the amendments, the number of applicants has not increased.
43 applications were submitted in 2020, 43 in 2021, and 34 in 2022.
Foreign manufacturers of veterinary medicines have previously stated in the media that no inspections were carried out during the pandemic. This information was provided by representatives of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM), which unites 4 foreign companies. However, VGNKI denied this information and reported that remote inspections had been carried out. In 2020, 16 such inspections were conducted, in 2021 - 32, in 2022 – 42.
In early March, the Rosselkhoznadzor reported on the refusal of foreign manufacturers to carry out inspections for production compliance with GMP requirements.
VGNKI experts added that after a refusal, manufacturers can re-apply for an inspection the very next day without hindrance.
"At the moment, the Rosselkhoznadzor's work regarding the organization and conduct of inspections for compliance with GMP requirements is planned and there is no excitement," the center's specialists said.
They cited the experience of foreign countries as an example. For example, in the European Union and the United States, the circulation of medicines that are manufactured on production sites that do not have a valid GMP certificate is prohibited.