top of page

Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA

This guidance document addresses a number of questions that 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.

As of 1st of November 2021, the registration of new sites and organisations for centrally-authorized medicinal products in Organisation Management Service (OMS) will become mandatory prior to the associated regulatory submissions to the Agency (e.g. transfer of the marketing authorisation, addition of a manufacturing site).

The EMA would like to emphasize the importance of these site/organisation registrations in OMS prior to pre- and post-authorization submissions, in order to avoid any delay in the start of these procedures, as this would constitute a validation blocking issue.


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.


In addition, MAHs are strongly recommended to inform the Agency and (Co-) Rapporteur of all upcoming post-authorization submissions for the following 6-12 months, in order to allow optimal planning, identification of procedural issues, and handling of overlapping applications.


Check out this guideline LINK for detailed information.

コメント


bottom of page