Medical communications & MLR glossary

Updated 2026-07-13 · markdown version

• Annotated References (Referenced Copy)

  Annotated references — UK usage "referenced copy" — are pharma deliverables marked with human-readable locators (source/page/column/paragraph) pointing every claim to the exact passage that substantiates it.

• Claims Library

  A claims library is the database form of a claims matrix — approved claims stored as reusable, versioned objects linked to their evidence, with usage tracked across deliverables.

• Claims Matrix

  A claims matrix is the controlled inventory of approved product claims paired with their substantiating evidence — the source of truth for what a pharma company may say and what backs each statement.

• Copy Approval & Certification (ABPI/PMCPA)

  Copy approval is the UK process for reviewing and certifying pharmaceutical promotional material before use under the ABPI Code — the UK counterpart of US MLR review, with legally accountable signatories.

• Fair Balance

  Fair balance is the FDA/OPDP requirement that pharmaceutical promotion present risk information with prominence and readability comparable to benefit claims — efficacy and safety in honest proportion.

• FDA Form 2253

  Form 2253 is the FDA submission that accompanies pharmaceutical promotional materials at time of first use — every promotional piece for a prescription drug is filed with OPDP on this form.

• Final Medical Signatory

  The final medical signatory is the UK-registered physician or pharmacist who personally certifies pharmaceutical promotional material under the ABPI Code — a legally accountable role with no direct US equivalent.

• ISI (Important Safety Information)

  ISI is the standardized block of a drug's key risk information — warnings, contraindications, adverse events — that accompanies US promotional materials to satisfy fair balance.

• MLR Review (Medical, Legal, Regulatory)

  MLR review is the internal medical, legal, and regulatory examination every piece of pharmaceutical promotional or medical material must pass before use — verifying claim substantiation, safety balance, and label consistency.

• OPDP (Office of Prescription Drug Promotion)

  OPDP is the FDA office that regulates prescription-drug promotion in the US — receiving Form 2253 submissions and enforcing truthful, balanced promotion through untitled and warning letters.

• Promotional Review Committee (PRC)

  The PRC is the cross-functional committee — medical, legal, regulatory, and often commercial — that conducts MLR review of pharmaceutical promotional materials and holds approval authority before use.

• Reference Pack

  A reference pack is the bundle of source documents — papers, data on file, prescribing information — submitted alongside a pharma deliverable so reviewers can verify every annotated claim.

• 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.

• Substantiation

  Substantiation is the evidentiary backing for a promotional claim — the demonstrable link between what a pharma material says and the data that supports it, verified during MLR review.