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