Extra 'No-deal' Brexit Info on Medicines and Clinical Trials

Peter Russell

January 09, 2019

Updated information on how medicines, medical devices, and clinical trials would be regulated in the event of a 'no-deal' Brexit were issued by the Department of Health and Social Care (DHSC).

The new guidance followed a public consultation led by the Medicines and Healthcare products Regulatory Agency (MHRA).

Regulation of Medicines

For medicines, the main arrangements include:

  • Automatically converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a process known as 'grandfathering'

  • Targeted assessment of new applications for products containing new active substances or biosimilars which have been submitted to the European Medicines Agency (EMA) and have received a Committee for Medicinal Products for Human Use (CHMP) positive opinion

  • Extending the period for amending packaging and leaflets for previously marketed products until the end of 2021

  • 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

Medical Devices

In the case of medical devices, those bearing a CE mark from a notified body in the UK or EU would continue to be recognised by UK law and given a UK marketing authorisation for a limited period of time.

The MHRA's registration system would also be expanded to all classes of medical device.

Future of Clinical Trials

For clinical trials, the key arrangements include:

  • 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

Dr Ian Hudson, chief executive officer at the MHRA said: "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."

'Preparing for All Eventualities'

The DHSC said it would remain focused on delivering the deal negotiated with the EU but that as a responsible government it had a duty to prepare for all scenarios and provide information so that other organisations could do the same.

It said it had always been the case that as the leaving date of March 29th 2019 approached, plans for a no-deal Brexit would be accelerated.


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