The Therapeutic Goods Administration (TGA) public consultation is now open on Updates to Australian medicine labelling rules to support medicine safety to seek feedback to make sure proposed changes to labelling rules support the safe use of medicines.

The TGA is proposing changes to labelling rules to help make sure that certain information important to health professionals is displayed clearly on labels or is available in the appropriate format. The TGA also wants to improve information about large oral dosage forms on listed medicines because the TGA continues to receive reports of serious choking related adverse events.

Medicine labelling rules

Medicines entered in the Australian Register of Therapeutic Goods (ARTG) for supply in Australia must comply with the requirements for labels set out in:

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

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

Have your say

The TGA wants to know your views on the rules we are proposing and if you think they support the safe use of medicines. 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.
3. Improve information on listed medicine labels about large solid oral dosage forms intended to be swallowed whole.

The TGA is particularly seeking feedback from health professionals on a proposal to allow a QR code to link to electronic instructions for preparation instead of a separate package insert, for certain medicines.

How you can give feedback

You can view the public consultation at Updates to Australian medicine labelling rules to support medicine safety on the TGA Consultation Hub. You are invited to give feedback by reading the consultation paper and completing our online survey. You are welcome to give us feedback on all 3 parts of this consultation, or only the parts that are important to you.

The public consultation will remain open until 11 July 2024.

Please email This email address is being protected from spambots. You need JavaScript enabled to view it. if you have any questions regarding this consultation.

This news item was issued on 30 May 2024 by Jill Smith, CEO of ASCIA, the peak professional body for clinical immunology and allergy in Australia and New Zealand.