eCTD Guidance Document - Europa

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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.

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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