MHRA advises on submissions in a no deal Brexit scenario

While stressing that leaving the European Union with a deal is the UK government’s priority, Medicines and Health products Agency (MHRA) has directed pharmaceutical companies and clinical trial sponsors to follow new guidelines for regulatory submissions that would have to be directly submitted to the MHRA if Britain leaves the EU without reaching an agreement by the end of this month.

The Agency is making preparations to ensure that in the event we leave the EU with no deal, you can continue to submit regulatory and notification information to the UK.

The following groups will need to ensure they follow the steps to gain access to MHRA Submissions, so they can make submissions from day one: