In advance of the UK leaving the European Union (EU) on 29 March 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has released a statement detailing its preparations for the event of a no-deal Brexit scenario.
There is ongoing concern that a no-deal Brexit may limit the availability of medicines in the UK, but pharmaceutical companies are “doing everything in their power” to minimise disruption to the supply of medicines should the no-deal scenario become a reality.
Since the outcome of the EU referendum, the MHRA said it has been 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 in the case of all eventualities.
The updated guidance outlines the UK’s proposed arrangements for regulation if a no-deal scenario occurs, including proposals such as automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), a process also known as ‘grandfathering’.
It also proposes to give free scientific advice, including for orphan medicines, for UK-based small and medium-sized enterprises (SMEs), and would give a period until the end of 2021 to amend packaging and leaflets for a product already on the market.
For medical devices, the key arrangement proposals include the expansion of the MHRA’s registration system to all classes of medical device, and 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 UK would continue to recognise existing clinical trial approvals, meaning there would be no need to re-apply, and would also require 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.
“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," said Dr Ian Hudson, chief executive of the MHRA.
“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.”