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”.

The guidance published under ‘Post-authorisation procedural Q&A’’ provides an overview for different types of post-authorisation procedures that occur frequently and, in each case, addresses a number of questions which marketing authorisation holders (MAHs) may have.

Applicants should 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 the Veterinary eSubmission website.


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