PharmaLexperts – taking a pragmatic approach to Brexit….
On 01 September 2020, MHRA laid out the future UK requirements for registering clinical trials, legal representation and importing Investigational Medicinal Products (IMP) after the end of the Brexit transition period at the end of 2020. Our team which includes SMEs from the UK and the EU, are here to work with you to map out the impact on your operations and offer cohesive, practical solutions to assist you with a smooth transition.
Key Changes for Clinical Trials:
- Registration of Clinical Trials: The MHRA have reminded Sponsors that from 01 Jan 2021 they will need to continue to register their trial on a publicly accessible database prior to commencement of the study. If the trial involves both UK and EU sites, this will be via a record in the EU Clinical Trials Register, or if it is a UK only trial, a register such as the ISRCTN registry should be used. Following trial completion, results should be published within the existing timelines in the applicable register.
- Legal Representation: For trials being conducted in the UK, the MHRA will continue to accept the Sponsor/Legal Representative being located in the UK or a country on the approved list of EU/EEA countries. For Rest of World Sponsors with a UK based Legal Representative, they must transfer this to an EU/EEA based Legal Representative if they have EU/EEA trial sites. This named position should be changed via submission of a substantial amendment to the relevant EU/EEA Competent Authorities.
- Importation of IMP: If the Sponsor of a UK trial is using IMPs imported from the approved list of EU/EEA countries, they will have 12 months from 01 Jan 2021 to ensure a UK MIA(IMP) holder puts in place an assurance system to confirm each batch of IMP has been certified by a QP before release to the trial. The IMP would not require recertification; however, this assurance system must be overseen by the UK MIA(IMP) QP. This oversight process will allow direct supply to both approved clinical trial sites and storage and distribution hubs and is in addition to the two-step release procedure described in EU GMP Annex 13. Sponsors in this position will need to submit a substantial amendment to include the details of the UK MIA(IMP) holder performing the ‘supply chain oversight’.
We will follow up with additional details/clarifications as more information becomes available and, in the meantime, please feel free to contact us at email@example.com for additional information.