MHRA updates â€˜no dealâ€™ Brexit guidance
Prescriptions from EU countries will continue to be recognised in the UK after Brexit, says the MHRA in updated guidance setting out proposed arrangements for regulation if the country leaves the EU on March 29 with no deal.
For medicines, other key arrangements include:
- Allowing the parallel import of medicinal products that hold a marketing authorisation from an EU or EEA country
- A period until the end of 2021 to amend packaging and leaflets for a product already on the market
- Automatically converting EU Centrally Authorised Products (CAPs) to UK marketing authorisations (‘grandfathering’)
- Targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a positive opinio
- A full accelerated assessment for new active substances
- Free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises
For medical devices, the key arrangements include:
- For a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market
- The expansion of the MHRA’s registration system to all classes of medical device.
Detailed guidance is available in the further guidance note on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal.