Submissions

Information

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01.11.2018

Update of eCTD and eDok specification documents

Documents are valid with immediate effect.

30.09.2018

Procedure for submitting applications according to HMV4 before 1 January 2019

As of 1 December 2018 Swissmedic will accept submissions with the documents updated according to HMV4.

30.09.2018

Updating of various specification documents connected with HMV4

Various eDok and eCTD specification documents are being updated

06.09.2018

Swiss eCTD: Updating of Module 1 as of January 2019

Changes to the specifications (folder structure) in Module 1 of the Swiss eCTD module due to the revision of the Therapeutic Products Ordinances

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.

Mode of submission

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

Contact

Swissmedic
Operational Support Services
Hallerstrasse 7
3012 Berne
Switzerland

If you have any technical questions on eCTD, eDok or paper submissions please contact: esubmission@swissmedic.ch