The Therapeutic Goods Administration (TGA) develops and maintains approved terminology to ensure the accuracy and consistency of information on the Australian Register of Therapeutic Goods (ARTG). This provides a consistent and standardised method for naming:
- ingredients
- components
- routes of administration
- dosage forms
- container types
- units of expression
- proportion.
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.
Approved terminology basics
- Where to find the approved terminology
- The legal basis for using approved terminology
- Methods to complete an approved herbal name
- Proposing a new ingredient name
Forms
Application forms for proposing:
Approved names for medicine ingredients
Herbal ingredient indexes
Herbal ingredients indexes
Further information about naming herbal ingredients in medicines:
Print version
Print version of TGA approved terminology for therapeutic goods (pdf,1.09Mb)*
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Related information
Notification of a proprietary ingredient
Version history
Version history of the TGA approved terminology for therapeutic goods
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | TGA | July 1999 |
| V2.0 | Updated | TGA | June 2016 |
| V3.0 |
Title of document changed to TGA Approved Terminology for Therapeutic Goods Addition of new information about:
Clarification to reflect current processes regarding:
Removal of information found in other documents, including some medicine labelling guidance. Minor formatting and structural changes. Corrections to minor errors. |
TGA | November 2019 |
| V3.1 | Clarifying definition of Approved Herbal Name to include algae, yeast or fungi. | TGA | March 2020 |