The presentation of non-prescription medicines is critical for their safe use.
Presentation includes the label, name, packaging and any promotion, advertising or other informational material associated with your non-prescription medicine.
Labelling
A product’s label includes the label attached to the container (for example: bottle, tube, sachet or blister pack) and the primary pack (for example: carton).
Sponsors must ensure the product's label and any printed information supplied with the medicine (for example: a package insert) complies with all relevant legislation before it can be supplied in Australia, including advertising requirements.
There are multiple pieces of legislation that are used to determine what can and cannot be displayed on your label:
- Basic and critical information of what needs to be on your label can be found in the Therapeutic Goods Order No. 92 – Standards for labels of non-prescription medicines (TGO 92).
- TGO 92 requires some over the counter and complementary medicine labels to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines. These are found in the Required Advisory Statements for Medicine Labels (RASML).
- The permissible ingredients and permitted indications you have selected for use may require advisory statements to be included on your label.
- The overall presentation of your label, including any graphics, claims or indications will also need to comply with the Therapeutic Goods Advertising Code.
See: Listed medicine presentation and labels for more information.
Additional requirements for sunscreens
The labelling and advertising of therapeutic sunscreens must comply with the same legislation as other non-prescription medicines and must also comply with:
Advertising must clearly position sunscreens as only being one part of sun protection. It must include prominently displayed statements or visual representations communicating:
- PROLONGED HIGH-RISK SUN EXPOSURE SHOULD BE AVOIDED
- FREQUENT USE AND RE-APPLICATION IN ACCORDANCE WITH DIRECTIONS IS REQUIRED FOR EFFECTIVE SUN PROTECTION.
See: The Advertising Code for more information.
Advertising
Other than your label and packaging, advertising can include other sources of information about your product. A website, blog post, social media post, flyer and radio all can count as advertising material.
We regulate the advertising of therapeutic goods and fines and penalties can apply. You are responsible for remaining compliant with your product's advertising.
In particular, be aware of:
- Restricted and prohibited representations in advertising
- The Advertising code and naming therapeutic goods
- The claim 'TGA approved' must not be used in advertising (Assessed listed medicines can still use their TGA assessed claim)
See How to advertise for help in understanding requirements.
Guidance and resources
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GuidanceGuidance to assist in meeting the Australian labelling requirements in TGO 91 and TGO 92.
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GuidanceGuidelines for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
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GuidanceGuidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM).
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PageAll advertising must comply with the 2021 Code rules from 1 July 2022.