For veterinary medicinal products, an application for a marketing authorisation must be submitted to the MEB Agency – 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.
Although it is not obligatory to submit dossiers regarding veterinary medicinal products electronically, the MEB does prefer to receive submissions in electronic format. If a paper version is submitted, the submission must meet the specifications as stated in Volume 6B Presentation and content of the dossier van de Notice to Applicants.
In the case of an electronic submission, the veterinary NeeS-specifications must be followed.
When submitting a dossier, the entire dossier must always be available either on paper or electronically. In the case of an electronic dossier, an original signed copy of the submission letter (cover letter) and the application form must always be submitted in case CESP is not used for submission.
Method of submission
Preferably, the electronic submission of a veterinary dossier is done by CESP. Alternatively, you can submit your veterinary medicinal product dossier (in electronic format or on CD/DVD) by postal service or courier (or via Eudralink in the case of additional information or answers to questions).
If you have any questions, please contact the Regulatory Information Centre (RIC) via telephone number: +31 (0)88 224 8000 or contact the MEB Agency, Veterinary Medicinal Products Unit.
The delivery address for electronic submissions sent by courier is:
Medicines Evaluation Board
f.a.o. Veterinary Medicinal Products Unit
Graadt van Roggenweg 500
3531 AH Utrecht