The eGov service licences – major changes is for the secure electronic submission of notifications of significant changes in accordance with Article 41, paragraph 2 MPLO to Swissmedic. The submitted documents are transferred in encrypted form. No locally installed software is needed to transmit a submission.
Companies that already have access to the Swissmedic eGov portal (electronic reporting system) can request to manage access to the licences – major changes eGov service for their employees by filling in the relevant registration form.
Once the contract has been extended accordingly, the administrators can authorise their users for the licences – major changes eGov service themselves.
Licences – major changes eGov service
- Secure electronic reporting process
The "Meldung Art. 41 Abs. 2 AMBV" form and the associated documents are transmitted in encrypted form. No locally installed software is needed to send a change notification. If you use the intuitive web application you will quickly receive feedback on the change notification you sent.
- Administration of user and access rights by the authorisation holder
The authorisation holder's user administrator manages the user and access rights to the eGov Licences – major changes service independently. This allows the authorisation holder to assign the corresponding access rights to users within the company. Submission to Swissmedic of the authority to deliver change notifications by third parties as previously required no longer applies.
- Confirmation of submitted change report in inbox
After successfully transmitting the change notification, the user receives a confirmation in their eGov Licences – major changes service inbox.
- Mailing of the official decision
Once the assessment of the change notification is complete, the official decision is sent by mail.
I-408.AA.02-A11e Information sheet Swissmedic eGov-Portal Standard functions licences - major changes (PDF, 3 MB, 01.11.2020)