Classifications for Market Registration

The Classifications page for a submission lets you associate the product governed by the submission product to one or more ATC or variation classifications.

Required access roles: Submission Lead on the submission project with Regulatory Lead or Regulatory User role, submission project owner, or Product Manager (when this page is accessed from a product).

You only see this page if IP Classification is installed.

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 for a submission project:

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

To access this page for a submission project:

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

To access this page for a 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 Classifications page tab.

This topic describes:

This page discusses:

Columns

Column NameDescription
Title Descriptive name of the class. Click to view its details.
NameThe first row shows the name of the submission project. The remaining rows show the name of the class.
TypeThe item type.
DescriptionAdditional descriptive information about the item.
StateThe current lifecycle state of the class.
OwnerThe person responsible for the class.
Classification PathThe library classification hierarchy for this item. The classes replicate the structure of the ATC or variation classification system, so that when combined, it shows the code for the product.
Note: A product can belong to more than one class.
Opens the class in a new window.

Actions/Toolbar Commands for a Submission

These actions show on Classifications page for a specific submission project.

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

Action NameDescription
Add ATC Classification Searches for and adds a classification from the ATC Classification library structure. Use this library for a submission that uses any regulatory activity category except Variation.

The search results show the library name and title. Expand the class structure until you reach the complete class definition for the product related to this submission.

Add Variation Classification Searches for and adds a classification from the Variation Classification library structure. Use this library for a submission that uses the Variation regulatory activity category.

The search results show the library name and title. Expand the class structure until you reach the complete class definition for the product related to this submission.

Remove Selected Removes the selected classification from the list. Click OK to confirm.

Actions/Toolbar Commands for a Product

These actions show on Classifications page for a specific product.

Required access roles: Submission project owner or Product Manager

Action NameDescription
Add Existing Searches for and adds a classification.

The search results show the library name. Expand the class structure until you reach the complete classification.

Remove Selected Removes the selected classification from the list. Click OK to confirm.