Languages List

You can view the list of languages for a submission template, submission project, or regulatory authority.

To view the list of languages for a submission project:

  1. Open the required submission project. See Opening a Submission.
  2. In the navigation pane, click Regulatory Information.
  3. Click the Languages page tab.

To view the list of languages for a submission template or regulatory authority:

  1. Open the required submission template or regulatory authority. See Opening a Submission Template or Opening a Regulatory Authority.
  2. Click the Languages page tab.

This topic describes:

This page discusses:

Columns

SectionColumn NameDescription
NameThe name of the language. Click to view its Properties page.
TypeThe item type: Language.
StateThe current lifecycle state of the language: Active or Inactive.

The list could include an inactive language if it was made inactive after it was added to a list.

Language Code 2 LetterThe 2-letter ISO code for the language.
3 LetterThe 3-letter ISO code for the language.
ISO CodeThe ISO numeric code for the language.
DescriptionDescriptive text about the language.

Actions/Toolbar Commands

For a submission project, you must be a Regulatory Lead for that submission to execute these actions. You can add and remove languages until the Market Authorization milestone for the submission project is completed.

For a regulatory authority or submission template, you must be a Regulatory Administrator to execute these actions and the authority or template must be inactive.

ActionDescriptionFor More Information
Create Language Creates a new language.Creating Languages
Create Local Language Creates a new local language.Creating Local Languages
Add Existing Adds additional languages to the list.

For a regulatory authority, you can only add languages that are already associated with a country associated with the authority.

For a submission template or submission project, you can only add languages that are already associated with any regulatory authority for this project or template.

If the submission project is beyond the Created state, you must provide a justification.

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Delete Local Language Deletes the selected local languages from the list. Click OK to confirm.-