The Medicines and Healthcare products Regulatory Agency (MHRA), the body responsible for regulating all medicines and medical devices in the UK, has announced proposals for arrangements should the UK leave the European Union on 29 March 2019 without a negotiated deal (termed 'no-deal Brexit'). The Agency has said that following the outcome of the EU referendum, they are working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.
Following a consultation process, the MHRA has issued arrangements and guidance for medicines, medical devices and clinical trials. Announced on 3 January 2019, they include: automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process known as ‘grandfathering’; a full accelerated assessment for new active substances; and aligning, where possible, with the EU Clinical Trials Regulation. A full list of arrangements can be found on the gov.uk website here.
Speaking about these proposals, Dr Ian Hudson, Chief Executive Officer at the MHRA said:
“The responses to our consultation have helped us prepare a robust plan to make sure our regulatory processes for medicines, clinical trials and medical devices are fit for purpose on exit day.
“We are committed to giving businesses and individuals as much certainty as possible, as soon as possible to make sure the UK continues to be at the forefront of regulatory innovation and processes.”
The MHRA proposals are still subject to Parliamentary approval of the relevant statutory instruments that are required to bring these proposals into law.
Read the official MHRA announcement here.