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 vitamin tablets
- receive an injection
- undertake a prescribed course of treatment to manage a serious illness.
What makes goods therapeutic?
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
- used to replace or modify of parts of the anatomy
A more precise definition of 'therapeutic goods' can be found in Section 3 of the Therapeutic Goods Act 1989.
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. Sometimes, a formal declaration is made as to whether a product is a food or a therapeutic good.
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 that 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
- if therapeutic claims are made on its label, or in advertising.
Content last updated: Wednesday, 23 April 2014
Content last reviewed: Wednesday, 23 April 2014
Web page last updated: Wednesday, 23 April 2014