Who must comply with the Therapeutic Goods Advertising Code?
The applicability test for Comply with the Therapeutic Goods Advertising Code (TGA), computed across 35 industries, 9 business structures and 6 size bands.
Short answer: Some businesses
Applies when the business has industry: Medical devices & therapeutic goods. Where the business has industry: Health practitioners or industry: Retail trade, check whether you advertise therapeutic goods.
What the obligation is
Advertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Part 5-1 Therapeutic Goods Act 1989 and Therapeutic Goods Advertising Code 2021 govern advertising to consumers. Prohibited representations (e.g. cancer treatment claims) require pre-approval. Schedule 4 prescription medicines cannot be advertised. Penalties for non-compliance significantly enhanced 2021.
The applicability test
Applies when the business has industry: Medical devices & therapeutic goods. Where the business has industry: Health practitioners or industry: Retail trade, check whether you advertise therapeutic goods.
How the regulator frames it: Sponsors, advertisers, social media influencers promoting therapeutic goods.
What triggers it: Promoting therapeutic goods to consumers.
Jurisdiction: Commonwealth law, so the test is the same in every state and territory.
Which industries are in or out
Outcome across the 35 industries Rules Mate maps (1 of 35: yes; 2 of 35: only if a further fact applies; 32 of 35: no).
| Industry | Answer |
|---|---|
| Medical devices & therapeutic goods | Yes |
| Health practitioners | Only if a further fact applies |
| Retail trade | Only if a further fact applies |
| No | 32 other industries |
Business structure and size
Structure does not change the answer in the 3 industries it can reach: for every structure the answer is "depends on size or structure".
Size does not change the answer in the 3 industries it can reach: at every size band the answer is "depends on size or structure".
Worked examples
Each line is one run of the Rules Mate applicability engine for a single business profile, with the reason the engine gives:
- Pty Ltd company in medical devices & therapeutic goods with 6–19 employees, turnover $1M–$3M: applies. Industry: Medical devices & therapeutic goods.
- Pty Ltd company in real estate agents with 6–19 employees, turnover $1M–$3M: does not apply. Requires industry: Medical devices & therapeutic goods.
- Pty Ltd company in health practitioners with 6–19 employees, turnover $1M–$3M: check whether it applies. applies only if you advertise therapeutic goods.
When you need to check further
The engine shows this obligation as "check whether this applies" when a business has industry: Health practitioners or industry: Retail trade. It then applies only if you advertise therapeutic goods. That fact is not something Rules Mate can infer from industry, structure or size.
What you must do, and when
- When due
- Continuous.
- Frequency
- Ongoing
- Evidence to keep
- Advertising compliance check, internal approval workflow, influencer briefing.
- Status
- Current
- Priority
- High
Penalty for not complying
Maximum penalty: Civil penalty up to $1.82M (individuals), $18.2M (corporations); criminal liability for serious offences.
Criminal liability
Audit or assurance level
Rules Mate has not yet classified the audit or assurance level for this obligation. Any audit, review or certification requirement is set by the regulator source listed below.
Obligations with the same applicability test
If this obligation applies to you, so does this one: the engine uses the same rule for each.
What usually applies alongside it
Across the 1,890 business profiles Rules Mate evaluates, these obligations apply to most of the businesses this one applies to, and are far more common among them than among businesses generally:
- In-vitro diagnostic medical device classification + ARTG: applies to 100% of the same businesses (35.0× the overall rate)
- Conduct post-market surveillance of therapeutic goods: applies to 100% of the same businesses (35.0× the overall rate)
- Notify ACCC of a voluntary recall within 2 days: applies to 100% of the same businesses (8.8× the overall rate)
Where it sits in the corpus
Rules Mate tracks 7 published obligations tagged "marketing", 0 of them rated critical. For a professional services Pty Ltd company with 6–19 employees operating in every state, 1 of those apply outright. This obligation is rated high priority and carries criminal liability, and is an ongoing duty.
Regulator, legislation and tools
Regulated by Therapeutic Goods Administration.
TGA: Regulator of therapeutic goods — medicines, medical devices, biologicals, and blood products. Administers the Therapeutic Goods Act and ARTG.
Therapeutic Goods Act 1989: Federal Therapeutic Goods Administration regime.
Free tools that help with this obligation:
Questions
- Who must comply with the Therapeutic Goods Advertising Code?
- Applies when the business has industry: Medical devices & therapeutic goods. Where the business has industry: Health practitioners or industry: Retail trade, check whether you advertise therapeutic goods.
- Do sole traders need to comply with the Therapeutic Goods Advertising Code?
- Depends on size or structure. Looking in the 3 industries it can reach and every size band, the engine's answer for a sole trader is: depends on size or structure.
- Do businesses with 1–5 employees need to comply with the Therapeutic Goods Advertising Code?
- Depends on size or structure (1–5 employees, turnover $100K–$1M).
- When is "Comply with the Therapeutic Goods Advertising Code" due?
- Continuous.
Related
Sources
Computed by the Rules Mate applicability engine from the published obligation corpus; facts last checked 3 October 2026. Rules Mate is not a law firm and this is general information, not legal advice. Confirm your position with the regulator source or a qualified adviser before acting.