AMS - R7.0 - changes for MAH in the automatic e-mail communication

We would like to inform you about changes in the automatic e-mail communication MAH is receiving through the Alert Management System (AMS). AMS has been operated and developed by our organisation since 2020. Based on comments and recommendations from users - pharmacies, distributors, MAH, NCA, the following changes will be implemented gradually:

  • The MAH/OBP will now also receive information about the alerts that occurred during the MAH/OBP transaction, always in bulk for all alerts for the previous day. If the MAH/OBP is in inactivity, it will receive the first escalation after 5 days, and the next after 10 days from the date of alert.
  • So far, the MAH/OBP has received information about the process error (alerts A7 and A24) immediately after the alert occurred. These alerts could only be investigated and closed after 9 days. From now on the MAH/OBP will receive notification of a new alert 48 hours after it has occurred and can start investigation immediately. In the meantime, the end-user has a deadline to resolve the alert.
  • In case of end-user procedural errors, only the end-user will be notified of inactivity.  The MAH/OBP will no longer receive escalation e-mails for inactivity. 
  • The escalation timeframes are changed for technical errors on the end-user side. Previously, the MAH/OBP was notified of inactivity after 5 and 10 days after the alert occurred. From now on the time limit will be shortened to first notification after 48 hours. Second remains after 5 days, third after 10 days from the date of the alert.

VIDEO - Notification and escalation system


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