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Brexit – supplying medicines in Northern Ireland

Brexit – supplying medicines in Northern Ireland
December 18, 2020 SueCarr

For another year (until 31 December 2021) investigational medicinal products (IMPs) can be supplied from GB to Northern Ireland (NI) applying EU rules on importation. Same for authorised medicines, EU rules on importation and unique identifier requirements are valid until the end of 2021. IMPs used in clinical trials in NI, and authorised products for the NI market, must follow the EU acquis as per the NI Protocol, which is set out in the draft EU Unilateral Declaration with the Withdrawal Agreement Joint Committee. This means QP certification and batch testing will continue to be required as per the requirements detailed in regulations 13(2) and 43 of the Medicines for Human Use (Clinical trials) Regulations for IMPs (as amended – see below) and/or regulation 41(2) of the Human Medicines Regulations 2012 for authorised products.

The two webpages also provide guidance on IMP/authorised product supply from 2022 onwards:

Supplying IMPs (new)

Supplying authorised medicines (new)