Guidance
Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports
Information relating to the disapplication of falsified medicines under UK Law.
Applies to England, Scotland and Wales
Documents
Details
From 1 January 2025, the EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland. EU FMD safety features will therefore not apply to parallel import licences. PLPI licence holders must still ensure packs are decommissioned correctly and cannot re-enter the EU supply chain.