Q&A: Post-authorisation measures (Recommendations, Conditions and Specific Obligations)
Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.
This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.
More information on this post-authorisation procedural advice Q&A.
As of 1 January 2017 it is 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:
- Procedural announcement on mandatory use of eSubmission Gateway for veterinary submissions as of 1 January 2017
- Veterinary eSubmission website
- eSubmission Gateway and Web Client information website