DataMatrix serialization (FMD) is the European system that identifies each individual medicine pack with a unique code, printed as a DataMatrix (a 2D barcode), to combat counterfeiting. It stems from the FMD (Falsified Medicines Directive, 2011/62/EU) and its delegated regulation.
How it works
Each pack carries a DataMatrix with a unique identifier (product code, serial number, batch, expiry) plus an anti-tampering seal. The code is uploaded to a European/national repository at manufacture and verified and “decommissioned” at the point of dispensing, ensuring the pack is genuine and not already sold.
What it means for distribution
For intermediate distributors (DIF), serialization affects goods-in, returns handling and verification, integrating with GDP requirements. In Italy the transition from the paper sticker to the FMD system is under way: the operational plan is described in DataMatrix-FMD towards 9 February 2027.
FAQ
What is the DataMatrix code on packs?
It’s a two-dimensional barcode containing the pack’s unique identifier (product, serial, batch, expiry), readable by a scanner to verify authenticity.
Are FMD and serialization the same thing?
FMD is the legislation; serialization (with a unique DataMatrix code) is the technical mechanism through which FMD is implemented to ensure anti-counterfeiting traceability.