Consultation: Proposed changes to labelling of medicines supplied in Australia

While the consultation is open you can make a submission at our consultation hub.

We then review the submissions prior to them being published with our decision on the same consultation page.

About this consultation

The Therapeutic Goods Administration (TGA) is asking for feedback on proposed changes to Australian medicine labelling rules.

We currently have two standards that detail the requirements on labels for different types of medicines:

• Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91), and
• Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

These orders will sunset (automatically revoke) in October 2026. We need to replace these standards with new rules. This is an opportunity to update and improve labelling requirements to support the safe use of medicines.

The proposed changes aim to:

• update the substances and warnings that must be declared on medicine labels
• improve information on medicine labels to help consumers make informed choices
• clarify rules for medicine sponsors
• modernise the standards
• align requirements with accepted labelling practices to reduce exemptions.

Clear medicine labels help people use medicines safely and correctly.

Your feedback is important to help make sure the new standards are clear, effective and support the safe use of medicines.

All recent consultations can be found on our TGA consultation hub.