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What are 'therapeutic goods'?

Many of us use medicines or medical devices in our daily lives. When we:

  • apply a bandage
  • relieve a headache with items from the supermarket
  • take echinacea
  • receive an injection, or
  • undertake a prescribed course of treatment to manage a serious illness.

In relation to the evaluation, assessment and monitoring done by the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
  • influencing inhibiting or modifying a physiological process
  • testing the susceptibility of persons to a disease or ailment
  • influencing, controlling or preventing conception
  • testing for pregnancy

This includes things that are:

  • used as an ingredient or component in the manufacture of therapeutic goods; or
  • used to replace or modify of parts of the anatomy

Is it a medicine or food?

How a product is presented can help to determine whether it will be treated as a food or a medicine. For example a clove of garlic is a food. However, if it is concentrated and marketed in capsule form with claims that it can be used to relieve cold and 'flu symptoms it will be treated as a medicine.

A product's principal use is of primary consideration when determining whether it is a food or a medicine.

Is it a therapeutic good or a cosmetic?

One of the main factors in determining whether a product is a cosmetic or a medicine (or a medical device) is the claims made about the product. For example, moisturisers which contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (e.g. 'helps protect skin from the damaging effects of UV radiation') are medicines.

Even if a product is intended for marketing as a cosmetic, it may be classified as a medicine this depends on:

  • its ingredients,
  • the route of administration, or
  • if therapeutic claims are made on its label, or in advertising.

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Content last updated: Wednesday, 5 March 2014

Content last reviewed: Thursday, 26 September 2013

Web page last updated: Wednesday, 5 March 2014

URL: http://www.tga.gov.au/about/information-what-are-therapeutic-goods.htm