Closing an alert in case the end user does not cooperate

Did you know that the MAH can now close an alert in cases where the end user has not provided additional information despite a request to do so?

Often the cause of the alert cannot be determined directly from the information available in the AMS and therefore MAH send a request for additional information (picture of the pack, explanation of the issue) to the end user. Such alert is set to the status „04a - MAH - info from end user“. The end user will then receive several notifications generated by AMS prompting them to cooperate in the investigation process. However, if there is no response within 14 days, the MAH can close the alert with the status „06o - Closed- End user does not cooperate - cannot be supplied“. Consequently, the concerned pack cannot be dispensed and must be kept in quarantine, until the requested information is provided to the MAH. This procedure has been approved by SÚKL (NCA).