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Compliance and enforcement
We monitor and enforce compliance with laws that regulate health products.
Last updated
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 compliance principles
We have re-aligned our approach to determining compliance priorities for 2026 and 2027. The new approach sees our priorities structured around five compliance principles, each supported by routinely reviewed priority focus areas. These principles guide how we address illegal import, export, manufacture, supply and advertising of therapeutic goods.
The five principles are:
- Safeguarding therapeutic goods
- Educate to empower
- Protect those most at risk
- Leverage digital capability
- Strengthen enforcement.
Learn more about our compliance principles
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.
Page history
'Know our compliance principles' section updated.
Original publication.
'Know our compliance principles' section updated.
Original publication.
Latest alerts
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We are advising consumers that Artri Ajo King tablets may pose a serious risk to your health and should not be taken.
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TGA continues to see imports of counterfeit Botox vials despite a previous warning issued in July 2025.
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TGA is issuing a safety advisory about the importation of unregistered GLP-1 products that are being promoted online for weight-loss.
Latest articles
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Key Promotional Products and an individual ordered to pay $2 million for the unlawful import and supply of COVID-19 rapid antigen tests
The Federal Court of Australia has ordered Key Promotional Products Pty Ltd to pay $1,750,000 for the unlawful import and supply of over 240,000 COVID-19 detection rapid antigen test kits. An individual was also ordered to pay $250,000. -
TGA issues infringement notices for alleged unlawful advertising of therapeutic goods involving prohibited representations
We have issued 4 infringement notices totalling $79,200 to Switch Nutrition Pty Ltd (Switch Nutrition) for the alleged unlawful advertising of therapeutic goods. -
Enforceable direction: Veganic SKN Limited
The delegate believes, on reasonable grounds, that it is in the interests of public health or safety to give Veganic SKN Limited directions under section 42YT of the Therapeutic Goods Act 1989.
Latest publications
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The report cards show the progress made by the TGA in the 3 strategies that make up the Action Plan for Medical Devices.
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Clarifies requirements for SAS and AP applications for healthcare practitioners to access Category 2, 3, 4 and/or 5 (i.e. Schedule 8) medicinal cannabis medicines for their patients under the age of 18 years (paediatric patients).
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This plan outlines our compliance and education priorities for 2024-2025.