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ARTICLE · 16 JANUARY 2019

MHRA's Updated Guidance On A Hard-Brexit

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As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...

United KingdomGovernment, Public Sector
Hannah Kerr-Peterson
Hannah Kerr-Peterson
Jacqueline Mulryne
Jacqueline Mulryne
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As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 without a deal, known as a "hard Brexit".

Following publication of the technical notice in August 2018, which we considered in an earlier blog, a consultation was launched in order to seek views on the mechanics behind some of the proposals. The consultation ended on 1 November 2018; the responses were reviewed and the technical notice updated. However, the notice states in a number of places that further guidance will be published in due course.

The overall approach in a no-deal scenario is for the MHRA to be a stand-alone medicines and medical devices regulator, which will require it to carry out certain functions that are currently undertaken at EU-level. The key points are considered below:

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