Paper submission / eDok

A "paper submission" is an application to Swissmedic for which the required documents are submitted in paper form.


For authorisation applications and applications for variations in paper format, Modules 1 to 5 (CTD) or Parts I to IV (NTA) respectively must always be submitted as a paper original.

 

All paper documents must be submitted in bound form (in loose-leaf binders or ring binders). The documents in the binders (loose-leaf or ring binders) must not be placed in transparent plastic folders.

Submission of documents with an eDok copy

 

  • The purely paper-based submissions must be submitted unstapled.
  • For paper applications with an eDok copy, Module 1 (CTD) and Parts Ia + b (NTA) must be submitted as paper originals and electronically as an eDok copy.
  • Modules 2-5 must be submitted in separate binders, meaning that no file separators / index sheets are necessary.
  • Cover sheets need not be inserted.
  • In addition, these documents must be submitted electronically as an eDok copy on CD or DVD, in line with the instructions in the eDok guidance (see link to the right).

Submission of documents without an eDok copy (purely paper-based)

 

  • The individual sections (Modules 2-5 for CTD or Parts Ic-Iz to IV for NTA) documents must be marked by file dividers or tab separators.
  • In addition, the documents for all modules / parts must be separated using cover sheets. These are necessary for the correct scanning of the documents at Swissmedic.
  • These cover sheets, with the name of the section and the barcode, are made available electronically by Swissmedic (see link to the left), and must be printed out by the applicant and always placed in front of each corresponding section or the dividers / tabs in the authorisation documentation.
  • The individual forms do not need cover sheets, since they already contain bar codes.