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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.
- Version 3.0 update on 7th of November 2022, changes in alert functionalities. Changes introduced by FiMVS Core release 1.10 have been addressed. The descriptions/functionalities regarding alerts NMVS_FE_LOT_12, NMVS_NC_PCK_20, NMVS_NC_PCK_21 and NMVS_NC_PCK_27 have been adapted. Links to reference documents have been updated.
- Version 4.0 update on 19th of November 2023, changes in alert functionalities. The entire working instruction has been updated considering the changes introduced in alert and return codes by the change of NMVS supplier. In scope of the working instruction are users connected to the NMVS via the REST API.
- Version 5.0 updated on 16th of May 2024, changes in alert functionalities. Changes introduced by FiMVS. Release 14 have been addressed regarding alerts A3 and A68. Links regarding lists of FiMVS operation codes and messages have been updated. Chapter regarding the alert of the expiry date mismatch has been updated.