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The Therapeutic Goods Administration (TGA) has 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.
It is alleged that the individual unlawfully imported vials containing botulinum toxin type A, and amoxicillin tablets, both of which are regulated as prescription-only medicines. Additionally, the individual allegedly imported potentially harmful prefilled syringes containing hyaluronic acid, which is also a prescription-only substance.
In Australia, these products can only be lawfully imported with a valid prescription or written authority.
The Personal Importation Scheme allows individuals to import certain therapeutic goods not entered in the Australian Register of Therapeutic Goods (ARTG), provided certain conditions are met. In this instance, the individual did not obtain the appropriate approval or authority.
The escalated response from the TGA underscores its commitment to enforcing Australia’s regulatory compliance framework and deterring repeated violations.
Individuals and businesses must understand their legal obligations prior to importing therapeutic goods. The infringement notices were issued after the individual was given multiple warnings.
The TGA will act where serious non-compliance is identified. This may include issuing infringement notices, directions and 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
