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 Variation Regulation and Change Requests November 2011 EMA Incorporation of Additional Change Requests and Q&A December 2012 EMA New Draft version including proposed DTD changes as requested by: CR 20120924 rev CR 20121119 CR 20091203 CR 20100408 CR 20101022-01 CR 20101214 CR 20110614 17 December 2012 EFPIA EFPIA changes, added PDF , , edited file allowed formats, added common for CP, adjustments to agency codes 20 December 2012 EFPIA Removed PIM, added HR to App , updated Spanish agency name in , removed AR from App 2 codes.

application. Applicant’s Information Regulatory information submitted by an applicant for, or to maintain, a marketing authorisation that falls within the scope of this guidance document. eCTD application or also known as a dossier A collection of electronic documents compiled by a pharmaceutical

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