# MLR Review vs Copy Approval: US and UK Promotional Review, Translated

> The same job has different names and different law on each side of the Atlantic — US MLR review under FDA/OPDP versus UK copy approval and certification under the ABPI Code and PMCPA. A side-by-side translation for teams working across both.

> **US "MLR review" and UK "copy approval" are the same job with different law behind it.** In the US, promotional material is reviewed by an internal Medical-Legal-Regulatory committee and submitted to FDA's OPDP on Form 2253 *at time of first use*. In the UK, material must be **certified** before use under the ABPI Code (Clause 8 in the 2024 Code, in force 1 October 2024; formerly Clause 14 in the 2019 Code) by a **final medical signatory** — a legally accountable, named individual. Same intent, very different accountability model.

## The translation table

| Concept | US | UK / EU |
|---|---|---|
| The review process | MLR (medical-legal-regulatory) review; promotional review; PRC | Copy approval; certification & examination; "med legal" review |
| The approving act | MLR approval (committee consensus) | **Certification** — a specific, legally meaningful act under ABPI Code Clause 8 (2024) |
| Who signs | Committee members per SOP | **Final medical signatory** — UK-registered physician or pharmacist, personally accountable |
| Regulator / code body | FDA (OPDP division) | MHRA (statutory); **PMCPA** administering the **ABPI Code** (self-regulatory) |
| Submission to regulator | **FDA Form 2253** at first use | No direct 2253 analog; complaints route through PMCPA |
| Safety text | Fair balance; ISI (Important Safety Information); PI | **SmPC** (Summary of Product Characteristics); PI |
| Linking claims to evidence | Claims annotation; annotated references; substantiation | **Referenced copy**; annotation |
| Claim inventory | Claims matrix; claims library; core claims document | Claims matrix |

## What actually differs (beyond vocabulary)

**Accountability shape.** The US model distributes responsibility across a committee and post-hoc FDA enforcement (OPDP letters). The UK model concentrates it: the final medical signatory personally certifies that the material complies — a role with **no US equivalent** — which makes UK signatories famously conservative and UK copy approval a personal-risk decision, not just a process step.

**Timing of regulator involvement.** Form 2253 means FDA sees US material when it launches. In the UK, PMCPA involvement is typically complaint-driven (often by competitors), so the certification step *is* the gate.

**Safety-text construct.** "Fair balance" and ISI are FDA constructs about proportionate risk presentation. The EU/UK anchor is the SmPC — claims must be consistent with it, and UK material carries prescribing information per the Code.

## Why this matters for tooling and content

Teams and writers working both markets constantly translate: a "claims annotation" workflow must produce what a US reviewer calls annotated references and a UK signatory calls referenced copy — same locators (page/column/paragraph of the substantiating passage), different sign-off ceremony downstream. Any tool that treats substantiation as first-class travels across both regimes; anything built purely around US committee workflow will feel alien to a UK certification process, and vice versa. (This is deliberate in [Claims](/): the substantiation layer — claim ↔ evidence locator — is regime-neutral; what changes per market is who signs and what gets filed.)

**One practical rule for cross-market writers:** keep the claims matrix regime-tagged. A claim approved against US labeling is not automatically usable under the SmPC, and the fastest way to fail a UK certification is to import a US deck's claims wholesale.

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Source: https://medcom.claims/resources/mlr-vs-copy-approval/ · Updated 2026-07-13 · © Mantir, Inc.