TGA Issues Infringement Notices for Unlawful Importation and Advertising

TGA Australia Media Releases

Filed January 29th, 2026

Detected March 12th, 2026

Summary

The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totaling $43,560 to 6 individuals for alleged unlawful importation of unapproved therapeutic goods and unlawful advertising of prescription-only medicines. These actions underscore the TGA's commitment to protecting public health.

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What changed

The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totaling $43,560 to six individuals for alleged violations of the Therapeutic Goods Act 1989. The alleged offenses include the unlawful importation of unapproved therapeutic goods, some of which were counterfeit cosmetic injectables, and the unlawful advertising of prescription-only medicines like botulinum toxin. These actions highlight the TGA's enforcement efforts against individuals who bypass regulatory assessments and pose potential health risks.

These notices serve as a strong warning to individuals involved in the importation and advertising of therapeutic goods. Regulated entities and individuals must ensure compliance with the Act, particularly regarding the importation of goods not listed on the Australian Register of Therapeutic Goods (ARTG) and the prohibition of advertising prescription-only medicines directly to consumers. Failure to comply can result in significant financial penalties, as demonstrated by these infringement notices.

What to do next

Review importation practices for therapeutic goods to ensure compliance with the Personal Importation Scheme and ARTG requirements.
Verify that advertising of prescription-only medicines adheres strictly to prohibitions against direct-to-consumer advertising.
Ensure all imported therapeutic goods are either ARTG-listed or meet the specific conditions of approved importation pathways.

Penalties

$43,560 in total fines issued across 11 notices.

Source document (simplified)

TGA issues infringement notices to 6 individuals for alleged importation and unlawful advertising of therapeutic goods

Published

29 January 2026

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- LinkedIn
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- Email The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totalling $43,560, to 6 individuals, for the alleged unlawful importation of unapproved therapeutic goods and the alleged unlawful advertising of therapeutic goods, in contravention of the Therapeutic Goods Act 1989 (the Act).

Therapeutic goods that are not entered in the Australian Register of Therapeutic Goods (ARTG), also referred to as unapproved therapeutic goods, have not been assessed by the TGA for quality, safety and efficacy and may pose a health risk.

The Personal Importation Scheme permits individuals to import certain therapeutic goods not included in the ARTG, provided all legislative conditions are met. In these cases, the individuals did not obtain the required approvals or authorities.

The importation of counterfeit products is unlawful under any circumstance.

All 6 individuals, including 3 Australian Health Practitioner Regulation Agency (Ahpra) registered health practitioners, are alleged to have imported unapproved therapeutic goods in breach of the Act.

One Victorian-based health practitioner is also alleged to have imported counterfeit cosmetic injectables, which pose serious safety risks due to unknown composition or contamination.

In addition, a NSW-based individual alleged to have unlawfully advertised botulinum toxin (botox) products on a social media platform.

In Australia, botulinum toxin type A is classified as a prescription-only medicine. Advertising prescription-only medicines directly to consumers is prohibited under the Act, as it can create inappropriate demand and undermine the relationship between patients and their treating health practitioner. The decision to use prescription-only medicines should be made between a prescribing health practitioner and their patient based on informed consent, including a discussion of possible side effects.

The TGA works in partnership with law enforcement agencies, other health regulators, and state and territory authorities to address unlawful activity relating to cosmetic injectables.

“These actions send a clear message that importing unapproved therapeutic goods or unlawfully advertising prescription-only medicines is unacceptable," said Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and Head of the TGA. “The TGA will continue to take strong compliance action and work closely with our regulatory and law-enforcement partners to protect Australians from unsafe or misleading products."

The TGA’s response reflects its continued and ongoing enforcement activities with therapeutic goods used in cosmetic procedures - Compliance Principles 2026 and 2027.

Individuals, health practitioners and businesses must understand their legal obligations under the Act before importing or advertising therapeutic goods. Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal proceedings.

If you suspect non-compliance in relation to therapeutic goods, or their advertising, you can report it to the TGA at any time.

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