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Labelling medicines to comply with TGO 91 and TGO 92

Guidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.

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Purpose

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Orders.

There are different risks and information requirements associated with medicines prescribed by a medical practitioner (or used in a clinical setting) to those self-selected by consumers. As a result, the labels for these two types of medicines need to reflect the different contexts in which they’re used.

In recognition of this, medicine label requirements are specified in two separate labelling Orders. Some medicines are exempt from the Orders, and these are described in section 5 of each Order.

Legislation

Guidance

This guidance is presented as a downloadable file because of its length.

 

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Page history

Show all page updates (8)

Addition of information about:

  • Expressing the quantity or proportion of active ingredients for injections, including complying with requirements for injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less) that were amended in 2024.
  • Injections requiring preparation before use, including providing instructions for preparation for injectable medicines administered by healthcare professionals.
  • QR codes, including using QR codes for medicines administered by healthcare professionals.

Minor corrections based on stakeholder feedback about:

  • Potassium for injection or infusion

Title changed from 'Medicine labels: Guidance on TGO 91 and TGO 92' to 'Labelling medicines to meet regulatory requirements ' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Update to include examples related:

  • Medicine name on the main label

Minor update to information due to end of the transition period.

Additional information to provide clarity on: 

  • Transition period
  • Declaration of benzoates
  • Reference to the CMI for Schedule 1 declarable substances
  • Multiple barcode guidance 

Minor corrections based on stakeholder feedback.

Addition of information about warning statements for neuromuscular blocking agents in parts 1, 2 and 3. 

Minor corrections based on stakeholder feedback.

Corrections based on feedback and clarification of existing information. 

Addition of latex labelling in best practice – part 3. 

Addition of guidance on determining when a Schedule 1 substance is present – part 1.

Original publication.

Addition of information about:

  • Expressing the quantity or proportion of active ingredients for injections, including complying with requirements for injectable medicines intended for electrolyte replacement (with a volume of 100 mL or less) that were amended in 2024.
  • Injections requiring preparation before use, including providing instructions for preparation for injectable medicines administered by healthcare professionals.
  • QR codes, including using QR codes for medicines administered by healthcare professionals.

Minor corrections based on stakeholder feedback about:

  • Potassium for injection or infusion

Title changed from 'Medicine labels: Guidance on TGO 91 and TGO 92' to 'Labelling medicines to meet regulatory requirements ' as part of migration to new 'Guidance' content type:

  • Consistent ‘Purpose’ heading.
  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • Updated page summaries.
  • Complex images include long descriptions.
  • New ‘Save as PDF’ feature.

Update to include examples related:

  • Medicine name on the main label

Minor update to information due to end of the transition period.

Additional information to provide clarity on: 

  • Transition period
  • Declaration of benzoates
  • Reference to the CMI for Schedule 1 declarable substances
  • Multiple barcode guidance 

Minor corrections based on stakeholder feedback.

Addition of information about warning statements for neuromuscular blocking agents in parts 1, 2 and 3. 

Minor corrections based on stakeholder feedback.

Corrections based on feedback and clarification of existing information. 

Addition of latex labelling in best practice – part 3. 

Addition of guidance on determining when a Schedule 1 substance is present – part 1.

Original publication.

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