Supplying investigational medicinal products to Northern Ireland
What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.
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 [email protected] or call 020 3080 6000. Alternatively, please contact the Proprietary Association of Great Britain (PAGB) by emailing [email protected].
Updates to this page
Published 31 December 2020Last updated 22 December 2021 + show all updates
-
Update to post-Brexit protocols
-
First published.