Signal confirmation by the PRAC Rapporteur or (lead) Member State

For the signal management process in the EU, the process of deciding whether or not a validated signal entered in the European Pharmacovigilance Issues Tracking Tool (EPITT) requires further analysis and prioritisation by the Pharmacovigilance Risk Assessment Committee (PRAC).

This process is not intended to be a full assessment of the signal. The fact that a signal is confirmed does not imply that a causal relationship has been established, but that the signal should be discussed at EU level and further investigated by the PRAC.

See also Validated signal, Confirmed signal, Non-confirmed signal, Signal management process