Updated weekly ・ last 2026-10-03JAEN
Pharma Promotion / Australia

Promotion of prescription medicines — Australia

Regulator: TGA ／ Main law: Therapeutic Goods Act 1989・Medicines Australia Code

The basics (source-verified)

Pre-review & approval

Use of a restricted representation, that is one referring to a serious form of a disease, condition, ailment or defect, requires prior approval by the Secretary, who must approve it if satisfied the representation is accurate, balanced and not misleading, and who is taken to have approved it if no written notice is given within 60 days of the application.

Source: Therapeutic Goods Act 1989, sections 42DF and 42DG (Compilation No. 86)（checked 2026-09-23）

Promotion to HCPs

Part 5-1 of the Therapeutic Goods Act 1989 does not apply to advertisements directed exclusively to health practitioners and the other listed categories such as wholesalers and hospital purchasing officers (section 42AA), and the statutory Advertising Code likewise does not apply. What actually governs promotion of prescription medicines to health professionals beyond that exclusion is the industry's own self-regulatory instrument, the Medicines Australia Code of Conduct (Edition 20, adopted 30 October 2024, effective 30 March 2025). Its Scope section states that the Constitution of Medicines Australia binds member companies to the Code, and that 'the Therapeutic Goods Administration states that, as a condition of registration, prescription medicines must be promoted in accordance with this Medicines Australia Code of Conduct, whether the Company is a member or non-member'. Part B section 1 permits promotion of prescription products to health professionals so long as all information, claims and graphical representations are current, accurate, balanced, consistent with the approved product information and do not mislead directly, by implication or by omission; companies are responsible for referencing all promotional claims and for ensuring the cited references provide the appropriate level of evidence, reflect the body of evidence and allow health professionals to evaluate the validity of the results independently. Qualifying statements must be linked to the claim by a readily identifiable symbol, placed directly below or adjacent to it and be prominent; claims based on animal or laboratory data must be appropriately qualified; claims for clinical benefit must be of a magnitude generally accepted as clinically meaningful; and the statistical significance of comparative claims must be clearly indicated. Overarching Principle 8 in Part A requires all promotional claims, including claims about competitor products, to be consistent with the Australian Product Information. Sanctions are set out in Part F section 15.6: cessation of conduct and withdrawal of the promotional activity, corrective action including corrective letters and advertising approved by the Code Committee before release, and monetary fines with a schedule of maximums (minor A$100,000; moderate A$150,000; severe A$200,000; a severe breach where the activity was completed and there is no opportunity for corrective action, and a repeat of a previous breach, A$250,000; failure to complete corrective action within 30 calendar days A$50,000; failure to pay a fine within 30 days A$50,000), fines being imposable individually or cumulatively up to a maximum of A$300,000 per complaint.

Source: Medicines Australia Code of Conduct, Edition 20 (adopted 30 October 2024, effective 30 March 2025), Scope, Part A Overarching Principles, Part B section 1, Part F section 15.6; Therapeutic Goods Act 1989 section 42AA（checked 2026-09-23）

Direct-to-consumer

It is an offence to advertise therapeutic goods where the advertisement refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 of the current Poisons Standard but not in Appendix H, other than a reference authorised or required by an Australian government authority.

Source: Therapeutic Goods Act 1989, sections 42DL(1)-(3) and 42DL(10) (Compilation No. 86, in force 1 October 2024)（checked 2026-09-23）

Digital & social media

An advertisement that directly facilitates the purchase or supply of a medicine that cannot be physically inspected before supply, which the Code's note says includes advertisements on a website, social media or a software application through which a transaction may be conducted, must also include the dosage form name, the quantity, each active ingredient, and either a list of, or a link to, any applicable health warnings.

Source: Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Schedule 1 section 19(2)-(3)（checked 2026-09-23）

Efficacy claims

An advertisement about therapeutic goods must be accurate, balanced and not misleading or likely to mislead, must only contain information substantiated by the advertiser before publication, and must not be inconsistent with any indication or intended purpose accepted for the goods' inclusion in the Register.

Source: Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Schedule 1 section 8 (Compilation No. 1, 20 December 2022, authorised version F2023C00019)（checked 2026-09-23）

Safety information

An advertisement about therapeutic goods must not contain any statement, pictorial representation or design that expressly or by implication represents the goods to be safe or without harm or side-effects, effective in all cases or a guaranteed cure, or infallible, unfailing, magical or miraculous.

Source: Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Schedule 1 section 9(1)（checked 2026-09-23）

Comparative claims

An advertisement about therapeutic goods must not compare the goods with other therapeutic goods, classes of therapeutic goods or therapeutic services where the comparison suggests that the comparator goods or services are harmful or ineffectual.

Source: Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, Schedule 1 section 9(3)(f)（checked 2026-09-23）

Enforcement & penalties

Advertising therapeutic goods in a way that does not comply with the Advertising Code carries a criminal penalty of up to five years' imprisonment or 4,000 penalty units where harm or injury results or is likely, up to 12 months or 1,000 penalty units otherwise, a strict liability offence of 100 penalty units, and a maximum civil penalty of 5,000 penalty units for an individual and 50,000 for a body corporate.

Source: Therapeutic Goods Act 1989, sections 42DM and 42DMA (Compilation No. 86)（checked 2026-09-23）

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Industry codes & rules 1

Litigation 1

Case law 0

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Industry-association papers 51

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