Updates to Australian medicine labelling rules to support medicine safety

We asked for feedback on proposed updates to rules for medicine labels to:

1. Make sure that quantities of active ingredients in injectable medicines intended for electrolyte replacement are clear on labels and 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.
3. Give consumers more information about large solid oral dosage forms on labels of listed medicines.

We received 60 submissions in response to this consultation. Respondents had a range of opinions about the 3 parts of the consultation.

Most respondents supported the proposed changes for expressing quantities of active ingredients in injectable medicines intended for electrolyte replacement. Some respondents suggested improvements to the proposed requirements.

We received mixed feedback about proposals for instructions for preparation of injectable medicines administered by healthcare professionals. Many respondents, including health professionals, raised concerns about electronic access to information when preparing medicines. For example, there may be situations where there is poor internet connectivity at time of administration, or where a QR code reader is not available or permitted.

We received a range of feedback about the proposed requirements for large solid oral dosage forms. Many respondents gave us feedback about the proposed dosage form sizes that would need information on the label.

We appreciate all the feedback we received and considered all responses before deciding on next steps.

Active ingredients quantities in injectable medicines intended for electrolyte replacement

We made changes to Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) to make medicine labels clearer for health professionals.

For injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less):

• The label must now express potassium chloride quantity in millimoles. Labels must also include the quantity of potassium chloride in weight except in certain circumstances.
• The label must continue to express the quantity of other active ingredients in weight. The label must also include the quantity in millimoles of each active ingredient.

We also used the feedback to make minor changes to the proposed requirements presented in the consultation paper. This gives more clarity to medicine sponsors about requirements for small containers containing potassium chloride.

Medicine sponsors have time to update labels with medicines manufactured or imported from 1 December 2026 having to comply with the updated requirements.

We have included guidance about the new requirements in Labelling medicines to comply with TGO 91 and TGO 92.

Instructions for preparation of injectable products administered by healthcare professionals

In response to concerns about access to electronic information at the time of administration, we are maintaining the current arrangement of requiring instructions for preparation of injectable medicines to be printed either on the label or as a package insert.  QR codes can be used but cannot replace printed information about how to prepare these medicines at this time. We have therefore not changed the requirements in TGO 91 about instructions for preparation.

However, we have updated the package insert template and Labelling medicines to comply with TGO 91 and TGO 92 to give more clarity to medicine sponsors about providing instructions for preparation.

We encourage medicine sponsors to supply electronic medicine information through machine readable codes on the label and other mechanisms (for example, QR codes), in addition to printed instructions for preparation.

Despite our decision at this time, we will reconsider the replacement of physical instructions for preparation in the future to support environmental benefits, technological advances, and international alignment. For example, we intend to seek feedback on updated proposals when we conduct a broader review of TGO 91 and TGO 92 in 2025.

Information on listed medicines about large solid oral dosage forms intended to be swallowed whole

We are still considering the feedback about proposed changes to TGO 92 to improve information about large oral dosage forms. We will inform stakeholders as soon as we decide on the changes to TGO 92.

More information about changes to medicine labels

Changes to medicine labels take time. We allow medicine sponsors time to update labels to support the medicine’s availability in the community. New labels appear gradually as new stock is distributed, and existing stock is used up. Medicines with new labels may be available at the same time as medicines with older labels.

For more information about the changes see:

• Updates to requirements and guidance for labels of injectable medicines