EU Summary of Product Characteristics — defined frequency bands as a tier convention

Summary

Claim: The EU Summary of Product Characteristics convention uses defined frequency bands with verbal labels:

  • Very common: ≥1/10
  • Common: ≥1/100 to <1/10
  • Uncommon: ≥1/1,000 to <1/100
  • Rare: ≥1/10,000 to <1/1,000
  • Very rare: <1/10,000
  • Not known: cannot be estimated from the available data

Low/Medium/High risk-matrix banding is likewise standard in safety and risk management.

Source: EU SmPC convention.

Confidence: Verified.

Why this matters for Candid: Bands are a recognized, legitimate format for inherently imprecise quantities. BUT verbal band labels MUST be anchored, or they fail — the EU experience is itself a cautionary tale (Knapp et al. 2004 — EU verbal frequency labels cause dramatic overestimation of medical risk).