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
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.
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.
Content last updated: Thursday, 26 September 2013
Content last reviewed: Thursday, 26 September 2013
Web page last updated: Thursday, 26 September 2013