TGA approved terminology for medicines

'Australian Approved Names'

9 April 2014

The document "TGA approved terminology for medicines (July 1999)" available on this page contains lists of ingredient names, forms and routes of administration that are not current.

The current list of approved ingredient names (chemical, biological and herbal) is located on the Ingredients Database on the eBusiness website. To access the Ingredients Database:

  • Click on the eBusiness hyperlink.
  • Click on Public TGA Information
  • Click on Ingredients

The list of other approved terminology for medicines (routes of administration, dosage forms etc) are located in the Code Tables on the eBusiness website. To access these Code Tables:

  • Click on the eBusiness hyperlink.
  • Click on Public TGA Information
  • Click on Code Tables

Current application forms for proposing ingredient names can be found below on this page.

In May 2013, the TGA sought comments on an update to the TGA approved terminology for medicines as part of the International Harmonisation of Ingredient Names project. A new version of this document, with guidance on approved terminology policies, will be published once agreed.

The TGA has developed and maintains lists of Australian approved terminology, to ensure accuracy and consistency in the information compiled in the ARTG. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration and units of expression and proportion. These lists are reproduced in this publication.

Australian approved terminology has been developed by the TGA as no single internationally agreed list or primary reference is available which covers comprehensively all substances or terms used, or likely to be used in therapeutic goods in Australia.

Application forms for proposing names

TGA approved terminology for medicines - Full document & amendments

The lists of ingredient names, routes of administration and dosage forms in the documents below are not current. Current approved terminology is available through the eBusiness website.

How to access a pdf document

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TGA approved terminology for medicines - individual sections

Chapter 1 - Australian approved names for therapeutic substances

Contents, introduction and general information

1. Chemical substances

2. Biological substances

3. Herbal substances

Chapter 2 - Australian approved terms for use in the completion of applications for the registration or listing of therapeutic goods

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