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Guidance 8: Product information

Previously ARGPM Appendix 8: Product information

31 July 2013

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Introduction

This guidance provides:

  • information to sponsors on the legislative basis for requiring Product Information (PI)
  • guidance on when and how to provide PI to the TGA
  • information about how the PI is supplied with the medicine for consumers.

Contents

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 1/07/2013

Book pagination