Regulatory Request Process Steps

Products

The Products panel lists the products associated with the regulatory request.


Column Name	Description
Product	The product whose market authorization is being requested by the regulatory request.
Type	The type of product associated with the regulatory request.
Marketing Name	The marketing name for the product.
Product Line	The product line to which the product belongs.
Revision	The current revision of the product.

Process Steps

The process steps for completing a regulatory request correspond to the regulatory request's lifecycle states.

Note: The process step numbering can be dependent upon decisions made by the regulatory request responder in previous steps, such as rejecting or cancelling the regulatory request.


Process Step	Process Step Description	Corresponding Regulatory Request Lifecycle State
1 Business Case	Define the business case and rationale for requesting a marketing authorization submission project be created for the product.	Create
2 Assign Request	Assign the regulatory request to a regulatory request responder for evaluation.	Requested
3 Evaluate Request	Evaluate the regulatory request's business case and rationale to determine whether a submission project for its market authorization should be created.	Assigned
4 Request Approval	Approve the regulatory request and create the submission project for the market authorization.	Review
5 Request Closed	Close the regulatory request once the submission project is initiated.	Closed
3 Request Rejected Note: This step only appears if the regulatory request is rejected.	The regulatory request was rejected and no submission project was created.	Rejected
4 Request Cancelled Note: This step only appears if the regulatory request is cancelled.	The regulatory request was cancelled.	Cancelled

The status bar shows you where you are in the process steps:

The completed process steps are shown in green.
The active process steps are shown in blue.
The process steps that are not yet available are shown in gray.
The currently-selected process step is shown with dark text (instead of white) and a border around the step number.

Each process step consists of several tasks that are optional or mandatory, and some that may be dependent on the completion of others. You must complete all mandatory tasks for a process step before you can start the next process step. An icon shows the status of each process step task:


Icon	Process Step Task Status
	The process step task is complete.
	The process step task is optional, but not completed. You can work on this task, but you are not required to complete it to move to the next process step. If you complete the optional task, it is then marked as complete.
	The process step task is mandatory and pending. You can begin work on this task, but you must complete it to move the next process step.
	The process step flow is blocked by this incomplete mandatory or dependent task.
	The process step task is not yet available for completion because another task on which is depends is not yet complete.

Process Step

Column Name

Description

1 Business Case

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Identify Countries for Regulatory Request	Mandatory	Identify the countries in which you will be requesting market authorization for the products.
Identify Products for Regulatory Request	Mandatory	Identify the products for which you will be requesting market authorization.
Include All Supporting Documents	Optional	Identify and attach all documents to support your request to initiate a submission project for market authorization of the products in the identified countries. If you add supporting documents, this optional task will be shown as completed.
Define Business Rationale and Impacts	Optional	Define the business rationale and impacts to the business for requesting the initiation of a submission project for market authorization. If you complete the reviewer questionnaire and submit it, this optional task will be shown as completed.
Complete Impact Assessment on Business due to Registration	Optional	Complete the impact assessment associated with the regulatory request to specify the impact on the business to get market authorization of the products. If you complete the impact questionnaire and submit it, this optional task will be shown as completed.
Submit Request	Mandatory	Submit the regulatory request for review and approval by the regulatory request responder.

Role

The role of the person who can complete this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Identify Countries for Regulatory Request	(Identify Countries for Regulatory Request)	Select one or more countries in which you want to request market authorization for the products.
Identify Products for Regulatory Request	(Identify Products for Regulatory Request)	Select one or more products for which you want to request market authorization in the selected countries.
Include All Supporting Documents	(Identify Reference Documents to add in Regulatory Request)	Drop documents on the Drop icon to add reference documents. Click Add Existing to add the existing refrence documents.
Define Business Rationale and Impacts	(Reviewer Questionnaire)	Complete and submit the Reviewer Questionnaire to answer questions about the business rationale for the request for market authorization of the products in the selected countries. See Questionnaire Tab for Reviewer Questionnaire.
Complete Impact Assessment on Business due to Registration	(Impact Questionnaire)	Complete and submit the Impact Questionnaire to assess the impact of this regulatory request on the business. See Completing an Impact Questionnaire.
Submit Request	(Submit Request)	Submit the regulatory request to the responder for review and evaluation. This promotes the regulatory request from the Create state to the Requested state.

