How are Therapeutic Goods Regulated in Australia?

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Table of Contents

• What are Therapeutic Goods?
• Classifying Therapeutic Goods
• Classes of Therapeutic Goods

Selling medicines in Australia comes with a significant dosage of government red tape. The rules and regulations set by the government apply to protect consumers from substances which are harmful or have harmful side effects, however if you want to sell medicine, Australia’s maze-like health laws can addle the brain. Regulation has steadily grown since 1938, the last time any and all medicines, usually ‘quack’ remedies, could be sold in an entirely unregulated market. This article provides a brief summary of the rules surrounding the sale of therapeutic goods in Australia. We will touch on the definition of therapeutic goods, whether a good is therapeutic and classes of therapeutic goods.

What are Therapeutic Goods?

You may not know it, but you use many therapeutic goods in your day to day life besides those you typically know as medicines. Medicines are used when you apply a bandage, relieve a headache with supermarket medicines, take vitamin tablets, have an injection or take a prescribed course of treatment for an illness. The question is, what makes these goods therapeutic?

Broadly defined, therapeutic goods are products used by and for humans in relation to:

• diagnosing or alleviating an ailment, defect, disease or injury;
• inhibiting or changing a physiological process;
• testing the susceptibility of persons to a disease or ailment
• influencing/controlling/prevention conception; or
• testing for pregnancy.

This definition is broad and catches many products. The definition also includes anything which is used as a component or ingredient in a therapeutic good or something that is used to replace parts of the anatomy. Therapeutic goods are defined in section 3 of the Therapeutic Goods Act 1989 (Cth). If the product you sell is used to diagnose or alleviate an ailment, for example, then it may be classified as a therapeutic good.

Classifying Therapeutic Goods

In many cases, therapeutic goods or medicines are beneficial and have been a huge part of the increase in living standards experienced throughout the 20th century. However, therapeutic goods work by changing physiological processes. With anything that alters the body’s natural workings, there are risks. This is part of the reason why therapeutic goods are regulated and why they must be entered into the Australian Register of Therapeutic Goods (ARTG) before they can legally be sold in Australia.

If you want to sell a particular medicine in Australia, you need to confirm whether it is classified as a therapeutic good. Some goods can be classed as a food or as a cosmetic which is regulated under other pieces of legislation. Other goods have been declared not to be therapeutic goods under the Therapeutic Goods Act 1989 (Cth).

Classes of Therapeutic Goods

There are different types of therapeutic goods available. A prescription medicine is a medicine that requires a prescription from a registered healthcare practitioner. Over the counter (OTC) medicines are medicines that can be purchased without a prescription but from a pharmacy or in some cases a supermarket. A complementary medicine is a herbal or ‘traditional’ and includes vitamins and homeopathic products.

In summary, selling therapeutic goods is highly regulated. If you want to sell medicines online, you need to check whether you are legally able to. Therapeutic goods are goods which relieve diseases, can test people for susceptibility to a disease or act as a contraceptive. Prescription medicines, over the counter medicines and complementary, medicines are some examples of classes of therapeutic goods. As this is a highly regulated area, seek advice from a business lawyer before you sell to ensure you can do so legally.