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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 .. File and folder structure Submission numbering File Naming Placement of Documents Correspondence .. Paper requirements .. Hardware .. File formats .. Portable Document Format (PDF) Other File Formats Bookmarks and hypertext links.

ICH Granularity Document and EU M1 specifications. For further guidance on file naming, please refer to the “FileFolder Structure & Names” work- sheet included in the NeeS validation criteria. The root folder of the submission should preferably benamed with an identification of the product

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