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The TGA has issued 5 infringement notices totalling $19,800 to a health practitioner and an individual for the alleged unlawful importation of unapproved cosmetic injectables. This importation is in contravention of the Therapeutic Goods Act 1989 (the Act).
A Victorian nurse, registered with the Australian Health Practitioner Regulation Agency, and a Victorian-based individual allegedly imported unapproved pre-filled syringes containing hyaluronic acid, poly-L-lactic acid and lidocaine. The individual also allegedly imported unapproved prescription-only tranexamic acid without an exemption.
The nurse was issued with 2 infringement notices totalling $7,920, and the individual was issued with 3 infringement notices totalling $11,880.
The infringement notices were paid in May 2026.
Therapeutic goods which have not been entered in the Australian Register of Therapeutic Goods, 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.
Individuals, health practitioners and businesses must understand their legal obligations under the Act before importing therapeutic goods. Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal proceedings.
The TGA works in partnership with law enforcement agencies, other health regulators, and state and territory authorities to address unlawful activity in the wellness and beauty industries, including cosmetic injectables.
In recognition of their potential harm and increased use, the TGA is targeting unapproved therapeutic goods used in cosmetic procedures as part of its Compliance Principles 2026 and 2027.
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
Profilo and sculptura are parallel imported cosmetic injectables not approved for the Australian market.
