Changes to TGO 91 for injectable electrolyte medicinesWe 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 labelsWe 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 medicinesWe 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 professionalsOver 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.
Brief
On 09/12/2024, the Therapeutic Goods Administration (TGA) issued an update regarding Updates to requirements and guidance for labels of injectable medicines. The TGA has made changes to Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) to clarify quantities of active ingredients on medicine labels for health professionals, particularly for injectable electrolyte replacement medicines with a volume of 100 mL or less.
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Purpose:
The primary objective of updating Therapeutic Goods Order No. 91 (TGO 91) is to make medicine labels clearer for health professionals by ensuring that quantities of active ingredients are clearly expressed on the label in units relevant to healthcare professionals. This update aims to enhance the accuracy and reliability of medicine labels, ultimately supporting improved patient safety.
Effects on Industry:
The changes to TGO 91 will have a significant impact on the pharmaceutical industry, particularly for sponsors of injectable electrolyte medicines containing potassium chloride. The update requires these sponsors to update their labels within a specified timeframe (by November 30, 2026) to ensure compliance with the new requirements. This may necessitate variations in labeling and packaging, which will require careful planning and execution by manufacturers. Additionally, health professionals may experience changes in product selection and administration procedures as new labels become available.
Relevant Stakeholders:
The stakeholders affected by these updates include:
- Medicine sponsors (pharmaceutical companies) responsible for updating their injectable electrolyte medicine labels to comply with the new requirements.
- Health professionals (doctors, pharmacists, nurses) who will need to adapt to changes in product selection and administration procedures as new labels become available.
- Patients who may experience temporary disruptions in medication availability due to label updates.
Next Steps:
To ensure compliance with the updated TGO 91 requirements, medicine sponsors are advised to:
- Review their current labeling practices for injectable electrolyte medicines containing potassium chloride.
- Update their labels within the specified timeframe (by November 30, 2026) to reflect the new requirements.
- Submit variations in labeling and packaging as necessary to comply with regulatory standards.
Any Other Relevant Information:
A transition period has been initiated to allow medicine sponsors time to update their labels and ensure a smooth implementation of the changes. During this period, both old and new labels will be available on the market. Medicine sponsors should consult the relevant guidance documents (Labelling medicines to comply with TGO 91 and TGO 92) for detailed information on complying with the new requirements and preparing package inserts.
