The Therapeutic Goods Administration (TGA) has issued 3 infringement notices totalling $11,268 to a Victorian-based individual for allegedly importing unapproved prescription-only medicines in contravention of the Therapeutic Goods Act 1989 (the Act).
The imported products, modafinil and armodafinil, are regulated as Schedule 4 prescription-only medicines in Australia.
The Personal Importation Scheme allows individuals to import therapeutic goods not entered in the Australian Register of Therapeutic Goods (ARTG) provided certain conditions are met. However, in this instance the individual did not obtain the appropriate approval or authority required to lawfully import prescription-only medicines.
These infringement notices were issued after a number of warnings, and a previous infringement notice in April 2024.
The escalated response from the TGA underscores its commitment to enforcing Australia's regulatory compliance framework and deterring repeated violations.
The TGA reminds consumers that decisions about prescription medications should be made in consultation with their treating medical practitioner.
Individuals and businesses must understand their legal obligations prior to importing therapeutic goods.
The TGA will continue to take action where serious non-compliance with the Act is identified in accordance with our regulatory compliance framework. 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.
