The Falsified Medicines Directive (FMD) mandates that every prescription drug sold in the European Union have an anti-tampering device and its own unique identifier in machine- and human-readable forms. Whether applied at the factory or by a packager, the machine-readable form must be a 2D barcode that contains the following:
Falsified Medicines Directive (FMD) requires that every prescription drug sold in the European Union have an anti-tampering device and its own unique identifier in machine- and human-readable forms. Whether applied at the factory or by a packager, the machine-readable form must be a 2D barcode that contains the following:
For every package introduced into the market, data must be transmitted to the European Hub managed by the European Medicines Verification Organization (EMVO). The EMVO then transmits a copy of your data to the national repositories where you intend to distribute your product.
If you’re still taking measures to comply or haven’t started your serialisation strategy, time is running out.
Systech is the global leader in serialisation. We pioneered it. Today, 95% of the top pharma companies call us their solution provider. Our serialisation stack solutions meet all EU FMD requirements: serial number randomization, barcode encoding, printing, verification and the software required to send serialisation and routing data to the European Hub. Our 30+ years of experience has taught us how to simplify and standardize the process to get you to compliance faster.
We partner with you from the beginning to determine the best serialisation strategy for your individual line needs. Our one-of-a-kind platform enables configurability with proven, plug-and-play components rather than customization. To future-proof your investment, our software easily adjusts to:
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