Create a Major Update Submission

You can update an existing application for a new business objective or regulatory activity. When creating a major update submission, an event is created and you can create a sequence, if needed.

Note: To create a major update submission, an application must exist for the product family and associated country, and you must have the appropriate security permissions.To create a major update submission:

1. Click Wizards > Create Submission.The Create Submission wizard opens to the Choose Submission Type page.
2. Click Major Update.
3. Click Next.The Complete Submission Properties page appears.
4. On the Complete Submission Properties (event/sequence) page, do any of the following:

   Option	Action
   To create an event:	Enter an Event Code, Keywords and Description.
   To use a timeline/event plan to create the event:	Select a Timeline/Event Plan from the drop-down list.
   To change the event type:	Select the value from Event Type drop-down list.
   To create a sequence:	Select the Create sequence? check box. Creating a sequence is optional.Note: If you choose to create a sequence, you can change the default sequence numbering of a P followed by four digits. This numbering scheme is the format recommended for an eCTD submission. If you change, the format, Ennov InSight will issue a message requesting confirmation that you accept the deviation from the default sequence numbering format.Select the Filing Type and Sequence Standard Type.

5. Click Next to confirm your selections.The Create Submission Confirmation page appears.
6. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

7. Do one of the following:

   Option	Action
   To confirm your selections.:	Click Next. The Create Submission Summary page opens, listing the created items. Additional items you can add to the submission may also be listed. Proceed to step 8.
   To return to previous pages to change your selections:	Click Back.
   To cancel the submission entirely and return to the view from which you invoked the wizard:	Click Cancel.

8. On the Create Submission Summary page, do any of the following:

   Option	Action
   To view the created event:	Click the event link.
   If you created a sequence and want to view it:	Click the sequence link.
   To update a PDS associated with the event. This option is available for PDM users:	Click the PDS link.
   To create an assembly:	Click the first assembly link. This link is available for SPT, ELP, and RDA users.
   If you create an assembly from an existing template, assembly, or view, to find an assembly:	Click Browse and use the Search Assembly wizard.
   To create an eCTD:	Click the second assembly link to start the eCTD wizard.
   To return to the location where you invoked the Create Submission Wizard:	Click Finish.