The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance regarding the availability of medicines and medical devices post-Brexit.
The agency says most human medicines on the UK market already have a UK marketing authorisation and this will be unaffected by Brexit. However, most novel medicines and biosimilars, and some generics, come to market via the European Medicines Agency’s (EMA’s) centralised authorisation route.
To ensure such medicines will continue to be authorised for use in the United Kingdom, all medicines which have been centrally authorised in Europe will automatically be granted UK marketing authorisation on exit day, under the grandfather process.
There will be “targeted assessment” of applications for products containing new active substances or biosimilars which have been submitted to the EMA but have not yet received final approval.
For medical devices, there will be a time-limited period during which devices that have a CE mark from a notified body based in the United Kingdom or a European Union (EU) country will continue to be recognised by the UK law and allowed to be placed on the UK market.
In relation to clinical trials, the MHRA aims to align, where possible, with the EU Clinical Trials Regulation when it applies. Trials which have already been approved will continue to be recognised in the United Kingdom. The sponsor or legal representative of the trial must be in the United Kingdom or a country on an approved country list, which would initially include countries in the EU or European Economic Area.