CMDv/BPG/012 BEST PRACTICE GUIDE for Informed …

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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.: 00 Page 3 of 10 1. Introduction Notice to Applicants, Volume 6A, Chapter 1, includes the possibility for obtaining a marketing authorisation based on consent to refer to the documentation supporting the marketing authorisation of an already authorised product.

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

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