Advertising Therapeutic Goods in Australia: What You Can and Cannot Say

Advertising a therapeutic good in Australia is not governed only by the general law against misleading conduct. It is subject to a dedicated regime in Part 5-1 of the Therapeutic Goods Act 1989 (Cth), supplemented by a mandatory Therapeutic Goods Advertising Code, and the regime starts from prohibition rather than permission.

Certain goods may not be advertised to the public at all, certain claims may never be made, and everything else must meet standards of accuracy, balance and substantiation that are considerably stricter than those applying to ordinary consumer products. This guide explains what counts as advertising, who is responsible for it, what may and may not be said, and how the TGA enforces the rules.

What counts as advertising?

The Act defines advertising broadly, as any statement, pictorial representation or design intended, whether directly or indirectly, to promote the use or supply of therapeutic goods (s 3(1)). Two features of that definition catch businesses out.

The features of this definition are:

• The first is that intention is assessed objectively. The question is not what the business says it intended, but how a reasonable consumer would understand the material. A campaign described internally as education or awareness will be treated as advertising if, viewed as a whole, it promotes a product.

  
  

• The second is that the definition reaches well beyond conventional advertisements. Websites, social media posts, product listings, packaging and labels, email newsletters, sponsored articles and influencer content can all fall within it. The main exclusions are genuine news and independent editorial content, general health information that does not refer to particular goods, and advice given by a practitioner directly to a patient in the course of treatment.

Who is responsible?

The Act applies to any person who advertises therapeutic goods or causes them to be advertised, which extends to manufacturers, retailers, clinics, marketing and public relations agencies, publishers, influencers and platforms.

What you cannot say

Advertising prescription medicines to the public

Prescription medicines, being those in Schedules 4 and 8 of the Poisons Standard, and certain pharmacist-only medicines in Schedule 3, may not be advertised to the public (ss 42DL, 42DLB). The prohibition extends to indirect references.

Advertising goods not on the Register

Goods that are not entered on the Australian Register of Therapeutic Goods may not be advertised, unless an exemption applies. A product supplied through a special access pathway remains unapproved, and cannot lawfully be promoted to the public on that basis.

Prohibited and restricted representations

Some claims are forbidden outright. A prohibited representation is one that refers to the treatment, cure, prevention, diagnosis or monitoring of cancer, sexually transmitted diseases, HIV/AIDS, hepatitis C or mental illness, or that suggests a product may induce an abortion (s 42DJ). These may be used only with a specific permission, which is granted in narrow circumstances.

A restricted representation is one that refers to a serious form of a disease, condition, ailment or defect (s 42DD). It may be used only if the TGA has approved it before publication (s 42DF). The approval must be in hand before the advertisement appears, and it is not enough that an application is pending.

What the advertising code requires

Where advertising is permitted, it must comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. Its core requirements are that advertising be accurate, balanced and not misleading, that claims be substantiated, that it promote safe and proper use, and that it not cause undue fear or distress. Specific classes of goods, including analgesics, sunscreens and weight management products, carry additional mandatory statements.

Testimonials, endorsements and influencers

The Code imposes particular restrictions on who may speak for a product in advertising directed to the public:

• health professionals, whether current or former, and persons working in the health industry may not give testimonials or endorsements

• paid or otherwise incentivised influencers may not give testimonials, and valuable consideration includes gifts, free products and discounts

• advertising may not state or imply endorsement by a government agency, the TGA, or a hospital or healthcare facility

Genuine testimonials from ordinary consumers who have received no benefit remain permitted, provided they are verified and consistent with the Code.

Advertising to health professionals

Advertising directed exclusively to health professionals, and to certain others such as wholesalers and hospital purchasing officers, falls outside most of Part 5-1 (s 42AA). The exemption depends on genuine exclusivity. Material placed where the public can readily access it does not attract the exemption merely because it was intended for practitioners.

Promotion of prescription medicines to health professionals is instead regulated principally through industry codes, most importantly the Medicines Australia Code of Conduct, now in its twentieth edition. Compliance with that Code is a condition of registration for prescription medicines, so it binds sponsors whether or not they are members of Medicines Australia. Promotion must remain consistent with the product's approved indications.

Where to from here

Advertising law in this field turns on a simple structure applied rigorously. Prescription medicines and unapproved goods may not be promoted to the public, certain claims are forbidden or require prior approval, and everything else must be accurate, balanced and substantiated. Responsibility extends to everyone involved in producing and publishing the material, and the TGA's enforcement is active, digitally focused and increasingly directed at clinics, agencies and publishers as well as sponsors. Marketing material in this sector should be reviewed against the Act and the Code before publication, not after a regulator has noticed it.

Seeking further advice

For more on the topics raised in this guide, please review our further guides.

If you need specific advice, please contact Wayne Condon at Biopharmalex. Wayne is one of Australia's most experienced life sciences lawyers, advising clients across the sector on therapeutic goods regulation, intellectual property and commercial arrangements.

This guide states the law at September 2026 and is general information only, not legal advice.