Use the Change Submittal Status Wizard

You can change the submission status of sequences using the Change Submittal Status wizard.

To modify the submission status of a sequence:

1. Choose Wizard > Change Submittal Status.The Change Submittal Status wizard opens to the Choose Submission Status Type page.
2. Click Submitted. Note: You can use this wizard for a planned event that enforces status progression. For such an event, the wizard works only if the current status precedes the Submitted status in the event country schedule.
3. Click Next.The Select Change Submission Status Properties page appears.
4. Do the following:
   1. Select the Current Sequence code.
   2. In the Confirmed Sequence Code field, verify the number for the new sequence to be created by the wizard.
   3. The confirmed sequence code is determined based on the number of sequences that have been submitted to this application lifecycle, not the planned number that was used when creating the sequence. All previously submitted sequences are considered, even if the current Sequence Status is set to Approved. This ensures that the final sequence number remains consistent with what you are submitting. You can change the Starting Sequence Number attribute in the application attributes. That number becomes the confirmed sequence code. The wizard issues a message if you deviate from the default four-digit value. Respond to the message to continue.
   4. For the Submittal Date, choose when the submission status is to become effective.
   5. Use the Comment box to enter a comment that appears on the event and sequence entities affected

      by this update.

   6. If the submission is being submitted as a lifecycle eCTD, select the Lifecycle check box. Checking Lifecycle creates a submitted dossier view for the application and requires that all subsequent application updates are controlled lifecycle assemblies.
5. Click Next.If a multi-country submission is possible, the Select Event Countries page appears with the option to select event countries. If a multi-country submission is not possible, you will see a message indicating that no input is necessary. Go to step 7.
6. Select one or more Countries for the submission. Only unlocked countries associated with the event are available for selection.
7. Click Next.The Change Submission Status Confirmation page appears.
8. Click Next to confirm the submission status.The Change Submission Status Summary page displays a list of the actions performed by the wizard.
9. Click Finish to close the wizard.