Updates to Australian medicine labelling rules to support medicine safety

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed changes to the rules for Australian medicine labels.

We want to make sure that certain information important to health professionals is displayed clearly on labels or is available in the appropriate format. We also want to give consumers more information about large oral dosage forms (including large tablets and capsules) when purchasing and taking listed medicines.

To help medicines be used correctly and safely, we are proposing to update:

• 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).

This consultation is about 3 medicine safety matters identified as needing action before we conduct a broader review of TGO 91 and TGO 92. We will conduct further public consultation about more improvements to labelling rules in the future.

Why your views matter

Medicine labels communicate information to health professionals and consumers that is critical to support the correct and safe use of medicines. If it is difficult to identify medicines, or to locate and understand critical information, then medication errors are more likely to occur.

The rules set out in TGO 91 and TGO 92 helped to make important information easier to find on medicine labels. But certain aspects of these labelling rules need further improvements to help medicines be used correctly and safely.

We are also proposing to give consumers more information about large oral dosage forms on labels of listed medicines because the TGA continues to receive reports of serious choking related adverse events.

We are seeking your feedback to make sure the proposed new rules support the safe use of medicines.

Consultation paper

This consultation paper outlines the proposed changes to TGO 91 and TGO 92 to support medicine safety in 3 parts.

Version 1.1 (published 9 July 2024 with minor corrections): Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety

Version 1.0 (original publication): Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety

The aim of the proposals is to:

1. Make sure that quantities of active ingredients in injectable medicines intended for electrolyte replacement are clearly expressed in units important to health professionals.
2. Make sure that clear instructions on how to prepare and store certain injectable medicines administered by healthcare professionals is available in the appropriate format. This is to support recent changes to the Product Information (PI) as a package insert for injectable products. We are particularly seeking feedback from health professionals on a proposal to allow a QR code to link to electronic information instead of a separate package insert where instructions for preparation cannot fit on the label, for certain medicines.
3. Improve information on listed medicine labels about large solid oral dosage forms intended to be swallowed whole. 

How to give us your feedback

1. Read the consultation paper (see link above).
2. Go to the online survey (see 'Give us your views' below), answer the questions and submit your response.

You are welcome to give us feedback on all 3 parts of this consultation, or only the parts that are important to you.

What happens next

We will consider all feedback received in response to this consultation before deciding on changes to labelling rules. We will inform stakeholders about any changes to TGO 91 and TGO 92 and related guidance.