Highlights from June EMA Management Board meeting

The EMA’s Management Board met on 12-13 June and discussed activities suspended during the Agency’s relocation to Amsterdam and its readiness for Brexit.

Ahead of the European Medicines Agency’s (EMA) relocation to The Netherlands, some activities were suspended, including guideline development and international engagement, allowing staff to focus on the move. The Board heard that most of these remain on hold, but some have now resumed. Information on these is available in the EMA press release.

Other topics for discussion included preparation for Brexit. The Board received statistics showing that 397 marketing authorisations out of 400 have been successfully transferred. Other changes, such as qualified persons for pharmacovigilance (QPPVs) have also progressed but not to the same extent – the change has only been made for 243 out of 335 medicines.

The Board reviewed developments such as the implementation of the IRIS system for orphan designation, and the creation of the Clinical Trials Information System.

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Published 21. June 2019 in News, News EU