Changing the (invented) name of a veterinary medicine

Guidance is available from the European Medicines Agency (EMA) on changing the name of a veterinary medicinal product in the form of questions and answers (Q&As). 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 the Veterinary eSubmission website.


How useful was this page?

Add your rating
1 rating