Transcription of EU Module 1 eCTD Specification
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EU Module 1 eCTD Specification
EU Module 1 eCTD Specification Version October 2015 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
2 codes, (p24), added –var to tracking table name, updated TOC 1.4.5 21 December 2012 M BLEY Acceptable file formats in EU Module 1 (XML), use of « common » as country sub-directory for CAP, further examples of filenaming convention, 2.0 27 February 2013 EFPIA/EMA/NCA/M BLEY All accepted change requests implemented.
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