Regulatory Requests List

Regulatory requests typically involve generating and delivering documents required for the submission dossier, but they can also be other tasks.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Requester, Regulatory Request Responder, Regulatory Lead, or Regulatory User

Regulatory Request Responders use the list as a task list and can accept or reject requests. Regulatory Requestors can view the list of requests they created and submit them to queues or specific people. Regulatory Administrators can view all regulatory requests.

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.

You can view these lists of requests:

  • Regulatory Requests page for the app lets you manage and access requests that you created, are assigned to you, or were added to a queue you belong to.
  • Requests page for a submission project. This page includes a tab for Related Requests. That tab lists the requests defined for specific tasks (including any phases, milestones, or gates) in the submission schedule.
  • Requests page for a schedule item also includes a Related Requests tab that lists requests for subtasks of that item.
  • Regulatory Requests page for a product that lets you access requests related to that specific product.

To access the list of all regulatory requests:

  1. Click Home .
  2. In the navigation pane, click Regulatory Requests.

To access this list from the home page:

  1. View the Market Registration home page.
  2. Click the Regulatory Requests page tab.

To access the list of requests for a specific submission:

  1. View the Regulatory Information page for the submission.
  2. Click the Requests page tab. This page also includes a Related Requests tab.

To access the list of requests for a specific item in the submission schedule:

  1. Open the submission.
  2. In the navigation pane, click Schedule.
  3. Click the name of the schedule item. The WBS and context pages for that item open.
  4. In the navigation pane, click Requests. This page also includes a Related Requests tab.

To access the list of requests for a product:

  1. View the Regulatory page for the product.
  2. Click the Regulatory Requests page tab. The list of requests for a product does not have any actions available.

To access the list of requests for a country:

  1. Open the country.
  2. In the navigation pane, click Regulatory Requests.

To access the list of requests for a regulatory request queue:

  1. View the Market Registration home page.
  2. In the navigation pane, click Regulatory Request Configuration.
  3. Click the Regulatory Request Queues page tab.
  4. Select a regulatory request queue.
  5. In the navigation pane, click Related Requests.

This topic describes:

This page discusses:

Columns

The order of the columns varies depending on whether you open the list of all requests, or the list of requests for a specific submission project.

Column NameDescription
Request NumberThe automatically generated number of the request. Click to view the Properties page. See Regulatory Request Properties.
TitleThe descriptive name of the regulatory request.
(Status)Status:

IconDescription
The request has not been accepted or rejected and the Reply By Date has passed.
The request is in process.
The request is complete.

StateThe current lifecycle state of the request:

StateDescription
CreateThe request has been created but not submitted to a person or queue. If the request is assigned to you, you can see the request.
Requested The request has been submitted, but has not been accepted or rejected.
AssignedTasks defined by the request have been assigned to individual Regulatory Users.
ReviewThe Regulatory Users have completed their tasks and the Regulatory Request is in review.
ClosedThe request has been approved.
RejectedThe request has been rejected.
CancelledThe request was cancelled.

OwnerThe person who created the request.

Does not show on the list of requests for a submission.

Originating CompanyThe company that originated the request.
Countries

Does not display when you access the Related Requests category for a country.

Countries where the device, if approved, would be sold.
Products

Does not display when you access the Related Requests tab from the Regulatory category of a product.

The products associated with the request. Click to view the Properties page for the product. See Product Line Management User's Guide: Product Properties Page.
Request TypeThe regulatory request type that defines what needs to be done to fulfill this request. The request type can include a questionnaire to determine who needs to review request deliverables.
Request AssigneeThe person assigned to respond to the request.
Request Queue

Does not display when you access the Related Requests category of a request queue.

The queue used by the request. The rules for the queue determine which queue the regulatory request is assigned to.

The person who created the request can assign a specific person, or let Market Registration determine who to show the request to based on the queue rules and membership.

A request has either a request assignee or a request queue value, but not both. If a specific person was not assigned the request, this column is blank until the request is submitted, then it shows the request queue.

