Transcription of BEST PRACTICE GUIDE for Veterinary Decentralised Procedure ...
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EMA/CMDv/63793/2006 CMDv/BPG/002 BEST PRACTICE GUIDE for Veterinary Decentralised Procedure (DCP) Edition number: 05 Edition date: 7 November 2013 Implementation date: 6 February 2006 CMDv Secretariat: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax. (44-20) 74 18 84 47 BEST PRACTICE GUIDE for Veterinary Decentralised Procedure (DCP) CMDv/BPG/002 Ed.: 05 Page 2 of 16 TABLE OF CONTENTS 1. AIM AND SCOPE .. 3 2. REFERENCES AND RELATED DOCUMENTS .. 3 3. DESCRIPTION OF THE Procedure .. 3 Pre-procedural Step and General Requirements .. 3 Assessment step I (120 days) .. 5 Assessment step II (90 days) .. 7 CMDv referral Procedure following a positive conclusion by the RMS .. 11 National step granting of the Marketing Authorisation.
With the entry into force of Directive 2004/28/EC amending a new Directive 2001/82/EC, procedure, the Decentralised Procedure (DCP) was created.
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