What is pharmaceutical serialization, why it matters, and how MedTracker makes compliance simple.
What is Pharmaceutical Serialization? Pharmaceutical serialization is the process of assigning a unique identifier to each individual saleable unit of a medicine typically a 2D DataMatrix code printed on the packaging. This code contains the product code, serial number, batch number and expiry date (the "4 data elements" required by EU FMD).
Why Does It Matter? Serialization is the foundation of drug traceability. It allows every pack to be verified as authentic at the point of dispensing, preventing counterfeit medicines from reaching patients. The EU Falsified Medicines Directive (FMD) made serialization mandatory for prescription medicines in Europe in 2019.
How MedTracker Makes It Simple MedTracker handles the full serialization workflow from number generation and label printing to aggregation and reporting to national verification systems. It integrates with existing packaging lines and ERP systems, minimizing disruption during implementation.
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