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Purpose

The purpose of this document is to describe the processes and procedures for handling alerts caused by the medicines verification system from the perspective of different user groups. The document can be used to further develop users' IT systems so that the user can quickly and easily see the content of the verification inquiry, the response from the FiMVS system, and can also distinguish whether it is an error message or an alert.

Revision history

  • Version 1.0 updated on 4th of December 2020, initial document created. SOP included in the Quality Management System and the structure has been aligned with the SOP template. Changes introduced by EU Hub R1.8 have been addressed. The most significant change is that all alerts are now propagated to the OBP.
  • Version 2.0 updated on 8th of November 2021, Changes in two alert functionalities. Document type has been changed to work instruction. Changes introduced by FiMVS Core release 1.09 have been addressed. The functionalities regarding alerts NMVS_NC_PCK_19 and NMVS_NC_PCK_22 have been modified.