Transcription of CMDv/BPG/003 Best Practice Guide For The Repeat …
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CMDv/BPG/003 Best Practice Guide For The Repeat …
CMDv Secretariat: 30 Churchill Place, Canary Wharf, London, E14 5EU, UK Tel. (44-20) 3660 6000 Fax. (44-20) 3660 5545 EMEA/CMDv/115257/2006 CMDv/BPG/003 Best Practice Guide For The Repeat Use Procedure Edition: 03 Edition date: 11 December 2014 Implementation date : 26 October 2006 BEST Practice Guide For The Repeat Use Procedure CMDv/BPG/003 Ed.: 03 Page 2 of 9 EMEA/CMDv/115257/2006 TABLE OF CONTENTS 1. Introduction 2. Aim and Scope 3. Description of Procedure Before submitting the application Case of withdrawal of the application during an earlier procedure Ongoing and related procedures ( , renewal) Updating of the dossier Updating of the assessment report Numbering of the RUP Submission of the documentation and assessment report Validation Communication during the assess
In case of electronic submissions the “Guideline on the specifications for provision of an electronic submission (esubmission) for a veterinary medicinal product- should be ”
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