Individual Australians have been hit with thousands of dollars in fines for importing prescription medicines, as the regulator also targets unapproved melatonin products.
The Therapeutic Goods Administration has fined individual Australians almost $16,000 for allegedly unlawfully importing prescription medicines, including tirzepatide, erectile dysfunction drugs, and cosmetic injectables.
The penalties were among 12 infringement notices worth a combined $126,720 issued to two companies and five individuals for alleged breaches of the Therapeutic Goods Act.
The largest penalty went to the Australian Centre for Functional Medicine Pty Ltd, which paid $59,400 across three infringement notices relating to the importation of unapproved melatonin products.
The TGA did not provide details about the formulations, strengths, or quantities of melatonin involved, or whether the products had been supplied to patients.
Chan and Khin Pty Ltd and a Queensland-based health practitioner were issued four infringement notices totalling $47,520 over the advertising of prescription medicines including lovastatin, baricitinib, and ketamine.
But the enforcement action also extended directly to individual importers.
One Victorian received two infringement notices totalling $7920 for importing Mounjaro (tirzepatide) pens, while another Victorian was fined $3960 for the same alleged contravention.
A NSW individual was fined $3960 over the importation of prescription-only erectile dysfunction medicines, while another Victorian received a $3960 penalty for importing cosmetic injectable products in pre-filled hyaluronic acid syringes. $3960 over the importation of prescription-only erectile dysfunction medicines, while another Victorian received a $3960 penalty for importing cosmetic injectable products in pre-filled hyaluronic acid syringes.
The TGA said the products were not included on the Australian Register of Therapeutic Goods and did not have the approval, authority, or exemption required for their importation or advertising.
Under Australia’s Personal Importation Scheme, people can import certain therapeutic goods for their own use or that of an immediate family member, provided they meet legislative requirements.
For prescription-only medicines, importers must hold a valid written authority, such as an Australian prescription, and imports are limited to no more than a three-month supply.
Products that do not meet the requirements of the scheme can be seized at the border, leaving consumers at risk of losing both the goods and the money they paid for them.
However, unlawful importation can also lead to further compliance or enforcement action.
The TGA uses measures ranging from warning letters and infringement notices to seizure of goods and civil or criminal proceedings, with the response determined by factors including the seriousness of the alleged non-compliance and the compliance history and behaviour of the person or business involved.
Australian Border Force monitors imports of therapeutic goods and refers products requiring further assessment to the TGA.
The TGA then assesses whether the import is consistent with the regulatory scheme, including whether it qualifies as a lawful import under the Personal Importation Scheme, and advises the ABF whether the goods should be released or seized.
The latest enforcement action nevertheless leaves unanswered what circumstances led to the individual importers receiving financial penalties rather than simply having their products stopped at the border.
Asked by Dermatology Republic about the cases, the TGA said it did not comment on individual matters beyond information published through its compliance actions and outcomes and media releases.
It therefore did not clarify whether the individuals claimed to be importing the products for personal use, whether there was evidence of intended resale or supply, or whether they had previously received warnings or had goods intercepted.
The regulator said its compliance and enforcement decisions were made in line with its 2026 and 2027 Compliance Principles, priority focus areas, and regulatory compliance framework.
TGA head Professor Anthony Lawler said therapeutic goods had to meet Australian regulatory requirements before they could be imported, advertised, or supplied.
“These requirements exist to protect consumers from products that may be unsafe, ineffective or of poor quality,” he said.
“The TGA will continue to take strong enforcement action where businesses or individuals do not meet their legal obligations.”
The regulator said therapeutic goods not included on the ARTG had not been assessed by the TGA for quality, safety, and efficacy and could pose a health risk.
All 12 infringement notices were paid between July and September this year.
