UK CLINICAL TRIALS – arrangements for submissions to MHRA and trial management after the end of the transition period on 31 December.
In advance of the UK’s exit from the EU at the end of the transition period on 31 December 2020, you may need to take action to be able to maintain your clinical trial authorisation from 1 January 2021. After this date, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines regulator. This has the potential to impact ongoing and new clinical trials as follows:
- Submission of initial clinical trial applications, amendments, and end of study notifications will need to be send via the MHRA Submissions portal (rather than via EU CESP);
- Batch release of investigational medicinal products (IMPs) intended for clinical trial sites in the EU will need to be authorised by a Qualified Person (QP) registered in one of the EU Member States. With regard to IMPs into the UK, the QP can reside in an EU or EEA country, but a UK contact person must be designated (a 12-month temporary exemption applies until 31 December 2021 for the UK contact person).
- Non-EEA Sponsors of clinical trials with UK-based EU Legal Representatives must submit a clinical trial amendment to appoint an EU Legal Representative based in an EU Member State (EEA-based EU Legal Representatives will continue to be accepted by MHRA after 1 January 2021).
With regard to submission, we would highly recommend that Sponsors with studies ongoing or planned in the UK register for the Submissions portal as soon as possible. This will allow the company to gain access and manage user permissions, enabling it to make submissions to the MHRA after 31 December. If you wish to have a third party such as Boyds continue to make submissions on the company’s behalf, it is possible to grant these permissions in the Portal. Further short guidance can be found here.
Should you require support with registration in the MHRA Submissions portal, or on arrangements for QP release of IMPs or EU Legal Representatives, please do not hesitate to contact us by emailing email@example.com and one of the team will be pleased to provide additional information and guidance.