Transcription of Harmonised Technical Guidance for Non-eCTD electronic ...
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Harmonised Technical Guidance for Non-eCTD electronic ...
Technical NeeS Guidance Page 1 of 19 Guidance for Industry on Providing Regulatory Information in electronic Format Harmonised Technical Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU Version October 2013 Technical NeeS Guidance Page 2 of 19 Table of Content 1 Introduction .. 32 General considerations .. Scope .. Types of product Types of submission Types of procedures Exceptions Structure of submissions .. Dossier Structure Table of Contents and bookmarks Moving to NeeS format applications .. General Submission Considerations.
Common Technical Document (CTD), which for paper submissions became mandatory in the European Union with effect from 1 July 2003. For NeeS applications the eCTD folder structure is used .The breakdown of the electronic submission should be in conformity with the ICH Granularity Document and the ICH and EU file eCTD naming conventions be
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