TGA consults on changes to the Therapeutic Goods Advertising Code

The TGA consulted from 9 July to 3 September 2026 on targeted Code changes. These are proposals only, and no outcome had been published.

9 July 20269 min read

From 9 July 2026 to 3 September 2026 the Therapeutic Goods Administration (TGA) consulted on targeted improvements to the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, the Code that sets the standards for advertising therapeutic goods to the public. The TGA says it is not a full review of the Code.

It is important to be clear about what this is. The consultation paper sets out options and proposals. None of them are law. The current Code continues to apply exactly as it is, and as at the date of writing no outcome had been published. The TGA has said that after the closing date it will review submissions and publish its decisions on the consultation page. Even so, the proposals are worth understanding now, because they show where the TGA is thinking of tightening or clarifying the rules, particularly for devices supplied through practitioners, health apps and AI-enabled software, testimonials and citations of research.

What the consultation is

The consultation was run by the TGA within the Department of Health, Disability and Ageing. The TGA said it was reviewing parts of the Code to make sure it is clear and easy to apply, reflects current advertising practices and supports safe and appropriate use of therapeutic goods. Feedback would help it decide whether to update the Code or instead provide clearer guidance, and to understand the impact of proposed changes.

The consultation paper (version 1.0, July 2026) has four parts:

Part 1: key issues raised by stakeholders, with options for change and, in some cases, a preferred option
Part 2: proposed targeted clarifications and amendments
Part 3: minor or technical administrative amendments
Part 4: issues the TGA proposes to address through guidance rather than Code changes

Related later change: separately from this consultation, a technical amendment to the Code commenced on 30 September 2026, replacing references to the old medicine labelling orders with the new labelling standards (TGO 115 and TGO 116). That amendment is not an outcome of this consultation.

Who it is relevant to

dental and orthodontic practices, orthopaedic practices and allied health providers who advertise devices that are only supplied through a practitioner
digital health and software providers, including those whose products use AI
pharmacies and businesses advertising sunscreens, vaccines or samples
anyone whose advertising cites scientific or clinical research

Prescription medicines are a separate matter. Advertising them to the public is generally prohibited under the Act, and the consultation does not propose to change that.

What the TGA proposed

Issue 1A: a new statement for goods available only through a health professional

Section 16 of the Code currently requires advertising for goods only available through a health professional to carry the statement “THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC”. The TGA’s examples of such goods are orthodontic appliances and prosthetic devices such as artificial joints. Stakeholders said this statement can give consumers the impression the product is not available to them at all.

The TGA put three options. Its preferred option (Option 1) is a new mandatory statement for goods supplied through a health professional, along the lines of “This product [or treatment with this product] is only available through a [Health Professional]”. The existing statement would be kept only for goods never supplied to consumers, such as laboratory IVD devices or MRI and x-ray machines. Option 2 would add the new statement but require no statement for goods never supplied to consumers. Option 3 would keep the status quo with clarifying guidance. Under all three, the TGA proposed updating guidance to explain that advertisers may add information about how consumers can access the goods.

For practices, the practical effect, if adopted, would be wording that points consumers to the relevant practitioner rather than telling them the product is unavailable.

Issue 1B: software-based medical devices and AI

The TGA regulates software and AI when it meets the definition of a medical device, known as software as a medical device (SaMD). Following its 2024 review of medical software and AI, it put forward four options, which the paper describes as exploratory only, with no preferred approach or commitment to legislative change:

Option 1: require the ARTG number to be shown in SaMD advertising and on platforms that facilitate direct purchase or supply. Feedback was also sought on an ARTG “tick” symbol, a link to instructions for use, sponsor contact details and the Unique Device Identification number.
Option 2: new software-specific mandatory statements, because “read the label” style statements may not suit apps. Example wording included “Always read the instructions for use”.
Option 3: require all relevant health warnings to be included in SaMD advertising that facilitates direct purchase or supply, rather than allowing a link.
Option 4: disclosure where a SaMD product is, or operates using, an AI model or system. Example wording included “This product uses artificial intelligence (AI) technology to support its intended purpose”, with a possible further statement for generative AI about limitations of AI-generated information.

This is the only TGA primary material our research found that addresses AI in advertising. It relates to advertising of AI-enabled medical device software, not to whether a practice uses AI to write its marketing.

Issue 1C: paid testimonials for therapeutic sunscreens

Some stakeholders asked the TGA to allow paid testimonials, including from influencers, for therapeutic sunscreens. The options were to allow paid testimonials about any aspect, to allow them only about physical attributes such as look and feel, or to keep the prohibition. The TGA’s preferred option is to keep the current prohibition, citing the conflict between a paid testimonial-giver’s interest in payment and their duty to give a genuine, unbiased view.

