Transcription of Harmonised Technical Guidance for Non-eCTD …
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Harmonised Technical Guidance for Non-eCTD …
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.
This Guidance Document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic format to the National Competent Authorities in the EEA (hereafter referred to as NCAs).
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