Changeover to electronic submission of notifications of major changes: 1 November 2020

As already announced, Swissmedic is modifying the procedure for submitting major changes. This will take place on 1 November 2020. From this date, it will only be possible to notify major changes electronically using the “Licences – major changes” eGov service.

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. As of 1 November 2020, it will only be possible to notify major changes electronically using the “Licences – major changes” eGov service.

To be able to use the “Licences – major changes” eGov service, the following conditions must be fulfilled:

The company requires

• An establishment licence according to the new legislation from 1 January 2019
• A login for the eGov portal
• The “Licences – major changes” eGov service
  

Application for establishment licence according to new legislation:
www.swissmedic.ch, Latest News > General communications > New application forms for operating licences available
Direct link to application

Application for a login for the eGov portal incl. the “Licences – major changes” eGov service:
www.swissmedic.ch, Services and lists > eGov services > Swissmedic Portal > Registration Swissmedic Portal > Licences – major changes
Direct link: Registration Swissmedic Portal

Application for an extension to the Licences – major changes eGov service:
www.swissmedic.ch, Services and lists > eGov services > Swissmedic Portal > Registration Swissmedic Portal > Licences – major changes
Direct link: Application for Licences – major changes

Until the new procedure is rolled out, companies can continue to submit all major changes by physical mail or e-mail. From 1 November 2020, it will only be possible to submit major changes according to Article 41, paragraph 2 MPLO via the eGov portal. It will no longer be possible to send notifications by physical mail or e-mail from 1 November 2020.

If you have any questions on the new procedure, please contact