For veterinary medicinal products, an application for a marketing authorisation must be submitted to the Veterinary Medicinal Products Unit before these products can be marketed. A dossier must be submitted to the MEB Agency. This dossier must meet the current European requirements regarding content and layout.
Once a veterinary medicinal product has been approved and authorised, the underlying dossier must be kept in compliance with legal requirements, meaning that changes to the existing dossier are submitted via a change application.
Method of submission
All veterinary medicinal product dossiers must comply with the specifications laid down in appendix II to the Veterinary Medicinal Products Regulation. The Guidance to Applicants - Veterinary Medicinal Products contains veterinary guidelines for the application for a marketing authorisation. In addition, all types of applications must be submitted electronically and must comply with the VNees (Veterinary Non-eCTD electronic Submissions) specifications.
The method of submission depends on the type of procedure:
- Variations without assessment (VNRA) can be submitted directly into the UPD.
- For Centralised procedures, the Common Repository is the correct route for submission.
- For Centralised procedures for marketing authorisation and variations including assessment (VRA) the Common Repository is the correct route for submission.
- For National, MRP and DCP procedures and variations including assessment (VRA), submission via the CESP portal is mandatory.
Contact
If you have any questions, please contact the Regulatory Datamanagement (RDM) unit via telephone number: +31 (0)88 224 8000 or contact the Veterinary Medicinal Products Unit.