Submissions

Information

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09.09.2019

Adaptation of the Form Renewal of authorisation HMV4

ZL201_00_007e_FO / ZL201_00_008e_FO / ZL201_00_010e_FO

09.08.2019

Modification of various documents relating to authorisation

ZL000_00_006e_VZ / ZL000_00_022e_WL / ZL105_00_004e_FO

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