Submissions Page

A submission is a specific type of project used to manage the process of obtaining market authorization for a regulated product.

Required access role: Regulatory Administrator (to view all submissions) or Regulatory User (to view the list of their submissions where the user is a project member)

For users to have access to a submission project and to be assigned tasks, they must be added as project members (see Project Management User's Guide: Working with Project Members for details).

Important: This app stores personal data in some settings. To follow good personal data management practices, Business Administrators might need to edit these settings to remove personal data, such as names, email addresses, and phone numbers.

To access the list of all submissions:

  1. Click Home .
  2. In the navigation pane, click Submissions.

To access the list of submissions related to a specific submission:

  1. Open the required submission. See Opening a Submission.
  2. In the navigation pane, click Regulatory Information.
  3. Click the Related Submissions page tab.

To access the list of submissions for a specific product:

  1. Open the required product. See Opening the Regulatory and Additional Details Categories for a Product.
  2. In the navigation pane, click Regulatory.
  3. Click the Submissions page tab.

To view submissions for a regulatory request that is associated with regulatory request type and has a regulatory context:

  1. Open the required regulatory request. See Opening a Regulatory Request.
  2. In the navigation pane, click Submission.

This topic describes:

This page discusses:

See Also
Submission Properties
In Other Guides
Grouping Rows in Structured Content

Columns

For the list of all submissions, Market Registration groups submissions by product. You can change the grouping method to suit your needs.

SectionColumn NameDescription
SubmissionNameThe automatically generated name of the submission.

Click to open the submission.

TypeThe object type: Submission.
StateThe current lifecycle state of the submission.
TitleA descriptive name of the submission.
Submission TypeThe type of regulatory submission type.
Regulatory CategoryRegulatory category requested for this submission.
Regulatory ActivityCategoryThe regulatory category defined for this submission.
Sub CategoryThe subcategory for the activity category.
Submission StatusNext MilestoneThe name of the next milestone that has a defined Milestone Purpose. Click to open the Schedule page for the milestone.

If a Lead Submission shows on this row (meaning that this submission belongs to a group of submissions), this column shows the milestone of the lead submission.

Current PhaseThe current Schedule phase of the submission. Click to open the Schedule page for the phase.
Dossier SubmittedThe type of submission evaluation:
  • Evaluation
  • Referral
  • Appeal

Regulatory Request Responders take this dossier evaluation type into consideration when preparing documents.

ResultsThe overall result of the submission. This column is blank until the results are entered.

How the regulatory authority ruled on the submission:

  • Approved
  • Rejected
  • Withdrawn

ProductThe products covered by this submission. Click the hyperlinked product count open a list of the products associated with the submission.
CountryThe countries covered by this submission. Click the hyperlinked country count open a list of the countries associated with the submission.
Cancellation

This section shows only when the page is filtered to show Hold or Canceled submissions and also if the current view is selected as Detailed View.

Cancellation DateIf the submission was canceled, the date it was canceled.
Cancellation TypeThe type of cancellation:
  • Canceled
  • Not Submitted
  • Withdrawn
Cancellation ReasonExplanation of why the submission was canceled.
Dossier Ready Finish Date This section shows if the current view is selected as Detailed View.EstimatedThe scheduled date of the milestone with the "Dossier Ready" purpose.
ActualThe actual date the milestone was completed.
Dossier Published Finish Date This section shows if the current view is selected as Detailed View.EstimatedThe scheduled date of the milestone with the "Dossier Published" purpose.
ActualThe actual date the milestone was completed.
Dossier Submitted Finish Date This section shows if the current view is selected as Detailed View.EstimatedThe scheduled date of the milestone with the "Dossier Submitted" purpose.
ActualThe actual date the milestone was completed.
Dossier Received Finish Date This section shows if the current view is selected as Detailed View.EstimatedThe scheduled date of the milestone with the "Dossier Received" purpose (the date the regulatory authority is expected to receive the dossier).
ActualThe actual date the milestone was completed (the dossier arrived at the regulatory authority).
Marketing Authorization Finish Date This section shows if the current view is selected as Detailed View.EstimatedThe scheduled date for the first milestone with the "Market Authorization" purpose. Your submission could have multiple milestones with this purpose.
ActualThe actual date the milestone was completed.
If shows, the submission is in Clock Stop, indicating that the submission is in an interactive review phase. Click to view the Properties page for the phase.
Number of Days This section shows if the current view is selected as Detailed View.From Creation To ResultsThe number of days from when the submission project was created until the Actual Date entered for the Results.
In Authority ReviewThe number of days from when the regulatory authority received the dossier until the first market authorization received.
In Clock StopThe number of days spent in the interactive review phase, if that phase is marked for clock stop.
Purpose

Only shows on the Related Submission page for another submission.

