Q&A: Type II variations vs Extension applications

 

This guidance only applies to procedures initiated under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012. before 28 January 2022.

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.

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