eDok

The eDok format is Swissmedic's own submission format for applications connected with medicinal product authorisations (human and veterinary medicinal products) It is not as complex, in technical respects, as the eCTD format, but many of the functions for managing medicinal product dossiers are not available with this format, nor is it compatible with the formats used in other countries.

When submitted via the portal, the eDok format is considered to be a purely electronic format without the need for any paper documents. When submitted by post, the eDok format is considered to be a paper format requiring the submission of a complete paper copy as the original paper version.

The electronic structure of the documents to be submitted is based on the definition of the Common Technical Document (CTD) and the Notice To Applicants (NTA). Swissmedic provides the folder structure templates, and the electronic files should be placed in the corresponding folders.

The eDok Guidance document regulates the submission of documents in the eDok format.