Article 59 of the Therapeutic Products Act (TPA) requires the manufacturer of therapeutic products or the distributor of ready-to-use therapeutic products to ensure that a reporting system is in place. This means, among other things, that the marketing authorisation holder or the manufacturer must designate a qualified person who is responsible for complying with reporting duties with respect to adverse drug effects and must inform Swissmedic of this person's name on request. Qualified means that the person responsible for PV (QPPV) has very good knowledge of pharmacovigilance and can produce the corresponding documentation / certificates on request. This person does not necessarily have to belong to the company, but his or her responsibilities must be set out in writing. The QPPV does not necessarily have to reside in Switzerland, but his or her name and address must be notified to Swissmedic on request.
AMBV Art. 12; VAM Art. 65
Last updated on: 01.01.2019