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Identify Countries for Regulatory Request	(Countries)	Opens the list countries associated with the regulatory request. See Collaboration and Approvals User's Guide: Countries Page.
Identify Products for Regulatory Request	(Products)	Opens the list of products associated with the regulatory request. See Request Products List.
Include All Supporting Documents	(Reference Documents)	Click Related Data icon to view the added documents.
Define Business Rationale and Impacts	(Regulatory Request Name)	Opens the questionnaire associated with the regulatory request. See Questionnaire Tab for Reviewer Questionnaire.
Complete Impact Assessment on Business due to Registration	(Regulatory Request Name)	Opens the impact questionnaire associated with the regulatory request. See Questionnaire Tab for Reviewer Questionnaire.
Submit Request	-	-

2 Assign Request

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Assign Regulatory person to evaluate the Request	Mandatory	If not assigned when the regulatory request was created, assign a regulatory request responder.
Accept/Reject Request from Queue	Mandatory	If you are assigned as the regulatory request responder, accept or reject responsibility for the regulatory request from the request queue.

Role

The role of the person who can complete this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Assign Regulatory person to evaluate the Request Note: You must be the regulatory request responder to view and use this action.	(Assign Regulatory Request)	Select a person to act as the regulatory request responder. See Assigning or Reassigning a Regulatory Request.
Accept/Reject Request from Queue	(Accept Regulatory Request)	Accept the responsibility of acting as the regulatory request responder for this regulatory request.
Accept/Reject Request from Queue	(Reject Regulatory Request)	Reject the responsibility of acting as the regulatory request responder for this regulatory request. This promotes the regulatory request from the Requested state to the Rejected state. See Rejecting Regulatory Requests.

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Assign Regulatory person to evaluate the Request	-	-
Accept/Reject Request from Queue	-	-

3 Evaluate Request

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Reassign Person Responsible for Evaluation	Optional	If necessary, reassign the regulatory request responder responsibility to another person.
Define Business Rational and Impacts	Mandatory	Define the business rationale and impacts to the business for requesting the initiation of a submission project for market authorization. This task is only available if it was not completed in Step 1.
Complete Impact Assessment on Business due to Registration	Optional	Complete the impact assessment associated with the regulatory request to specify the impact on the business to get market authorization of the products. This task is only available if it was not completed in Step 1. If you complete the impact questionnaire and submit it, this optional task will be shown as completed.
Include All Supporting Documents	Optional	Create or search for and add all documents that support this regulatory request. This task is only available if it was not completed in Step 1. If you add supporting documents, this optional task will be shown as completed.
Cancel Request	Optional	If necessary, cancel the regulatory request.
Submit Request for Review	Mandatory	Submit the regulatory request for review.

Role

The role of the person who can complete this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Reassign Person Responsible for Evaluation	(Assign Regulatory Request	Reassign the regulatory request responder responsibility to another person. See Assigning or Reassigning a Regulatory Request.
Define Business Rational and Impacts	(Reviewer Questionnaire)	Complete and submit the Reviewer Questionnaire to answer questions about the business rationale for the request for market authorization of the products in the selected countries. See Questionnaire Tab for Reviewer Questionnaire.
Complete Impact Assessment on Business due to Registration	(Impact Questionnaire)	Complete and submit the Impact Questionnaire to assess the impact of this regulatory request on the business. See Completing an Impact Questionnaire.
Include All Supporting Documents	(Reference Documents)	Create or search for and add all documents that support this regulatory request. See Collaboration and Approvals User's Guide: Reference Documents.
Cancel Request	(Cancel Regulatory Request)	Cancel the regulatory request. This promotes the regulatory request from the Assigned state to the Cancelled state. See Cancelling a Regulatory Request.
Submit Request for Review	(Submit Request for Review)	Submit the regulatory request for review. This promotes the regulatory request from the Assigned state to the Review state.

