Transcription of Version 1.4.1 November 2011 - Europa
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Version 1.4.1 November 2011 - Europa
eu module 1 Specification Version November 2011 Document Control Change Record Version Date Author(s) Comments July, 2001 Stan van Belkum Draft September, 2001 Stan van Belkum Draft October, 2001 Stan van Belkum Draft November , 2001 Stan van Belkum Draft February, 2002 Stan van Belkum Draft February, 2002 Stan van Belkum Draft March, 2002 Stan van Belkum Draft October, 2002 Stan van Belkum Draft November , 2002 Stan van Belkum Draft February, 2003 Stan van Belkum Draft July, 2003 Stan van Belkum Draft February 2004 M. Bley Draft May 2004 EMEA Draft 28 May 2004 EMEA Draft 23 June 2004 EMEA Draft July 2004 EMEA Final December 2005 EMEA Integration of PIM May 2006 EMEA Structural changes from CTD October 2006 EMEA Alignment to CTD and Change Requests May 2008 EMEA Incorporation of paediatric requirements and Change Requests August 2009 EMEA Alignment to the New Variation Regulation and Change Requests November 2011 EMA Incorporation of Additional Change Requests and Q&A Reviewers Version Name Organisation EU Regulators EU Regulatory Authorities, EMEA Interested
This document describes only the region-specific information that is common to all submissions in the different Member States. However, at the same time the EU Module 1 Specification allows for
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