The problem that nobody had solved centrally
European Union Falsified Medicines Directive (EU FMD) alerts are one of those operational realities that every pharmaceutical company on the European market deals with. When a medicine pack is scanned at a pharmacy or hospital and something does not match, whether an expired code, an unrecognised product identifier, or a data discrepancy, the European Medicines Verification System (EMVS) generates an alert. That alert flows from the relevant National Medicines Verification System (NMVS) to theEMVS hub and eventually to the Marketing Authorisation Holder (MAH), who is responsible for investigating and resolving it.
In practice, the process is fragmented at an architectural level. While the EMVS provides a central European hub, severalNational Medicines Verification Organisations (NMVOs) operate their own independent alert management systems that do not connect to the European AlertManagement System (EAMS). For a Marketing Authorisation Holder (MAH) operating across multiple European markets, this means logging into several disconnected systems to monitor, investigate, and resolve alerts country by country. There is no single view of alert status across markets, no unified reporting on volumes or resolution times, no structured workflow for triage or assignment, and no mechanism for tracking an investigation from creation through to closure. Most companies fill these gaps with spreadsheets, email threads, and manual processes. The result is predictable: delayed responses, in consistent triage, limited visibility, and a compliance process that depends on specific individuals rather than a repeatable system.
What makes this particularly stubborn is that no all-encompassing solution exists in the market. Alert management services exist, and several vendors offer outsourced triage support, but an end-to-end orchestrated platform that handles ingestion, classification, multi-stakeholder investigation, resolution, and reporting in a single environment? That did not exist.
Watch the presentation:
Process Collaboration Solution Innovation Showcase: FutureLink Barcelona 2025 (Amalia at 11:05)
Why POET, and why Amalia
TraceLink’s Process Orchestration forEmpowered Teams (POET) is a no-code development environment designed to let partners and customers build business processes on top of the TraceLink network. For a use case like EU Alert management, POET offered something no standalone tool could: direct integration with the alert source, a workflow engine capable of multi-stakeholder orchestration, and a platform architecture that was already embedded in the compliance infrastructure of hundreds of pharmaceutical companies.
Amalia’s team had been working with TraceLink across serialisation, compliance, and partner connectivity for several years.The EU Alerts gap was not discovered in a strategy workshop. It surfaced through repeated conversations with clients who were all managing the same problem in roughly the same inadequate way. The question was not whether a solution was needed, but whether POET was mature enough to build one on.
Amalia decided to find out. The approach was deliberate: build a working proof of concept quickly, test it against real-world requirements, and present it publicly to validate both the platform’s capability and the market need.
What was built
The proof of concept was built in approximately one month. A small team, working hands-on with the POET development environment, designed and assembled a solution covering the full alert lifecycle.
Alerts were designed to flow from TTS into the POET workflow automatically. On ingestion, each alert is classified by type and severity, enabling structured triage rather than the manual review that characterises most current processes. From there, the workflow engine assigns investigation tasks to the appropriate stakeholders, which may include the MAH’s quality team, a CMO, or a logistics partner, with role-based access controlling who sees what.
Resolution tracking and reporting completed the lifecycle. Instead of investigating alerts in isolation and hoping someone remembered to log the outcome, the POET solution provided a single environment where every alert’s status, investigation trail, and resolution was recorded and reportable. The reporting capabilities go well beyond what exists today, giving MAHs genuine visibility into alert volumes, resolution times, and root cause patterns.
Beyond the EU Alerts solution itself, Amalia also began building a reusable software development lifecycle framework on POET, designed to accelerate future solution delivery. Common components such as audit trail management, user access controls, and configuration patterns were modularised so they could be reused across subsequent builds, reducing development time and maintaining the quality standard required in regulated environments.
Presenting at FutureLink Barcelona
In October 2025, Amalia presented the EU Alerts Management solution at TraceLink’s FutureLink Barcelona conference aspart of the Process Collaboration Solution Innovation Showcase. The presentation by Thrasyvoulos Kotsonis, our Managing Director, starting at the 11:05 mark, demonstrated the solution, along with showcases from Arcolab and Kinaxis, with TraceLink’s own team closing the session with a broader POET development demonstration.
The reception confirmed the market need.Several pharmaceutical companies expressed interest in adopting the solution, and Amalia began scheduling workshops with early adopters to capture their specific requirements and refine the design.
TraceLink also recorded a dedicated interviewwith Amalia’s Managing Director, exploring in depth what POET means for lifesciences organisations and what Amalia has been building on the platform. In that interview, Amalia’s perspective on POET is captured succinctly: POET represents creativity and the freedom to design solutions that wouldotherwise not be available. Many members of the Amalia team come from workingday-to-day in regulated companies. They have seen the pain points. POET allowsthem to build solutions that address those pain points directly.
The interview also describes how the close partnership between Amalia and TraceLink, developed over four to five years, has enabled both organisations to iterate quickly, test new ideas, and jointly shape solutions for real customer challenges. As the first European partner implementing POET, Amalia has been able to provide direct feedback on the platform’s development while simultaneously building capability on it.
Where things stand
The EU Alerts POET initiative is currently paused. Technical constraints in the platform for this specific use case became apparent as the project moved beyond proof of concept. That is an honest assessment, not a failure.
The proof of concept demonstrated two things clearly. First, that the EU Alert management gap is real, recognised by the companies dealing with it, and commercially viable. Second, that Amalia’s combination of TraceLink platform knowledge and EU compliance domain expertise enables the kind of rapid solution development that POET was designed to unlock, with a working prototype delivered in under a month and validated publicly at TraceLink’s flagship conference.
Amalia’s team has an existing capability and has proven its know-how in building PEOT solutions. We’re now actively engaged with clients in doing just that.
For organisations managing EU alerts today
If your alert management process currently runs across multiple disconnected systems, or depends on individuals ratherthan a documented workflow, the problem is not going away. Alert volumes are increasing, regulatory expectations around response times are tightening, and the gap between what basic alert services offer and what an orchestrated platform solution can deliver is widening.
Amalia Technologies works with life sciences companies on TraceLink implementation across serialisation, partner connectivity, and process orchestration. Our POET implementation and country compliance teams bring hands-on experience with the platform that few others inEurope can match.
Learn More:
