EU Module 1 eCTD Specification - Europa
1.2.1 October 2006 EMEA Alignment to CTD and Change Requests 1.3 May 2008 EMEA Incorporation of paediatric requirements and Change Requests 1.4 August 2009 EMEA Alignment to the New Variation Regulation and Change Requests 1.4.1 November 2011 EMA Incorporation of Additional Change Requests and Q&A
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