UK

SOPs and removal of FMD requirements in Northern Ireland

The Windsor Framework, agreed between the UK and the EU in February 2023, will be fully implemented on January 1st 2025. It ensures that the MHRA, will be, once again, responsible for licensing medicines in Northern Ireland as well as the rest of the UK. 

From January 1st 2025, the current NI UK(NI) Medicines Verification Organisation, SecureMed, will decommission the UK(NI) National Medicines Verification System (NMVS). The European Medicines Verification Organisation (EMVS) will disconnect the UK(NI) NMVS from EMVS on the same date. It will then not be possible to verify or decommission medicines in Northern Ireland from January 1st 2025. As such, there will no longer be a requirement for Northen Ireland pharmacies to verify or decommission medicines from the supply chain under EU FMD requirements.

As a result, Numark has updated the relevant Standard Operating Procedures (SOPs) that contained information surrounding FMD processes to remove any reference to FMD.

The Numark procedural review date on individual SOPs remains the same in the new version as it was in the previous version, but we recommend that you review and amend your current SOPs to reflect the changes.

The SOPs that have been reviewed and come into effect from January 1st 2025 are:

The SOP for FMD - responding to errors and alerts has also been archived.

If you have any questions or concerns regarding SOPs contact Information Services on 0800 783 5709 option 2.