UK – How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal

Updated information for stakeholders so they can make informed IT plans and preparations in the event of leaving the EU with no deal.

Details

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.

If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA.

We have a contingency programme in place to deliver new systems and processes should we lose access to the current EU IT systems. Where feasible, we are trying to minimise additional administrative burdens and are trying to make any changes as simple to use as possible…