Technical cause of the alert - closing the alert directly by the end user
Did you know that as of Q2 2021, the end user can close in Alert management system alerts caused by a technical error on their side as long as the subsequent verification is successful?
If there is an obvious technical error, i.g. incorrect scanner or keyboard settings (CapsLock, switched keyboard), software error or incorrect manual entry, the end user can close such an alert directly without the need of the Marketing Authorization Holder (MAH).
If the technical cause has been eliminated and the subsequent verification of the package has been successful, the alert can be closed in AMS immediately with the status "06b - Closed – End User - Technical error", either via the API dirrectly in end-user software or the web interface of AMS. This procedure significantly speeds up the entire investigation process, saves time for both, the end user and the MAH. And mainly, it allows immediate dispensing of the medicinal product to the patient without the need to quarantine the package, as imposed by the FMD obligation for the time of investigation of the alert cause. Therefore, we highly recommend closing such alerts directly, provided that the verification and the decommission of the unique identifier has been successful.