Submission Process Steps

The submission's Process Steps page lists the submission content associated with the submission and shows the process steps required to complete the submission project.

You can now promote a submission from the Draft to To Do state before the process of creating related market authorizations is completed. The message is displayed about the progress status of creating market authorization in the Process Steps page of the submission.

You can also restart the process of creating a market authorization using the Process Steps page of the submission if the market authorization is failed. The error message is displayed with the Restart link, to start the process of creating a market authorization. The submission cannot be promoted from the To Do state to the next state if the process of creating a market authorization is not completed or failed.

If the process of creating a market authorization required more time than the configured time, a notification is sent to the user about the background job status either it is completed or failed. The notification message provides the hyperlink to the name of a submission so you can navigate to the Process Steps page of a Submission.

This page discusses:

Submission Content

The Submission panel lists the submission dossier and published dossier associated with the submission project. This panel is collapsed by default after the submission project reaches the In Work state and the Market Authorization panel is available.

Column Name Description
Folder Name The name of the dossier.
Action

The following actions are available for the submission dossier:

Icon Action Description
Subscription Options

View and select subscriptions for the submission project's submission dossier. See Collaboration and Approvals User's Guide: Subscription Management.
Publish If the publishing file format is set to eCopy, publish the submission dossier files as PDF.
Publish Without PDF If the publishing file format is set to eCopy, publish the submission dossier files in their native file formats.
Package If the publishing file format is not set to eCopy, package the submission dossier files as PDF.
Package Without PDF If the publishing file format is set to eCopy, package the submission dossier files in their native file formats.

The following action is available for the published dossier:

Icon Action Description
Subscription Options

View and select subscriptions for the submission project's published dossier. See Collaboration and Approvals User's Guide: Subscription Management.

Owner The owner of the submission project.
Modified The date on which the submission was last modified.

Market Authorization

The Market Authorization panel lists the market authorization associated with the submission project. This panel is only available after the submission project reaches the In Work state. It is expanded by default.

Column Name Description
Name A hyperlink to the market authorization associated with the submission project.
State The current lifecycle state of the market authorization.
Products A numbered hyperlink to the products associated with the market authorization. The number of products is the title of the hyperlink. If the single product is associated with the market authorization, by default, the Regulatory view is opened of the context product.
Parts The numbered hyperlink to the parts associated with the market authorization. The number of parts is the title of the hyperlink
Country The country associated with the market authorization.
Authorization Number The authorization number assigned to the market authorization.
Effectivity Date The date on which the market authorization becomes effective.
Approved Date The date on which the market authorization was authorized.
Expiration Date The date on which the market authorization expires.

Process Steps

The process steps for completing a submission project loosely correspond to the its lifecycle states.

Note: The process step numbering is dependent upon whether an interactive review is added to the submission project.

Process Step Process Step Description Corresponding Submission Project Lifecycle State
1 Preparation Define the regulatory information to set up the submission project. Draft
2 Planning Schedule and track the activities required to gather the submission documents. Draft
3 Dossier Assembly Manage the submission dossier folder structure and gather the submission documents. To Do
4 Dossier Publishing Create the finalized publication dossier from the submission dossier contents. In Work
5 Dossier Submission Submit the published dossier to the regulatory agency that grants market authorizations. In Work
6 Interactive Review if there is a regulatory calendar or an interactive review associated with the submission project. Manage the regulatory questions associated with the published dossier. In Work
6 Market Authorization if there is no regulatory calendar or an interactive review associated with the submission project.

or

7 Market Authorization if there is a regulatory calendar or an interactive review associated with the submission project.

 Manage the product registration information for the market authorization. In Work, In Approval
7 Complete Submission if there is no regulatory calendar or an interactive review associated with the submission project.

or

8 Complete Submission if there is a regulatory calendar or an interactive review associated with the submission project.

 Close the submission project. In Approval

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 Preparation 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 Products for Market Registration Mandatory Add the products to which the market registration applies.
Identify Countries to Register Products Mandatory Add the countries that will provide market registrations for the products.
Assign Regulatory Authority, Regulatory Category and Submission Type Mandatory Add the regulatory context that applies to the market registration.
Specify Country of Origin for Following Countries Mandatory Identify the Leading Country for the submission project.
Specify Publishing File Format Mandatory Specify the publishing file format that will be used for the submission project's published dossier.

