Update to the eDok Guidance Document and templates

01.09.2014 - As a result of feedback from the information event held on 16 May 2014, the eDok Guidance Document and the templates have been updated.
For the CTD template, the binder structure has been modified in order to be aligned with the eCTD structure, and errors were corrected in the folder names.

Errors in the folder names were corrected in the templates for NTA TAM and KPA .

The previous versions of the templates will continue to be accepted during a transitional phase ending on 31 October 2014.

Most important change: The folder names are no longer case-sensitive, i.e. whether letters are in lower case or upper case need not be taken into consideration. This means, for example, that Modules 2-5 from a NeeS can be used for the eDok.

Further information

https://www.swissmedic.ch/content/swissmedic/en/home/services/submissions/news-submissions/archiv/aktualisierung-guidance-edok-und-templates-edok.html