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CMDv/BPG/012 BEST PRACTICE GUIDE for Informed consent …

EMA/ cmdv /377880/2010 CMDv/BPG/012 BEST PRACTICE GUIDE for Informed consent for MRP and DCP procedures Edition number: 00 Edition date: 14 June 2013 Implementation date: 1 September 2013 BEST PRACTICE GUIDE on Informed consent for MRP and DCP procedures CMDv/BPG/012 Ed.: 00 Page 2 of 10 TABLE OF CONTENTS 1. INTRODUCTION 2. AIM AND SCOPE 3. LEGAL FRAMEWORK 4. REFERENCES AND RELATED DOCUMENTS 5. GENERAL 6. DESCRIPTION OF THE PROCEDURE ANNEX 1: TEMPLATE FOR LETTER OF ACCESS FOR AN APPLICATION UNDER ARTICLE 13C OF DIRECTIVE 2001/82/EC ( Informed consent APPLICATION) BEST PRACTICE GUIDE on Informed consent for MRP and DCP procedures CMDv/BPG/012 Ed.

BEST PRACTICE GUIDE on informed consent for MRP and DCP procedures CMDv/BPG/012 Ed.: 00 Page

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