European Union

Marketing Authorization Holders with relatively simple supply chain needs must still comply with the EU Falsified Medicines Directive (EU FMD)—but often with fewer resources and tighter budgets. To help companies like yours control costs and minimize business impact, TraceLink offers EU FMD Express: a cost-effective, simplified compliance solution based on the same proven technology that has made TraceLink the world’s largest track-and-trace network for connecting the life sciences supply chain.

EU FMD Express is a complete, turnkey solution that lets smaller manufacturers comply with EU FMD and integrate with the EU Hub through a single, secure connection to the TraceLink Life Sciences Cloud. And EU FMD Express removes the burden of software maintenance and upgrades—and insulates companies from regulatory changes.

Fast, expert deployment

Stay focused on your business while TraceLink manages your EU FMD Express implementation. TraceLink sets up and configures your solution—often in as little as a week. TraceLink then provides support and training during testing and validation before going live.

• Project Start – During the kickoff meeting, TraceLink will provide training on what information and master data your company must provide for TraceLink to complete the configuration.  We also recommend that your company start the EU Hub registration process.
• Configuration – TraceLink handles your solution configuration. We upload your master data, define users, and configure your serial number templates, serialization modules, and EU compliance module. We also configure your line systems or CMOs.
• Testing – TraceLink provides user training to your team and supports your software testing and QA and validation process.
• Go-Live – When your solution is tested and validated, TraceLink uploads your master data, serial number templates and users to your production environment, where we configure your serialization modules CMOs, and EU compliance module.

Upon successful completion of these steps, the system is fully configured and you are ready to start communicating the required information to the EU Hub.

Streamlined CMO connectivity

EU FMD Express customers can take advantage of TraceLink’s extensive network of contract manufacturing organizations (CMOs) who can exchange serial numbers with you through an integrated, automated approach or through a simple—and secure—user interface.

If the CMO is already operating on the TraceLink network, it’s likely that they have already integrated and automated the serial number exchange process. If the CMO is not on the network, TraceLink will work with that CMO to define them on the network and support their integration if that is the preferred method for data exchange.

Additional services

EU FMD Express can be easily extended to include training, testing, and QA support for additional product lines and markets as well as LMS and CMOs. TraceLink gives manufacturers unmatched flexibility and predictability in balancing business needs with regulatory requirements—and eliminates the uncertainty of low-cost, high-risk compliance solutions.