Major Changes according to Art.41, paragraph. 2 MPLO

Start of sales activity and reporting major changes according to Artikel 41, paragraph 2 MPLO

According to Article 41, Paragraph 2 MPLO, major changes (I-SMI.TI.22e Notifications Art. 41 MPLO) must be notified to Swissmedic prior to their implementation using the form Notification Art. 41 Paragraph 2 MPLO (German form only). The reason for this is that, depending on the type of change, Swissmedic may instruct the cantonal inspectorate to inspect the major change. If, in the case of a new company, the ERP system, for example, is inspected as part of the basic inspection when sales have commenced, the implementation of the ERP system does not have to be reported as a major change. If this is not the case, a major change must be submitted via eSubmission Platform.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director

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