Submission Master Records List

Starting with the initial submission (the regulatory activity category for the submission project) for a product, the submission master record binds the latest information together to present complete information about the product authorizations.

You do not create submission master records. Market Registration creates a submission master record when you create a submission master record with the regulatory activity category set to initial submission.

After regulatory activity category is obtained, the product may require additional submissions for regulatory activities such as variations, supplements, renewals, repeal, commitments, or sunset clause exemptions may be pursued. Each of these activities is managed by a separate submission project. The submission master record provides the complete view of submissions for a product. When all market authorizations connected to a submission master record become obsolete, Market Registration archives the submission master record.

Required access roles:

  • Baseline: Leader
  • App-specific: Regulatory Administrator, Regulatory Lead, Regulatory User, or Submission Master Record Owner

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 this page:

  1. Click Home .
  2. In the navigation pane, click Submission Master Records.

This topic describes:

This page discusses:

Columns

Column NameDescription
NameAutomatically-generated name of the submission master record.
TitleDescriptive name for the submission master record.

Market Registration automatically creates the submission master record without a title. You can edit the properties to add a descriptive title.

TypeThe item type: Submission Master Record.
Submission TypeThe submission type for the master record. Click to open the Properties page for the submission type.

The Submission Type and Regulatory Category only show values for completed submission projects.

Regulatory CategoryThe regulatory category (such as drug or medical device) for the submission.
Modified OnThe most recent date that changes were made to the submission master record. Click to open the history for the submission master record.
OwnerThe person who owns the master record, originally the same person who owns the submission project for the Initial Submission.
Market AuthorizationsTotal number of released authorizations collected by this submission master record. Click to open the list. See Market Authorizations List
Ongoing SubmissionsList of incomplete submissions related to this master record. Click a submission name to open its Properties page.
ExpirationThe earliest expiration date from any market authorizations associated with this submission master record.
DescriptionDescription for the submission master record, originally taken from the description of the submission it was created from.
Scope of AuthorizationShows Restricted if the regulatory activity category is Restricted Authorization. For all other regulatory activity categories, shows as Full.

Filters

You can use the drop-down box on the page toolbar to show either Active or Archived submission master records. You cannot list all submission master records.