A recent decision by the Federal Court demonstrates that  companies can face sizable penalties if they import or supply therapeutic goods in contravention of the Act - even in the absence of a demonstrated health risk to consumers.

In this particular case the company is required to pay penalties of over $3.1m for importing and distributing products that were not listed on the Australian Register of Therapeutic Goods (ARTG). Although not deliberate, the company concerned accepted that they were in contravention of the Act. Their co-operation with the TGA's investigation resulted in a discount in the penality being applied. Nevertheless the penality is a sizeable amount. Further details are available from the TGA website.