Issue 2A: “prominently displayed or communicated”

The TGA proposed amending the Code’s definition so that visual statements must “stand out”. It said this reflects its existing expectations and current guidance, so compliance costs should be minimal.

Issues 2B and 2C: vaccines

The TGA proposed an exception so that vaccine advertising made under a restricted representation permission is not caught by general medicine requirements that do not fit, such as stating a trade name or “Always read the label”. It also proposed amending the definition of “serious form” of a disease in section 28 to expressly include all vaccine-preventable diseases, which it described as clarifying its long-standing position that references to these diseases are restricted representations.

Issue 2D: permitted samples

The TGA proposed adding disposable insulin pen needles (with a condition limiting them to people with diabetes already trained in using insulin pens) and unmedicated topical nappy rash products to the list of permitted samples in Annexure 2. It did not propose adding topical pain relief, topical scar treatments or the broad category of skin barrier emollients.

Part 3: administrative amendments

Remove paragraph 6(1)(c), the Code exception for advertising under the 2022 COVID-19 vaccines permission, so COVID-19 vaccine advertising is treated like other vaccine advertising. Government campaign materials would remain usable by businesses such as general practices.
Make clear that the basic product information requirements (name, description, accepted indications or intended purpose) apply to the three types of advertisements in Division 2 of Part 4.
Allow medical device mandatory statements to say “instructions for use” as an alternative to “directions for use”.

Part 4: guidance rather than Code changes

The TGA proposed publishing guidance on “generic information”, and updating guidance on when the citation requirements in subsection 11(3) of the Code apply. Subsection 11(3) requires an advertisement that refers to scientific or clinical research, expressly or by implication, to identify the researcher, identify the financial sponsor where the advertiser knows or ought reasonably to know, and properly cite the research so consumers can access it.

An attachment sets out draft examples. Express references include naming a study, institution or journal and quoting numerical findings. Implied references, which the TGA says still trigger the citation requirement, may include phrases such as “clinically tested ingredients” or “clinically trialled formula”, graphs and trend lines, and before and after results that appear to be data driven.

What it means for your marketing

Right now

Nothing changes yet. Keep complying with the current Code, including the existing section 16 statement where it applies to your advertising.

Website

If you advertise practitioner-supplied devices, note where the mandatory statement appears, so you can update it quickly if the Code changes. Review any claims that refer to research: under the current Code, express or implied references already require proper citation.

Health apps and digital tools

If your practice promotes or supplies software that meets the medical device definition, watch for possible ARTG number, warning and AI disclosure requirements.

Social media and influencers

The TGA’s preferred position keeps the ban on paid testimonials for sunscreens. For registered health practitioners, Ahpra’s separate prohibition on testimonials in advertising regulated health services is unaffected by this consultation.

Printed and in-clinic material

Brochures and posters for practitioner-supplied devices may need new wording if Option 1 is adopted.

Common mistakes we see

Treating proposals as if they are already law.
Using “clinically proven” or “clinically tested” style claims without citations.
Leaving out the current section 16 statement where it is required.
Assuming that because sunscreen testimonials are being discussed, paid testimonials are generally becoming acceptable.

A practical checklist

Identify which advertising carries the current section 16 statement.
List research claims, express or implied, and check that each has a proper citation.
Check that mandatory statements and warnings currently stand out clearly.
Note any SaMD or AI-enabled products you promote.
Watch the TGA consultation page for published decisions.
Plan a review once any Code amendment is made and its commencement date is known.

How this fits with other rules

The Code sits under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. It applies to advertising of therapeutic goods that can be advertised to the public. Ahpra’s guidelines on advertising a regulated health service apply to registered practitioners, and the Australian Consumer Law applies to all advertising.

Frequently asked questions

Has the Code changed?

Not as a result of this consultation, at the time of writing. The consultation closed on 3 September 2026 and the TGA said decisions will be published on the consultation page. A separate technical labelling amendment commenced on 30 September 2026.

Will the “not available for purchase” statement disappear?

Under the TGA’s preferred option, it would be kept only for goods never supplied to consumers, with a new statement for goods supplied through a health professional. That is a proposal, not a decision.

Are there new rules on AI?

Only options for AI-enabled medical device software, which the TGA described as exploratory. No rule has been made.

Will paid sunscreen testimonials be allowed?

The TGA’s preferred option is to keep the prohibition.

Does this affect prescription medicine advertising?

No. The general prohibition on advertising prescription medicines to the public is in the Act and is not part of these proposals.

Need a hand?

If you advertise practitioner-supplied devices or make research-based claims, it is worth checking your current material against the existing Code now. Our TGA advertising compliance service can review it, and we work with dentists and allied health practices on compliant device and treatment content.

This article is general guidance based on the published rules, not legal advice. Final responsibility for advertising sits with the registered practitioner, and complex situations may need independent legal advice.