In July 2014 EMA started to issue quarterly Updates primarily aimed at providing marketing-authorisation holders (MAHs) with information on the development of new systems and services, to help MAHs prepare for business change.

Each issue has focussed on the most critical questions: what needs to be done by whom and by when.


This Update provides you with an overview on the highlights so far and the next steps for 2016.


We wish you a happy Christmas and New Year and look forward to continued collaboration in 2016.



Posted on the EMA website on December 2015