Cancelling or Placing a Submission on Hold

You can place a submission project on hold (indicating at some point you plan to continue with the submission), or you cancel the submission project.

You cannot place the submission project on hold or cancel it if the background job to create market authorizations is in progress.

Required access roles to place a submission on hold: Submission Lead on the submission project with Regulatory Lead or Regulatory User role, or submission project owner

The message is displayed about the progress status of cancellation of a submission in the Process Steps page.

You can also restart the process of cancelling a submission using the Process Steps page of the submission if the process of submission cancel is failed. The error message is displayed with the Restart or Delete link, to start or delete the process of cancelling a submission.

If the process of cancelling submission is required more time than the configured time, a notification is sent to the user about the background job status either it is completed or failed. The notification message provides the hyperlink to the name of a submission so you can navigate to the Process Steps page of a submission.

Required access role to cancel a submission: Submission Project Owner

Before you begin: View the list of submissions. See Submissions Page.
  1. Select the submission project you want to cancel or place on hold.
  2. In the Actions menu or toolbar, click Hold or Cancel.
  3. If you selected Cancel, click OK to confirm.
  4. Enter these details:

    Field NameDescription
    DateShows the current date, or you can select a different date.
    TypeFor cancel only:

    Select why the submission project is cancelled:

    • Not Submitted
    • Withdrawn

    JustificationExplain why the submission project is cancelled or put on hold.

  5. Click Done.

The submission project is moved to the hold or cancel state. If you cancelled the submission, any market authorization changes for this submission project are closed.