This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

 

It will be updated regularly to reflect new developments, to include guidance on further post-authorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication.

 

The Agency emphasises the importance of pre-submission meetings between MAHs and the EMA/(Co-) Rapporteur. The product team is available to address any questions MAHs may have regarding a particular upcoming post-authorisation applications. Where appropriate, a pre-submission meeting could be organised at the Agency in order to obtain further procedural and regulatory/legal advice.

 

Posted on the EMA website on 26 March 2013