Fig. 5From: Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)—a company experienceInformation to consider when evaluating safety concerns for reclassification or removal from the RMP. AR, Assessment Report; EU HA, European health authorities; PV, pharmacovigilance; RMP, Risk Management Plan; SmPC, Summary of Product CharacteristicsBack to article page