Submissions Page for a Other Objects

The Submissions page lists those submissions associated with a submission master record or market authorization.

To view submissions for a submission master record:

  1. Open the required submission master record. See Opening a Submission Master Record.
  2. In the navigation pane, click Authorizations.
  3. Click the Submissions page tab.

To view submissions for a market authorization:

  1. Open the required market authorization. See Opening a Market Authorization.
  2. In the navigation pane, click Submissions.

This topic describes:

This page discusses:

Columns

SectionColumn NameDescription
NameThe automatically-generated name of the submission.

Click to open the Properties page for the submission in a new window.

TypeThe object type: Submission.
TitleA descriptive name of the submission.
Regulatory ContextRegulatory AuthorityThe market authorization in this market authorization.
Submission TypeThe type of regulatory market authorization in this regulatory context.
Regulatory CategoryRegulatory category in this regulatory context.
Regulatory ActivityCategoryThe regulatory activity category defined for this submission.
Sub CategoryThe subcategory for the activity category.
Publishing File FormatThe file format required for submitting the regulatory activity category for this submission.
Submission Status StatusThe current lifecycle state of the submission.
Dossier SubmittedThe type of submission evaluation:
  • Evaluation
  • Referral
  • Appeal
  • Consensus Reached

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

ResultsThis column is blank until the results are entered.

How the regulatory authority ruled on the submission:

  • Approved
  • Rejected
  • Withdrawn

Actual Finish DateThe actual finish date of the submission project.
Lead SubmissionShows the lead submission of a group of submissions. Only shows a value if this submission belongs to a group submission.
Market Authorization ChangesThe market authorization changes associated with the submission project.

Does not show on the list of submissions for a submission master record.

DescriptionDetails about the submission project.
OwnerThe person responsible for the submission. Click to view the Properties page for that person. In edit mode, you can change the owner, but you can only select users with the Regulatory Lead role.

Actions/Toolbar Commands

You only see actions on the submission list for a submission master record. The submissions list for a market authorization does not have any actions available.

The Initial Submission project managed by the submission master record must be complete before you can create any other types of submissions.

Action NameDescriptionFor More Information
Create Submission >
  • Initial
  • Variation
  • Renewal
  • Sunset Clause Exemption
  • Repeal
  • Commitment
Creates a new submission using the listed name as the regulatory activity category.

You cannot create a submission that uses the restricted authorization category from this page.

Required access role: Submission Lead on the submission project with Regulatory Lead role

Creating Submissions
CopyCreates a copy of the selected submission project.

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

Copying Submissions