# Supplying investigational medicinal products to Northern Ireland

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a674aa00-8439-4b12-b74c-0c614088a845
Type: Detailed Guide
Published: December 31, 2020
Updated: December 22, 2021

> 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.

---

## Content

Supply of investigational medicinal products IMPs can be supplied from Great Britain to Northern Ireland with a pragmatic approach to applying European Union ( EU ) rules on importation requirements. Apart from a pragmatic approach to importation requirements, IMPs used in clinical trials in Northern Ireland must follow the EU acquis as per the Northern Ireland Protocol. This is as set out in the draft EU Unilateral Declaration in the Withdrawal Agreement Joint Committee . Qualified Person ( QP ) certification will continue to be required to use an IMP in a UK, Northern Ireland or Great Britain clinical trial as per the requirements detailed in regulations 13(2) and 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). QP certification done in Great Britain will enable supply of IMP to Northern Ireland. QP certification done in the EU /European Economic Area ( EEA ) will also enable supply of IMP to Northern Ireland via Great Britain. Batch testing may be performed outside the EEA , including in Great Britain or Northern Ireland, where this is performed to standards equivalent to those required by the UK and EU . This will be permitted under regulations 13(2) and 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). IMP may also be supplied to Northern Ireland directly from the EEA Supply of authorised medicines used in clinical trials Some clinical trials use unmodified authorised medicines as the investigational medicinal product, or as additional therapy in the trial design. Guidance on the requirements for supplying authorised medicines to Northern Ireland . Further information For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, please contact the Proprietary Association of Great Britain (PAGB) by emailing regulatory@pagb.co.uk .