Following the Brexit, the United Kingdom (U.K.) will become a “Third country”. From March 30th 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 batch release
and pharmacovigilance activities the QP and QPPV will also have to be resident here. 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 provides solutions for your (re-)entry to business in the EU!
HWI Campus supports companies with their (re-)entry into the EU and offers attractive and efficient solutions throughout the complete life-cycle of the products.
Companies from non-EU countries or “Third countries” who intend to enter the European market need smart strategic plans for the implementation of regulatory requirements in the EU. The HWI Campus provides individual concepts for these companies:
- HWI provides the infrastructure for the establishment and registration as pharmaceutical entrepreneur at HWI Campus.
- HWI supports the application procedure for an EU import licence (according to §72 AMG) and/or a wholesale licence (according to §52a Abs. 6 AMG).
- HWI provides EU release testing and EU batch release.
- HWI supports the establishment of QA- and pharmacovigilance systems.