News - December 14, 2020

Brexit: Guidance on Supplying Medicines to Northern Ireland

According to the MHRA Guidance, up until 31 December 2021, medicines can be supplied from Great Britain (GB) to Northern Ireland (NI) with a “pragmatic approach” to applying EU rules on importation and unique identifier requirements. Outside of these two areas, medicines supplied to NI have to follow EU rules (as set out in the NI Protocol). Batch testing and Qualified Person (QP) certification will continue to be required to place a product on the UK market. Additionally, up until 31 December 2021:

  • Batch testing and QP certification done in GB (England, Wales and Scotland) will enable supply to NI
  • Batch testing and QP certification done in EU will also enable supply to NI via GB
  • Medicines supplied from GB to NI will not require additional regulatory import controls (manufacture and import authorisation, batch testing and QP certification done in NI or an EEA state)

From 1 January 2022 onwards, medicines supplied from GB to NI will require the following importation controls done in NI or an EEA state:

  • Importation via a Manufacture and Importation (MIA) holder
  • Batch testing
  • Certification by a Qualified Person

Unique identifiers on UK packs exported to GB by an EEA manufacturer or wholesaler will require decommissioning. If these packs will be later supplied to NI, new identifiers should be applied to them and uploaded to the EU medicines verification hub, unless they were placed on the market before 11 p.m. on 31 December 2020.