Alerts and Exceptions
When pharmacies, wholesalers or other end users check a pack against EMVS, the database always sends a response back to the end user. Some warnings also generate alerts which are sent to the pharmaceutical company.
e-VIS has published recommendations for how warnings and alerts should be handled in the EMVS. The recommendations are a supplement to the EMVO Best Practice on Alert Handling.
When pharmacies, wholesalers or other end users check a pack against the SMVS (e-verification database), the database always sends a response back to the end user. The response may either be information that the decommission of the pack was successful, or an exception from the system. Certain exceptions also generate alerts, which means that e-VIS and the pharmaceutical company are notified of the exception.
e-VIS has developed recommendations for how exceptions and alerts should be handled in the e-verification system. e-VIS recommendations for the handling of exceptions and alerts from SMVS have been developed together with pharmacies, wholesalers and pharmaceutical companies. The recommendations complement the EMVO Best Practice on Alert Handling.
End users (pharmacies, wholesalers and healthcare providers) must investigate all exceptions, alerts and unexpected responses generated in the SMVS after checking and decommissioning packs.
“Provide for investigation of alerts”
e-VIS must ensure that all alerts generated by end users in Sweden are investigated. e-VIS does this by collecting investigations of the alerts from end users (pharmacies, wholesalers and healthcare providers) and from the MAH/pharmaceutical company.
The purpose of investigating exceptions and alerts is to ensure that a technical or process-related cause can be found with the end user or the pharmaceutical company and thus ensuring that warning or alert does not represent a possible falsification.
Reporting or feedback to e-VIS from end-users and MAH:s should occur as soon as possible, but no later than within 2 working days.
Reporting of packs with errors in EMVS via the claims channels – reklameraläkemedel.se
End users must report packs with suspected or confirmed quality issues to the MAH or their local representative. If the cause of the alert cannot be found on the end user’s side, the pack should be reported.
- Always put alerts@e-vis.se in copy when reporting, giving feedback and corresponding regarding reports about exceptions and alerts.
End user documentation of causes for alerts in NMVS Alerts
If a cause can be found on the end user’s side and the exception has generated an alert, the end user must inform e-VIS of the cause of the alert. Reporting to e-VIS should be done via the e-VIS alert portal NMVS Alerts.
MAH investigations of alerts
MAHs are requested to inform e-VIS about their investigation of A2, A3 and A52 alerts, including information about whether a cause can be found on the MAH side or not.
- e-VIS has connected our national AMS NMVS-Alerts to the eAMS hub. When e-VIS now is connected, e-VIS can receive information about the MAH’s investigation directly if the MAH uses the eAMS hub.
- Information can still be sent via e-mail to alerts@e-vis.se
Information requested by the MAH when investigating alerts and packs reported end-users
- Whether a cause for the alert can be found on the pharmaceutical company’s side. If a cause is found at the MAH, the alert does not represent a potential falsification.
- e‑VIS and the end‑user do not need to know the actual root cause of the alert or what corrective actions the company will or has taken.
- When a cause is found on the company’s side: Is the defect causing the alert correctable?
- If the defect can be corrected, the end‑user may return the pack to the supply chain.
- If the defect cannot be corrected, the company must inform the end‑user how the non‑compliant pack should be handled.
- If the defect cannot be corrected, the pack may no longer remain in the supply chain. Inform the pharmacy, with e‑VIS in copy, whether:
- The end‑user (pharmacy) may dispose of the pack themselves
- The pack should be returned to the wholesaler
- The pack should be sent to the MAH for further investigation
- If the defect cannot be corrected, the pack may no longer remain in the supply chain. Inform the pharmacy, with e‑VIS in copy, whether:
If no cause can be found on the MAH’s side, the case must be reported so the case can be further investigated by the end-user.d user via the complaint channels.