Pharmacovigilance for Export Licenses
Q: What are the PV obligations for a company that has only an export license for its products? If the products concerned are neither exported abroad nor sold in Switzerland, 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: A company that manufactures or sells medicinal products in Switzerland must report to Swissmedic any medicinal product risks, including quality defects identified abroad (according to Article 35 and 36 of the Swiss Ordinance on Medicinal Products).
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 (according to Article 39 of the Swiss Ordinance on Medicinal Products).
A professionally qualified person must be designated to fulfil the reporting obligation. This person does not have to be domiciled in Switzerland.