Transcription of eCTD Guidance Document - Europa
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eCTD Guidance Document - Europa
Page 1 of 60 Guidance for Industry on Providing Regulatory Information in Electronic Format Harmonised Technical Guidance for ectd Submissions in the EU Version August 2013 Technical ectd Guidance Page 2 of 60 Table of Contents Table of Contents .. 2 List of Tables .. 4 List of Figures .. 4 1. INTRODUCTION .. 5 Glossary .. 6 2. GENERAL CONSIDERATIONS .. 7 Scope .. 7 Structure of Submissions .. 7 Transitional 8 Moving to ectd Format from Paper or NeeS Type Applications .. 8 General Submission Considerations .. 9 Correspondence .. 9 Paper 10 Hardware .. 10 General Technical ectd Information .. 10 Other Technical Information .. 16 Number of Media Requested .. 18 Technical Baseline Applications .. 19 3. MODULE SPECIFIC INFORMATION .. 23 General Information .. 23 Module 1 ectd Envelope, Administrative Information and Prescribing Information Folder 23 Module 2 Overviews and Summaries Folder .. 26 Module 3 Quality Folder.
Page 1 of 60 . Guidance for Industry on Providing Regulatory Information in Electronic Format . Harmonised Technical Guidance for . eCTD Submissions in the EU
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