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Consultation: Medicine label advisory statements

Related information

  • Required advisory statements for medicine labels, published in the Commonwealth of Australia Gazette, No. GN 25, 23 June 2004
13 December 2002

This paper was released in November 2002 for comment. It remains on this website as a historical reference.

The TGA's Review of the Labelling Requirements for Medicines recommended that warning and advisory statements from various sources (such as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and the Therapeutic Goods Regulations) be consolidated into a single document.

This consultation document proposes a method for implementing that recommendation and a process for ensuring the resulting document is maintained in an efficient and effective manner.

How to access a pdf document

Medicine label advisory statements - consultation document (pdf,59kb)

Contents

  • Background
  • Guiding principles
  • Part A Transfer of advisory statements
    • What is being proposed
    • Legislative change
    • Timetable for the transfer
    • Effect/impact of the proposal
    • Benefits of the proposal
    • Questions and answers
  • Part B Updating and maintenance of required advisory statements for therapeutic goods
    • Overview
    • Changing advisory statements
    • Questions and answers
  • Attachment 1: Addition/amendment of a label advisory statement