Skip to main content
All CollectionsSmall Markets (Brexit)
How to treat the batches that go to Great Britain and Northern Ireland at the same time?
How to treat the batches that go to Great Britain and Northern Ireland at the same time?
T
Written by Tracy Slosse
Updated over 2 years ago

Batches that are distributed to both Great Britain and Northern Ireland must have a marketing authorisation that applies in Northern Ireland so the MA must be for UK-wide MA (PL) or a Northern Ireland only (PLNI). Packs with UK wide or NI only licenses must have the FMD safety features applied and the batch/pack data uploaded.

UK Parallel Imported packs are given a license designator PLPI on the list of published MHRA authorisations but the actual pack will have either a PL or PLGB license number printed on it.

CAP authorised medicines under the EMA Centralised Procedure can also be distributed to Northern Ireland; these packs must have the FMD safety features and their pack/batch data must be uploaded to the UKNI MVS where those packs are destined for NI.

Did this answer your question?