Submission Template Properties

The Properties page for a submission template lists details about the template and provides access to additional information.

Required access role: Regulatory Administrator

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.

To access this page:

  1. View the list of submission templates. See Submission Templates List.
  2. Click the name of the submission template.
  3. Select the Properties tab.

This topic describes:

This page discusses:

See Also
Opening a Submission Template

Fields

Field NameDescription
NameThe automatically-generated name of the submission template.
TitleThe descriptive name for the submission template.
PolicyThe policy that governs the template's lifecycle.
OwnerThe person responsible for maintaining the template.
Regulatory Activity CategoryThe regulatory activity category this template supports.
Regulatory Activity Sub CategoryThe subcategory for the above category.
Group Products Under One MA

Only shows when the Regulatory Activity Category is Initial Submission.

Specifies whether a market authorization covers multiple products per country when it is created:

ValueDescription
YesA single market authorization is created to cover multiple products per country.
NoA market authorization is created for each product per country.

Note: If this value is set to No, a separate market authorization is created for each product per country. Additional products can be added to any of these market authorizations after they are released. Therefore, this value does not necessarily mean that the market authorizations can only ever cover one product per country, just that they did at the time they were created.
DescriptionA description of the purpose for this template.
Publishing File FormatThe file format required for submitting to the regulatory authority. You could see any of these formats:
  • eCopy: The electronic submission is an exact duplicate of the paper-based submission. (You must select this format to see the Publishing category for a submission.)
  • eCTD: The electronic submission content is based on the Common Technical Document (CTD) format.
  • NeeS: The electronic submission is in a non-eCTD format.
  • Paper-based: The submission is paper-based.
Creation DateThe date this submission template was created.
Company NameThe name of the company responsible for the template.
Registration Fee The fee for regulatory submissions created based on this template.
Co-Owners The co-owners of the submission template.

Co-Owners

Columns Description
Name The name of the co-owner for the submission template.
E-Mail The email id of the co-owner.
Phone The contact number of the co-owner.

Actions/Toolbar Commands

Required access role: Submission template owner with Regulatory Administrator role.

ActionDescriptionFor More Information
Edit Edits the properties of asubmission template, which is in the Draft state.Editing Submission Template Properties
Add
Note: This option is present in the toolbar of the Co-Owners section.
 Adds the existing Administrator as the co-owner to the submission template.
Note: The Search Results list the administrators that are added in the company or orgnaization of the context submission template.
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Remove
Note: This option is present in the toolbar of the Co-Owners section.
 Lets you remove the selected co-owner from the submission template. -