Frequently Asked Questions (FAQs)

Therapeutic goods advertising compliance is a complex area. And compliance needs to be assessed based on the advertisement’s likely impact on the audience to whom it is directed. This requires an “at arm’s length” assessment, in which you put yourself in the shoes of the audience. Undoubtedly difficult to do when there are competing priorities in your business. So engaging an experienced, professional advertising compliance consultant, like Seeside Advisory, can help with an independent assessment of the compliance of your advertising and identify any changes needed for compliance.

Non-compliance can result in consumer and competitor complaints to the Therapeutic Goods Administration (TGA). If the TGA identifies non-compliance, it may issue the advertiser with fines (infringement notices), warnings or directions to remove or amend advertising. The TGA may also pursue civil or criminal court action, the penalties for which can run into millions of dollars. Finally, where the TGA takes action, it can generate unwanted media attention. So ensuring your therapeutic goods advertising is compliant before release can save time, money and your reputation.

Seeside Advisory offers a wide range of professional services to help you achieve your advertising and marketing goals in a way that complies with the medicine and medical device advertising laws. We have listed our most popular services here, but if you need something a bit different, we can work with you to tailor something.

To book an appointment with Seeside Advisory, simply book online or give us a call at 0406 646 728. We will assist you in finding a convenient time for your appointment.

The duration of a typical appointment at Seeside Advisory varies depending on the nature and complexity of the service. Our team will provide you with an estimated timeframe when you book your appointment.

Please note that cancellations made less than 24 hours in advance may be subject to a cancellation fee.

Therapeutic goods are products that are for therapeutic use. Therapeutic use includes use in preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury. It also includes use in influencing, inhibiting or modifying a physiological process or replacing or modifying parts of the body. However, it does not matter whether the good can actually achieve that therapeutic purpose – if it is presented in connection with a therapeutic purpose, it is considered a therapeutic good. The only exceptions are where the TGA has declared the product to not be a therapeutic good (i.e., an excluded good) or the product is classified as a food.

In Australia, therapeutic goods are classified as medicines, medical devices, biologicals or ‘other therapeutic goods’ (e.g., hard surface disinfectants). The medicines class captures the full spectrum of medicine types, including prescription medicines and complementary medicines (which are regulated in some other countries as ‘dietary supplements’).

The Therapeutic Goods Administration (TGA) regulates therapeutic goods in Australia. Specifically, the TGA administers the Therapeutic Goods Act 1989, which sets out the controls and requirements that must be met in relation to the import, export, manufacture, supply and advertising of therapeutic goods. The import, export and supply requirements for medicines, medical devices, biologicals and ‘other therapeutic goods’ can differ. However, there is a common requirement that goods must generally be included in the Australian Register of Therapeutic Goods (ARTG) before being manufactured, imported, exported, supplied or advertised.

The process by which goods are included in the Australian Register of Therapeutic Goods (ARTG) varies based on the type of good and the risk profile of the good, with higher risk goods requiring prior evaluation by the TGA. Lower risk goods, such as complementary medicines, can be listed in the ARTG without prior evaluation, provided they contain only ingredients that have been specifically authorised by the TGA for use in listed medicines and the indications are limited to those authorised by the TGA. For further information, refer to the TGA’s guidance on How therapeutic goods are regulated in Australia.

The laws that the Therapeutic Goods Administration (TGA) administer refer to ‘therapeutic goods’, which is a collective term for medicines, medical devices, biologicals and ‘other therapeutic goods’ (e.g. hard surface disinfectants). However, the TGA sometimes refers to ‘health products’ on its website. Health products can be considered a much broader description, which could include therapeutic goods, some foods and maybe some other products associated with health benefits. However, the TGA only has jurisdiction over therapeutic goods.

The Therapeutic Goods Administration (TGA) regulates the advertising of therapeutic goods to ensure compliance with the advertising requirements in the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code.

However, consumer advertising for therapeutic goods is also subject to Australian Consumer Law, which is administered by the Australian Competition and Consumer Commission (ACCC) and corresponding state and territory departments.

Some therapeutic goods advertising may also be subject to self-regulatory frameworks. For example, the Australian Association of National Advertisers Codes. Members of peak industry bodies like Consumer Healthcare Products Australia, Complementary Medicines Australia and the Medical Technology Association of Australia may be subject to additional advertising and promotion requirements under their body’s code of practice or conduct.

If you are advertising a therapeutic good to Australian consumers, the laws apply and it is most important to ensure the advertising complies with those laws.

If you don’t know whether the product concerned is a therapeutic good, we recommend finding out before advertising it. Retailers can check the Australian Register of Therapeutic Goods for the product and confirm with the product supplier.

Product manufacturers and sponsors should consider the Therapeutic Goods Administration’s guidance as to whether the product is a therapeutic good. Take care with product claims though – marketing a product that is ordinarily a cosmetic or regular consumer good with therapeutic claims is likely to result in the product becoming a therapeutic good.