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.
Regulatory information must be structured in accordance with the . Common Technical Document (CTD), which for paper submissions became mandatory in the European Union with effect from 1 July 2003.
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