What is an NMVS alert?
The European Medicines Verification System (EMVS) checks the authenticity and status of serialised medicine packs by verifying each pack’s unique identifier (encoded in a 2D DataMatrix) against the relevant NMVS. An alert occurs when the pack data or requested transaction does not match what the NMVS holds.
Three stages in the workflow
- ScanningThe device reads the pack’s DataMatrix.
- VerificationThe NMVS checks the code and transaction; alerts are generated here.
- InvestigationYour team determines the cause and next action.
An alert indicates that something is inconsistent, not that the pack is necessarily falsified. How you investigate depends on the alert type, national requirements and your approved procedures.
Where can the workflow break down?
A European Commission study identifies several operational issues associated with FMD alerts, including incomplete or incorrect data uploaded by on-boarding partners (OBPs) or marketing authorisation holders (MAHs), scanner and software problems, human error, batch ID mismatches, and attempts to decommission packs more than once. The study notes that the precise contribution of each cause cannot be quantified. [1]
[1] European Commission, Directorate-General for Health and Food Safety (2024). Study supporting the report on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU. Published 17 June 2024.
In practice, alert causes fall into three areas. Many alerts have operational causes rather than falsification.
Pack and scanning
Print quality, damage, readability; device, software, configuration and environment.
Transaction and handling
Workflow steps, double decommissioning, returns, recalls.
Product data and trends
Missing or incorrect master data; recurring patterns by product, batch, device or operator.
Suspected falsification
Consider this only after the above causes are ruled out. Then follow your procedure and notify the relevant parties or authorities where required.
An NMVS alert is a trigger for investigation, not the investigation itself.
What should you do after an alert?
Follow your approved standard operating procedure (SOP) and applicable national requirements. Use the steps below as a practical starting point.
Hold
Steps 1–2- Pause the transactionDo not treat it as a successful verification.
- Segregate the packKeep it out of saleable stock pending investigation.
Investigate
Steps 3–5- Check the physical packCompare the pack with the scan result.
- Confirm the scan and transactionVerify pack, device, user and transaction type.
- Check for wider issuesDetermine whether this alert is isolated or part of a pattern.
Close
Steps 6–7- Escalate if unclearUse your approved route when the cause is not obvious.
- Document the outcomeRecord the alert, checks performed and final decision.
How can teams reduce avoidable causes of alerts?
Investigation explains one alert; prevention reduces the next ones. Build these controls into everyday scanning.
Pack and scanning
- Check that DataMatrix codes are readable and undamaged.
- Use suitable lighting and focus.
- Maintain correctly configured devices and software.
Transaction and handling
- Define one action per workflow: verify, decommission, return or export.
- Make repeat scans and already-processed packs clearly visible.
- Use separate staging for returns, quarantine and decommissioned stock.
Product data and trends
- Review alerts over time by product, batch, device and operator.
- Escalate recurring master-data issues to the responsible data owner or marketing authorisation holder (MAH).
- Apply corrective and preventive action (CAPA) where appropriate.
The pack, scanning and transaction controls all depend on what operators see while scanning. NexRx is built for that step.
How NexRx can support the workflow
NexRx uses augmented reality to capture multiple packs in one pass and show each pack’s scan status, including FMD alerts, on the operator’s device as they scan. For alert handling, this allows your team to:
- Locate the relevant pack quicklyLive, colour-coded status appears on packs in view.
- Find the pack linked to an unexpected resultFilter by batch, expiry, serial number or FMD status.
- See scanning completenessCaptured codes and duplicates are flagged as you scan, helping operators identify over-scanning, under-scanning or unintended batch mixing.
Good to know: NexRx does not determine why an alert occurred or replace your investigation. It supports the scanning and identification steps around it.
Practical NMVS alert investigation checklist
Use this checklist when reviewing an unexpected NMVS result. Tick each item as it is completed.
This article is general educational information. It is not legal, regulatory or quality-system advice. Alert categories, reporting routes, national requirements and system processes can vary. Always follow your approved procedure and current guidance from the relevant NMVO and competent authority.