Updates to requirements and guidance for labels of injectable medicines

Changes to TGO 91 for injectable electrolyte medicines

We have 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.

These changes will help to make quantities of active ingredients clear on labels and in units important to health professionals.

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

• The label must express potassium chloride quantity in millimoles on the label. 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. It must also include the quantity in millimoles of each ingredient.

A transition period has started to give medicine sponsors time to update labels, outlined below.

We consulted and feedback showed support for making these changes to TGO 91. Read more about our consultation: Updates to Australian medicine labelling rules to support medicine safety.

Updates to guidance about medicine labels

We have updated Labelling medicines to comply with TGO 91 and TGO 92 to include more information for medicine sponsors about:

• complying with the new requirements for injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less)
• providing instructions for preparation where injectable medicines are administered by healthcare professionals.

We have also updated the instructions for preparation package insert template to give more clarity to medicine sponsors. Read more about including a package insert and the template: ensuring compliance after removing the product information insert.

For sponsors of injectable electrolyte medicines

We are applying a transition period until 30 November 2026. From 1 December 2026, applicable products imported or released for supply must comply with the new requirements.

You must make a variation when updating your labels. Please use the following Self-assessable request (SAR) code if you meet the conditions:

• LOEI - Label - changes to the method of expressing the content of active ingredients or excipients, in accordance with the current labelling TGO.

If LOEI is not applicable, consider using:

• LOTG - Label - changes to comply with current TGOs for labels that have previously been evaluated and approved by the TGA.

For health professionals

Over the next few years, you may see some changes to labels of injectable electrolyte medicines containing potassium chloride. The quantity of potassium chloride may change to be displayed in millimoles on the label to align with clinical practice. For example, potassium chloride 10 mmol in 10 mL.

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 will appear 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.

Take care when prescribing, dispensing, and administering medicines to ensure correct product selection as sponsors update their labels.

There may not be changes to labels of other electrolyte medicines.