From 9 February 2019, market authorisation holders have been required to place two safety features on all prescription medicines distributed in Europe:
- 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
- An anti-tampering device (ATD).
From 9 February 2019, community pharmacy teams have been required as part of the dispensing process to:
- Check the anti-tampering device to ensure it is intact prior to dispensing; and
- 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 ended on 31 December 2020.
On that date, some regulatory requirements will no longer apply but certain EU legislation continued 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 issued an update outlining the position of the Falsified Medicines Directive (FMD) in Northern Ireland post 31 December 2020 available: here
- 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.
Below are key links to the SecurMed website (UKNI’s medicines verification organisation) which will assist contractors in ensuring full compliance with the FMD requirements:
- Registration guide
- How to login
- How to reset password
- Certificate guidance
- Tips and Advice
Further information can be found here:
Windsor Framework
Under the Windsor Framework (announced on 27 February 2023) a range of proposals in respect of medicines supply as detailed below:
- Patients in Northern Ireland will be able to access the same medicines in the same packs, with the same labels, as the rest of the UK – permanently protecting the supply of UK medicines for Northern Ireland.
- The UK regulator, the MHRA, will always be able to approve all medicines on the market in Northern Ireland, whatever the drug, whatever the setting.
- Removal of EU Falsified Medicines Directive (FMD) packaging, labelling and barcode requirements for medicines.
- Medicines sent from Great Britain to Northern Ireland will travel via the new Green Lane which means that goods staying in the UK will be freed of unnecessary paperwork, checks and duties, with only ordinary commercial information required.
- Medicines produced in Northern Ireland will continue to enjoy frictionless access to the EU market – preserving access for Northern Ireland’s world-leading pharmaceutical and medical technology firms.
These matters are under discussion currently with a proposed implementation date of 1 January 2025. However, in the interim, FMD requirements still apply here and contractors are advised to:
- Ensure that their dispensary teams are aware of FMD requirements.
- Ensure that their pharmacy is registered with SecurMed UK here if not already registered; and
- Continue to verify and decommission FMD-compliant packs of prescription medicines. Refresher training should be carried out if needed.
- It is important that you have appropriate SOPs in place which include the FMD processes.
Recent CPNI Correspondence
18 Dec 24 CPNI CU#241218B RE: Windsor Framework: arrangements for medicines
28 Feb 23 CPNI CU#230228B RE: Windsor Framework
06 Feb 23 CPNI CU#230206B RE: Update on Falsified Medicines Directive Training
17 Jan 23 CPNI CU#230117A RE: Falsified Medicines Directive Training
01 Feb 22 CPNI CU#220201C RE: Falsified Medicines Directive: Action Required By April 2022: Update
01 Feb 22 CPNI CU#220201A RE: Falsified Medicines Directive: Action Required by April 2022
16 Nov 21 CPNI CU#211116A RE: Decommissioning UKHSA-Supplied Vaccines Under FMD
09 Feb 21 CPNI CU#210209A RE: FMD – SecurMed Support
13 Jan 21 CPNI CU#210113A RE: DoH Correspondence FMD
17 Nov 20 CPNI CU#201117A RE: FMD
Supporting Documentation
09 Jun 23 Windsor Framework Medicines Announcement – GOV.UK (www.gov.uk)
14 Nov 22 Application of the Falsified Medicines Directive: Safety Features in Northern Ireland
FMD Interim Guidance from the UK FMD Working Group for Community Pharmacy
CPNI Falsified Medicines Directive Factsheet
Useful Websites
