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:
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:
The data for each package introduced into the market must be transmitted to the European Hub offered 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:
Contact us to jump-start your serialisation journey today.
With the United States being far and away the largest pharmaceutical market in the world, complying with necessary…
Meeting this mandate is not simple. It requires serialization, track and trace and
data integrations with regulatory repositories…
Explore Systech Insight™ to access your line data for greater visibility and improved operations.
©2024 Systech. All rights reserved.
EN 
PT 
FR 
DE 
