FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

MHRA Issues Plans for No-Deal Brexit Data Submission Portal

Jan. 31, 2019
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released new contingency plans for a scenario in which the UK leaves the European Union on March 29 without a deal.

In the event of a no-deal Brexit, the UK will no longer be part of the EU’s regulatory networks for drugs and medical devices, and medicine-related submissions would need to be submitted directly to the MHRA. A no-deal EU exit will leave the British pharmaceutical industry unable to submit data via EU portals such as the Common European Submission Portal.

As a contingency, the MHRA is developing UK equivalents of EU portals, although EU portals will remain available for EU-related transactions. In a webinar the agency made available this week, MHRA outlined regulatory submissions for such a scenario.

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