National Bottlenecks
If you’re resolving alerts without involving your NMVO, or worse, relying solely on EMVO – you’re working uphill.
When the EU’s Falsified Medicines Directive went live, it promised a bold new standard: protect patients using real-time verification and serialisation across a harmonised European framework.
Years later, the infrastructure largely works. But the majority of alerts generated under the FMD aren’t signaling falsified medicines – they’re reflecting something else: inconsistent systems, ineffective processes, and misaligned responsibilities across national boundaries.
Most alerts aren’t about Counterfeits. Analysis across multiple MAHs and national systems shows a clear pattern: alert volumes are driven not by fraud, but by technical and operational inefficiencies.
These alerts may be triggered in pharmacies but often originate much earlier – during manufacturing, serial number generation, or premature and missing data uploads.
False alerts require significant investigation effort. A single alert might consume 30 minutes across QA, IT, and supply chain. When thousands of alerts are triggered monthly, the resource drain is substantial, leading to alert fatigue and the risk of missing genuine anomalies.
Alert Management Starts with National Systems – Not EMVO
A persistent challenge is misunderstanding the flow of alert responsibility. EMVO serves an essential function through its Alert Management System (AMS), especially via the EAMS hub, but it currently connects to just 5 national markets. By contrast, NMVS Alert is already connected to 16 countries and making it the primary channel for operational investigation and communication between NMVOs and MAHs. That distinction matters.
EMVO AMS is an excellent platform for alert reception and routing. But resolution, root cause analysis, and direct follow-up with the scanning party all happen at the national level. Compliance obligations and response timelines are determined by national regulations, not EMVO guidance alone.
Another contention is Client ID management as it is not consistent across Europe. In some markets, NMVOs provide rapid access to the scanning party — enabling timely resolution. In others, data protection interpretations block this, making MAH-led investigations slow or even impossible.
When Client ID data is unavailable or routed through slow intermediaries, alert cycles stretch — especially when follow-up evidence (like pack photos or user explanations) is needed.
- Are you seeing repeated A3s for a specific GTIN? Check your pack data, batch uploads, or scan configurations.
- Multiple A7s in a single market? Revisit your inter-market and parallel trade decommissioning protocols.
- High false alert rates from a particular pharmacy group? Collaborate with your NMVO to investigate scanner setups or local workflows.
Let’s talk.