Creating Regulatory Requests

You can create regulatory requests for work required for the submission project. You can create regulatory requests from the submission project, tasks in the submission schedule, or independent of the submission project.

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

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.

  1. To start from the list of regulatory requests:

    1. View the list of all regulatory requests. See Regulatory Requests List.
    2. From the filter on the page toolbar, select All or Initiated.
    3. Click Create .

    To start from anywhere: click Add > Market Registration > Create Regulatory Request.

    To create a request for a submission project:

    1. View the Regulatory Information page for the submission project.
    2. Click the Requests page tab.
    3. Click Create .

    To create a request for a schedule item for a submission project:

    1. View the Schedule page for the submission project.
    2. Click the name of the schedule item needed for the request.
    3. Click the Requests page tab.
    4. Click Create .

  2. Enter these details:

    Field NameDescription
    TitleEnter a descriptive name for the request.
    Request TypeSelect the type of regulatory request to create.
    DescriptionEnter details about the request.
    CountriesClick to select the countries related to this regulatory request.

    If you select a regulatory request type, this field is automatically populated with the countries that are part of the regulatory context of that regulatory request type. You can use all or only some of those countries for this regulatory request.

    If there is no regulatory context for the regulatory request type, all Active countries are available for selection.

    When creating a request for a submission project or schedule item, you can only choose countries associated with the submission.

    ProductsClick to select the products associated with the request.
    NotesEnter additional information or instructions.
    Need by DateClick to set the date that the response to the request is needed by.
    Responding OrganizationClick to select a company responsible for fulfilling this request.
    Request AssigneeClick to select a specific person for this request.

  3. Click Done.

Market Registration creates the regulatory request in the Create state.

To complete the definition of the regulatory request:

  • Add tasks. If the request involves more than one person, add a task for each person.
  • Add reference documents. These documents can provide background information or additional details about what needs to be done to fulfill the request.
  • Add additional countries, if appropriate. When creating a request for a submission project or schedule item, you can only choose countries associated with the submission.
  • Add additional products, if appropriate.
  • Submit the regulatory request. You can submit it from the list of regulatory requests or from the Properties page for the request. You can also use the Lifecycle page to promote the request.

When you submit the request, Market Registration shows the request in the selected Responder's Pending view. If you did not specify a Responder, Market Registration evaluates the available request queues. If it finds a matching queue, it adds the queue name to the regulatory request, and the request shows in the Pending view for all people defined as Members of that queue. A queue matches if its rules include the same request type, countries, or companies that the regulatory request specifies.