TGA Infringement Notices Exceed $126k for Unlawful Medicines
The TGA has issued 12 infringement notices totalling $126,720 to companies and individuals for unlawful importation and advertising of prescription-only medicines, including Mounjaro pens.
The Therapeutic Goods Administration (TGA) has announced a significant round of enforcement, issuing 12 infringement notices totalling $126,720 to two companies and five individuals across Australia. These actions address alleged contraventions of the Therapeutic Goods Act 1989 (the Act) related to the unlawful importation and advertising of prescription-only medicines.
The infringement notices, which were paid between July and September 2026, targeted a range of illicit activities. Notable cases include:
- Chan and Khin Pty Ltd and a QLD-based health practitioner: Issued four notices totalling $47,520 for advertising prescription medicines such as lovastatin, baricitinib, and ketamine.
- The Australian Centre for Functional Medicine Pty Ltd: Received three notices totalling $59,400 for the importation of unapproved melatonin products.
- VIC-based individuals: Received notices totalling $11,880 for the importation of Mounjaro pens.
- NSW-based individual: Issued one notice for $3,960 related to the importation of prescription-only erectile dysfunction medicines.
- Another VIC-based individual: Received one notice for $3,960 for the importation of cosmetic injectable products (hyaluronic acid pre-filled syringes).
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, underscored the public health risks associated with such activities. “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,” Professor Lawler stated. He reaffirmed the TGA’s commitment to robust enforcement, noting that “The TGA will continue to take strong enforcement action where businesses or individuals do not meet their legal obligations.”
Under Australian law, therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) prior to lawful advertising, importation, or supply, unless a specific approval, authority, or exemption is in place. The products involved in these infringement cases were not listed on the ARTG and lacked the necessary permissions for their advertising or importation.
The TGA stresses that unapproved therapeutic goods have not undergone assessment for quality, safety, and efficacy, thus posing potential health risks to consumers. Furthermore, advertising prescription-only medicines can artificially inflate demand and potentially sway consumers towards treatments without proper clinical oversight. Such decisions, the TGA advises, should always be made in consultation with a qualified health professional.
This series of infringement notices serves as a stern reminder to individuals, health practitioners, and businesses alike about their critical legal obligations under the Therapeutic Goods Act. Compliance is not optional; it is a fundamental requirement designed to safeguard public health and maintain the integrity of Australia’s therapeutic goods framework.
For educational purposes only. This content is informational and reflects publicly reported developments. It is not legal, medical, or regulatory advice. Consult a qualified professional for compliance questions.