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.
Technical eCTD Guidance v3.0 Page 4 of 60 List of Tables Table 1: Example of an initial MAA in the Centralised Procedure.....11
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