"Brexit" will turn U.K. into a "Third Country" from 31st October 2019"

Following the Brexit, the United Kingdom (U.K.) will become a “Third country”. From 31^st October 2019 marketing authorisation holders based in the U.K. will need to have a registered office and/or a manufacturing site with a corresponding manufacturing authorisation in the EU/EEA.

For EU/EEA batch release and pharmacovigilance activities the QP and QPPV will also have to be resident there. This is clarified by the European Commission and EMA in their “Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use", published in May 2017.

HWI Campus supports companies with their (re-)entry into the EU and offers attractive and efficient solutions concerning registered office, QM, EU batch release, pharmacovigilance, life-cycle management and a lot more.
Further informationen zum HWI Campus.