Copy Approval & Certification (ABPI/PMCPA)

Updated 2026-07-13 · markdown version

Copy approval is the UK pharmaceutical industry's process for reviewing and approving promotional material before use, culminating in certification — a legally specific act under the ABPI Code of Practice (Clause 8 in the 2024 Code, in force 1 October 2024; the equivalent was Clause 14 in the 2019 Code). Certification is performed by a named final medical signatory, personally accountable that the material complies with the Code.

Functionally, copy approval is the counterpart of US MLR review: claims are verified against evidence ("referenced copy" is the UK term for annotated references), safety text is checked for consistency with the SmPC, and prescribing information requirements are confirmed. The difference is the accountability model — a committee consensus in the US versus a named individual's certification in the UK — and enforcement, which runs through the PMCPA (Prescription Medicines Code of Practice Authority, administering the ABPI Code) largely on a complaints basis, alongside the MHRA's statutory role.

The vocabulary translates but doesn't map 1:1; teams working both markets should keep a translation table in the style guide. We maintain one in MLR vs Copy Approval.