Since May 2017, the pharmaceutical industry has been reminded by the Norwegian Medicines Agency, the European Medicines Agency and the European Commission about the impact of UK’s withdrawal from the Union and its legal repercussions. Industry has been continuously informed of the need to adapt processes and to consider changes to the terms of marketing authorisations in order to ensure their continuous validity and exploitation, after the United Kingdom has left the Union. Information notices and guidance documents on legal, regulatory and procedural requirements for companies have been published and regularly updated.
Any of the following activities previously located in the UK should now have been moved to a EU/EEA member state, applied for and approved:
- Marketing authorisation holder
- Pharmacovigilance system master file
- Qualified Person for Pharmacovigilance
- Batch control site(s) for finished product (in absence of an agreed time-limited exemption)
- Batch release site(s) for finished product
Marketing authorisations that still have any of these activities in the UK are invalid and may be suspended. Any marketing authorisation holder that still have any of these activities located in the UK for any product should contact the Norwegian Medicines Agency as soon as possible.