Information for submission of applications (Submissions)

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

31.08.2018

Swissmedic eGovernment services: New customer portal

System enhancements and new eGov service as of September 2018

10.07.2018

Changes to the Guidance document on time limits for authorisation applications

The changes to the Guidance document take immediate effect.