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Non-eCTD electronic Submission (NeeS)

  • BfArM will also accept electronic submission following the requirements set out in the NeeS-Guideline, without the XML backbone of the eCTD format. Detailed information about structuring and formatting of Non-eCTD electronic Submissions (NeeS) is available at the website of the eSubmission Change Management Boards (Sub CMB).
  • If a submission concerns multiple applications or authorised products (e.g. several ENRs) the respective folders have to be created named by <procedure number.> or <ENR> (e.g. de-h-09999-001, de-h-09999-002 etc.).

root directory concerning submission of multiple applicationsNeeS multiple applications

 

  • Beneath the root directory, the sequence folder and the folder for working documents should be created. The sequence folder will contain the folder for the modules and the table of contents “ctd-toc.pdf”. Working documents are understood as those which are required to be submitted in office format (doc or docx) by the submission ordinance AMG-EV, namely Module 1.3.1 and Module 2. The folder is named “<sequence>-workingdocuments”.

root directory with sequence folderroot directory with sequence folder

  • Before uploading the sequence via CESP or sending CDs / DVDs you have to be sure that the data can be read correctly. (E.g. CRC errors which may occur during the copying process must be ruled out.)
  • For the technical validation, make sure that the sequence for testing is entirely identical to what you will upload via CESP or burn on CD.
  • BfArM does not require a report on technical validation; however, you should have the report available in case questions are raised.
Date 2016.02.09