Life Sciences Newsletter No. 7

This guidance document acts as a reminder that EU law requires that marketing authorisation holders are established in the EU (or EEA) and that some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release, etc. In addition, the Commission and the EMA expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes and recalls that the necessary transfer or variation requests will need to be submitted in due time, considering the procedural timelines provided in the regulatory framework. In its readiness to support marketing authorisation holders, the Commission and the EMA also announced the preparation of a series of Q&amp,A…