Hard Brexit: MHRA Preparations

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Boris Johnson's election as Prime Minister has made it very likely that the UK will leave the EU on 31 October this year. And the likelihood of a withdrawal without an agreement ("Hard Brexit ") can no longer be dismissed. Pharmaceutical authorities see challenges for pharmaceutical manufacturers in many areas, not only in terms of drug availability or drug testing.

The MHRA has already published several guidelines for a possible no-deal scenario. This concerns the following areas:

• Medical Devices
• Clinical Trials
• Biologicals and ATMPs
• List if approved countries
• Trading in drug precursors
• QPPV and PV Master File

A comprehensive overview can be found in the Collection "MHRA guidance and publications about a possible no-deal Brexit".