Q&A: Extension applications

 

This guidance only applies for procedures started under Directive 2001/82/EC and Regulation (EU) 726/2004 before 28 January 2022.

The guidance 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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