The European Union Falsified Medicines Directive (FMD) is close to taking full effect. On February 9, 2019, all regulations regarding serialization and traceability become enforced. Failure to comply with these regulations will inevitably cause product launch delays. No serial number means no sale.
Serialization will be a necessity for sale of virtually all prescription only medications in Europe. But it is not enough to just print a serial number onto every batch.
Each individual unit must contain a 2D data matrix barcode that contains a unique Global Trade Item Number (GTIN) that refers to a specific stock-keeping unit, a unique serial number, the batch number, and the product’s expiry date. Some countries require even more information.
Further, each individual product needs to be able to be traced from manufacturer all the way to the pharmacist’s point of sale. For the pharmacist to be able to reference this information, each unique barcode will be logged with the European Medicines Verification Organization (EMVO) hub.
The process for becoming compliant is not short, and putting off starting the serialization journey is dangerous, especially as the EMVO on-boarding queue starts to bottleneck as more and more companies enter that stage in their serialization process. Acting fast can save months of time and ensure compliance by the February 2019 deadline.
But choosing the right partner with the right serialization solutions can help this otherwise onerous process, as well as help with compliance in other regions, as deadlines for serialization in other countries are also fast approaching.
With our 60 day implementation plan, rfxcel provides a quick on-boarding plan for all of your serialization needs. rfxcel’s solutions are secure as well as comprehensive, providing compliance for a multitude of regions, including the EU.
For more information on the European Union Falsified Medicines Directive and compliance needs, rfxcel provides a number of resources, including a comprehensive whitepaper found here