With this release, we are welcoming marketing authorisation holders to the Swissmedic Portal for the first time, specifically to the Medicinal Products module. Here, you can view the specialist data for your company’s complementary medicines in the notification procedure (Chapter 7 KPTPO; basic company dossier, master dossier and medicines (single notifications)) for marketing authorisation holders.
For the establishment licence holders, this release enables the submission of major changes in accordance with article 41 (2) of the MPLO. With that you will be able to use the Swissmedic Portal as communication channel related to your submitted applications.
New features
- Related to complementary medicines:
- Overview page for specialised data relating to basic company dossiers, master dossiers and medicines (single notifications) associated with your organisation
- Detail pages for the specific artefacts listed above
- Related to establishment licences:
- Creation of major change application draft
- Submission of such major change application
- Detail page of submitted application with case status and responsible person Swissmedic
- Communication module with collaboration feature (Create new message, Receive messages)
Call to action
This call to action concerns only delegated managers from companies who deal with complementary medicines. As we are introducing the new Medicinal Products module, we also launch our new role and permission handling. In accordance with this, you, as your company’s representive delegated manager, have to configure the user profiles of your affiliated users / employees. Otherwise, your employees cannot use the Swissmedic Portal functionalities regarding complimentary medicines.
Please read this instruction for further information and guidance.
Technical Details / Installation Notes
The Swissmedic Portal can be accessed using any current internet browser at
To log in, use your existing AGOV-Login credentials, the same ones you have always used to access Swissmedic eGov Portal applications.
Excerpt from the official page. The original is authoritative.