Origination DateThe date the request was created.
Reply By DateThe date the request must be accepted or rejected in the regulatory request queue. Market Registration automatically allows 10 days for replies. Your Business Administrator can change the default value.
Needed By DateThe date the request must be complete.
NotesSpecific instructions from the person who created the request.

Does not show on the list of requests for a submission.

DescriptionAdditional details about the request.

Does not show on the list of requests for a submission.

WBS

Only shows on a Related Requests page tab.

The name of the schedule item associated with this related request. Click to open the WBS and context pages for that specific schedule item.

Filters for Regulatory Requests

The filter allows you to choose which regulatory requests show in the list. If you do not see a command that you need, it might show when you select a different filter. See Actions/Toolbar Commands for the Regulatory Requests Page to see which commands show when which filter is selected. Filters are not available when you access the Regulatory Requests page from a country or product.

Filter OptionDescription
AllShows all requests that meet the initiated, pending, or assigned criteria.
InitiatedShows requests that you created, including those that have not been submitted to Regulatory Responders or queues.
PendingDoes not show for Regulatory Requestors.

Shows requests that are in the Requested state but have not been accepted or rejected. The requests in this list are either assigned directly to you or to a request queue that you belong to.

AssignedDoes not show for Regulatory Requestors.

Shows requests assigned to you.

Filters for Related Requests

The filter allows you to choose which regulatory requests related to the regulatory request queue show in the list. Filters are only available when you access the Related Requests category of a request queue.

Filter OptionDescription
OpenShows all regulatory requests that are not in the Closed, Rejected, or Cancelled states.
ClosedShows all regulatory requests that are in the Closed, Rejected, or Cancelled states.
AllShows all regulatory requests.

Actions/Toolbar Commands for the Regulatory Requests Page

The actions that show depend on which filter option you select. Regulatory Requestors have access to commands only on the All and Initiated filter views. Actions are not available when you access the Regulatory Requests page from a country, product, or request queue.

ActionFilter OptionDescriptionFor More Information
Create Regulatory Request InitiatedCreates a new regulatory request.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Requester, Regulatory Request Responder, Regulatory Lead, or Regulatory User

Creating Regulatory Requests
Submit InitiatedSubmits the selected requests to the Request Responder. The request must be in the Create (to submit) or Rejected (to resubmit) states.

This action promotes the request to the Requested state, and the assignee or queue members can accept or reject it.

Required access role: Regulatory request owner

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Accept PendingMarks the request as accepted and assigns it to you.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Request Responder, Regulatory Lead, or Regulatory User

-
Reject PendingRejects the request.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Request Responder, Regulatory Lead, or Regulatory User

Rejecting Regulatory Requests
Assign PendingAssigns the request to another user.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Request Responder, Regulatory Lead, or Regulatory User

Assigning or Reassigning a Regulatory Request
Resassign AssignedIf the request is assigned to you, transfers it to another responder.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Request Responder, Regulatory Lead, or Regulatory User

Assigning or Reassigning a Regulatory Request
Delete All, InitiatedDeletes the request. Click OK to confirm. You can only delete requests that are in the Create state.

Required access role: Regulatory Request Administrator or regulatory request owner

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Cancel Initiated, AssignedCancels the request.

Required access roles in the Requested state: Regulatory request owner

Required access roles in the Assigned state: Regulatory Administrator or Regulatory Lead

Cancelling a Regulatory Request

Actions/Toolbar Commands for the Requests Page for a Submission or Schedule Item

See the Properties page for the request to access additional commands. The Related Requests page has no actions available.

ActionDescriptionFor More Information
Create Creates a new regulatory request.

Required access roles: Regulatory Request Administrator, Regulatory Administrator, Regulatory Requester, Regulatory Request Responder, Regulatory Lead, or Regulatory User

Creating Regulatory Requests
Submit Submits the selected requests to the Request Responder. Requests must be in the Create or Rejected states. This action promotes the request to the Requested state, and the assignee or queue members can accept or reject it.

Required access role: Regulatory request owner

-
Delete Deletes the request. Click OK to confirm. You can only delete requests that are in the Create state.

Required access roles: Regulatory Request Administrator or regulatory request owner

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