Self-certification is the regime. The record is the substance.
The United Kingdom trusts companies to certify their own promotional material — and backs that trust with statute that makes off-label promotion a criminal offence. MHRA supervises after the fact; the industry code, administered by the PMCPA, holds every claim to accurate, balanced, and substantiable. The UK ruleset is authored against both.
- MHRA — Medicines and Healthcare products Regulatory Agency
- PMCPA — ABPI Code of Practice
What the regulator requires
Ten requirements govern promotional communication to UK HCPs, anchored on the Human Medicines Regulations 2012 with the ABPI Code of Practice 2024 layered on top. Where this page says the law requires something, it means the statute; where it is the industry code, it says so.
- Three cumulative statutory requirements.
- Under the Human Medicines Regulations 2012, an advertisement must comply with the SPC particulars, present the product objectively without exaggerating its properties, and not be misleading. All three, at once, on every communication.
- Off-label promotion is a criminal offence.
- Promoting outside the SPC's indications or patient groups is barred, and breach carries up to two years' imprisonment on indictment. This is statute, not guidance.
- The only carve-out is strictly reactive.
- A factual answer to a genuinely unsolicited question is permitted — and any activity designed to solicit such questions is itself a breach.
- Fair balance is a positive obligation.
- The industry code requires claims to be accurate, balanced, fair, objective, unambiguous, and substantiable — with significant limitations stated, and absolute values given alongside relative ones.
- Absolute-safety language is banned.
- Stating or implying that a medicine is "safe" is unacceptable. "Well tolerated" needs evidence; a "well-established safety profile" needs extensive post-marketing experience.
- Obligatory accompanying information.
- Promotional material must carry prescribing information and the Yellow Card adverse-event reporting statement — plus the black triangle for products under additional monitoring.
- No pre-clearance — the company certifies its own material.
- MHRA supervises after the fact, and companies self-certify under the industry code. The company owns every communication it sends.
- Prescription-only medicines are never advertised to the public.
- Promotional content is HCP-audience-only.
- Effectively zero gifts.
- Statute permits only the inexpensive and relevant; the industry code prohibits gifts outright; the Bribery Act sits behind both — and soliciting a benefit is itself unlawful. Samples move only on a signed, dated request.
- Anyone promoting a medicine is a regulated category.
- Every statement must be checkable against the SPC, safety information received from HCPs must be forwarded to the scientific service, and all suspected adverse reactions are recorded — serious within 15 days, non-serious within 90.
How the receipt answers the regulator
The four checks on the receipt — in scope, grounded in approved material, fair-balanced, audit-recorded — are jurisdiction-agnostic. The authored UK ruleset maps them onto the requirements above and ships with UK deployment, after counsel review and productization.
Off-label is refused outright — criminal exposure warrants refusal, not a caveat — and routed to the reactive medical-information path; the product routes those questions, it does not answer them. Promotional content is held to HCP audiences. (Requirements 2–3 and 8.)
Every claim stays inside the SPC envelope and remains checkable against the SPC on demand — the standard the law sets for any rep. (Requirements 1 and 10.)
Limitations and risk context are paired with every claim, and absolute-safety language never ships. (Requirements 4–5.)
Every conversation is recorded and reviewable — the substance behind self-certification. Safety signals are forwarded for the 15- and 90-day clocks, and the Yellow Card statement is carried on promotional surfaces. (Requirements 6–7 and 10.)
AI identity is disclosed at the first interaction — the platform's default in every jurisdiction, not a posture the UK statute compels. No gifts or inducements, ever; sample requests are never fulfilled in conversation — the signed, dated request process stays with your team. (Requirement 9.)