EU FMD Compliance for Pharmacies

Compliance and Digital Information Platform for Pharmacies with EU FMD Requirements

In February 2019, those who manufacture, sell, and dispense medications in the European Union must comply with new regulations outlined in the Falsified Medicines Directive (FMD). Under the law, pharmacies across the region must now scan a new 2D DataMatrix barcode (containing GTIN/NTIN, serial number, lot number, expiry, and optional National Reimbursement Code), which is applied by the manufacturer to every pack of medicines, and verify the authenticity against information held in a national system.

Under these new regulations, dispensers will need to meet the following requirements:

Requirement Description 
Verify Pack (optional)  Verify serial number against national system. 
Dispense (Decommission Pack)  Notify national system that pack has been dispensed. National system performs verification of serial number, and once verification is confirmed, serial number is decommissioned in national system.  
Reintroduce Dispensed Pack  Reintroduce dispensed pack back into stock at the same pharmacy location within 240 hours (10 days) of initial dispense (e.g., when patient does not pick up the prescription). 
Decommission Pack  Decommission pack for destruction or sampling by National Competent Authorities (NCA), including reason for decommissioning. 
Undo Decommissioned Pack  Reverse decommission of pack for destruction or sampling within 240 hours (10 days). 

TraceLink Compliance and Digital Information Platform

For pharmacies with EU FMD requirements, the TraceLink Compliance and Digital Information Platform enables dispensers to meet their verification and decommissioning requirements under the law without any disruption to existing workflows. Pharmacists simply use a mobile device to scan any prescription medicine and submit the product code (GTIN/NTIN), serial number, lot number, and expiry date with the verification or decommission request, and the application will receive the status from the national system.

Pharmacies that subscribe to the TraceLink platform will also:

  • Gain deep insights into their dispensing operation – using the integrated dashboard that tracks and stores information about medicine scans, expiry dates, dispensation trends, and product inventory.
  • “Opt in” to receive additional information from pharmaceutical manufacturers participating in the service – opening a new communication channel for receiving specific and contextual product information directly from pharmaceutical companies—including details about drug indications, usage, administration, dosage forms and strengths, warnings and precautions—empowering them to deliver a more engaging and informative consultation when dispensing medicines to patients.
  • Keep pace with ongoing changes to national systems – leveraging TraceLink multi-tenant architecture that provides pharmacies with application updates as soon as critical changes occur.
  • Access 24x7 local support – providing answers to any technical questions about the application and its capabilities.
  • Spend more time on quality patient care and less time on compliance – by allowing TraceLink to manage all authentication and message exchange with their national system in a secure, confidential application that is fully validated against GxP standards.
  • Protect personal data – ensuring individual pharmacy data will remain confidential and won't be shared with any third parties unless previously agreed by the pharmacist, who remains the data owner.
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