EMA will provide updated guidance in accordance with the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) in due course.
The Q&As provide an overview of the EMA's position on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
Applicants should use the eSubmission Gateway / Web Client for all veterinary post-authorisation procedural submissions submitted to EMA.
For more information, including links to guidance on registration with the system, see:
From January 2025, marketing authorisation holders should use the IRIS platform when managing post-authorisation measures after the original submission.
Further guidance on the use of the IRIS platform and how to prepare submissions is available on the dedicated IRIS website:
IRIS does not replace the current submission gateway; they coexist serving different functions.