Government has published technical notices outlining the preparations and planning required in the event of a no-deal Brexit. A number of these notices are relevant to our sector including: guidance on Horizon 2020 funding; the regulation of medicines, devices and clinical trials; batch testing of medicines; and submitting regulatory information on medical products. The overarching message is one of alignment and recognition with the EU in order to minimise disruption.

The notices outline that the MHRA would take on the functions currently undertaken by the EU for medicines in the UK market, which would require changes to UK law, and that a public consultation is planned for early autumn on some of the key proposed legislative changes.

Government also reiterated its commitments to align with the new Clinical Trials Regulation where possible and without delay when it does come into force in the EU, and its commitment to guaranteed funding for competitively bid EU projects submitted before the UK leaves the EU, including Horizon 2020 projects.

In a no-deal scenario, the plans set out in these documents would take effect from 29 March 2019.

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