Advocacy with Therapeutic Goods Administration on Advertising Compliance and Applications

Navigating regulatory correspondence can be challenging

The TGA uses regulatory language and expects businesses to understand their regulatory obligations. When it comes to compliance matters, timely, respectful, and constructive engagement is key to preventing further action. However, the TGA won’t provide a detailed checklist of what you need to fix in your advertising, and failing to respond appropriately is likely to escalate regulatory action. Seeside can:

• translate the TGA’s correspondence for you to advise you on the legal requirements and the TGA’s compliance expectations
• assess your advertising for compliance and advise on changes needed, and
• assist in drafting responses that address the TGA’s concerns effectively.

The TGA tightly controls references to serious diseases or conditions in advertising (restricted representations) due to their potential to mislead vulnerable consumers. Before using restricted representations, advertisers must obtain TGA approval by demonstrating that their representations are accurate, balanced, and not misleading.

Seeside can:

• review your evidence to assess whether your representations are supported;
• refine representation wording to reflect your evidence and align them with regulatory requirements;
• prepare and submit applications to seek TGA approval; and
• engage with the TGA to address any follow-up questions.

Seeside’s Principal Consultant, Leanne McCauley, was a TGA decision-maker for restricted representation applications. With her experience, we can guide you through the process to achieve the best possible outcome, as efficiently as possible.