Article 41 paragraph 2 of the Medicinal Products Licensing Ordinance MPLO requires establishment licence holders (individuals and companies) to notify Swissmedic of major changes to installations, facilities and procedures. Up to now, establishment licence holders have been able to submit notifications and the necessary accompanying documentation by physical mail or e-mail. Swissmedic is now modifying the procedure for submitting notifications. As of autumn 2020, it will only be possible to notify major changes electronically using the “licences – major changes” eGov service. This will guarantee secure data communication between companies and Swissmedic.
To be able to use the “licences – major changes” eGov service, the following conditions must be fulfilled:
- Companies must have an establishment licence issued under the new legislation.
- Companies must have access to the eGov portal
Requirements for access to the eGov portal
Access rights are required to use eGov services. Only companies that have an establishment licence issued on or after 1 January 2019 under the new legislation can apply for access rights.
This means that:
- Companies that do not yet have an establishment licence issued under the new legislation must first apply to have their licence transferred to the new format. They can then apply for access to the eGov portal. Swissmedic recommends applying for an establishment licence issued under the new legislation straight away.
You will find the application form on our website at: www.swissmedic.ch, “Latest News” > “General communications” > “New application form for operating licences available”
Click here to go straight to the application - Companies that already have an establishment licence issued under the new legislation and access to the eGov portal should apply to have the “licences – major changes” eGov service added to their existing products.
You will find the appropriate application on our website www.swissmedic.ch, “Services & lists” > “eGov services” > “Swissmedic Portal” > “Registration Swissmedic Portal” > Licences – major changes.
Click here to apply for the Licences – major changes eGov service - Companies that already have an establishment licence issued under the new legislation, but do not yet have access to the eGov portal, should request first-time access rights and access to the “licences – major changes” eGov service on Swissmedic’s website www.swissmedic.ch, “Services & lists” > “eGov services” > “Swissmedic Portal” > “Registration Swissmedic Portal” > Licences – major changes.
Click here to go straight to Registration Swissmedic Portal
Swissmedic recommends applying for access to the eGov portal straight away.
We expect to provide further information on the planned changes in August 2020. Until such time as the new procedure is rolled out, companies can continue to submit all major changes by physical mail or e-mail.
If you have any questions on the new procedure, please contact