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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
According to Article 59 of the Therapeutic Products Act, any person manufacturing or distributing ready‑to‑use medicines or medical devices must put in place a system of notification. It must notify the Federal Agency for Therapeutic Products (Swissmedic) of any adverse event or reaction that is or may be attributable to the therapeutic product itself, its use or incorrect labelling or instructions, or which may endanger or harm the health of the consumer, the patient or a third party. Further, any person manufacturing or distributing therapeutic products must notify Swissmedic of any quality defects or further findings and assessments that could influence the basis of evaluation for granting the respective authorisation.
What data protection issues should be considered when conducting pharmacovigilance activities?
Information that relates to adverse events or reactions must be reported in an anonymised form (see Article 35(2) of the Ordinance on Medicines).
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