- Foreign manufacturers of veterinary medicinal products
To whom?
Obtaining a Decision to conduct an inspection is an opportunity to initiate registration procedures BEFORE receiving a Conclusionon the compliance of the production site with GMP of the EEU, namely:
- Registration of veterinary medicinal products
- Obtaining a final expert opinion
- Registration confirmations of previously registered veterinary medicinal products
- Making changes to the registration documents of previously registered VMP, in cases where the submission of the EEU GMP Conclusion from the authorized regulatory bodies is required
- Inclusion in the State Register of Pharmaceutical Substances Produced for Sale
For what?
Decision on GMP inspection
- Individual expert advice on the procedure for inspecting the production site of a foreign manufacturer
- Initial assessment of documents and information about the production site
- Development of a strategy for conducting inspections of the production site
- Preparation of an Inspection Application for submission to the authorized regulatory bodies of the Russian Federation and the EEU countries
- Preparation of a set of documents in strict accordance with current legal requirements
- Assistance in organizing the payment of state duties of the Russian Federation and the EEU countries for foreign companies
- Assistance in technical translation of dossier materials
- Assistance in notarization of documents on the territory of the Russian Federation
- Representing the interests of the company in the authorized regulatory bodies of the Russian Federation in preparation for the inspection of the production site
- Submission of the Application and a set of documents to the authorized regulatory body
- Supervising the process of preparing for the inspection of the production site
- Informing the client about the progress of the process
- Timely completion of materials upon requests from authorized regulatory bodies
- Receipt of final documents by our experts in the authorized regulatory bodies of the Russian Federation and transfer of documents to the company
- Organization of remote inspection and its technical support
Procedure algorithm:
