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What are 'therapeutic goods'?

15 August 2011

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, or

Some products, even though they may technically meet the definition of a therapeutic good, are declared not to be therapeutic goods under section 7 of the Therapeutic Goods Act 1989. Information on these products is available on this website under the Therapeutic Goods (Excluded Goods) Order. Likewise some products that do not meet the definition of a therapeutic good can be declared to be therapeutic goods in order to allow the TGA to regulate them.

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.

Sometimes it can be quite difficult to determine if a product is a food or a medicine. In these cases it is best to contact the experts at the TGA or Food Standards Australia New Zealand.

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.

Sometimes it can be quite difficult to determine if you product is a therapeutic good or a cosmetic. In these cases it is best to contact the experts at the TGA or the National Industrial Chemicals Notification and Assessment Scheme.

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