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Compliance and enforcement

We monitor and enforce compliance with laws that regulate health products. 

This page is in Beta testing. We welcome your feedback and suggestions as we look to improve this page.

How we manage compliance

We take a risk-based, evidence-drive approach that puts public safety first. Under the Therapeutic Goods Act 1989, we work to protect Australians by educating industry, assessing risks and taking action when needed. 

Watch our video to learn more or explore our regulatory compliance framework.

Report a breach

We want to hear about: 

  • breaches of the Therapeutic Goods Act
  • counterfeit products
  • questionable practices
  • non-compliant advertising related to therapeutic goods.

Know our priorities

Our compliance priorities for 2023-2025 include the illegal import, advertising or supply of the following products: 

  • nicotine vaping products
  • medicinal cannabis and beauty products
  • poor quality and fake therapeutic products
  • traditional and alternative medicines.

Other areas of focus include software and AI medical device compliance, pharmacovigilance and good clinical practice inspection programs, among others. 

Find a compliance outcome

When we receive a report of a breach, we investigate and take action based on the level of risk to public health and safety. Our actions range from education and warnings to fines and legal action.

Understand the ways we respond to breaches of therapeutic good regulations and find the latest outcomes.

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