Transcription of BEST PRACTICE GUIDE For Type II Variations CMDv/BPG/006 ...
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BEST PRACTICE GUIDE For Type II Variations CMDv/BPG/006 ...
EMA/CMDv/115377/2010 BEST PRACTICE GUIDE For Type II Variations CMDv/BPG/006 Edition 03 Edition date: 19 July 2013 Implementation date: 1 January 2010 BEST PRACTICE GUIDE For Type II Variations CMDv/BPG/006 Ed.: 03 Page 2 of 13 Index 1. Introduction 2. Aim and Scope 3. Reference documents and/or related documents 4. Timescales 5. Type II variation procedure: Pre-submission phase Submission phase Automatic Validation phase Start of variation procedure Evaluation phase Outcome of the variation procedure Annexes 1. Examples of: Acceptance of a Type II variation Rejection of a Type II variation 2.
1.4 Type II variations may be grouped together with other variations in a single application. If the highest ranking variation is a Type II variation, this will be
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