Copying Submissions

You can copy an existing submission to take advantage of any folders, deliverables, or tasks (Schedule list) defined by the existing submission. The new submission also uses the regulatory context of the source submission.

For example, if you want to submit a supplemental submission, you might want to keep all of the folder content and create a different Schedule task structure. The copy process lets you choose what items from the source submission you to include in the new Submission, and what items you do not want to include. The copied submission uses the same regulatory context as the original submission.

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

Before you begin: View the list of submissions, or the list of submissions within a submission master record.
See Also
Submissions Page
  1. Select the needed submission.
  2. In the page toolbar or Actions menu, click Copy .
  3. Select how you want to copy from the selected submission to the new submission:

    Submission ItemDescription
    Folder ContentsSelect how the app should copy folders and folder content:

    OptionDescription
    CopyCreate a copy of existing items (changes made to these copies are independent of the originals).
    IgnoreDo not include folder content in the new submission.
    Reference ExistingLink to the existing items (changes made affect both submissions).

    TasksSelect if the app should copy the schedule to the new submission:

    OptionDescription
    CopyCreate a copy of all existing tasks in the Schedule.
    IgnoreDo not copy existing tasks.

    Task DeliverablesIf you selected Ignore above, you cannot copy or reference deliverables.

    If you selected Copy above, select how the app should copy task deliverables:

    OptionDescription
    CopyCreate a copy of existing items (changes made to these copies are independent of the originals). The copy includes the regulatory calendar.
    Reference ExistingLink to the existing items (changes made affect both submissions).
    IgnoreDo not include task deliverable content in the new submission.

    Related to source as

    OptionDescription
    Related SubmissionAfter creating the new submission, add it to the Related Submissions page of the original submission.
    Not RelatedThe new submission is not added to the Related Submissions page.
    RevisionYou can only choose Revision if the original submission uses Variation as its regulatory activity category.

    The new submission is connected to the original submission as a revision and does not show in the Related Submissions page.

    The revision lets a Regulatory lead update the regulatory information and track different assessments of the same variation by the regulatory authorities.

    Submission Master RecordClick if you need to choose a different submission master record for this submission.

    You do not see this field if you started from the list of submissions for an existing submission master record.

    You do not see this field if the existing submission use the Initial Submission or Restricted Authorization regulatory activity category. In this case, a new submission master record will be created for the new submission.

  4. Click Done, then click OK to clear the confirmation message.

The app creates the new submission and titles it Copy of TITLE, where TITLE is the title of the original submission. You can edit this title in the list of submissions or on the Properties page for this submission.

In addition to the items selected in the dialog box, Market Registration includes these items from the source submission with the new submission:

  • Regulatory contexts
  • Products
  • Countries
  • Regulatory activity category and subcategory
  • Regulatory guideline
  • Regulatory calendar template

In some cases, such as the regulatory calendar template and products, Market Registration does not make a copy, but connects the item to the new submission. In other cases, such as tasks, copies of the items in the source submission are created for the new submission.

The market authorization changes are NOT copied to the new submission.