Important communication for End Users regarding the Falsified Medicines Directive (FMD) with effect from January 2022


The European Commission has announced an update on medicines and the Northern Ireland Protocol. The UK Government has responded to these proposals and has established the Northern Ireland MHRA Authorised Route (NIMAR).

The European Commission and UK Government have taken significant practical steps towards resolving outstanding issues with the regulation and supply of medicines under the Northern Ireland Protocol.

The Falsified Medicines Directive will continue in operation in Northern Ireland until 2024.  The UK, in respect of Northern Ireland, is committed to meeting the requirements of the EU FMD safety features Delegated Regulation, and the MHRA expects all stakeholders in the supply chain to comply with these requirements.

Please visit Gov.uk for their latest updates.