Dossier Format: Regulatory and procedural guidance

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Application Dossier - CTD

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Application Dossier - eCTD

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Document(s) Language Status First published Last updated Effective Date
ICH: M 2: Electronic common technical document (e-CTD) - Step 5 (English only) adopted 2004-05-01 2010-09-24 2004-05-01

Electronic submissions to the European Medicines Agency

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