Calyx RIM Publisher

Create an Amendment Submission

You can create a new sequence for an existing application and event. You must have the appropriate security permissions to create an amendment using the Create Submission wizard.

To create an amendment submission:
  1. Click Wizards > Create Submission.
    The Create Submission wizard opens to the Choose Submission Type page.
  2. Click Amendment.
  3. Click Next.
    The Complete Submission Properties page appears.
  4. Choose the applicable procedure in the table below to enter an electronic signature in wizards:
    Scenario Steps
    When electronic signature and SSO are enabled
    1. In the confirmation page, select a reason and enter comments for the reason.
    2. Click Next.
    3. Validate your identity by entering your user credentials in the dialog box.
    When electronic signature is enabled and SSO is disabled
    1. Select a reason and enter comments for the reason.
    2. Enter user ID and password and click Next.
  5. Enter the properties for the submission. 
    Concerned Member States will display only if the procedure type is MRP.
    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. The sequence code must be unique within the application. If you change default numbering format, the wizard will issue a message requesting confirmation that you accept the deviation from the default sequence numbering format.
  6. Click Next.
    The Create Submission Confirmation page appears.
  7. On the Create Submission Confirmation page, do one of the following:
    • To confirm your selections, click Next to confirm the creation. The Create Submission Summary page appears, indicating that a sequence has been created. Additional items that you can add to the submission may also be listed. Proceed to step 10.
    • To return to previous pages to change your selections, click Back.
    • To cancel the submission and return to the view form which you invoked the wizard, click Cancel.
  8. On the Create Submission Summary page, do any of the following:
    • To view the newly created sequence attributes, click the sequence link.
    • To create an assembly, click the first assembly link. This link is available for or 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. See Searching for an Assembly.
    • To create an eCTD, click the second assembly link to start the eCTD wizard.
    • To return to the location from which you invoked the Create Submission wizard, click Finish.