EU Module 1 eCTD Specification - Europa
1.4 August 2009 EMEA Alignment to the New Variation Regulation and ... « common » as country sub-directory for CAP, further examples of filenaming convention, 2.0 27 February 2013 EFPIA/EMA/NCA/M BLEY ... administrative and product information. The content and numbering of Module 1 for the EU is
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