Brexit: Investigational Medicinal Products, Qualified Person Release & Regulatory Compliance
The main change can be seen on the imports of IMPs from EU/EEA to Great Britain starting 01 January 2022. Sponsors of United Kingdom Clinical trials will need to appoint a United Kingdom Manufacture & Importation Authorization (MIA) (IMP) holder who will be responsible for implementing an oversight process to confirm each batch has been certified by a Qualified Person before its release to the Sites. EU/EEA Qualified Person released batches will not need recertification in Great Britain if the oversight process is in place and detailed in the Clinical Trial Approval.