Beginning in 2016, in order to register new medicinal products (MPs) in Russia, all pharmaceutical companies must submit proof of compliance with Good Manufacturing Practice (Resolution of the Government of the Russian Federation No. 1314 of 03.12.2015). In the event that the product was manufactured outside of the Russian Federation, a comparable document/license from the relevant agency of the country of origin must be submitted. In 2017, enforcement of Good Manufacturing Practice for registration renewal and registration dossier changes also went into effect.
The executive authority on inspection matters is the Ministry of Industry and Trade (Minpromtorg of Russia). The inspection is performed by the Federal Budgetary Institution’s State Institute of Drugs and Good Practices (FBI SID and GP) of the Ministry of Industry and Trade.
After the adoption of the law (No. 140-FZ “On Circulation of Medicines” of 04.06.2018), the procedure for registration of MPs manufactured outside the Russian Federation, and the procedure for making changes to the registration documents, have been simplified. However, if comparable proof regarding foreign pharmaceutical GMP compliance is not accepted by Minpromtorg, the Russian Federation may deny state registration/re-registration and any new changes to the registration dossier.
Raifarm provides thorough, competent, well-tested assistance to prepare our clients for Russian state inspection of a variety of medical products manufactured outside the country. Our services include:
- Consultations for the preparation and execution of foreign manufacturer inspection and advice on current inspection procedures
- Working in concert with the manufacturer to prepare necessary documents for submission to the Minpromtorg of Russia
- Assistance preparing responses to inspectors' findings from previous inspections (CAPAs), if necessary
- Communicating with authorities regarding requests for additional materials and management of inspection follow ups (including coordinating with the manufacturer on scheduled inspections of FBI SID and GP)
- Providing support to resolve logistics (or any other) issues, as part of the preparation for the Russian inspection
- Facilitating communication between manufacturing site employees and inspectors and, if necessary, accompanying the inspectors during the site inspection
- Working in concert with the manufacturer to prepare any additional materials needed to draw up the inspection report, negotiate draft GMP conclusion, and confirm its receipt
Raifarm is well-equipped to perform preliminary audits on foreign manufacturing sites to prepare for subsequent inspections to comply with the Order of the Minpromtorg of Russia No. 916 of 14.06.2013 "On Approval of Good Manufacturing Practice Rules.” We will issue a detailed report addressing any potential site complications and non-compliances, in accordance with established GMP standards, and supply specific recommendations for all relevant corrective actions.