The Medicines and Healthcare products Regulatory Agency has published updated guidance on the supply of authorised medicines to Northern Ireland (NI) until 31 December 2021.
The guidance states that medicines can be supplied from Great Britain (GB) to NI with “a pragmatic approach” to applying EU rules on importation and unique identifier requirements until 31 December 2021.
The guidance stipulates that, until 31st December 2021 (an additional 12 months beyond the end of the transition period):
- batch testing and QP certification done in both GB and the EU/EEA will enable supply to NI
- medicines can be supplied from GB to NI without requiring additional regulatory importation controls
- the unique identifiers on packs with a marketing authorisation valid in NI (including UK-wide marketing authorisations) supplied by a manufacturer or wholesaler in the EEA will not require decommissioning when exported to the UK.
From 1 January 2022, medicines supplied from the GB market to NI will require the following importation controls done in Northern Ireland or an EEA state:
- importation via a Manufacture and Importation Authorisation (MIA) holder
- batch testing
- certification by a Qualified Person.
Please read the full guidance from MHRA for more information.