Following the MHRA’s consultation on how medicines, medical devices and clinical trials which would be regulated in the case of a no-deal Brexit, updated guidance has been issued setting out the UK’s proposed arrangements for regulation if the UK leaves the EU with no deal.
For medicines, the key arrangements include:
• 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.
Further detailed guidance is available in the Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal.
Dr Ian Hudson, Chief Executive Officer at the MHRA, said of the guidance:
“The MHRA’s vision for the future of medicines and medical devices regulations is underpinned by three clear principles: that patients should not be disadvantaged; that innovators should be able to get products to the UK market as quickly and simply as possible; and that the UK continues to play a leading role promoting public health.
“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.
“These proposals are still subject to parliamentary approval of the relevant statutory instruments that are required to bring these proposals into law.”