Knowledge Assessment: Important Identified Risks

It necessarily violates the requirement to include all trial events in the SmPC It fails to distinguish routine adverse reactions from safety concerns that are important for ongoing risk management It prevents the use of spontaneous reports in the RMP It means that no risk can subsequently be removed

Only a fixed five-year interval, regardless of new evidence A validated signal, important new epidemiological evidence, a relevant label change, or scheduled periodic review Only a request from the marketing department Only evidence showing that the risk has increased

Select the category with the least regulatory consequence and omit the uncertainty Automatically classify the concern as an Important Identified Risk to avoid under-management Document alternative classifications considered, the evidence and thresholds used, and the rationale for the final decision Defer the decision indefinitely until absolute certainty is available

An Important Identified Risk always requires an additional post-authorisation study Routine PV is irrelevant once a risk has been classified Routine PV may be sufficient in some cases, while additional PV or RMMs should be added when the risk requires further characterisation or control An Important Identified Risk can be managed only through changes to the SmPC

Important Identified Risk Important Potential Risk Missing Information Identified but not important

A single unverified report with a long latency and several competing causes A consistent temporal association, biologically plausible mechanism, dose-response relationship, and positive dechallenge A high background rate with no difference between exposed and unexposed groups A theoretical concern based only on an unrelated product class

Use a single universal numerical threshold regardless of indication or population Avoid quantitative information because clinical seriousness is sufficient Consider absolute and relative measures in the context of indication, population, duration of use, and benefit–risk Use only the spontaneous reporting rate because it represents incidence

The RMP owner prepares and controls the RMP, the QPPV oversees the PV system, and a multidisciplinary committee reviews classification and plans The QPPV delegates all classification decisions to Regulatory Affairs and does not need to understand the rationale The signal review team alone approves final RMP wording and regulatory commitments The Safety Governance Committee owns all document version control without involvement from the RMP owner

Whether the outcome is life-threatening Whether the exposed population is large Whether alternative explanations have been adequately considered Whether an educational programme is feasible

Remove it immediately if the new study has a reassuring headline result Retain it permanently because an identified risk can never be reclassified Document a scientific rationale, assess predefined criteria and related RMMs, obtain appropriate approvals, and address regulatory commitments Change only the risk title while leaving the RMP and label unchanged