Pharmacovigilance for export licenses

What are the PV obligations for a company that has only an export license for its products? The products concerned are neither exported abroad nor sold in Switzerland. In this case, does a Responsible Person for PV (QPPV) need to be appointed? Are there any other reporting requirements apart from the reporting of signals from abroad?

A company that manufactures or sells medicinal products in Switzerland must report to Swissmedic any medicinal product risks (including quality defects) identified abroad (Art. 35, 36  of the Swiss Ordinance on Medicinal Products (VAM)). Individual case reports must be reported only from Switzerland, but this is not the case for an export license. All safety-relevant information must be collected and evaluated centrally (Art. 39 of the Swiss Ordinance on Medicinal Products (VAM)). A professionally qualified person must be designated to fulfil the reporting obligation. This person does not have to be domiciled in Switzerland.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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