Products List for a Submission

The Products page lists the products governed by the submission project. The page lists the products, but does not show the relationship between those products, such as which products are derived, revised, or branched from other products.

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 Products page tab.

This topic describes:

This page discusses:

See Also
Products
Products List for a Submission Master Record or Country

Columns

Column Name Description
Marketing Name The marketing name of the product.
Name The name of the product. Click to open that product.
If shows, a higher revision of the product exists.
If shows, an engineering change order exists for this product.
Model Shows the model with which the product is associated.
Revision Shows the product revision number or code.
Type Shows the type of product.
Description Descriptive information about the product.
Start Effectivity The start effectivity date of the product.
End Effectivity The end effectivity date of the product.
Governing Project The project that manages the product development (separate from this submission project that manages the submission effort associated with the product).
Current Phase The current milestone or phase of the governing project.
Phase Completion The estimated completion date of the current phase of the governing project.
State The current state of the product in its lifecycle.
Owner The person responsible for the product.
Design Responsibility The organization or project that has the design responsibility for the product.

Actions/Toolbar Commands

You cannot add or remove products if the first market authorization milestone is complete.

Action Description For More Information
Add Existing Searches for a product to add to this list.

You can only add products if the submission has not reached the Submitted state.

Tip: When adding a product to a submission project, check the Regulatory Information page first. If the Follows Leading Country field on the Regulatory Information page uses the "As Defined" or "With Deviation" options, make sure that a Leading Country is also defined.

When using a leading country, you can only add products that have a market authorization for the leading country in the In Work, Authorized, or Released state.

If the submission is beyond the Created state, you must provide a justification. Market Registration creates a new market authorization (and its associated market authorization change) for each product. Separate market authorizations are created for each country connected to the submission master record.

If the product has any indications, Market Registration copies those indications and connects them to the submission project.

You can only add products that are not attached to a submission master record, unless all of the market authorizations for that product are obsolete.

If the submission type is initial submission, restricted authorization, or variation, you can add additional products to the list.

About Searches and Justifying Changes to Submissions
Remove Selected Removes the selected product from the list.

You cannot remove a product if it has a related market authorization change beyond the In Work state.

If the dossier submitted milestone is complete, Market Registration marks all market authorizations and market authorizations for this product (one for each country connected to the submission master record), as closed or obsolete, and using withdrawn as the status.

Any indications that were added to the submission from this product are NOT removed from the submission. You can manually remove the indications if appropriate.

If a removed product is attached to a regulatory activity, Market Registration creates a new market authorization and associated market authorization change.

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Revisions Lets you select the current revision of the product that is connected with the SMR or all the revisions of the product.