Transcription of BEST PRACTICE GUIDE For Type IB Variations CMDv/BPG/005 ...
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BEST PRACTICE GUIDE For Type IB Variations CMDv/BPG/005 ...
EMA/CMDv/115405/2006. BEST PRACTICE GUIDE . For Type IB Variations CMDv/BPG/005 . Edition 05. Edition date: 10 April 2015. Implementation date: 10 April 2015. CMDv/BPG/005 . BEST PRACTICE GUIDE . Ed.: 05. For Type IB Variations Page 2 of 10. Index 1. Introduction 2. Aim and Scope 3. Reference documents and/or related documents 4. Type IB Notification procedure: Pre-submission phase Submission phase Validation phase Start of notification procedure Evaluation phase Outcome of the notification procedure Annexes 1. Examples of: Acceptance of a Type IB notification Rejection of a Type IB notification 2. Flow Chart for Type IB Variations EMA/CMDv/115405/2006 Page 2 of 10. CMDv/BPG/005 . BEST PRACTICE GUIDE . Ed.: 05. For Type IB Variations Page 3 of 10. 1. Introduction This Best PRACTICE GUIDE is the consequence of the implementation of Commission Regulation (EC) No.
1.4 Type IB variations may be grouped together with other variations in a single notification. If the highest ranking variation is a Type IB variation,
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