Transcription of Best Practice Guide for preparing Regulatory Impact ...
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BEST Practice Guide FOR preparing Regulatory Impact STATEMENTS december 2003 TABLE OF CONTENTS INTRODUCTION .. 3 BACKGROUND TO Regulatory 5 National Competition Policy .. 5 Business Regulation Review Committee .. 5 Mutual recognition .. 6 OTHER REASONS FOR Regulatory REFORM .. 7 Market failure .. 7 Institutional failure .. 7 Regulatory 7 STEPS TO Regulatory 8 WHAT IS A Regulatory Impact STATEMENT (RIS)?.. 9 RIS AS A DEVELOPMENTAL TOOL .. 10 WHY SHOULD A RIS BE PREPARED?.. 11 REQUIREMENTS OF A RIS .. 13 Consultation .. 13 1. Identify the 15 2. State the objectives of government intervention .. 15 3. List the options .. 16 4. Identify any Mutual Recognition 18 5. Undertake Impact analysis.
best practice guide for preparing regulatory impact statements december 2003
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Regulatory, GUIDELINES, Clinical Evaluation of Vaccines: Regulatory Expectations, Guidelines on Compliance and Enforcement, Biologic: Regulatory Requirements for Marketing Authorization, Clinical Evaluation of Vaccines:, Handbook for Undertaking Regulatory, Handbook for undertaking regulatory impact