Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 12, 2026
Approximately 5 minutes
Advertising Compliance and Reporting for Therapeutic Goods in Australia
Advertising Compliance and Reporting for Therapeutic Goods in Australia
1. Overview of Compliance Responsibilities
Compliance with advertising requirements for therapeutic goods is the responsibility of the sponsor or advertiser. All advertisements must comply with the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code). The TGA actively monitors advertising and takes enforcement action where necessary to protect public health. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
2. Monitoring and Enforcement Approach
The TGA monitors advertising through various channels, including proactive surveillance, reactive responses to complaints or reports, and intelligence gathering. When non-compliance is identified, the TGA may issue warnings, require corrective actions, or pursue formal enforcement measures such as infringement notices, civil penalties, or court proceedings. Outcomes of enforcement actions are published where appropriate. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
3. Reporting Suspected Non-Compliant Advertising
Members of the public, health professionals, or industry can report suspected breaches of advertising rules via the TGA's online reporting form or by email/phone. Reports should include details of the advertisement (e.g., where seen, screenshots if possible), the product involved, and reasons for concern. Anonymous reports are accepted, but providing contact details allows follow-up if needed. The TGA assesses all reports and may investigate further. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
4. What Happens After a Report
Upon receiving a report, the TGA reviews the advertisement against the Act and Code. If a breach is substantiated, actions may range from education/advisory letters to the advertiser, to requiring withdrawal or correction of the advertisement, up to more serious sanctions. Complainants are generally informed of the outcome unless confidentiality applies. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
5. Enforcement Outcomes and Transparency
The TGA publishes summaries of enforcement actions taken for advertising non-compliance, including the nature of the breach, actions required, and any penalties. This promotes transparency and deters future breaches. Detailed case information may be available on request or through freedom of information processes in some instances. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
6. Annual Compliance Reports
The TGA produces annual reports on advertising compliance activities, including statistics on the number of reports received, investigations conducted, types of breaches identified, and enforcement outcomes. These reports provide insights into trends, common issues, and the effectiveness of compliance efforts. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
7. Additional Resources and Guidance
For more information on compliance expectations, refer to related TGA advertising guidance pages, the Advertising Code, and enforcement policies. The TGA encourages proactive compliance and offers resources to help advertisers understand and meet requirements. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-compliance-and-reports
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Basics of Advertising Therapeutic Goods in Australia
The Therapeutic Goods Administration (TGA) regulates advertising of therapeutic goods in Australia to ensure claims are truthful, balanced, and do not mislead consumers. Requirements vary by product type, ingredients, mechanism, and intended claims, with strict prohibitions on advertising certain products to the public and limitations on representations, guided by the Therapeutic Goods Advertising Code.
Approximately 5 minutes
Prohibition on Using 'TGA Approved' Claims in Advertising Therapeutic Goods in Australia
The Therapeutic Goods Administration (TGA) strictly prohibits the use of statements such as 'TGA approved', 'TGA certified', 'TGA listed', or similar terms implying official endorsement in advertisements for therapeutic goods. Such claims are considered misleading as they suggest a level of evaluation or approval that does not align with the actual regulatory processes for listed or exempt goods, and their use constitutes a breach of the Therapeutic Goods Act 1989 and the Advertising Code.
Approximately 5 minutes
Legal Framework Governing Advertising of Therapeutic Goods in Australia
The advertising of therapeutic goods in Australia is governed by a comprehensive legal framework under the Therapeutic Goods Act 1989, supported by the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 and related regulations. This framework ensures that promotional claims are truthful, balanced, evidence-based, and do not mislead consumers or health professionals, with specific rules applying to different categories of therapeutic goods and audiences.
Approximately 5 minutes
Advertising Therapeutic Goods on Social Media in Australia
The Therapeutic Goods Administration (TGA) applies the same advertising rules to social media as to traditional media, requiring all promotional content for therapeutic goods to comply with the Therapeutic Goods Act 1989 and the Advertising Code. This includes user-generated content, influencer posts, comments, and platform features such as likes/shares that can constitute advertising, with specific considerations for platform limitations, global accessibility, and real-time moderation.
Approximately 5 minutes
Advertising to Health Professionals: Exemption from Consumer Rules in Australia
In Australia, advertisements for therapeutic goods directed exclusively to health professionals are exempt from the consumer-directed advertising rules under the Therapeutic Goods Act 1989 and the Advertising Code. This allows broader promotional content, including restricted representations and certain claims prohibited for the public, provided the material is genuinely targeted only to qualified professionals and not accessible to consumers.