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.
human within the competence of NCAs in the EEA. This includes prescription, over the counter medicines, innovative and generic product submissions. The product types include small molecules, biotech products, herbals, vaccines, homeopathics and blood products.
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