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 Products for Market Registration (Add Products) Select the products to be associated with the market registration.
Identify Countries to Register Products (Add Countries) Select the countries that will provide market registrations for the products.
Assign Regulatory Authority, Regulatory Category and Submission Type (Add Regulatory Context) Select a regulatory context for the submission project to define its regulatory authority, regulatory category, and submission type.
Specify Country of Origin for Following Countries (Edit Leading Country) Select the Lead Country for the submission project.
Specify Publishing File Format (Specify Publishing File Format) Select the publishing file format for the submission's published dossier.

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

Task Icon Description
Identify Products for Market Registration (Products) Opens the products list for the submission project. See Products List for a Submission.
Identify Countries to Register Products (Countries) Opens the country list for the market registration. See Countries Page.
Assign Regulatory Authority, Regulatory Category and Submission Type (Regulatory Context) Opens the regulatory context list for the submission project. See Regulatory Contexts List.
Specify Country of Origin for Following Countries (Submission Name) Opens the regulatory information properties page for the submission project, which shows the Leading Country field. See Regulatory Information Properties Page.
Specify Publishing File Format (Submission Name) Opens the regulatory information properties page for the submission project, which shows the Publishing File Format field. See Regulatory Information Properties Page.
Note: After all of these tasks are completed, the next process step is automatically available.
2 Planning 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
Define Project Team Optional Select one or more members who are part of the submission project team. If you add project team members, this optional task will be shown as completed.
Define Tasks to Track All Phases of Dossier Creation and Regulatory Authority Interaction Mandatory Add any needed submission project milestones other than the default ones already present in the schedule.
Assign Tasks to Team Members Optional Assign the project tasks to project team members.
Set Schedule Preferences & Reminders Optional Set the preferences for the submission project such as enabling approvals, schedules, tasks, milestones, and reminders.
Manage Country Information Optional Configure information for the countries associated with the submission project, such as regional company representatives and distributors.
Start Gathering Documents to Prepare Dossier Mandatory Complete the planning phase so that you can begin assembling the contents of the submission dossier.

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
Define Project Team (Define Project Team Select the users who should be part of the submission project team.
Define Tasks to Track All Phases of Dossier Creation and Regulatory Authority Interaction (Schedule) Automatically check to see that the default milestones exist in the submission project schedule. If needed, add project milestones, regulatory calendars, and tasks to the submission project schedule. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.
Assign Tasks to Team Members (Assign Tasks to Team Members) Select project team members to assign to tasks and milestones. See About the Schedule Page.
Set Schedule Preferences & Reminders (Set Schedule Preferences & Reminders) Set the preferences for the submission project such as enabling approvals, schedules, tasks, milestones, and reminders. See Setting Notification Preferences for Regulatory Milestones
Manage Country Information (Manage Country Information) Edit the information for the countries associated with the submission project, such as regional company representatives and distributors. See Countries Page.
Start Gathering Documents to Prepare Dossier (Start Gathering Documents to Prepare Dossier) Promote the submission project from the Preparation state to the To Do state so that you can begin assembling the contents of the submission dossier.

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

Task Icon Description
Define Project Team (Project Team Members) Opens the Sharing page that lists project team members. See Sharing Page.
Define Tasks to Track All Phases of Dossier Creation and Regulatory Authority Interaction - -
Assign Tasks to Team Members - -
Set Schedule Preferences & Reminders - -
Manage Country Information - -
Start Gathering Documents to prepare Dossier - -

3 Dossier Assembly 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
Manage Dossier Folders Optional Create the submission dossier folders and manage the structure that will be used in the published dossier.
Gather Documents & Create Dossier Technical File Optional Add submission documents to submission dossier folders. Synchronize contents between local and master folders.
Manage Contacts for Submission Optional Manage the people who are contacts for the submission project, such as from the regulatory authority and other involved parties. If you add a contact, this optional task will be shown as completed.
Update Correspondence of Pre-Submission Meeting with Authority Optional Manage correspondence regarding the submission project, such as communications between your company and the regulatory authority and other involved parties. If you add correspondence, this optional task will be shown as completed.
Complete Milestone 'Dossier Ready' End Date: <Date>

After you complete the task, the date is no longer shown.

 Mandatory Complete the submission project's Dossier Ready milestone so that can publish the dossier.

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
Manage Dossier Folders (Manage Dossier Folders) Use the tabs in the submission's Folders category to create the submission dossier folders and manage the structure that will be used in the published dossier. See Folder Lists for Submissions.
Gather Documents & Create Dossier Technical File (Gather Documents & Create Dossier Technical File) Use the tabs in the submission's Folders category to perform library-related tasks. See Folder Lists for Submissions.
Manage Contacts for Submission (Contacts) Add and remove contacts for the submission project, such as from the regulatory authority and other involved parties. See Contacts Page.
Update Correspondence of Pre-Submission Meeting with Authority (Update Correspondence) Add and remove correspondence records regarding the submission project, such as communications between your company and the regulatory authority and other involved parties. See Correspondence List.
Complete Milestone 'Dossier Ready' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Complete Milestone) Complete the submission project's Dossier Ready milestone to promote the submission from the To Do state to the In Work state.

