Harmonised Technical Guidance for Non-eCTD …

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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.

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

  Guidance, Technical, Marketing, Harmonised, Authorisation, Harmonised technical guidance for non, Marketing authorisation