# SmPC (Summary of Product Characteristics)

> The SmPC is the approved EU/UK document defining a medicine's licensed indications, dosing, and safety information — the reference against which all European promotional claims are checked.

> The **SmPC (Summary of Product Characteristics)** is the legally approved EU/UK document that defines what a medicine *is* for regulatory purposes: licensed indications, posology, contraindications, warnings, interactions, adverse reactions. In European promotional review, the SmPC is the anchor document — **claims must be consistent with it**, and promotion beyond it is off-label by definition.

The SmPC plays the role that approved labeling (the USPI) plays in the US, and the constructs differ accordingly: the US pairs claims with [fair balance](/glossary/fair-balance/) and ISI blocks, while UK/EU review checks claim-by-claim consistency with the SmPC and the Code's prescribing-information requirements. An SmPC update — new warning, revised indication — instantly stales every deliverable and [claims matrix](/glossary/claims-matrix/) row that touched the changed section, making "PI/SmPC change triage" one of the highest-value maintenance rituals in medical communications.

Cross-market note for writers: a claim substantiated against US labeling is *not* automatically usable in Europe. Regime-tag your claims matrix; the fastest route to a failed UK certification is importing a US deck wholesale. See [MLR vs Copy Approval](/resources/mlr-vs-copy-approval/).

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Source: https://medcom.claims/glossary/smpc/ · Updated 2026-07-13 · © Mantir, Inc.