Pharmacovigilance system

A system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance [DIR 2001/83/EC Art 1(28d)].

In general, a pharmacovigilance system is a system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.