Falsified Medicines Directive (FMD)

From 9 February 2019, market authorisation holders have been required to place two safety features on all prescription medicines distributed in Europe:

  1. A unique identifier (UI) in the form of a 2D data matrix (barcode) which contains the batch number, expiry date, product identifier and a unique serial number for the pack; and
  2. An anti-tampering device (ATD).

From 9 February 2019, community pharmacy teams have been required as part of the dispensing process to:

  1. Check the anti-tampering device to ensure it is intact prior to dispensing; and
  2. Check the status of the pack (‘verification’) in the UK’s National Medicines Verification System (the UK hub) and change it from “active” to “inactive—supplied” (‘decommissioning’). This involves scanning the 2D barcode on each pack.

FMD and Pharmacies in Northern Ireland

As you are aware, the UK has left the EU and the Transition Period ends on 31 December 2020.

On that date, some regulatory requirements will no longer apply but certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol (NIP) (part of the UK’s Withdrawal Agreement with the EU).

The UK FMD Working Group for Community Pharmacy has issued an update outlining the position of the Falsified Medicines Directive (FMD) in Northern Ireland post 31 December 2020 available: here

Under the terms of the NIP, the FMD will still apply in Northern Ireland, for at least four years (until the NIP is due to be reviewed).

  • All end users in Northern Ireland, including pharmacy contractors, will remain connected to the UK National Medicines Verification System (UKMVS) run by SecurMed UK.  They need to continue to verify and decommission any packs with FMD safety features (unique identifiers and anti-tamper devices) in line with the requirements of relevant EU and UK medicines legislation.
  • SecurMed UK will continue to provide end user registration and necessary support to enable Northern Ireland end users to decommission packs with FMD identifier features into 2021 and beyond.

Further information can be found here:

*** Act Now ***

Contractors are asked to:

  1. Ensure that their dispensary teams are aware of FMD requirements
  2. Ensure that their pharmacy is registered with SecurMed UK here if not already registered; and
  3. Continue to verify and decommission FMD-compliant packs of prescription medicines.  Refresher training should be carried out if needed.
  4. It is important that you have appropriate SOPs in place which include the FMD processes.

Recent CPNI Correspondence

CPNI CU 210209A RE: FMD – SecurMed Support 9 Feb 2021

CPNI CU 210113A RE: DoH CORRESPONDENCE FMD 13 Jan 2021

CPNI CU 201117A RE: FMD 17 Nov 2020

Supporting Documentation

CPNI Falsified Medicines Directive Factsheet

FMD interim guidance from the UK FMD working group for community pharmacy

FMD Source FAQs

Useful Websites

FMD Source
GOV.UK
DOH – EU Exit – Frequently Asked Questions