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Work-Flow

Reporting a product that breaches the Therapeutic Goods Advertising Code 2007 is straight forward.

To provide a substantial, and sufficiently evidenced complaint to the TGACRP every allegation should have three parts:

• Provide evidence that the claim exists,
• Explain why the claim is fallacious or erroneous, and
• Cite the legislation the claim breaches.

Before we start, we should note that in relation to the evaluation, assessment and monitoring done by the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
  • influencing inhibiting or modifying a physiological process
  • testing the susceptibility of persons to a disease or ailment
  • influencing, controlling or preventing conception
  • testing for pregnancy

There are some grey areas to this addressed by the TGA here.

Below is a diagram that outlines key areas of Reporting a Rort.

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A successful TGACRP complaint should result in the withdrawal of claims, and if justified, products on the Australian Register of Therapeutic Goods (ARTG) should be removed. Subsequently, the product can no longer be sold as a Therapeutic Good, or make claims that may be defined as “Therapeutic Use”.

If the product continues to be advertised and/or sold, a complaint can be submitted to the ACCC that alleges the product is unfit for purpose; this report should focus on the manufacturer and reference any action the TGACRP takes.

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