Consultation on proposed changes to labelling of medicines supplied in Australia

Overview

Medicine labels give health professionals and consumers important information to help use medicines safely and correctly. If labels are hard to read or understand, medication errors are more likely.

Medicines prescribed or given by a health professional have different risks and need different information on the label compared to medicines chosen off the shelf by a consumer. Because of this, there are two labelling standards in Australia that set out what information must appear on labels and when:

• 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).

It is time to replace these standards with new legislative instruments. This gives us an opportunity to update and improve requirements for medicine labels to support the safe use of medicines.

Why your views matter

Clear and informative medicine labels help people use medicines safely and correctly.

The rules set out in TGO 91 and TGO 92 helped to make important information easier to find on medicine labels. However, certain aspects of these labelling rules may benefit from improvements to support the safe use of medicines, reduce regulatory burden, or to give medicine sponsors more clarity.

We plan to introduce new standards by 1 October 2026, when the current standards expire (a process called ‘sunsetting’ under the Legislation Act 2003).

The Therapeutic Goods Administration (TGA) is seeking your feedback to help make sure the new rules are clear, effective and support the safe use of medicines.

Consultation paper

This consultation paper outlines the proposed changes to medicine labelling requirements.

Medicine labels: Proposed changes to rules for the new standards replacing TGO 91 and TGO 92

Some key aims of the proposals include:

1. Update the substances and warnings that must be declared on medicine labels. For example, to more closely align with food labelling rules, we propose to require wheat to be declared on medicine labels. We also propose to change when sulfites must be declared.
2. Improve information available on medicine labels to help consumers make informed choices. This includes giving consumers more information about large oral dosage forms following reports of serious choking related adverse events.
3. Clarify rules for medicine sponsors. We aim to make some of the rules clearer and to give sponsors improved guidance.
4. Modernise the standards. For example, we plan to update the rules to support increased use of technologies such as QR codes.
5. Reduce exemption applications. By aligning requirements with accepted medicine labelling practices, we hope to reduce the number of exemptions under Section 14 of the Therapeutic Goods Act 1989.

How to give us your feedback

1. Read the consultation paper (see link above).
2. Complete the online survey (see 'Share your views' below).

You are welcome to give us feedback on all parts of this consultation, or just the parts that are important to you.