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Information for submission of applications (Submissions)

04.05.2022

Technical requirements for the submission of clinical trial applications for medicinal products

The technical requirements have been summarised and clearly presented.

01.03.2021

Standardisation of headers and footers in Authorisation division guidance documents and forms

The adjustments are of a purely formal nature

25.01.2021

Login for eGovernment applications as of 28 Jan. 2021

02.07.2020

Public consultation on the draft Swissmedic eCTD v4.0 Implementation Guides

28.05.2020

Submission of DMF/ASMF documents via eGov Portal

Further information on the procedure

01.04.2020

Update of eCTD specification documents

The published documents are valid as of 1 April 2020.

07.02.2020

Completion of the Public Review for eCTD M1 Specification v1.5

23.12.2019

Public Review of the new eCTD M1 Specification v1.5

01.12.2019

Modification of various documents relating to authorisation

ZL000_00_024e_WL / ZL101_00_007e_WL / ZL300_00_001e_WL

06.11.2019

End of transition period for changeover to eCTD DTD v1.4

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