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TGA Issues Infringement Notices for Unlawful Importation of Therapeutic Goods

Favicon for www.tga.gov.au TGA Australia Media Releases
Filed March 26th, 2026
Detected March 26th, 2026
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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

  1. Review importation and advertising practices for therapeutic goods to ensure compliance with the Therapeutic Goods Act 1989.
  2. 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.
  3. 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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    • Email The Therapeutic Goods Administration (TGA) has issued 6 infringement notices totalling $23,760 to 3 health practitioners for the alleged unlawful importation of unapproved therapeutic goods, in contravention of the Therapeutic Goods Act 1989 (the Act).

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:

Images of the unapproved therapeutic goods

Topics
- Compliance and enforcement
- Import and export
- Advertising

Related content

29 January 2026

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.
-

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.

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
TGA
Filed
March 26th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Therapeutic Goods Act 1989

Who this affects

Applies to
Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Unlawful importation of therapeutic goods Importation of unapproved therapeutic goods
Geographic scope
Australia AU

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Pharmaceuticals Product Safety

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