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

Task Icon Description
Manage Dossier Folders - -
Gather Documents & Create Dossier Technical File - -
Manage Contacts for Submission - -
Update Correspondence of Pre-Submission Meeting with Authority - -
Complete Milestone 'Dossier Ready' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Dossier Ready) Opens the Dossier Ready milestone page. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.

4 Dossier Publishing 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
Organize eCopy Content and Sequence

Only shows if the Publishing File Format is eCopy.

 Optional Finalize the content of the submission dossier folders and documents before publication.
Publish eCopy

Only shows if the Publishing File Format is eCopy.

 Optional Publish the submission dossier in eCopy format.
Download Submission Dossier Package

Only shows if the Publishing File Format is not eCopy.

 Optional Publish the submission dossier as a package
Review Submission Dossier Optional Review the contents of the published submission dossier.
Complete Milestone 'Dossier Published' End Date: <Date>

After you complete the task, the date is no longer shown.

 Mandatory Complete the submission project's Dossier Published milestone.

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
Organize eCopy Content and Sequence

Only shows if the Publishing File Format is eCopy.

 (Organize eCopy Content and Sequence) If necessary, rearrange the submission dossier's content and folder structure. Determine whether the use volumes in the published dossier. See Organizing the Submission Dossier Structure.
Publish eCopy

Only shows if the Publishing File Format is eCopy.

 (Publish) Publish the submission dossier in eCopy format, opting to convert all files to PDF. See Publishing the Submission Dossier.
(Publish Without PDF) Publish the submission dossier in eCopy format, opting to leave all files to in their native file formats. See Publishing the Submission Dossier.
Download Submission Dossier Package

Only shows if the Publishing File Format is not eCopy.

 (Download Submission Dossier Package) Package the submission dossier as a ZIP package containing either all dossier contents converted to PDF or all dossier contents in their original file formats. See Packaging the Submission Dossier.
Review Submission Dossier (Review Submission Dossier) Review the contents and structure of the published dossier to verify its accuracy and completeness. See Folder Lists for Submissions
Complete Milestone 'Dossier Published' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Complete Milestone) Complete the submission project's Dossier Published milestone. The submission project remains in the In Work state.

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

Task Icon Description
Organize eCopy Content and Sequence

Only shows if the Publishing File Format is eCopy.

 - -
Publish eCopy

Only shows if the Publishing File Format is eCopy.

 - -
Download Submission Dossier Package

Only shows if the Publishing File Format is not eCopy.

 - -
Review Submission Dossier - -
Complete Milestone 'Dossier Published' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Dossier Published) Opens the Dossier Published milestone page. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.

5 Dossier Submission 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
Update Submission with Application Number assigned by Regulatory Authority on receiving Dossier Mandatory Add the authorization application number issued by the Regulatory Authority to the submission's regulatory information properties.
Define type of Dossier evaluation after submitting to Authority Mandatory Specify the type of dossier that you submitted to the Regulatory Authority.
Complete Milestone 'Dossier Submitted' End Date: <Date>

After you complete the task, the date is no longer shown.

 Mandatory Complete the Dossier Submitted milestone.
Manage Reviewers for Submission Optional Specify who should review the submitted dossier. If you add a reviewer, this optional task will be shown as completed.
Update Correspondence with Dossier received acknowledgement from Authority Optional Add or edit correspondence about the submitted dossier. If you add correspondence, this optional task will be shown as completed.
Define Regulatory Calendar to track Regulatory Approval Process Optional Add or edit a regulatory calendar for the submission project. If you add a regulatory calendar, this optional task will be shown as completed.
Complete Milestone 'Dossier Received' End Date: <Date>

After you complete the task, the date is no longer shown.

 Mandatory Complete the Dossier Received milestone.

