Site notifications

Sub menu

 
 

Medicine labels: Guidance on TGO 91 and TGO 92

Guidance to assist in meeting the Australian labelling requirements in TGO 91 and TGO 92.

Published
Last updated

Purpose

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

Legislation

Guidance

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

Downloads

Topics
Featured in

Page history

Show all page updates (7)

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.

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.

Related guidance

Help us improve the Therapeutic Goods Administration site