What is the Falsified Medicines Directive (FMD)?
The Falsified Medicines Directive (FMD) is a regulation introduced by the European Union to protect patients from falsified (counterfeit) medicines entering the legal supply chain. It requires that all prescription medicines be verified for authenticity before they are dispensed to the public.
The directive came into force in February 2019 and applies across all EU member states, with the aim of improving traceability, safeguarding patients, and securing the pharmaceutical supply chain
How does the FMD help prevent counterfeit medicines?
FMD introduces two key safety features for each pack of medicine:
- A unique identifier: A serialised code printed on the packaging.
- An anti-tampering device: A seal or similar feature that shows if the packaging has been opened or altered.
Together, these features ensure that:
- Each pack can be traced back to its manufacturer.
- Any attempt to tamper with or counterfeit the medicine can be detected before it reaches the patient
How does GS1 enable the FMD?
In the context of FMD, GS1 standards are used to create, capture, and share the data required for medicine authentication. The connection lies in the fact that GS1 standards enable the encoding and sharing of the unique identifier required by the FMD.
What data should be included in an FMD barcode?
| Data | Purpose | Application ID/AI |
|---|---|---|
| Global Trade Item Number (GTIN) | Identifies the product uniquely | (01) |
| Serial number | Provides a unique identifier for each pack. | (21) |
| Batch or lot number | Supports traceability and recall processes | (10) |
| Expiry date | Ensures safety and compliance | (17) |
Which barcode should I use?
GS1 DataMatrix:
This encodes the above data in a machine-readable 2D barcode.
What is the GS1 DataMatrix?
The GS1 DataMatrix is a two-dimensional (2D) barcode that is compact, high-capacity, and well-suited to small packaging like medicine cartons. It can hold all required information (GTIN, serial number, expiry date, and batch number) in a single, scannable symbol.
Because of its reliability and efficiency, the GS1 DataMatrix is the barcode of choice for pharmaceutical packaging under the FMD.
How does the verification process work?
Manufacturer:
Applies a unique GS1 DataMatrix 2D barcode on each pack and uploads the data to a central European repository.
Pharmacy or hospital:
Scans the barcode at the point of dispensing
Authentication:
The scan checks the data against the central system. If the pack is genuine, it is dispensed. If not, it triggers an alert for further investigation.
This end-to-end process ensures that only authentic medicines are dispensed to patients.
What benefits do GS1 standards bring to FMD compliance?
Using GS1 standards helps stakeholders across the healthcare supply chain to:
• Comply with regulatory requirements.
• Increase supply chain visibility.
• Enable efficient data sharing between systems.
• Improve recall management and reduce errors.
• Protect patients from counterfeit or expired medicines.
Is the FMD applicable outside the EU?
While the FMD is an EU regulation, many non-EU countries are adopting similar requirements for pharmaceutical serialisation and verification. GS1 standards are global and adaptable, making them a valuable foundation for any regulatory framework aiming to enhance medicine safety.
By enabling secure, standardised data exchange across the pharmaceutical supply chain, GS1 helps manufacturers, wholesalers, pharmacists, and hospitals work together to keep counterfeit medicines out of patients’ hands.