Compliance and enforcement
We monitor and enforce compliance with laws that regulate health products.
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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.
Latest alerts
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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.
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We are issuing a safety advisory regarding imported unregistered melatonin products following testing by TGA Laboratories.
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We are issuing a safety advisory about the increasing importation and use of unregistered oral methylene blue (methylthioninium chloride) products in Australia.
Latest articles
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Queensland-based individual issued infringement notices for allegedly importing and advertising counterfeit botulinum toxin type A
We have issued 2 infringement notices totalling $7,716 to a Queensland-based individual for the alleged unlawful importation of counterfeit botulinum toxin type A and the unlawful advertising of cosmetic injectables. -
NSW-based individual issued infringement notices for allegedly importing cosmetic injectables
We have issued 5 infringement notices, totalling $19,800, to a NSW-based individual, for the alleged unlawful importation of unapproved prescription-only medicines in contravention of the Therapeutic Goods Act 1989. -
Changes to the Prescription Medicines Minor Variation (PMMV) form
We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026.
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.