Modify Additional Information

Configure additional attributes specific to the folder to easily incorporate regulatory changes.

Prerequisites

To make the Additional Information option available under More menu of the eCTD 4.0 assembly folder, you must have the Context of Use Code field populated for selected folder.

To view or modify the additional information:

  1. On the assembly tree, select the folder you want to change.
  2. In the More list, click Additional Information.

    This icon is displayed if the Context of Use Code field is populated for selected folder.

  3. On the Additional Information page, click Edit.

    This option is not available if Additional Information is invoked from a locked Submitted view and sequence assembly added to a life cycle.

    Note: The regional information attributes are displayed according to the CV service configuration.

  4. Modify the attributes.
  5. Click Save.