TGA Advertising Code

TGA Advertising Code: a 2026 guide for therapeutic goods marketing

Q: What is the TGA Advertising Code?

The Therapeutic Goods Advertising Code (TGAC) is the legally binding code that governs advertising of therapeutic goods to Australian consumers. It sits under the Therapeutic Goods Act 1989 and is administered by the TGA. The current edition is the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, with ongoing amendments. The Code covers what claims can be made, what evidence is required, when warning statements must appear, and which categories of product (prescription medicines, certain Schedule 3 medicines, restricted representations) can't be advertised to consumers at all.

A practical guide to the Therapeutic Goods Advertising Code for supplement brands, device companies, pharmacies, and clinics that promote therapeutic goods in Australia.

Last updated: May 2026. Reflects the current Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 and TGA guidance.

The TGA Advertising Code is the legally binding framework that governs advertising of therapeutic goods to Australian consumers. Officially the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, it sits under the Therapeutic Goods Act 1989 and is enforced by the Therapeutic Goods Administration. If your business advertises medicines, supplements, medical devices, or biologicals to consumers, the Code applies.

We've worked with supplement brands, medicinal cannabis clinics, medical device companies, pharmacies, and cosmetic practices where the TGA Code overlaps with AHPRA's advertising rules. This guide is the working version: how the Code actually applies in production, what trips most businesses up, and how to build marketing that doesn't end up in front of a compliance officer. For the AHPRA side of the picture, see our What is AHPRA? explainer and the AHPRA advertising guidelines page.

Product Categories and What They Mean

The TGA classifies products differently, and each classification has different advertising rules. Understanding where your products fit is the starting point.

Prescription Medicines (Schedule 4 and 8)

Consumer advertising is prohibited for prescription medicines. Full stop. You cannot mention specific prescription medications in consumer-facing marketing, even indirectly.

Advertising to healthcare professionals is permitted through appropriate channels, but with strict requirements around balanced information, disclaimers, and evidence.

Over-the-Counter Medicines (Schedule 2 and 3)

OTC medicines can be advertised to consumers, but must comply with the Therapeutic Goods Advertising Code. Note that Schedule 3 (Pharmacist Only) medicines can only be advertised if they appear in Appendix H of the Poisons Standard.

Advertising must ensure:

Claims are substantiated by evidence
Required warning statements appear
No misleading claims or unreasonable expectations

Complementary Medicines

Vitamins, minerals, herbal products, and similar products are typically "listed" (AUST L) rather than "registered" (AUST R) with the TGA. Listed products have different requirements: indications must be held in the Australian Register of Therapeutic Goods and evidence must support any claims.

AUST L vs AUST R

Listed products (AUST L) are based on sponsor self-certification of low risk. This is not TGA pre-approval of efficacy claims. The distinction matters when planning what you can say in advertising.

Medical Devices

Everything from bandages to diagnostic equipment falls under medical device regulations. Advertising requirements are consistent under the Code, but the evidence required depends on your specific claims and device classification. All advertising must be truthful, substantiated, and not misleading.

For aesthetic devices used in healthcare settings, you may also need to comply with AHPRA guidelines.

What You Cannot Say

The Therapeutic Goods Advertising Code limits certain representations:

Prohibited Representations: You cannot refer to serious conditions like cancer, HIV/AIDS, or mental illness in consumer advertising.
Restricted Representations: References to conditions like diabetes or heart disease require prior TGA approval.
Misleading Claims: You cannot exploit knowledge gaps, abuse consumer trust, or make false representations.

Evidence Requirements

All claims must be substantiated. The TGA recognises a hierarchy of evidence:

Systematic reviews and meta-analyses provide the strongest support.
Randomised controlled trials with appropriate methodology.
Non-randomised studies carry less weight but may support claims.
Traditional use evidence can support certain claims for complementary medicines.

The level of evidence required matches the strength of your claim. "May assist" requires less evidence than "treats" or "cures."

Where TGA Meets AHPRA

If you're a registered health practitioner selling or recommending therapeutic goods, you need to comply with both TGA and AHPRA requirements. This creates overlapping obligations in areas like:

Cosmetic injectables: TGA governs the products, AHPRA governs your practitioner advertising
Pharmacy services: Both frameworks apply to how you advertise
Medical aesthetics: Devices and practitioner services both have requirements

What We've Learned

Navigating overlapping TGA and AHPRA requirements is where experience matters most. We've worked with supplement brands, medicinal cannabis clinics, pharmacies, and aesthetics practices. We know how these frameworks interact in practice.

