Medicines

Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92; (93 page(s), in English)

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. We regulate therapeutic goods for safety, efficacy, performance and quality to help protect and improve the health of Australians.

There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as Therapeutic Goods Orders (TGOs), can specify particular labelling, packaging or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia.

The following TGOs for labelling medicines are due to sunset (expire) on 1 October 2026:

·        Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)

·        Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

They apply to medicines entered in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia.

TGO 91 and TGO 92 set out the type of information that must be included on the label and in what circumstances, as well as general requirements, to support the safe and quality use of medicines.

TGO 91 and TGO 92 are working well, but several areas for improvement have been identified. We plan to replace them with new standards before they expire. The new standards will include some changes to requirements to further support the safe use of medicines and give more clarity to medicine sponsors.

The TGA is conducting a public consultation between December 2025 and February 2026 to seek feedback on proposed changes to labelling requirements for the new standards. Some key proposed changes include:

·        Update the list of substances that must be declared on medicine labels.

·        Require a warning on non-prescription medicines that are large oral dosage forms.

·        Improve access to information about excipient ingredients on labels of medicines that are self-selected by consumers.

·        Stop allowing embossing or debossing of batch numbers and expiry dates on the saleable pack unless they are also printed or clearly contrast with a dark background. 

·        Make minor changes to how active ingredients and their quantities can be displayed.