Possible ways of closing alerts according to the type of alert

• Alerts that are generated by CZMVS end users and identified as a technical error (i.e. fixable), i.g. an incorrect scanner or keyboard setting (CapsLock, switched keyboard), a software error or an incorrect manual entry, can be closed in the Alert Management System with the status "Closed - EU - Technical Error" by end user once their cause has been removed. The medicinal product can be dispensed once it has been successfully verified and the unique identifier decommissioned.

  

• Alerts caused by an  end-user error where cause of the alert is identified as a process error

The most often the cause are  incorrectly set processes in the end user organization, human error or rules set in the end user software causing repeated unique identifier decommission. Alerts caused due the one of the mentioned reason can be closed in the AMS with the status: “Closed – EU - Process error" even directly by the end user. Part of the closing of the alert must be documentation/justification, what led to the occurrence of the alert (within the AMS NOOL it will be possible to select one of the preset causes and, if necessary, add a comment). Subsequently, it will be possible in defined cases to release the packaging of the medicinal product from quarantine and release it to the public. 

This is a pre-negotiated procedure with NCA and we are currently working on defining requirements for closing individual alerts with relevant explanations and documentation. Once it is approved by NCA, in the AMS NOOL will be set to select a variant of the reasons justifying the occurrence of the alert. All entities will be informed in advance of the start of this procedure.

• Alerts clearly generated by MAH/OBP may be closed by marketing authorization holders without any detailed investigation. Marketing authorization holders must state the cause of the alert and use the appropriate option to close the alert in the Alert Management System.