IX.C.8. Record management in the European Pharmacovigilance Issues Tracking Tool (EPITT)

The Agency should enter in the EPITT the signals it has validated and validated signals notified by marketing authorisation holders. Member States should enter in EPITT signals they have validated. The following elements should be entered:

• a description of the validated signal;
• for non-confirmed signals: justification for not confirming;
• for confirmed signals: signal assessment report, timetables, PRAC recommendations.

The Agency also enters in EPITT relevant information on emerging safety issues (see IX.C.2.)