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TGA approved terminology for therapeutic goods

Guidance on our approved terminology for medicines.

Published
Last updated

This document is referenced in legislation and must remain on the site.

Information within this document can be easily found on the site, including forms to submit ingredient name applications. See: Ingredients in therapeutic goods. 

Purpose

We develop and maintain approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). 

Approved terminology provides a standardised format for identifying ingredients used in 
therapeutic goods as part of: 

  • Applications to register or list a medicine on the ARTG
  • Labels and packaging for medicines
  • Product Information documents provided with medicines
  • Consumer Medicine Information documents provided with medicines
  • Other promotional material where use of approved terminology is required.

Legislation

Guidance

This guidance is presented as a downloadable file because of its length. 

Downloads

Topics

Page history

Show all page updates (5)

Migration to new 'Guidance' content type included changes to the following:

  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • New ‘Save as PDF’ feature.

Clarifying definition of Approved Herbal Name to include algae, yeast or fungi.

Title of document changed to TGA Approved Terminology for Therapeutic Goods

Addition of new information about:

  • approved cell and tissue names information - part 5
  • what is approved terminology - part 1
  • where to find approved terminology and how to search the Ingredients Table and Code Tables - Appendix 3

Clarification to reflect current processes regarding:

  • Herbal Component Names (HCNs)
  • Legal basis for using approved terminology
  • Herbal naming references

Removal of information found in other documents, including some medicine labelling guidance.

Minor formatting and structural changes.

Corrections to minor errors.

Updated.

Original publication.

Migration to new 'Guidance' content type included changes to the following:

  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • New ‘Save as PDF’ feature.

Clarifying definition of Approved Herbal Name to include algae, yeast or fungi.

Title of document changed to TGA Approved Terminology for Therapeutic Goods

Addition of new information about:

  • approved cell and tissue names information - part 5
  • what is approved terminology - part 1
  • where to find approved terminology and how to search the Ingredients Table and Code Tables - Appendix 3

Clarification to reflect current processes regarding:

  • Herbal Component Names (HCNs)
  • Legal basis for using approved terminology
  • Herbal naming references

Removal of information found in other documents, including some medicine labelling guidance.

Minor formatting and structural changes.

Corrections to minor errors.

Updated.

Original publication.

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