Information here relates to Part 7 of the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).
Our guidance material provides more detailed information and examples:
The Code is the legal source of this information:
Requirements for samples
You must not offer a sample unless:
- the goods are included in Annexure 2 of the Code and the conditions for the item (if any) are met
- the goods do not contain substances included in Schedule 2, 3, 4 or 8 of the Poison Standard
- the goods can be lawfully advertised to the public. For more information see What can and cannot be advertised to the general public.
If the goods are included in the ARTG, the sample must only be supplied in the approved container or packaging as entered in the ARTG (for example, do not remove foil sachets from their box).
In addition, the sample must be compliant with all other aspects of the Code.
Samples offered by healthcare professionals to their patients during a consultation or course of treatment do not have to comply with these requirements.
Apply for a therapeutic good to be used as a sample
You can apply for a therapeutic good to be included in Annexure 2 of the Code.
More detail can be found in our Guidance Applying the Advertising Code rules: samples and incentives.