EU FMD (Falsified Medicines Directive)
What Is EU FMD (Falsified Medicines Directive)?
EU FMD (Falsified Medicines Directive) is a European Union regulation designed to prevent falsified, counterfeit, or illegally altered medicines from entering the legal supply chain.
Implemented in 2019, FMD mandates unique identification, tamper-evident packaging, and end-to-end verification for all prescription medicines sold within the EU.
The system relies on a central verification infrastructure known as EMVS (European Medicines Verification System), enabling real-time authentication at pharmacies and dispensing points.
Objectives of EU FMD
- Protect patients from counterfeit or unsafe medicines
- Ensure authenticity at the point of dispensing
- Improve supply chain transparency
- Enforce standardized safety features across all EU member states
- Strengthen trust in Europe’s pharmaceutical ecosystem
EU FMD is one of the strongest anti-counterfeit frameworks globally.
Key Requirements Under EU FMD
1. Unique Identifier (UI) on Every Pack
Includes:
- GTIN/NTIN product code
- Serial number
- Batch/lot number
- Expiry date
- Optional national reimbursement number
2. Tamper-Evident Seal
Packaging must show if the pack has been opened or altered.
3. Upload to EMVS
Manufacturers must send serialized pack data to the European Medicines Verification System.
4. Verification at Pharmacy
Pharmacists scan each pack to verify authenticity before dispensing.
5. Decommissioning
Once dispensed, the pack is marked as inactive to prevent reuse or diversion.
How EU FMD Works in Practice
- Manufacturer serializes packs and uploads data to EMVS.
- Wholesalers verify product identity during receipt and distribution.
- At the pharmacy, the pack is scanned through national verification systems.
- If the serial is valid, the system approves dispensing.
- If the pack is suspicious (stolen, duplicated, expired), it is quarantined.
This ensures only genuine medicines reach patients.
Example: EU FMD at a Pharmacy Counter
A pharmacist scans a serialized box of antibiotics:
- EMVS checks serial number, batch, and expiry.
- Verification response returns “active and authentic.”
- Pharmacist dispenses the medicine.
- The system decommissions the pack to ensure it cannot re-enter the supply chain.
If the status was “unknown” or “already dispensed,” the pack would be isolated immediately.
Industries Covered
- All prescription medicine manufacturers
- Contract manufacturing organizations (CMOs)
- Pharmaceutical distributors
- Hospital and retail pharmacies
Non-prescription medicines may be included based on national rules.
How Acviss Supports EU FMD Alignment
Acviss helps brands strengthen and complement FMD requirements through:
- Serialization and secure QR code generation
- Tamper-evident and non-cloneable label technologies
- Digital Twin traceability linked to FMD data
- Authentication events and anomaly detection
- Audit-ready logs for compliance reviews
Acviss enhances FMD compliance and adds extra layers of anti-counterfeiting protection.
Related Terms
- DSCSA
- Regulatory Traceability
- Serialization
- Audit Trail (Supply Chain)
- Supply Chain Integrity
Related Articles
A Comprehensive Guide to Online Brand Protection Tools
Essential Online Brand Protection Strategies for Combatting Brand Abuse
