Therapeutic Goods Advertising Code
Advertising of therapeutic goods to AU consumers must comply with TGA Advertising Code.
Who must comply
Any person who advertises therapeutic goods to the public, or causes them to be advertised, by any means: sponsors, manufacturers, retailers and pharmacies, clinics, agencies, and social media influencers paid or incentivised to promote a product. Advertising directed exclusively to health professionals is outside the Code, although the Act still prohibits promoting an indication not included in the ARTG entry to anyone.
What triggers it
Publishing or causing the publication of any statement, image or design intended to promote the use or supply of a medicine, medical device, biological or other therapeutic good to members of the public, including online posts, hashtags, paid partnerships and in-store material.
When due
Before each advertisement is published, and for as long as it remains in circulation; each day a non-conforming advertisement continues is a separate contravention.
Evidence required
Completed TGA advertising compliance checklist or equivalent pre-publication review for each advertisement; ARTG entry showing the approved indications; evidence substantiating every claim; mandatory statements in place; written briefs and approval records for influencers and testimonials; any s 42DF approval or s 42DK permission relied on for a restricted or prohibited representation.
Max penalty
Civil penalty for an advertisement that does not comply with the Code (Therapeutic Goods Act 1989 s 42DMA) or that contains an unapproved restricted or prohibited representation (s 42DLB): 5,000 penalty units ($1.82M) for an individual and 50,000 penalty units ($18.2M) for a body corporate, with each day of a continuing contravention a separate contravention. Criminal offences also apply (s 42DM).
Who must comply with this? The applicability test by industry, business structure and size.
Summary
The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, made under s 42BAA of the Therapeutic Goods Act 1989, sets the standard every advertisement for therapeutic goods directed to the public must meet. Advertisements must promote safe and proper use, must not mislead or create unrealistic expectations of performance, must support informed health care choices and must not be inconsistent with current public health campaigns. The Code is organised in parts: general accuracy and balance (Part 3), mandatory statements (Parts 4 and 5), testimonials and endorsements (Part 6), samples and incentives (Part 7), restricted and prohibited representations (Part 8) and price lists for pharmacy and prescription-only medicines (Part 9). The Act separately bars public advertising of Schedule 3, 4 and 8 substances, claims of government endorsement (including 'TGA approved') and indications not in the ARTG entry.
Enforced by
Source legislation
Topics
Related
- CWLTHCosmetic surgery advertising standards (Medical Board reforms 2024-2025)Stricter cosmetic surgery + procedure advertising from 2024 — bans on idealised body imagery + before/after misuse.
- CWLTHInfluencer + ad disclosure under ACL + AANA CodePaid content must be clearly disclosed as advertising — #ad #spon are not enough on their own.
- CWLTHDisplay comparison rate on credit product advertisingAnnual percentage + comparison rate must accompany credit product ads under NCCP Regulations.
- CWLTHPHI Prudential Standards (APRA)Private health insurers must meet capital + governance standards.
- CWLTHComply with AANA Code of Ethics + community guidelinesSelf-regulatory advertising standards enforced by Ad Standards (formerly ASB).
Frequently asked questions
- Who must comply with Therapeutic Goods Advertising Code?
- Any person who advertises therapeutic goods to the public, or causes them to be advertised, by any means: sponsors, manufacturers, retailers and pharmacies, clinics, agencies, and social media influencers paid or incentivised to promote a product. Advertising directed exclusively to health professionals is outside the Code, although the Act still prohibits promoting an indication not included in the ARTG entry to anyone.
- What triggers Therapeutic Goods Advertising Code?
- Publishing or causing the publication of any statement, image or design intended to promote the use or supply of a medicine, medical device, biological or other therapeutic good to members of the public, including online posts, hashtags, paid partnerships and in-store material.
- When is Therapeutic Goods Advertising Code due?
- Before each advertisement is published, and for as long as it remains in circulation; each day a non-conforming advertisement continues is a separate contravention.
- What is the maximum penalty for Therapeutic Goods Advertising Code?
- Civil penalty for an advertisement that does not comply with the Code (Therapeutic Goods Act 1989 s 42DMA) or that contains an unapproved restricted or prohibited representation (s 42DLB): 5,000 penalty units ($1.82M) for an individual and 50,000 penalty units ($18.2M) for a body corporate, with each day of a continuing contravention a separate contravention. Criminal offences also apply (s 42DM).
- What evidence is required for Therapeutic Goods Advertising Code?
- Completed TGA advertising compliance checklist or equivalent pre-publication review for each advertisement; ARTG entry showing the approved indications; evidence substantiating every claim; mandatory statements in place; written briefs and approval records for influencers and testimonials; any s 42DF approval or s 42DK permission relied on for a restricted or prohibited representation.
Source: https://www.tga.gov.au/products/regulations-all-products/advertising/applying-advertising-code. Rules Mate is not a law firm. Always verify against the live regulator source before acting.