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.
particular medicinal product are submitted in NeeS format. Applicants can switch from NeeS to eCTD at the start of any new regulatory activity. Applicants should however not change from eCTD back to NeeS. In exceptional circumstances, if this should be needed, please contact the concerned NCAs in advance.
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