EU Module 1 eCTD Specification - Europa

EU Module 1 eCTD Specification Version November 2017 2 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 Novem

1.4 August 2009 EMEA Alignment to the New Variation Regulation and ... « common » as country sub-directory for CAP, further examples of file naming convention, 2.0 27 February 2013 EFPIA/EMA/NCA/M BLEY ... administrative and product information. The content and numbering of Module 1 for the EU is

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