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Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal

Guidance for those engaged in clinical trials, regarding continuity of supply of Investigational Medicinal Products (IMPs) in the event of a no-deal

TheAgency

A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome. With talks ongoing, we remain committed to reaching agreement in the Autumn. However, it’s our duty as a responsible Government to prepare for all eventualities, including ‘no deal’ and that is exactly what we are doing.

Although the Government is working to minimise possible border disruptions on the UK’s exit from the EU, it is sensible to assure clinical trial participants in the UK that their ongoing trials will not be disrupted. The Government has set up the Medicines Supply Contingency Programme to ensure the continued supply of licensed medicines in the UK in the event of a ‘no deal’ Brexit, read this page for more information.

We would encourage organisations running clinical trials in the UK to consider their supply chains for IMPs ahead of the 29th March 2019. Clinical Trials that use IMPs which come from or via the EU/EEA will need to ensure appropriate arrangements to assure supplies in the event of any possible border delays that may arise in the short term in the unlikely event of a no-deal Exit that we reach March 2019 without agreeing a deal with the EU.

It may be necessary to start making any contingency arrangements ahead of the 29th March 2019 to provide assurance to trial participants and for the trials.

The life sciences sector may also wish to consider the relevant technical notices published on 23 August, under the heading ‘Regulating medicines and medical equipment’.

If you have further queries concerning IMPs please contact imp@dh.gsi.gov.uk

Published 12 October 2018