Comply with the Therapeutic Goods Advertising Code
Advertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Who must comply
Sponsors, advertisers, social media influencers promoting therapeutic goods.
What triggers it
Promoting therapeutic goods to consumers.
When due
Continuous.
Evidence required
Advertising compliance check, internal approval workflow, influencer briefing.
Max penalty
Civil penalty up to $1.65M (individuals), $16.5M (corporations); criminal liability for serious offences
Summary
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.
Enforced by
Source legislation
Industries
Topics
Related obligations
- CWLTHConduct post-market surveillance of therapeutic goodsARTG-included goods must be monitored post-market for safety + performance.
- CWLTHIn-vitro diagnostic medical device classification + ARTGIVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
- CWLTHComply with the Spam Act 2003 (consent, identify, unsubscribe)All commercial electronic messages must have consent, identify the sender, and offer a working unsubscribe.
- CWLTHWash outbound marketing lists against the Do Not Call RegisterLists must be washed within 30 days of the call/SMS unless valid consent.
- CWLTHInfluencer + ad disclosure under ACL + AANA CodePaid content must be clearly disclosed as advertising — #ad #spon are not enough on their own.
- CWLTHAPP 7 direct marketingAPP 7 restricts using or disclosing personal information for direct marketing and requires a simple opt-out — when it applies, the exceptions and penalties.
Frequently asked questions
- Who must comply with the Therapeutic Goods Advertising Code?
- Sponsors, advertisers, social media influencers promoting therapeutic goods.
- What triggers the Therapeutic Goods Advertising Code?
- Promoting therapeutic goods to consumers.
- When is the Therapeutic Goods Advertising Code due?
- Continuous.
- What is the maximum penalty for the Therapeutic Goods Advertising Code?
- Civil penalty up to $1.65M (individuals), $16.5M (corporations); criminal liability for serious offences
- What evidence is required for the Therapeutic Goods Advertising Code?
- Advertising compliance check, internal approval workflow, influencer briefing.
Source: https://tga.gov.au/advertising-therapeutic-goods. Rules Mate is not a law firm. Always verify against the live regulator source before acting.