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TGA approved terminology for therapeutic goods

29 March 2021

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

Forms

Application forms for proposing:

Approved names for medicine ingredients

Herbal ingredient indexes

Further information about naming herbal ingredients in medicines:

Print version of TGA approved terminology for therapeutic goods (pdf,1.09Mb)*

How to access a pdf document

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Notification of a proprietary ingredient

TGA Business Services

Version history

Version history of the TGA approved terminology for therapeutic goods

Version history
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:

  • 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.

 TGA November 2019
V3.1 Clarifying definition of Approved Herbal Name to include algae, yeast or fungi. TGA March 2020

Contact details

If you are telephoning us to report a problem, please call between 9am to 5pm, Monday to Friday.

Approved names for chemical or biological ingredients or terminology to describe medicines: TGA Names.

Approved names for herbal ingredients: Complementary Medicines

Approved names for herbal ingredients: 1800 044 114