Supplying investigational medicinal products to Northern Ireland

The supply of investigational medicinal products IMPs from Great Britain to Northern Ireland can be pragmatic in applying EU rules on importation requirements. IMPs used in clinical trials must follow the EU acquis as per the Northern Ireland Protocol. Qualified Person QP certification is still required for using an IMP in a UK, Northern Ireland, or Great Britain clinical trial. Batch testing outside the EEA may also be performed, including in Great Britain or Northern Ireland, if to standards equivalent to those required by the UK and EU.