The Power of Unique Identifiers
Since February 9, 2019, the European Union has mandated that most prescription medicines, as well as certain over-the-counter (OTC) products (particularly those eligible for reimbursement), must include two critical safety features: a unique 2D barcode and a physical anti-tampering device. This combination creates a powerful barrier against counterfeiters.
Think of serialization as giving each medicine package its own unique digital fingerprint. Just as no two human fingerprints are identical, no two packages of the same medicine should share the same serial number. This unique identifier, presented in both human-readable format and as a data matrix code, contains critical information: the product code, batch number, expiration date, and the unique serial number itself.
The Journey of a Serial Number
The path from creation to verification of a serial number is fascinating and complex. Before a package ever reaches a pharmacy shelf, its journey begins in sophisticated software systems where unique numbers are generated and allocated to specific products. These systems integrate with production line equipment that prints this information on packaging materials.
Manufacturing facilities always generate more serial numbers than needed for a production run. This surplus accounts for various scenarios: quality control samples, damaged packages during production, and regulatory requirements. This is where the concept of “reconciliation” becomes crucial.
The Critical Role of Reconciliation
Reconciliation in serialization isn’t just about counting numbers – it’s about maintaining the integrity of the entire system. At the end of a production run, the number of “active” serial numbers must exactly match the number of packages produced. Any discrepancy could signal a serious problem.
Consider this scenario: if fewer serial numbers are active than packages produced, some medicines might reach pharmacies with “inactive” numbers, preventing legitimate sales. On the other hand, if more numbers remain active than packages produced, those excess active numbers could potentially be exploited by counterfeiters.
The Verification Network
Once reconciliation is complete and the batch is released, the serial numbers enter a sophisticated cloud-based verification network. This network serves as a central nervous system for the pharmaceutical supply chain, allowing wholesalers and pharmacists to instantly verify the authenticity of any package they handle.
When a pharmacist scans a package before dispensing it, the system performs an instantaneous check. Upon sale, the serial number is marked as “used,” preventing any possibility of the same number being used again – a crucial safeguard against counterfeit products entering the legitimate supply chain.
Looking Forward
The pharmaceutical industry continues to evolve, and with it, the threats from counterfeiters grow more sophisticated. Serialization represents a crucial line of defense in this ongoing battle. As we’ve seen from recent events, the system works not just in theory but in practice, protecting patients from potentially harmful counterfeit medicines. At this instance, serialization is only mandatory for prescription drugs for human use. Shall the legislation change to include over-the-counter medicinal products or veterinarian drugs? Follow us to stay updated on the latest news.
Conclusion
The FMD, through serialization and tamper-evident packaging, is a critical safeguard against counterfeit drugs. By ensuring each medicine package has a unique identifier and is verified throughout the supply chain, the pharmaceutical industry significantly strengthens patient safety. As counterfeiters grow more sophisticated, the ongoing implementation of FMD ensures that only authentic medicines reach patients, protecting both their health and the integrity of the industry.
As wholesaler, you have important legal duties to perform when it comes to FMD: verifying and decommissioning of the unique identifier. Are you up-to-standard? Contact us and we will happily guide you through the process to ensure full compliance.
By Laïs Gryffroy