Transcription of CHAPTER 8: GUIDANCE ON EFFICACY REQUIREMENTS
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CHAPTER 8: GUIDANCE ON EFFICACY REQUIREMENTS
Chemicals Regulation Directorate Data REQUIREMENTS Handbook 26/11/2010 CHAPTER 8 - 1 EFFICACY CHAPTER 8: GUIDANCE ON EFFICACY REQUIREMENTS CONTENTS Section Page 1 Introduction 2 EFFICACY REQUIREMENTS 2 Meeting EFFICACY REQUIREMENTS 2 Contact information 3 2 Scope of EFFICACY REQUIREMENTS 4 Legislative basis 4 Areas to be addressed under PPPR 4 Differences in areas addressed under COPR 7 3 Meeting EFFICACY REQUIREMENTS 8 Introduction 8 Presentation of EFFICACY information 9 Levels of control expected to be demonstrated 10 Overseas evidence 12 Extrapolation 14 Public domain evidence 15 Data owned by others 16 Experimental Data 16 Conducting
Chemicals Regulation Directorate Data Requirements Handbook 26/11/2010 Chapter 8 - 1 Efficacy CHAPTER 8: GUIDANCE ON EFFICACY REQUIREMENTS CONTENTS
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