Documents are valid with immediate effect.
As of 1 December 2018 Swissmedic will accept submissions with the documents updated according to HMV4.
Various eDok and eCTD specification documents are being updated
Changes to the specifications (folder structure) in Module 1 of the Swiss eCTD module due to the revision of the Therapeutic Products Ordinances
OS000_00_001d_MB / OS000_00_002dMB
System enhancements and new eGov service as of September 2018
The changes to the Guidance document take immediate effect.
ZL000_00_016d_MB / ZL000_00_017d_MB
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