Government publishes additional no-deal Brexit medicines regulation guidance

More information on how medicines, medical devices and clinical trials would be regulated following a no-deal Brexit has been issued by the Department of Health and Social Care.

The updated guidance, released following a public consultation led by the Medicines and Healthcare products Regulatory Agency (MHRA), sets out the proposed arrangements for regulation if the UK leaves the EU on 29 March 2019 with no deal in place.

Following the consultation, changes were made in some areas, such as allowing all existing holders of UK wholesale authorisations to purchase medicines that have been Qualified Person-certified in the EU/EEA.

Arrangements for medical devices include ongoing legal recognition of CE-certified devices from a notified body based in the UK or the EU, allowing them to be placed on the UK market. The MHRA’s registration system will also be expanded to all classes of medical device.

Clinical trials will continue to recognise existing approvals, meaning that there will be no need to re-apply. Future trials will require the sponsor or legal representative of the clinical trial to be in the UK or a country on an approved country list, which would initially include EU and EEA countries.

The MHRA noted that the majority of responses received were supportive of the consultation proposals.

Ian Hudson, chief executive officer of the MHRA, said the responses to its consultation had “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”.