EMVS Alerts and Notifications

This document describes the alerts and notifications provided by the European Medicines Verification System (EMVS) to stakeholders, including National Medicines Verification Organisations (NMVOs), the European Medicines Verification Organisation (EMVO) and European Hub on-boarding partners (OBPs). Ultimately, it describes notifications for exceptions which mainly concerned the detection of Potential Suspect Falsification packs.

The document is based on a document (EMVS0670 EMVS National System NMVO Alerts and Notifications) which explains alerts and notifications from the perspective of NMVOs operated by Solidsoft Reply. It extends the original content to support multiple perspectives, including the national systems operated by Arvato, the European Hub, EMVO and OBPs.

The document at hand describes the alerting requirements specified by the European stakeholders for systems that operate as part of the EMVS, and it is the result of a joint work between EMVO, the Blueprint System providers and the NMVOs to support the harmonisation of alerts across the EMVS. Readers can use this document to identify the triggers that may result in the EMVS issuing alerts for Potential Suspect Falsification packs, and to understand additional process of notifications and reports concerning suspicious activities and events.

Readers may also use this information to design processes and procedures for investigation and handling of Potential Suspect Falsification packs and other scenarios where suspicious activity is detected.