The purpose of the submission in the list:

PurposeDescription
<blank>The submission was manually added to this list.
GroupingThis submission is part of a multi-activity submission.
RevisionThis submission is a variation of the context submission. This purpose is set when you use the Copy Submission command to revise the submission.
CommitmentThis submission was created using the Create Submission > Commitment command.

Lead Submission The name of the submission that groups multiple submissions (including the one on this row) for various regulatory activities.
SubmissionDescription This column shows if the current view is selected as Detailed View.Details about the submission project.
OwnerThe person responsible for the submission.

Filter

You can use the Filter menu to select which submissions to show in the list by their status:

Filter OptionDescription
ActiveLists only the submission projects that are currently active.
CompleteLists only the submission projects that are currently complete.
HoldLists only the submission projects that are currently on hold.
CancelLists only the submission projects that are canceled.
AllLists all submissions.

Actions/Toolbar Commands: Submissions

When viewing the Submissions category for a product, no actions are available.

ActionDescriptionFor More Information
Create Submission

When viewing the Submissions category for a regulatory request, this is the only action available.

Creates a new submission project.

If you accessed this page from a regulatory request, the regulatory request must be in the Review state to create a submission project.

Required access role: Regulatory Lead

Creating Submissions
Copy Copies the selected submission to create a submission project.

The new submission includes most definitions of the original submission, such as regulatory context, regulatory authority, contacts and reviewers, and more. It does not include the region or any defined correspondence or issues.

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

Copying Submissions
Add Selected ToAdds the selected submissions to a dashboard. Select the dashboards, then click Submit.

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

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DeleteDeletes the selected submission. Click OK to confirm.

You can only delete a submission when it is in the Create state.

Required access role: Submission project owner

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Hold

You do not see this action if you filtered the page to show Hold or Canceled submissions.

Inactivates the selected submission (puts it on hold). You can only put a submission on hold if it is in the Draft, To Do, In Work or In Approval states.

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

Cancelling or Placing a Submission on Hold
Resume

You only see this action if you filtered the page to show all submissions or submissions on hold.

Resumes the submission process for the selected submission at the state it was in when it was put on hold. The submission must currently be on hold. You cannot resume canceled submissions.

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

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Cancel

You do not see this action if you filtered the page to show Canceled submissions.

Cancels the selected submission. You can only cancel a submission if it is in the Draft, To Do, In Work or In Approval states. You cannot resume a canceled submission. Any related market authorization is promoted to Obsolete, and the associated market authorization changes are promoted to Closed.

Required access role: Submission project owner

Cancelling or Placing a Submission on Hold
Enable Edit Toggles the page into Edit mode. In this mode, you can edit any cell that has a triangle in the upper left corner.
Note: To change dates for milestones, use the Schedule page tab.

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

Structured Content in Edit Mode
Disable Edit Toggles the page into the View mode.-
Customize / View Click the arrow to select a menu item:
  • Default View: Lists the default columns of the submission.
  • Detailed View: Lists all the columns of the submission.
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Actions/Toolbar Commands: Related Submissions

ActionDescriptionFor More Information
Add ExistingAdds an existing submission as related to the current submission.

You cannot add related submissions if the current submission is in archived, revised, or canceled.

About Searches
Create Submission > CommitmentCreates a submission with the regulatory activity category set to Commitment.

You must be the Regulatory Lead for the submission to perform this action. You can create a commitment submission even if the context submission is completed.

Creating Submissions
Create Submission > Renewal or Variation Creates a submission with the regulatory activity category set to Renewal or Variation.
Note: When you select the submission from the Related Submissions and create a submission as renewal or variation in the context of SMR, the latest revisions of a product also consider even the submission is created with the earlier revision of the product.

The user assigned with the Administrator can configure the setting to define whether only the latest product revisions are copied to the created submission from the SMR or not to copy. For more information, see Configuring Related Submissions.

 Creating Submissions
RemoveRemoves the selected submission. Click OK to confirm. The selected submission is no longer related to the context submission.

You cannot add related submissions if the context submission is in archived, revised, or canceled.

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Group Regulatory Activity > Add ExistingSearches for submission projects to add as a group to this submission. This submission becomes the lead submission for the added submission projects.

You cannot add a submission project if it has completed the Dossier Submitted milestone but the lead submission has not completed that milestone.

About Searches and Grouped Submissions
Group Regulatory Activity > RemoveRemoves the selected submission project from the group of submissions. Click OK to confirm.

Because all of the configuration for the grouped submission project was removed when it was added to the lead submission, you need to select a submission template for the disconnected submission project.

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