TGA targets unlawful importation of prescription medicines

The Therapeutic Goods Administration (TGA) has issued 5 infringement notices totalling $13,320 to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines.

The 3 separate cases involved the importation of medicines purchased from overseas websites and intended to treat patients. They include:

• a Queensland-based osteopath who allegedly imported 2 strengths of unregistered injectable procaine - a prescription-only local anaesthetic
• a New South Wales-based general practitioner who allegedly imported unregistered botulinum toxin type A - a prescription-only medicine often used in cosmetic procedures to smooth wrinkles on the face
• a Victoria-based dentist who allegedly imported unregistered tinidazole - an antibiotic.

The medicines have been seized at the border and will not be released.

The action taken comes as a result of the TGA’s work to ensure medicines meet Australia’s high standards for quality, safety and efficacy. Unregistered prescription medicines have not been evaluated by the TGA and may be unsafe. 

In Australia, therapeutic goods must not be imported, exported, manufactured, supplied (administered to patient/s, sold or given away) or advertised unless they are included on the Australian Register of Therapeutic Goods (ARTG), or an approval or exemption applies. 

The health practitioners had no prior approval or exemption from the TGA to import the medicines, and they were not on the ARTG.

Only the approved supplier (sponsor) can import therapeutic goods into Australia for commercial supply (including use), and the product must be the approved version for the Australian market.

Health practitioners need to be aware of the regulatory requirements and lawful access pathways for unregistered goods. Lawful access pathways include the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

Contact for members of the media:

• Email: news@health.gov.au  
• Phone: 02 6289 7400