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The Therapeutic Goods Administration heavily regulates the supply and marketing of advertising therapeutic goods in Australia. Therefore, if you are providing or selling certain goods, it is important to know whether those goods are therapeutic goods. This will help you to understand what regulatory requirements and limitations might apply. This article will explain:

  • how to determine if a good is a therapeutic good;
  • whether cosmetics and foods are therapeutic goods;
  • what to do if your product is a therapeutic good;
  • whether you can advertise a therapeutic good; and
  • what will happen if you do not comply with regulations. 

1. How Do I Determine if a Good is a Therapeutic Good?

In Australia, you can generally define therapeutic goods as goods that can treat an illness or ailment or those goods that are represented in any way to be, or that are likely to be taken for therapeutic use. Further, they commonly fall into three main categories: 

  • medicines;
  • biologicals; and
  • medical devices. 

For a product to be a therapeutic good, it must be 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; or
  • testing for pregnancy.

When considering whether your good is a therapeutic good, you should consider what claims you are making about the health effects that you intent the product to have. Generally, if you are making any claims or references that suggest someone can use your product in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, or defect of the human body, then it is likely to be a therapeutic good. 

2. What About Cosmetics or Foods? 

Cosmetics and foods are not included as therapeutic goods. 

Whether a product is cosmetic will largely depend on the: 

  • composition of the product; and 
  • proposed use and claims made about the product. 

Any product that can be consumed orally, that is not a medicine, you can consider as a food and it must therefore meet applicable food standards. 

It is important to know whether your product is a therapeutic good, food or cosmetic as each category is subject to specific laws that set out the requirements for the sale and marketing of these products. For example, each state and territory regulates foods separately by reference to the Australia New Zealand Food Standards Code. However, the Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulations contains the law regarding cosmetic products.

3. What Do I Do If My Product is a Therapeutic Good?

If you think that your product is a therapeutic good, you must list or register it on the Australian Register of Therapeutic Goods (ARTG) before you can advertise or sell the product. This process to enter your product on the ARTG is referred to as market authorisation. 

The application process for market authorisation and the costs involved will depend on the type, classification and risk level of your particular therapeutic good. Generally, this process will require you to compile the relevant supporting data in relation to the quality, safety and efficacy of your product. The TGA will then process your application. Depending on the nature and risk profile of your product, the TGA can request for additional information before they make a decision.

If you are successful in registering your product, you will have ongoing responsibilities to ensure that your product continues to comply with the requirements in the Therapeutic Goods Act 1989 (Cth) (TG Act), in particular as it relates to the advertising and marketing of your product. 

4. Can I Advertise My Therapeutic Good? 

There is heavy regulation of the advertising and marketing of therapeutic goods. It must comply not only with the TG Act, but also comply with:

  • the Australian Consumer Law;
  • the National Health Practitioner Law (where applicable); and 
  • state and territory poisons legislation.

Generally, any advertisement for a therapeutic good must be valid, accurate and substantiated such that it supports the safe and proper use of the product. The advertising of the product must also be consistent with the product’s entry details on the ARTG. Under the Therapeutic Goods Advertising Code, there are also limitations and prohibited representations that you cannot make in relation to therapeutic products without TGA approval. These are referred to as restricted representations.

You should also be aware that you cannot advertise certain therapeutic goods, including prescription medicines, to the general public at all.

This article explains the details of what you need to know before advertising therapeutic goods. 

5. What Happens if I Do Not Comply? 

Therapeutic goods are regulated by the Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health. The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods. Additionally, the TGA undertakes a combination of:

  • pre-marking assessment;
  • post-market monitoring; and
  • enforcement of standards.

The TGA as a regulator continually monitors the market for contraventions of the TG Act and has compliance and enforcement powers, such as: 

  • warning letters for non-compliance;
  • suspensions from the ARTG;
  • cancellations from the ARTG;
  • recall action of a therapeutic good;
  • advertising directions notices;
  • infringement notices;
  • enforceable undertakings;
  • injunctions;
  • civil penalties; and 
  • criminal penalties.

This article explains how to respond to a TGA infringement notice.  

Key Takeaways

Before advertising any therapeutic claims about your product, consider first whether your product relates to preventing, diagnosing, curing or alleviating a disease, ailment, or defect of the human body. If so, your product may be a therapeutic good and you will need to register it on the ARTG before any supply in Australia. It is particularly important to be clear on the details of your product when applying for registration as any subsequent advertisements or marketing about the product needs to be consistent with the product’s entry on the ARTG. Failure to do so may result in infringement notices, penalties and in some cases, criminal action by the TGA. For advice about advertising your therapeutic goods or making therapeutic claims, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.

Frequently Asked Questions

What is a therapeutic good? 

Therapeutic goods are generally defined in Australia as goods that can treat an illness or ailment or those goods that are represented in any way to be, or that are likely to be taken for therapeutic use. 

Are cosmetics and foods therapeutic goods?

No, cosmetics and foods are not therapeutic goods. Further, whether a product is cosmetic will largely depend on the composition of the product and proposed use and claims being made about the product. On the other hand, any product that can be consumed orally (that is not a medicine) is a food. 

What do I need to do if my product is a therapeutic good?

If you think your product is a therapeutic good, you must list or register it on the Australian Register of Therapeutic Goods before you are able to advertise or sell the product. In addition, any advertising or marketing of therapeutic goods must comply with the relevant laws and regulations.

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