Drug Shortages due to Brexit: EU gives Answers

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

If the United Kingdom (UK) leaves the European Union (EU) without a withdrawal agreement ("no deal scenario" or "hard brexit"), EU law will no longer apply in the UK. In this case, companies carrying out certain activities in the UK will have to make changes in order to to comply with EU law and continue to supply medicines in the EU.

The EMA has now published a question-and-answer document and points out that in the event of a withdrawal agreement, there will be a transitional period during which EU law will continue to apply in the UK. This should ensure that access to medicines is not compromised.

The questions and answers explain how the EMA, the European Commission and the EU/EEA Member States have been working closely together since May 2017 to advise companies on how to apply for the necessary changes to minimise the impact on the supply of medicines.

This document applies to both human and veterinary medicines and will be updated as necessary.