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Reassign Person Responsible for Evaluation	-	-
Define Business Rational and Impacts	(Regulatory Request Name)	Opens the questionnaire associated with the regulatory request. See Questionnaire Tab for Reviewer Questionnaire.
Complete Impact Assessment on Business due to Registration	(Regulatory Request Name)	Opens the impact questionnaire associated with the regulatory request. See Impact Questionnaire Tab for Responses.
Include All Supporting Documents	-	-
Cancel Request	-	-
Submit Request for Review	-	-

4 Request Approval

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Complete Impact Assessment on Business due to Registration	Mandatory	Complete the impact assessment associated with the regulatory request to specify the impact on the business to get market authorization of the products. This task is only available if it was not completed in Steps 1 or 3.
Start Regulatory Submission tracking process	Mandatory	Create a submission project from the regulatory request to request market authorization for the products in the selected countries.
Approval task name Note: There may be multiple tasks for the regulatory request.	Mandatory	Complete the approval route task.
Close Request	Mandatory	Close the regulatory request after the submission project has been created.

Role

The role of the person who can complete this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Complete Impact Assessment on Business due to Registration	(Regulatory Request Name)	Opens the impact questionnaire associated with the regulatory request. See Impact Questionnaire Tab for Responses.
Start Regulatory Submission tracking process	(Create Submission)	Create a submission project from the regulatory request. See Creating Submissions.
Approval task name Note: There may be multiple tasks for the regulatory request.	(Approve)	Note: Click Edit Details to provide approval comments before you approve the task. Enter your User Name and Password, then select the check box to provide your electronic signature for the task approval.
	(Reject)	Note: Click Edit Details to provide rejection comments before you reject the task. Enter your User Name and Password, then select the check box to provide your electronic signature for the task rejection.
	(Edit Details)	Click Edit Details to provide approval or rejection comments before you approve or reject the task.
Close Request	(Complete Request process)	Close the regulatory request. This promotes the regulatory request from the Review state to the Closed state.

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Complete Impact Assessment on Business due to Registration	(Regulatory Request Name)	Opens the impact questionnaire associated with the regulatory request. See Impact Questionnaire Tab for Responses.
Start Regulatory Submission tracking process	(Manage Submission)	Opens the list of submission projects created from the regulatory request. See Submissions Page.
Approval task name Note: There may be multiple tasks for the regulatory request.	(Approval Task Name)	Opens the list of tasks for the regulatory request. See Collaboration and Approvals User's Guide: Tasks Page for a Route.
Close Request	-	-

5 Request Closed

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Request Closed	Mandatory	The regulatory request is closed.

Role

The role of the person who can complete this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Request Closed	-	-

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Request Closed	-	-

3 Request Rejected

Note: This step only appears if the regulatory request is rejected.

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Re-instate Regulatory Request	Optional	If necessary, reinstate the regulatory request for approval.

Role

The role of the person who completed this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Re-instate Regulatory Request	(Re-instate Regulatory Request)	Reinstates the regulatory request. This demotes the regulatory request from the Rejected state back to the Requested state.

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Re-instate Regulatory Request	-	-

4 Request Cancelled

Note: This step only appears if the regulatory request is cancelled.

Task

and

Task Type

The tasks that can be completed for this process step and an indication of whether it is mandatory that they must be completed:


Task	Task Type	Description
Reject or Cancel Request	Mandatory	The regulatory request has been cancelled. It is in the Cancelled state.

Role

The role of the person who can complete this process step task.

Owner

The ID of the person who owns this process step task.

Actions

The actions that you can perform while completing this process step task:


Task	Icon	Description
Reject or Cancel Request	-	-

Related Data

A link to other data that is relevant for or related to this process step task:


Task	Icon	Description
Reject or Cancel Request	-	-