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Falsified Medicines Directive (FMD) Safety Features

"The Falsified Medicines Directive (FMD) will be rolled out in Europe from February 2019 to address the threat of fake medicines and will impact the entire supply chain..."

Under the Falsified Medicines Directive (FMD) Delegated Regulation (EU2016/161), all new packs of prescription medicines put on the market from 9th February 2019 will have two safety features:

  1. A unique identifier or 'UI' (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain

  2. Tamper evident features (anti-tampering device or 'ATD') on the pack.

Unique Identifier: The UI is a unique 2D data matrix barcode made up of four key elements (shown above).

If the pack size permits, it will also carry the same information printed in text adjacent to the barcode.

Must include: Product code, unique serialisation number, expiry date and lot / batch number.

Weyfringe can supply Easylabel software to help you design your 2D data matrix barcode, a range of thermal barcode label printers to print your 2D UI barcodes, and Axicon 2D barcode verifiers to verify your printed 2D data matrix barcodes.  

In many cases pharmaceutical companies use 300dpi printers, however the introduction of GS1 Unique Device Identification specififcations and EUFMD means 600dpi printers are becoming more popular particularly for printing 2D data matrix barcodes.

If you would like to arrange a FREE no obligation demonstration please follow the link below or call 01642 490121

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