Regulatory Contexts List

Depending on your role, you can view the list of regulatory contexts for an item.

Required access roles: Regulatory Administrator or Regulatory Lead

If you can access the parent item, such as a submission template, regulatory guideline, or regulatory request type, you can access the list of regulatory contexts for that item.

To access this page for a submission template:

  1. Open a submission template. See Opening a Submission Type.
  2. Click the Contexts page tab.

To access this page for a submission project or submission master record:

  1. Open a submission project or submission master record. See Opening a Submission or Opening a Submission Master Record.
  2. In the navigation pane, click Regulatory Information.
  3. View the Contexts page tab.

To access this page for a regulatory calendar template or regulatory guideline:

  1. Open a regulatory calendar template or regulatory guideline. See Opening a Regulatory Calendar Template or Opening a Regulatory Guideline.
  2. In the navigation pane, click Regulatory Contexts.

To access this page for a regulatory request type:

  1. Click Home .
  2. In the navigation pane, click Regulatory Request Configuration.
  3. View the Request Types page tab.
  4. Select a regulatory request type.
  5. In the navigation pane, click Regulatory Contexts.

For the list of regulatory contexts for an initial submission, rows show highlighted in green. When market authorization is received, the contexts do not show any highlighting. For subsequent submissions within a submission master record, approved contexts have no highlighting, new contexts for that submission (such as a variation) show highlighted in green, and contexts removed from the submission show highlighted in red.

This topic describes:

This page discusses:

See Also
How Market Registration Creates Regulatory Contexts
Regulatory Authorities List
Submission Types List
Regulatory Categories List

Columns

SectionColumn NameDescription
NameThe name of the regulatory context.
Regulatory ContextRegulatory AuthorityThe regulatory authority for this context.
Regulatory CategoryThe regulatory category of this context.
Submission TypeThe submission type of this context.
Regulatory Activity

Only shows on the category page of a regulatory calendar template or regulatory guideline.

Category

The regulatory activity affected by this context.

Sub Category

The subcategory of a regulatory activity.

Actions/Toolbar Commands

Required access roles:

  • Submission template: Regulatory Administrator
  • Regulatory guideline: Regulatory Administrator
  • Regulatory calendar template: Regulatory Administrator
  • Submission project: Regulatory Lead
  • Regulatory request type: Regulatory Request Administrator

The Regulatory Contexts list for a submission master record does not have any actions available.

Action NameDescriptionFor More Information
Add Existing Allows you to search for and select a regulatory context to add to the object.

You can only add regulatory contexts to Inactive submission templates, regulatory calendar templates, regulatory request types, and regulatory guidelines.

You can add regulatory contexts to a submission project until the first market authorization is received (indicated by the market authorization change being promoted to the approved state). If the submission project is beyond the Preliminary state, you must also enter a justification.

Only regulatory contexts that have different regulatory authorities can be added to a regulatory request type.

The search results include active regulatory contexts and contexts that do not include regulatory submission types that depend on other submission types.

About Searches
Remove Selected Removes the selected regulatory context from the list. Click OK to confirm.

You can only remove regulatory contexts from submission templates, regulatory calendar templates, regulatory request types, and regulatory guidelines that are in the Inactive state.

For a submission, you cannot remove all of the regulatory contexts, and you can only remove regulatory contexts until the first market authorization change is approved. If the submission is beyond the Preliminary state, you must also enter a justification.

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Enable Edit

Not shown on the Category page for a submission.

Toggles the page into edit mode. In edit mode, you can edit the regulatory activity category and subcategory.

You can only edit regulatory contexts from submission templates, regulatory calendars, and regulatory guidelines that are in the Inactive state.

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Disable Edit

Not shown on the Category page for a submission.

Toggles the page into the view mode.