The European Medicines Verification System (EMVS) provides alerts and notifications to stakeholders when critical exceptions occur during verification and pack state change operations. These alerts are primarily designed to detect Potential Suspect Falsification packs—medicinal products that may deliberately or fraudulently misrepresent their identity, source, or history.
Alerts require timely investigation and appropriate action. They protect patients from falsified medicines and ensure supply chain integrity.
Most common alerts in the EMVS
Product code does not exist in NMVS database
Unique identifier not found in the system
Pack has already been supplied or decommissioned
Pack not found after Intermarket Transaction
Expiry date does not match stored data
Batch identifier does not match serial number
Alerts are distributed to multiple stakeholders depending on escalation level and alert type:
Receives all alerts generated within their market and monitors for suspicious activity patterns.
Notified of alerts related to their products, allowing them to investigate potential counterfeits.
Receives alerts for products they manage on behalf of MAHs.
Monitors system-wide alerts for patterns and coordinates responses across markets.
Each alert contains detailed information to facilitate investigation:
When a National System cannot locate a unique identifier in its local records, it may initiate an Intermarket Transaction (IMT) via the European Hub. The Hub routes the request to another National System where the pack may be registered.
1. Initiating Market: Cannot find pack locally
2. EU Hub: Routes request to fulfilling market(s)
3. Fulfilling Market: Checks and responds
4. Alert #A24: Raised if pack still not found
OBPs should perform retrospective uploads when new markets are authorized or onboarded. This ensures existing batch data is distributed to new markets, reducing the need for IMTs.
Not all failed operations raise alerts. For example, attempting to undo decommissioning when a pack is already ACTIVE will not trigger an alert.
If undo operations fail due to batch being RECALLED or product being WITHDRAWN, no alert is raised—these are expected system behaviors.
Manual data entry increases error risk. Systems flag manually entered data in alert messages to aid investigation.
Separate category of alerts for serial number randomization issues, typically identified during data upload validation.
Define standard operating procedures for alert handling, investigation, and escalation.
Ensure pharmacy and dispensing staff understand alert types and appropriate responses.
Track recurring alerts or patterns that might indicate systematic issues or counterfeiting.
Keep open channels with NMVO, MAHs, and regulatory authorities for quick resolution.
Information may be outdated. Always consult official documentation from EMVO, EMA, GS1, and national regulatory bodies for current requirements.