Advertisements of Unapproved Goods

The TGA regulates the advertising of therapeutic goods through the administration of the Therapeutic Goods Act 1989 (the Act), and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).

‘Advertise’ as the Act defines is “any statement, pictorial representation or design that is intended, directly or indirectly, to promote the use or supply of the goods”.

Subsection 42DL(10) of the Act prohibits references (whether expressed or implied) to prescription medicines in advertisements about therapeutic goods that are directed to the general public. Furthermore, subsection 42DL(12) of the Act prohibits the advertising of unapproved therapeutic goods to the public.

A reference to the brand name or generic name of a prescription medicine in an advertisement to the public is likely to be considered as a breach under the Act. The advertisement must not have the effect of promoting the trial good and must not allude to any claimed benefits of the product. 

For further information please refer to the TGA Advertising Hub. 

When submitting an advertisement for a clinical trial to the HREC, please ensure the following: 

·    The Advertisement identifies the researcher name and contact number/email for inquiries

·    The Advertisement identifies the financial sponsor of the research

·    The Advertisement includes references to support any claims

·    The Advertisement does not mention the Investigational Medicinal Product

·    The Advertisement does not mention the class of drug of the Investigational Medicinal Product or its mode of action

·    The Advertisement contains a statement that the trial has been approved by the SLHD HREC (RPAH Zone) (with the study protocol number)

·    The Advertisement contains a footer with a version number and date