TGA fines ACPharm Queensland $99,000 for unlawful advertising of therapeutic goods

The TGA has issued five infringement notices, totalling $99,000, to ACPharm Queensland Pty Ltd for the alleged unlawful advertising of therapeutic goods, in breach of the Therapeutic Goods Act 1989 (the Act). ACPharm Queensland paid the infringement notices in October 2025.

ALLEGED BREACHES

It is alleged that ACPharm Queensland advertised medicinal cannabis and other therapeutic goods that were not included in the Australian Register of Therapeutic Goods (ARTG).

Under Australian law, prescription-only medicines such as medicinal cannabis must not be advertised directly to consumers. This safeguard exists to prevent inappropriate consumer demand and to protect the integrity of the patient–practitioner relationship. Decisions about suitable treatment options should always be made in consultation with a qualified health professional.

The TGA also alleges that the advertising promoted therapeutic goods for the treatment of serious diseases, conditions or disorders. Such statements are known as restricted or prohibited representations under the Act. These types of representations may only be used if prior approval or permission has been granted by the TGA, which was not the case in this matter.

WHY THESE SAFEGUARDS EXIST

In Australia, all therapeutic goods must be entered in the ARTG before they can be lawfully manufactured, supplied or advertised, unless a specific exemption applies. The ARTG acts as a critical safeguard to ensure that therapeutic goods available to consumers are safe, of acceptable quality, and perform as intended.

Advertising rules are a key part of this framework. They ensure consumers receive accurate, evidence-based information about therapeutic goods and are protected from misleading, unsubstantiated or potentially harmful claims.

CONSEQUENCES OF NON-COMPLIANCE

Businesses that manufacture, supply or advertise therapeutic goods must understand their legal obligations under the Act. Failing to comply may lead to significant regulatory action, including infringement notices, civil penalties or criminal proceedings.

The TGA continues to monitor the advertising of therapeutic goods and will take enforcement action where advertisements are found to breach the law.