Basics of Advertising Therapeutic Goods in Australia

1. Overview

Advertising of therapeutic goods in Australia is regulated by the Therapeutic Goods Administration (TGA) to protect public health by ensuring promotional materials are accurate, balanced, and not misleading. The rules apply to all forms of advertising, including print, online, social media, broadcasts, and point-of-sale materials. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics The requirements depend on the product type (e.g., prescription medicines, over-the-counter medicines, medical devices, complementary medicines), ingredients, how the product works, and the specific claims made. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics

2. What Constitutes Advertising

Advertising includes any statement, pictorial representation, or design intended to promote the use or supply of therapeutic goods, whether direct or indirect. This covers claims about benefits, efficacy, safety, or intended use. Even non-promotional content can be considered advertising if it influences purchasing or use decisions. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics

3. Who Can Advertise and To Whom

Advertising rules differ based on the audience:

• To the general public (consumers): Permitted for certain products like listed medicines (e.g., many complementary medicines) and some registered over-the-counter medicines, but with strict controls on claims.
• To health professionals: Broader allowances for prescription medicines and certain restricted products, as professionals can assess information critically. Certain therapeutic goods, particularly prescription-only and some high-risk items, are prohibited from direct-to-consumer advertising. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics

4. Key Prohibitions and Limitations

Some products are completely prohibited from advertising to the public, including most prescription medicines, certain medical devices, and goods with high-risk claims. For allowable products, advertising must comply with limitations on what can be claimed (e.g., no absolute or unqualified efficacy claims, no misleading implications of superiority). Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics Restricted representations (e.g., serious conditions) and prohibited representations (e.g., implying treatment/cure for serious diseases) are tightly controlled. Testimonials must be genuine and not misleading. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics

5. Compliance with the Advertising Code

All advertising must adhere to the Therapeutic Goods Advertising Code, which sets standards for truthfulness, balance, substantiation of claims, and avoiding harm or offense. The Code includes requirements for clear disclosure, appropriate language, and no undue fear inducement. Non-compliance can result in enforcement actions, including fines or product removal. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics

6. Practical Considerations

Advertisers should review product ARTG entry, ensure claims match approved indications, and substantiate all statements with evidence. For complex cases, pre-approval or consultation with the TGA may be advisable. The TGA provides guidance documents and resources for compliant advertising practices. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics

7. Additional Resources

Further details are available on TGA advertising pages, including specific guidance for different product types, the Advertising Code, complaint mechanisms, and enforcement information. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-basics