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Analyze change history for marketing authorization holder/applicant

In pharmacovigilance, the Marketing Authorization Holder (MAH) refers to the entity that holds the marketing authorization or license for a pharmaceutical product. Until the authorization is obtained, the entity is considered a marketing authorization applicant.

For all the marketing authorization holders or applicants previously configured in PV, you can view the history of changes performed to their data by the system users in a structured way that is easy in tracking. You can see who and when performed each action, the reason for that, if any, old and new values, if applicable, and so on.

To analyze the change history for marketing authorization holder or applicant

  1. In the PV application header, select the CONFIGURATION tab.

  2. On the page that opens, from the left pane, select Applicant / Holder.

    Accessing applicant and holder configuration
    Figure 1. Accessing applicant and holder configuration

  3. In the Applicant / Holder table that appears, locate the record for which you want to view the change history. Then next to it, from the Actions column, select More more_icon.png > Change History history_icon.png.

    Accessing change history for marketing authorization holder or applicant
    Figure 2. Accessing change history for marketing authorization holder or applicant

    Tip

    Alternatively, you can access the change history by opening the details page of the record of your interest and from the workspace toolbar, selecting More more_icon.png > Change History history_icon.png.

    Selecting to view change history from detailspage
    Figure 3. Selecting to view change history from detailspage

  4. In the Change History dialog that opens, view the structured history of all changes performed to the marketing authorization holder or applicant, who performed them, when, and so on.

    Analyzing change history for marketing authorization holder or applicant
    Figure 4. Analyzing change history for marketing authorization holder or applicant

You have analyzed the complete history of actions with marketing authorization holder or applicant data. Select ok_button_red_white.png to close the dialog.

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