Version 4.0 of the Swissmedic Document on Notifications of Changes Published
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On 23 September 2026, Swissmedic published Version 4.0 of the Technical Interpretation “Notifications according to Article 41, MPLO” (I-SMI.TI.22e).
The document replaces the previous Version 3.0 (I-SMI.TI.22e_03) dated 21 May 2025:
The Technical Interpretation addresses the major changes to facilities, equipment, systems and procedures that are subject to notification under Article 41 of the Medicinal Products Licensing Ordinance (MPLO) in the context of the manufacture, import and export, wholesale and distribution of medicinal products.
Swissmedic Portal Replaces the Previous eGov Service
The main practical change concerns the notification procedure. Version 4.0 introduces the Swissmedic Portal as the new submission channel for notifications of changes. The previous eGov service is replaced by the Swissmedic Portal. Paper-based submissions are no longer possible.
In future, notifications of changes and the related documents must be submitted exclusively online via the Swissmedic Portal. The company’s responsible employees must first apply for access to the portal. Relevant supporting documents must be uploaded as PDF files. The portal also enables communication between the notifying company and Swissmedic in connection with the submitted notification.
No new GDP-relevant Categories of Changes
The new version does not contain any new GDP-relevant categories of notifiable changes. Swissmedic itself describes the changes in Chapters 1 and 4 as minor editorial amendments.
The following remain particularly relevant for companies operating in the GDP sector:
- the construction or expansion of temperature-controlled storage areas for medicinal products, ATMPs, active substances or intermediates
- the introduction of complex computerised systems for material management, such as an ERP system
- the introduction or replacement of software incorporating artificial intelligence or machine learning functions in the area of supply
- other major changes to facilities, systems or procedures that may have a quality-relevant impact on the distribution or wholesale of medicinal products
The PDF file is available in the GMP/GDP documents section of the Inspectorates website.
