Swissmedic Technical Interpretation: What Counts as a Major Change in GDP?

On 21 May 2025, Swissmedic published Version 3.0 of its Technical Interpretation "Notifications according to Article 41, MPLO" (Document number I-SMI.TI.22e). It was made available on the GMP/GDP documents section of the Inspectorates website.

According to Article 41, paragraph 1 of the Medicinal Products Licensing Ordinance (MPLO), "holders of a licence must apply to Swissmedic with the necessary documentation for any amendments to the content of the licence." Paragraph 2 states that "they must report the essential details of all major changes to facilities, equipment or procedures used in the manufacture, testing or import and export of medicinal products, for wholesale trading or in trading abroad with medicinal products or for brokerage or agency activities in connection with medicinal products and which could influence quality."

The updated Technical Interpretation outlines the understanding of paragraph 2 by the Swiss inspectorates. While the guidance primarily addresses manufacturers, it also includes several important points relevant to companies operating in the Good Distribution Practice (GDP) environment, such as companies involved in distribution or wholesale activities.

A list of common examples of major changes is summarized in Table 1 of the document. Relevant for the GDP area are the following:

• "Construction or extension of temperature-controlled storage area (e.g., climate chamber/rooms for controlled room temp./cold or cool storage, high rack storage area) for medicinal products, active substances, intermediates or ATMPs."
• "Introduction of new complex major computerized systems used for the purpose of process control in manufacturing (incl. automation systems, manufacturing execution system) or material management systems (e.g., ERP system)."
• "Introduction or replacement of computerized system software with Artificial Intelligence/Machine Learning software for use in manufacturing or supply."

Such changes generally require prior notification via Swissmedic’s eGov portal using the “licences – major changes” service.

The full Technical Interpretation as a PDF document can be found on the Swissmedic website.