Therapeutic Goods Advertising Code: Requirements and Penalties

1. Key takeaways

The full statutory title of the Australian medical device advertising instrument is the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (registration number F2021L01661); abbreviated titles lose precision in compliance documents. The criminal penalty for advertising otherwise than in accordance with the Code is a maximum of imprisonment for 5 years or 4,000 penalty units, and the civil penalty for a body corporate is a maximum of 50,000 penalty units. The severity of these tiers is a deliberate signal: advertising is treated as a front-line consumer protection surface, not as a marketing afterthought. Because every outward-facing material is an advertisement in the statutory sense, the compliance burden lands on materials that marketing teams produce daily, and the only sustainable control is a pre-publication review process that is faster and easier than the violation is tempting. Experience across clients shows that the materials which cause findings are rarely the flagship campaigns; they are the small, fast-turnaround items produced outside the standard workflow, which is exactly why the review process must cover every channel rather than only the large ones.

2. Legal basis

1. Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, registration number F2021L01661; made under section 42BAA of the Therapeutic Goods Act 1989 (Act No. 21, 1990); current compilation F2026C01083 (C02), registered on 27 October 2026, effective on 30 September 2026; sunsets on 1 April 2032 under section 50 of the Legislation Act 2003.
2. Prior amendments: the Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (2022 Measures No. 1) Instrument 2022 (F2022L01650, 15 December 2022); the Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (Consequential Amendments from Labelling Standards) Instrument 2026 (F2026L01329, 29 September 2026).
3. Criminal penalties: section 42DM(1)–(6) of the Therapeutic Goods Act 1989 — where harm is caused or is likely to be caused: imprisonment for 5 years or 4,000 penalty units, or both; in general cases: imprisonment for 12 months or 1,000 penalty units; a third tier is strict liability, 100 penalty units; continuing offences attract a further amount per day of 10% of the maximum.
4. Civil penalties: section 42DMA(1)–(2B) — a maximum of 5,000 penalty units for an individual and 50,000 penalty units for a body corporate; broadcasters, datacasters, and SBS are exempt in specified circumstances; continuing contravention attracts a further amount per day of 10%.
5. Prohibited representations: the representations “TGA approved” and “TGA registered”, and any expression implying government endorsement (including names of foreign government agencies, the TGA logo, and the Commonwealth coat of arms), must not be used, pursuant to section 42DL(9), section 42DLB(6), and clause 16(2) of the Code; the compliant representation is “Product X is entered in the ARTG, (ARTG number)”.

3. Expert insights

Insight 1: The statutory name carries brackets; abbreviations lose precision. The full title of the Instrument contains the expression “Therapeutic Goods” twice. If contracts, compliance declarations, and internal SOPs write only “Advertising Code 2021”, the citation may fail to point to a unique instrument in a dispute. This is not pedantry: several similarly named instruments exist in the therapeutic goods space, and an ambiguous citation invites an argument about which text governed a given conduct. The fix is cheap relative to the exposure; a house style rule fixing the full title and registration number costs one line in a template.

Insight 2: The penalties run in three tiers, and the strict liability tier ignores intent. The third tier under section 42DM is strict liability (100 penalty units) and requires no proof of fault. This is the tier most easily triggered in daily operations, because it corresponds to formal violations. A material that is substantively accurate but formally non-compliant still engages the strict liability tier, which means the control that matters is not judgement about truthfulness but mechanical conformity with the representation rules, checked before publication rather than after.

Insight 3: “Entered in the ARTG” and “approved” are two different sentences. Australia permits stating that a product is entered in the ARTG together with its number, but does not permit implying government approval or endorsement. The expression commonly used by Chinese teams, “certified by TGA”, is a prohibited representation in Australia. The distinction is conceptual, not cosmetic: entry in the register records that statutory requirements have been met, while approval language attributes an evaluative judgement to the state that the law does not permit advertisers to claim. Training marketing staff on this conceptual line is more durable than policing individual phrases, because new paraphrases of the prohibited claim appear constantly and only an understanding of the principle catches them.

4. Practical recommendations

1. Establish a pre-publication review process for advertising materials: every outward-facing item (website, e-commerce pages, trade show panels, social media) passes a prohibited representations checklist before release, without exception for minor formats.
2. Add the terms “TGA approved” and “TGA registered” to the blocked-term list in the content management system, so that the most frequent violations are intercepted mechanically rather than by reviewer vigilance.
3. Standardise a compliant claim template: product name plus “is entered in the ARTG” plus the ARTG number, and distribute it to marketing as the default wording rather than as a correction.
4. After each compilation update of the Code (current C02, effective 30 September 2026), re-review the historical materials in the asset library, because an archive that was compliant when published may not be compliant after the Code changes.

5. Verification checklist

• □ Internal documents use the full title of the Instrument and the registration number F2021L01661
• □ A prohibited representations list has been established and wired into the content publication process
• □ All materials have been standardised to the “entered in the ARTG plus number” formulation
• □ The marketing team has been trained on the three criminal penalty tiers of section 42DM
• □ Historical materials have been re-reviewed after the latest compilation update of the Code

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages TGA inclusion and ARTG listing applications, coordinates conformity assessment evidence, and supports post-market vigilance obligations. Business enquiries: info@grzan.cn