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.