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 postauthorisation 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.
This guidance information and fruitful pre-submission dialogue between MAHs and the Agency should
enable MAHs to submit applications, which are in conformity with the legal and regulatory
requirements and which can be validated and processed promptly.