Supplying investigational medicinal products to Northern Ireland

AI Summary

This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) details the protocols for supplying investigational medicinal products (IMPs) from Great Britain to Northern Ireland. While clinical trials in Northern Ireland must comply with the European Union acquis under the Northern Ireland Protocol, the MHRA has implemented a pragmatic approach regarding importation requirements from Great Britain. The primary regulatory framework governing these activities is the Medicines for Human Use (Clinical Trials) Regulations 2004. A mandatory requirement for all trials is certification by a Qualified Person (QP). Certification issued in either Great Britain or the European Economic Area (EEA) is valid for supplying products to Northern Ireland. Furthermore, the guidance allows for batch testing to be performed in Great Britain, Northern Ireland, or other locations outside the EEA, provided the testing standards are equivalent to those required by the UK and EU. Clinical trial sponsors are expected to ensure their supply chains maintain these certification and testing standards. Direct supply from the EEA to Northern Ireland also remains permitted. This document serves as general guidance rather than a report on a specific company or inspection violation. For further assistance, stakeholders may contact the MHRA Customer Services Centre or the Proprietary Association of Great Britain.