- Foreign manufacturers of veterinary drugs
To whom?
- Obtaining the EEU GMP Certificate is an opportunity to initiate registration procedures on the territory of all EEU countries, namely:
- Registration of veterinary medicinal products
- Confirmation of registration of previously registered veterinary medicinal products
- Making changes to the registration documents of previously registered VMPs
- The ability to maintain the market share occupied by the veterinary drug
For what?
Inspection according to the GMP rules of the EEU
- Individual expert consultation on the procedure for inspecting a foreign manufacturer's production site according to the GMP rules of the EEU
- Initial assessment of documents and information about the production site
- Development of a strategy for conducting an inspection of the production site
- Preparation of the Inspection Statement 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 in the territory of the Russian Federation and the EEU countries
- Representation of the company's interests in authorized regulatory bodies of the Russian Federation and the EEU countries in preparation for inspection of the production site
- Submission of the Application and a set of documents to the authorized regulatory body
- Supervising the process of preparation for inspection of the production site
- Informing the client about the progress of the process
- Preparation and execution of additional materials upon requests from authorized regulatory bodies
Procedure algorithm:
