What is the Falsified Medicines Directive (FMD)? Medicine verification explained

Every pack of prescription medicines in Europe now carries a 2D code that must be scanned. That is no coincidence, but the result of the Falsified Medicines Directive. In this article we explain what this directive entails, how verification works and what it means for the equipment in pharmacies and healthcare institutions.

What is the Falsified Medicines Directive?

The Falsified Medicines Directive (FMD, directive 2011/62/EU) is the European directive against falsified medicines. Its goal: preventing falsified medicines from entering the legal supply chain. Since 9 February 2019, prescription medicines in the EU must carry safety features and be verified before being dispensed to the patient.

The two safety features

The directive prescribes two features on the packaging. First, a unique identifier in a 2D data matrix, containing among others the product code, serial number, batch number and expiry date. Second, an anti-tampering device, which shows whether the pack has been opened.

How does verification work?

When dispensing, the pharmacist or caregiver scans the 2D data matrix. The system checks the unique code against the European verification database and decommissions the pack. If something is wrong, an alert follows and the medicine may not be dispensed.

What does FMD require from your equipment?

Verification stands or falls with reliable scanning. That requires a scanner that reads 2D data matrix codes quickly and without errors, including small codes on small packs. A medical barcode scanner with an antibacterial housing matches the hygiene requirements of pharmacy and care. For verification at the bedside or on the move, a handheld such as the Athena Medical PDA with integrated 2D scanner is the practical choice.

FMD in the daily workflow

Smart institutions combine FMD verification with their medication process. A medication trolley with scanner and all-in-one PC brings verification to the bedside: scan, check and sign off in one action. The mandatory check becomes a natural part of safe medication administration instead of an extra step.

Frequently asked questions