Supplying authorised medicines to Northern Ireland – Latest Guidance from MHRA

Medicines for the Northern Ireland market must follow the EU acquis in accordance with Annex 2 of the Northern Ireland Protocol with a pragmatic approach to applying EU rules on importation and unique identifier requirements. This is as set out in the Directive (EU) 2022/642 which amends Directives 2001/20/EC and 2001/83/EC as regards derogations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland.

For the latest guidance from the MHRA (updated 23/01/2023), visit the Government website here