Labelling Medicines to Comply with TGO 91 and TGO 92

“This document outlines updated guidelines for medicine labeling in Australia, addressing the requirements under Therapeutic Goods Orders (TGO) 91 and TGO 92. It provides detailed information on labeling standards for prescription and non-prescription medicines, ensuring compliance with Australian regulatory requirements.

Key Features of the Guidelines:

• Scope and Title Update:
  • The document, formerly titled ‘Medicine labels: Guidance on TGO 91 and TGO 92,’ is now called ‘Labelling medicines to meet regulatory requirements’ to align with the new ‘Guidance’ content type.
• Labeling Requirements:
  • Covers labeling for prescription and non-prescription medicines in Australia.
  • Provides details on the structure and mandatory content of labels, including the display of active ingredients and their quantities or proportions for injections.
• Updates and Additions:
  • Includes guidance on injections requiring preparation before use.
  • Adds the use of QR codes on labels to enhance information accessibility.
  • Implements minor corrections based on feedback from stakeholders.
• Transition Period for Compliance:
  • Details the four-year transition period for implementing TGO 91 and TGO 92.
  • Specifies compliance requirements for medicines released for supply before the end of this period.
• Required Advisory Statements:
  • Notes that ingredients listed in the Required Advisory Statements for Medicine Labels (RASML) Schedule 1 may include substances unintentionally present due to the manufacturing process.
• Guidance for Stakeholders:
  • Provides information on Australian labeling orders, including mandatory display requirements and advisory statements.
  • Emphasizes the importance of clear and accurate labeling to ensure safety and compliance.

This updated guidance ensures manufacturers and sponsors understand the regulatory requirements, aiding in the smooth implementation of TGO 91 and TGO 92 standards across the industry.

Region: Australia

Source: https://www.tga.gov.au/sites/default/files/2024-12/labelling-medicines-to-comply-with-tgo-91-tgo-92.pdf