Summary
The European Union Falsified Medicines Directive (2011/62/EU) has been introduced to address the issue of falsified medicines and ensure a secure medicines supply chain.
Community pharmacy contractors are required to comply with the FMD legislation by 9th February 2019.
The FMD legislation requires manufacturers to introduce safety features to their packaging including an anti-tamper device and 2D matrix code.
The 2D matrix code (barcode) will contain specific unique information relating to the medicine. This matrix code is called the Unique Identifier (UI).
The information contained in the UI will be submitted by the medicine manufacturer to the National Medicines Verification System. Medicine suppliers will be able to scan the UI to confirm the data contained on the pack coincides with the data held by the NMVS and that the medicine is genuine.
FMD will require community pharmacy teams to include additional steps within their dispensing processes, including:
- Visually checking the Anti-Tamper Device (ATD) to confirm it is intact
- Scanning the Unique Identifier (UI) to decommission the product
Pharmacy teams will need to have procedures for responding to red or amber scan alerts
Further information on the requirements of FMD can be accessed from: