Brexit: Sponsors Need to Establish an EU-QP

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

Since 1 February 2020, the UK has withdrawn from the EU. The transition period ends on 31 December 2020. Since no extension was requested as of July 1 2020, there is no possibility for further extension beyond that date.

What is the legal situation after the end of the transition period for the qualified person (QP) and the sponsor?

• Sponsors of all ongoing trials need to establish an EU-QP. IMPs used in clinical trials can be imported only after their batch-release has been certified by an EU-QP. There are currently a number of trials where the QP is established in the UK and which have been authorized in at least one Member State other than the UK. 
• For trials authorized in at least one EU Member State where the sponsor is established in a third-country and with a legal representative in the UK, the sponsor needs to establish its legal representative in the EU by the end of the transition period. At the end of the transition period, the sponsor or its legal representative has to be established in the EU for all ongoing trials.

More information is provided in the Joint technical notice to sponsors by the European Commission, EMA and HMA.