Transcription of Harmonised Technical Guidance for Non-eCTD electronic ...
{{id}} {{{paragraph}}}
Example: biology
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.
This guidance does not apply to the electronic submission of p-marketing authorisation (re MA) information such as scientific advice, clinical trial applications, orphan drug designations, PIP submissions and related submission
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
AWS Command Line Interface, Docs, MECHANICAL VENTILATION INDICATIONS: Respiratory, MECHANICAL VENTILATION INDICATIONS: Respiratory Failure, TEACHER’S GUIDE TO HYDROCEPHALUS, Guidelines & Templates for Performance, Performance Improvement Plan, ECTD Guidance Document, Chronic, FINGER FRACTURES AND DISLOCATIONS