The protocol on Ireland / Northern Ireland (NI) forms an integral part of the withdrawal agreement concluded by the EU and the UK. It will become fully applicable in January.
The protocol is subject to periodic consent of the NI Legislative Assembly. Its initial period of application extends to four years after the end of the transition period. It provides that EU pharmaceutical law as laid out in the ‘acquis communautaire’ applies to and in the UK in respect of NI.
The guidance reflects the situation as laid down in legal provisions in force on the date of its publication, and without prejudice to any of the ongoing discussions between the EU and the UK concerning the application of the ‘acquis communautaire’ concerning medicinal products in respect of NI after the transition period.