EU Module 1 eCTD Specification
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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Guideline on the specifications for provision of an ...
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EU Module 1 eCTD Specification - Europa
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