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
Update Submission with Application Number assigned by Regulatory Authority on receiving Dossier (Update Authority Application Number) Enter the Authority Application Number issued by the Regulatory Authority for the submission and the Reason for Change for this change to the submission project. See Regulatory Information Properties Page.
Define type of Dossier evaluation after submitting to Authority (Update Dossier Submitted Status) Select the type of dossier that you submitted to the Regulatory Authority and the Reason for Change for this change to the submission project. See Regulatory Information Properties Page.
Complete Milestone 'Dossier Submitted' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Complete Milestone) Complete the Dossier Submitted milestone. The submission project remains in the In Work state.
Manage Reviewers for Submission (Reviewers) If necessary, search for and select the people who should review the submitted dossier. See Reviewers List.
Update Correspondence with Dossier received acknowledgement from Authority (Update Correspondences) If necessary, add or edit correspondence about the submitted dossier. See Correspondence List.
Define Regulatory Calendar to track Regulatory Approval Process (Schedule) If necessary, add or edit a regulatory calendar in the submission project's schedule. See Timeline for a Regulatory Calendar Page.
Complete Milestone 'Dossier Received' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Complete Milestone) Complete the Dossier Received milestone. The submission project remains in the In In Workstate.

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

Task Icon Description
Update Submission with Application Number assigned by Regulatory Authority on receiving Dossier (Submission Name) Opens the regulatory information properties page for the submission project, which shows the Authority Application Number field. See Regulatory Information Properties Page.
Define type of Dossier evaluation after submitting to Authority (Submission Name) Opens the regulatory information properties page for the submission project, which shows the Dossier Submitted field. See Regulatory Information Properties Page.
Complete Milestone 'Dossier Submitted' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Dossier Submitted) Opens the Dossier Submitted milestone page. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.
Manage Reviewers for Submission - -
Update Correspondence with Dossier received acknowledgement from Authority - -
Define Regulatory Calendar to track Regulatory Approval Process (Regulatory Calendar) Opens the regulatory calendar page for the submission project. See Timeline for a Regulatory Calendar Page.
Complete Milestone 'Dossier Received' End Date: <Date>

After you complete the task, the date is no longer shown.

 (Dossier Received) Opens the Dossier Received milestone page. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.

6 Interactive Review

Only appears if the submission project has a regulatory calendar or an interactive review associated with it.

 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
Create Interactive Review Optional Add an interactive review to the submission project.
Manage questions from Deficiency Letter

Only shows if an interactive review was added.

 Optional Manage the questions from the Regulatory Authority about the submitted dossier.
Review Question Responses

Only shows if an interactive review was added.

 Optional Provide answers to the questions from the Regulatory Authority about the submitted dossier.
Complete Interactive Review

Only shows if an interactive review was added.

 Optional Complete the interactive review. If someone completes the interactive review, this optional task will be shown as completed.
Complete Regulatory Calendar Mandatory Complete the regulatory calendar.

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
Create Interactive Review (Create Interactive Review) To add an interactive review to the submission project schedule, on the Regulatory Calendar page, select Actions > Add Interactive Review.
Manage questions from Deficiency Letter

Only shows if an interactive review was added.

 (Manage questions from Deficiency Letter) To manage questions, on the Review Questions page, select Actions > Enable Edit . See Managing the Question and Answer Phase.
Review Question Responses

Only shows if an interactive review was added.

 (Review Question Responses) To review question responses, on the Review Questions page, expand the question structure to see all questions and their answer text. See Review Questions for the Regulatory Calendar.
Complete Interactive Review

Only shows if an interactive review was added.

 (Complete Interactive Review) After all of the questions have been answered, the interactive review is automatically completed. See About the Interactive Review Phase.
Complete Regulatory Calendar (Complete Regulatory Calendar) After all of the interactive reviews and milestones defined in the regulatory calendar are complete, the regulatory calendar is automatically completed. See Timeline for a Regulatory Calendar Page.

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

Task Icon Description
Create Interactive Review - -
Manage questions from Deficiency Letter

Only shows if an interactive review was added.

 - -
Review Question Responses

Only shows if an interactive review was added.

 - -
Complete Interactive Review

Only shows if an interactive review was added.

 (Schedule) Opens the submission project schedule. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.
Complete Regulatory Calendar (Schedule) Opens the submission project schedule. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.

6 or 7 Market Authorization 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 Market Authorization Milestone Mandatory Complete the submission project's Market Authorization milestone.
Enter Authorization Number, dates for Approval & Start Effectivity Optional Enter the relevant information for the market authorization. If all required market authorization date fields are set, this optional task will be shown as completed.
Finalize Market Authorization Change Mandatory Close the market authorization after finalizing all of the relevant details.
Update Submission Status Results based on Regulatory Authority response Mandatory Update the results status of the submitted dossier.
Promote all Tasks/Phases to In-Review

This task no longer appears after you complete it.

