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.
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.
MAH’s 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
- Access to the eAMS portal is provided by EMVO.
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.
- The MAH should always add alerts@e-vis.se on copy in the investigation with the end-user.
- 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.