The European Medicines Agency provides guidance documents to companies and individuals involved in developing and marketing veterinary medicines in the European Union. These include guidance on dossier requirements, submission dates, procedures as well as templates and checklists for applications.
The use of electronic Application Forms (eAF) is mandatory for all application procedures (authorisations and variations requiring assessment).
It is also mandatory for applicants to use the eSubmission Gateway / Web Client for all veterinary procedural submissions to the Agency.
For more information, including links to guidance on registration with the system, see:
- Information on summary of product characteristics requirements can be found in the veterinary Product information requirements page - Quality review of documents (QRD) section.