The Medicines and Healthcare products Regulatory Agency (MHRA) ran a consultation in Autumn 2018 about the consequences of leaving the European Union without a deal in place. Their response to the consultation has now been released, explaining some of the detail of the Agency’s planning for this eventuality. The announcement is accompanied by an update to the MHRA page Making a Success of Brexit.
In the response, the Agency discusses arrangements for medicines and medical devices. These are crucial as both trade agreements and regulations will impact on the supply of drugs between the UK and EU.
- automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process known as ‘grandfathering’
- targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the EMA and received a Committee for Medicinal Products for Human Use (CHMP) positive opinion
- a full accelerated assessment for new active substances
- free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs)
- a period until the end of 2021 to amend packaging and leaflets for a product already on the market
- allowing the parallel import of medicinal products that hold a marketing authorisation from an EU or EEA country
- continuing to recognise prescriptions issued in EU or EEA countries.
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.
The response also includes information on clinical trials, regulation of which could change substantially once the UK leaves the EU.
- continuing to recognise existing approvals so there will be no need to re-apply
- requiring the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list which would initially include EU or EEA countries
- aligning, where possible, with the EU Clinical Trials Regulation when it applies.