Working Within the Rules

The TGA actively monitors advertising and investigates complaints. Penalties can be substantial: infringement notices, public warnings, and civil penalties that can reach millions of dollars for corporations. The TGA also publishes enforcement actions, creating reputational risk.

For businesses in this space, working with specialists who understand these requirements helps keep you protected. We know what works within the rules, and we've never had a TGA issue across any of our clients.

"We understand the regulatory landscape so you don't have to. It's one less thing to worry about."

Let Us Handle This

TGA compliance can be complex. When you work with Medical Marketing Group, we build it into everything we do: product claims are checked, evidence requirements are understood, required statements are included. You focus on your business while we ensure your marketing stays on the right side of the regulations.

Common Questions

TGA advertising
answered.

What businesses most often ask about therapeutic goods advertising.

What is the TGA Advertising Code?

The Therapeutic Goods Advertising Code (TGAC) is the legally binding code that governs advertising of therapeutic goods to Australian consumers. It sits under the Therapeutic Goods Act 1989 and is administered by the TGA. The current edition is the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, with ongoing amendments.

The Code covers what claims can be made, what evidence is required, when warning statements must appear, and which categories of product (prescription medicines, certain Schedule 3 medicines, restricted representations) can't be advertised to consumers at all.

What does the TGA regulate?

The TGA regulates therapeutic goods in Australia: prescription and over-the-counter medicines, complementary medicines (vitamins, herbal products), medical devices, and biologicals. Where those goods are advertised to consumers, the TGA Advertising Code applies.

Different product categories carry different requirements. Prescription medicines are the most restricted (consumer advertising is prohibited outright). Listed complementary medicines have more flexibility, but claims still need to be substantiated and within permitted indications.

Can I advertise prescription medicines to consumers?

No. Advertising prescription medicines (Schedule 4 and 8) directly to consumers is prohibited in Australia.

Prescription medicines can only be advertised to healthcare professionals through appropriate channels, with strict content requirements.

Can I advertise Schedule 3 (Pharmacist Only) medicines?

Schedule 3 medicines can only be advertised to consumers if they are specifically listed in Appendix H of the Poisons Standard. Most Schedule 3 medicines cannot be advertised to the public.

This is a common compliance trap. Always verify your product appears in Appendix H before planning consumer-facing advertising.

What claims can I make about supplements and complementary medicines?

Claims must be supported by evidence and cannot be misleading. The TGA maintains permitted indications for listed medicines.

Lower-level claims like "may assist", "helps maintain", or "supports" are generally acceptable. Higher-level therapeutic claims require more substantial evidence.

What are the penalties for non-compliant advertising?

Penalties can be substantial. For corporations, civil penalties under the Therapeutic Goods Act 1989 can reach into the millions of dollars. The TGA has secured penalties of more than $20 million against a single company.

Beyond financial penalties, the TGA publishes enforcement actions on its website, creating significant reputational risk. Even infringement notices (the lower-tier sanction) are routinely published by company name.

Where do the TGA Advertising Code and AHPRA rules overlap?

For any practitioner selling or recommending therapeutic goods, both regimes apply at the same time. The clearest example is cosmetic injectables: the TGA governs whether you can name a Schedule 4 product brand to consumers (you can't), while AHPRA governs how the practitioner's services can be advertised.

The same overlap appears in pharmacy, supplements offered alongside clinical services, and medical device-based treatments. We cover the AHPRA half on the AHPRA advertising guidelines page and the broader context on the What is AHPRA? explainer.

Who enforces the TGA Advertising Code?

The TGA itself runs the compliance program. It receives complaints through its online portal, issues warnings, accepts undertakings, issues infringement notices, and refers serious matters for civil penalty proceedings. Decisions and outcomes are published on the TGA's compliance hub.

The TGA Advertising Code is enforceable as a legislative instrument, which means breaches are breaches of law rather than of a voluntary code. That's why penalties can be so high.

How often does the TGA Advertising Code change?

The Code itself is amended periodically (the current instrument dates from 2021, with subsequent amendments). The TGA also publishes guidance documents, permissions for restricted representations, and category-specific updates throughout the year. Recent focus areas have included nicotine vaping products, medicinal cannabis, weight-loss medicines, and influencer marketing of complementary medicines.

We track these changes for the clients we work with. This page reflects guidance current as of May 2026.

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