Transcription of EU Module 1 eCTD Specification - Europa
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EU Module 1 eCTD Specification - Europa
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.
Term Definition Applicant A pharmaceutical company or its agent that is submitting information in support of an application. Applicant’s Information Regulatory information submitted by an
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