(major changes according to Article 41 paragraph 2 MPLO)
02.11.2026
As announced, the process for notification of major changes was transferred to the new Swissmedic Portal (SMC Portal) with effect from 24 September 2026. However, until now it was still possible to submit a notification via the MLP Portal. From 1 November 2026, notifications of major changes must be submitted exclusively via the SMC Portal.
The Medicinal Products Licensing Ordinance (MPLO; Article 41 paragraph 2) requires establishment licence holders to notify Swissmedic of major changes to facilities, equipment, systems and processes (see also Technical Interpretation I-SMI.TI.22e). Until 31 October 2026, these notifications could be submitted via the eGov service “Licences – major changes”. From 1 November 2026, only the SMC Portal can be used.
Requirements:
The following requirements must be met to submit notifications of major changes:
- Access to the SMC Portal: https://www.portal.swissmedic.ch
- Necessary roles and authorisations for establishment licences: Instructions
- An active establishment licence from Swissmedic
If you have questions regarding the new process, please contact
Supplementary information
- Technical Interpretation:
I-SMI.TI.22e_Notifications_Art_41_MPLO - Instructions for SMC Portal – major changes:
I-408.AA.02-A14e Information sheet Swissmedic Portal – Standard functions licences – major changes