The Therapeutic Goods Administration (TGA) has issued 12 infringement notices totalling $126,720 to 2 companies and 5 individuals for alleged contraventions of the Therapeutic Goods Act 1989 (the Act).
The infringement notices relate to the alleged unlawful importation and advertising of prescription-only medicines.
| Business/individual | Alleged contraventions | Number of infringement notices | Infringement notice amount |
|---|---|---|---|
| Chan and Khin Pty Ltd and a QLD-based health practitioner | Advertising of prescription medicines, such as lovastatin, baricitinib and ketamine | 4 | $47,520 |
| The Australian Centre for Functional Medicine Pty Ltd | Importation of unapproved melatonin products | 3 | $59,400 |
| VIC-based individual | Importation of Mounjaro pens | 2 | $7,920 |
| VIC-based individual | Importation of Mounjaro pens | 1 | $3,960 |
| NSW-based individual | Importation of prescription-only erectile dysfunction medicines | 1 | $3,960 |
| VIC-based individual | Importation of cosmetic injectable products (hyaluronic acid pre-filled syringes) | 1 | $3,960 |
The infringement notices were paid between July and September 2026.
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said the unlawful importation and advertising of therapeutic goods could put public health at risk.
“Therapeutic goods must meet Australia’s regulatory requirements before they are imported, advertised or supplied to the public. These requirements exist to protect consumers from products that may be unsafe, ineffective or of poor quality.
“The TGA will continue to take strong enforcement action where businesses or individuals do not meet their legal obligations,” Professor Lawler said.
Under the Act, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully advertised, imported or supplied in Australia, unless an approval, authority or exemption applies. The products were not entered in the ARTG and did not have the required approval, authority or exemption to permit their advertising or importation.
Therapeutic goods that have not been entered in the ARTG have not been assessed by the TGA for quality, safety and efficacy and may pose a health risk.
Advertising prescription-only medicines can encourage inappropriate demand and may influence consumers to seek particular treatments without adequate clinical oversight. Decisions about treatment options should be made by individuals in consultation with their health professional.
Individuals, health practitioners and businesses must understand their legal obligations under the Act before importing, advertising or supplying therapeutic goods. Consequences of non-compliance may include infringement notices, direction or prevention notices, civil penalties or criminal prosecution.
This action reflects the TGA’s ongoing compliance and enforcement activities for therapeutic goods as outlined in the TGA’s Compliance Principles 2026 and 2027.
If you suspect non-compliance in relation to therapeutic goods, or their advertising, you can report it to the TGA at any time.
