DMF submission possible via the eGov Portal

Does the new function change the submission process for the marketing authorisation holder?

Since June 2020, a new function has been available on the eGov Portal. This function generates a link that can be sent to the DMF holder for a pending application. The DMF holder can use this link to submit the relevant DMF (and any further documents, such as Assessment Reports for applications according to Art. 13 TPA) for the corresponding application in the form of an eDok or eCTD. This new function ensures that the DMF is clearly assigned to the relevant application. Apart from the generation of the link, there are no changes to the process for marketing authorisation holders in Switzerland. As before, the Applicants Part of the DMF can be integrated into Module 3 of the application. It is important that the newest Swissmedic eCTD specifications are also used by the DMF holder otherwise the DMF must be resubmitted with a delay to the review timetable.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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