GMP CERTIFICATION
- Application submitted to Rosselkhoznadzor
- Inspection fee paid by the Overseas Manufacturer
- On-site inspection performed
- Inspection results filed
- GMP Certificate issued
In case the medicinal product is produced at multiple production sites at different locations, the application is submitted for each production site separately.
LEGISLATION
As of 1 January 2017 the legislation which regulates circulation of medicinal products for veterinary use in the Russian Federation survived a number of changes. Hence the State Registration or Confirmation of State Registration procedures now require that the manufactures of medicinal products for veterinary use, produced outside the territory of the Russian Federation (hereinafter – the Overseas Manufacturers) have to provide a copy of the Certificate of GMP-compliance of their production sites, issued by an authorized federal executive body, which in respect of veterinary pharmaceuticals would be the Federal Service for Veterinary and Phytosanitary Surveillance (hereinafter – Rosselkhoznadzor).
By the Decree No 97 issued by Rosselkhoznadzor on 29 February 2016 FGBU VGNKI was designated as an authorized inspection body.
INSPECTION FEE
An inspection fee is calculated in accordance with the Regulation No 865 of Rosselkhoznadzor of 25 November 2016 «On the establishment of the procedure for calculation of maximum fee payable for the conduct of inspections of manufacturers of veterinary medicinal products, produced outside the territory of the Russian Federation, aimed at the issue of Certificates of GMP compliance of the manufacturers of veterinary medicinal products.
