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’.
