Submissions

Submissions for authorisation applications can be submitted to Swissmedic in the eCTD and eDok formats and on paper, either via the Swissmedic portal or by post.

For reasons of efficient processing and the quality of the submitted documentation, Swissmedic prefers submissions via the portal in the eCTD format.

Submissions via the portal are purely electronic submissions. They do not require paper-based documentation or signed documents.