TGA approved terminology for therapeutic goods
Links to information on TGA approved terminology for medicines
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:
- routes of administration
- dosage forms
- container types
- units of expression
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
Application forms for proposing:
Approved names for medicine ingredients
Herbal ingredient indexes
Herbal ingredients indexes
Further information about naming herbal ingredients in medicines:
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|Version||Description of change||Author||Effective date|
|V1.0||Original publication||TGA||July 1999|
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.
|V3.1||Clarifying definition of Approved Herbal Name to include algae, yeast or fungi.||TGA||March 2020|