Who must comply with Therapeutic Goods Advertising Code?

Advertising of therapeutic goods to AU consumers must comply with TGA Advertising Code.

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.

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: 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.

Jurisdiction: Commonwealth law, so the test is the same in every state and territory.

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).

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".

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.

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.

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.

Frequency

When a triggering event occurs

Evidence to keep

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.

Status

Current

Priority

High

Maximum 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).

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.

If this obligation applies to you, so does this one: the engine uses the same rule for each.

• Comply with the Therapeutic Goods Advertising Code

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)

Rules Mate tracks 2 published obligations tagged "health", 0 of them rated critical. For a professional services Pty Ltd company with 6–19 employees operating in every state, 0 of those apply outright. This obligation is rated high priority, and is triggered by events.

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 Administration

Therapeutic Goods Act 1989: Federal Therapeutic Goods Administration regime.

• Therapeutic Goods Act 1989

Free tools that help with this obligation:

• Compliance calendar builder