TGA Issues Infringement Notices for Unlawful Importation of Therapeutic Goods
Summary
The TGA has issued infringement notices totalling $23,760 to three health practitioners for allegedly importing unapproved therapeutic goods unlawfully. These goods, including unregistered botulinum toxin and hyaluronic acid, have not been assessed by the TGA and may pose health risks.
What changed
The Therapeutic Goods Administration (TGA) has issued infringement notices totaling $23,760 to three health practitioners for alleged unlawful importation of unapproved therapeutic goods, in contravention of the Therapeutic Goods Act 1989. The practitioners, a nurse, a podiatrist, and a medical practitioner, are accused of importing unregistered substances such as botulinum toxin and hyaluronic acid, which have not undergone TGA assessment for quality, safety, and efficacy.
Health practitioners and businesses must ensure they comply with the Therapeutic Goods Act 1989 before importing or advertising therapeutic goods. Failure to obtain required approvals or authorities can result in significant penalties, including infringement notices, direction or prevention notices, or civil or criminal proceedings. The TGA encourages reporting of suspected non-compliance.
What to do next
- Review importation and advertising practices for therapeutic goods to ensure compliance with the Therapeutic Goods Act 1989.
- Verify that all imported therapeutic goods are entered in the Australian Register of Therapeutic Goods (ARTG) or meet the conditions of the Personal Importation Scheme.
- Report any suspected non-compliance with therapeutic goods regulations to the TGA.
Penalties
Total of $23,760 in infringement notices issued to three practitioners.
Source document (simplified)
TGA issues infringement notices to 3 health practitioners for alleged unlawful importation of therapeutic goods
Published
26 March 2026
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The 3 unrelated health practitioners, who are registered with the Australian Health Practitioner Regulation Agency ( Ahpra), are:
- a Victorian-based nurse who allegedly imported vials of unregistered botulinum toxin, and pre-filled syringes of hyaluronic acid and lidocaine
- a Victorian-based podiatrist who allegedly imported unregistered pre-filled syringes containing hyaluronic acid, and
- a NSW-based medical practitioner who allegedly imported unregistered vials containing glutathione for a NSW IV clinic. 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 the above cases, the individuals did not obtain the required approvals or authorities to import the goods.
The TGA works in partnership with law enforcement agencies, other health regulators, and state and territory authorities to address unlawful activity relating to the wellness and beauty industries, including cosmetic injectables.
The TGA’s response reflects its ongoing enforcement activities with therapeutic goods used in cosmetic procedures as outlined in TGA’s 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.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400
Images of the unapproved therapeutic goods
Topics
- Compliance and enforcement
- Import and export
- Advertising
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Media releases We have issued 11 infringement notices totalling $43,560, to 6 individuals, for the alleged importation and unlawful advertising of therapeutic goods.
- ### NSW-based individual issued infringement notices for allegedly importing cosmetic injectables
18 December 2025
Media releases 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.
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Victorian issued further infringement notices for allegedly importing unapproved therapeutic goods
25 September 2025
Media releases We have issued 3 infringement notices totalling $11,268 to a Victorian-based individual for allegedly importing unapproved prescription-only medicines.
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