1. Post-Authorisation Safety Studies (PASS)

1. Scope of a Post-Authorisation Safety Study (PASS)


A Post-Authorisation Safety Study (PASS) is a study that is conducted after a medicine has been authorised. It serves to obtain further information on a medicine's safety and benefit-risk profile, or to evaluate the effectiveness of risk-management measures (see also Directive 2001/83/EC, Art. 1(15)) and support regulatory decision-making. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs (see also 1.4) and for assessing their results.