The TGA regulates advertising for therapeutic goods in Australia: medicines, medical devices, supplements, and biologicals. If your business sells or recommends these products, TGA requirements apply alongside other regulations like AHPRA guidelines.
We've worked with supplement brands, medicinal cannabis clinics, device companies, and pharmacies. We know how these rules work in practice, and we've built that knowledge into our approach.
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.
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
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.
Contact us to talk about your products or practice.