 Mandatory Promote any remaining submission project tasks to the In Approval 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
Complete Market Authorization Milestone (Complete Market Authorization Milestone) Complete the submission project's Market Authorization milestone. The submission project is promoted from the In Work state to the In Approval state.
Enter Authorization Number, dates for Approval & Start Effectivity (Enter Authorization Number, dates for Approval & Start Effectivity) Enter the relevant information for the market authorization in the Authorization section, such as Number, Approval Date, Start Effectivity Date, Expiration Date (if it expires), and Sunset Clause Date (if there is one).
Finalize Market Authorization Change (Finalize Market Authorization Change) Make any necessary final changes to the market authorization, then select Close.
Update Submission Status Results based on Regulatory Authority response (Update Submission Status Results based on Regulatory Authority response) Select the results for the submitted dossier, then click Done:
  • Approved
  • Denied
  • Withdrawn
Promote all Tasks/Phases to In-Review

This task no longer appears after you complete it.

 (Schedule) Promote any remaining submission project tasks to the In Approval state. The submission project remains in the In Approval state.

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

Task Icon Description
Complete Market Authorization Milestone (Market Authorization) Opens the Market Authorization milestone page. See Project Management User's Guide: Working the Schedule of Tasks within a Project or Task.
Enter Authorization Number, dates for Approval & Start Effectivity - -
Finalize Market Authorization Change - -
Update Submission Status Results based on Regulatory Authority response (Submission Name) Opens the regulatory information properties page for the submission project, which shows the submission's Results field. See Regulatory Information Properties Page.
Promote all Tasks/Phases to In-Review

This task no longer appears after you complete it.

 - -

7 or 8 Complete Submission 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
Freeze Submission Dossier & Published Dossier folders Optional Release the Submission Dossier and Published Dossier folders to freeze their contents.
Update Submission Master Record with latest Dossier contents Optional Synchronize the content of the submission master record with the submission's folders.
Create Commitment Submission Optional Create the Commitment submission. If a Commitment submission is created, this optional task will be shown as completed.
Review Task Due Date: < Date>

After you complete the task, the date is no longer shown.

 Mandatory Approve or reject the review task.
Complete Submission Mandatory Complete the submission project.

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
Freeze Submission Dossier & Published Dossier folders (Freeze Submission Dossier & Published Dossier folders) Select the Submission Dossier. Select its Basic Information category. Click Release to freeze its contents and release it. Repeat this process for the Published Dossier.
Update Submission Master Record with latest Dossier contents (Update Submission Master Record with latest Dossier contents) Select the submission project folder in the Local Folders tab and the submission master record folder in the Master Folders tab. Select Actions > Sync Local/Master.
Create Commitment Submission (Create Commitment Submission) Create a submission project with the Regulatory Activity Category of Commitment. See Creating Submissions.
Review Task Due Date: < Date>

After you complete the task, the date is no longer shown.

 (Approve)
Note: Click Edit Details to provide approval comments before you approve the review task.

Enter your User Name and Password, then select the check box to provide your electronic signature for the review task approval.
(Reject)
Note: Click Edit Details to provide rejection comments before you reject the review task.

Enter your User Name and Password, then select the check box to provide your electronic signature for the review task rejection.
(Edit Details) Click Edit Details to provide approval or rejection comments before you approve or reject the review task.
Complete Submission (Complete Submission) Complete the submission project. This promotes the submission project from the In Approval state to the Completed state.

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

Task Icon Description
Freeze Submission Dossier & Published Dossier folders - -
Update Submission Master Record with latest Dossier contents - -
Create Commitment Submission (Related Submissions) Opens the Related Submissions page. See Submissions Page.
Review Task Due Date: < Date>

After you complete the task, the date is no longer shown.

 (Route Task Name) Opens the list of tasks for the submission project. See Collaboration and Approvals User's Guide: Tasks Page for a Route.
Complete Submission - -

Process Steps for On Hold Submission

The On Hold Submission has below process steps.

Process Steps Step Description Submission State
On Hold Submission is on hold On Hold

Tasks for On Hold Step

Task Title Task Type Role Owner Actions Related Data
Resume or Cancel Submission Mandatory Project Lead Submission Owner Click the Resume icon to resume the Submission.

Click the Cancel icon to cancel the Submission.

 Click the Submission icon to open the Submission PowerView page.

Process Steps for Cancelled Submission

The cancelled Submission has below process steps.

Process Steps Step Description Submission State
Cancelled Submission is cancelled Cancelled

The color of the cancelled step is red.

Tasks for Cancelled Step

Task Title Task Type Role Owner Actions Related Data
Submission is Cancelled Mandatory - Submission Owner No actions. -