Labelling, packaging and promotion of non-prescription medicines

The presentation of non-prescription medicines is critical for their safe use. 'Presentation' is defined as 'the way in which the goods are presented for supply, including matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods'.

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 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 current labelling order, Therapeutic Goods Order No. 92 – Standards for labels of non-prescription medicines (TGO 92).

Australian labelling requirements for non-prescription medicines (Therapeutic Goods Order No. 92) require 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 advisory statements are set out in the TGA document 'Required Advisory Statements for Medicine Labels' (RASML).

The overall presentation of your label, including any graphics, claims or indications will also need to comply with the Therapeutic Goods Advertising Code.

The permissible ingredients  and permitted indications you have selected for use may also have requirements for advisory statements to be included on your label.