Medicine label advisory statements
Consultation document
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 It remains on this website as a historical reference.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 <http://www.tga.gov.au/docs/html/labelrev.htm> 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.
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