Creating Submission Templates

Regulatory Administrators can create submission templates used as the basis for creating submission projects.

Required access role: Regulatory Administrator

Before you begin: Geography (regions, countries, and languages), and regulatory contexts (composed of regulatory authority,regulatory category, and submission type) must already be defined.
See Also
Submission Master Record and Regulatory Activity Categories
  1. Do one of the following:
    1. Select Add > Market Registration > Create Submission Template.
    2. From the list of submission templates, click Create Submission Template . See Submission Templates List.
  2. Enter these details:

    Field NameDescription
    TitleEnter a descriptive name for your template. The name shows in selection lists when Regulatory Leads create submissions based on templates.
    Regulatory Activity CategorySelect the category, such as Initial Submission, from the list.
    Regulatory Activity Sub CategorySelect a subcategory. You can only select subcategories defined for the selected activity category.
    DescriptionEnter details about the submission template.

  3. Click Done.

Market Registration creates the template in the Draft state and assigns a name using this format: ST- followed by the next sequential number.

Note: Submission templates have a local folder called Submission Dossier that is created automatically. This folder has two virtual folders: STATISTICAL DATA (which includes all statistical type files) and MISC (which includes all video and image files).

To continue defining the template:

  • Add a regulatory context.
  • Add at least one country. You can only add countries that belong to the regulatory context.
  • Add any languages used by the regulatory authorities (regulatory authorities are part of the regulatory context).
  • Attach the regulatory guideline specific to the this template.
  • Edit the submission template properties to define the registration fee and publishing file format. See Editing Submission Template Properties.
  • Define controlled folders to prepare the dossier for submitting task deliverables to the regulatory authority.
  • Define phases, tasks, and milestones in the Schedule page tab (sometimes called the Work Breakdown Structure or WBS) and choose the volume (controlled folder) to contain that task's deliverables.

When all additional details are defined, promote the template to the In Work state.