Objective, verifiable, SmPC-bound — the EU standard, encoded.
EU medicines-advertising law asks for objectivity: every promotional statement must match the Summary of Product Characteristics, carry essential safety information, and stand up to verification. And from August 2026, the AI Act requires AI identity to be disclosed at the first interaction — a behavior this platform treats as its default. The EU ruleset is authored against those requirements.
- Member-State competent authorities (Directive 2001/83/EC)
- EFPIA Code of Practice
- EU AI Act (applies from 2 August 2026)
What the regulator requires
Ten requirements govern promotional communication to EU HCPs, drawn from Directive 2001/83/EC, the EFPIA Code, and the EU AI Act. The EU pharmaceutical-legislation reform will renumber the directive's provisions — the obligations carry forward — so this page states them in plain language.
- No authorization, no advertising — and every ad must match the SmPC.
- Advertising an unauthorized medicine is prohibited. All advertising must comply with the Summary of Product Characteristics, encourage rational use, and present the product objectively, without exaggerating its properties.
- HCP-directed advertising must carry essential information.
- Promotion to HCPs must include the essential, SmPC-compatible information — safety included — together with the medicine's supply classification.
- Accurate, verifiable, complete.
- Information must be accurate, up to date, verifiable, and sufficiently complete for the clinician to form their own opinion of the medicine's value. Quoted literature must be faithfully reproduced, with precise sources.
- Purpose decides, not framing.
- Under EU case law, content with a promotional purpose is advertising no matter how scientific its dress. Framing never launders promotion.
- Off-label promotion is prohibited.
- The only carve-out is a reactive, individual, non-promotional, documented reply to a genuinely unsolicited HCP enquiry.
- No promotion of prescription medicines to the public.
- Direct-to-consumer advertising of prescription medicines is banned outright; promotional content belongs to HCP audiences only.
- AI identity, disclosed at first interaction.
- The EU AI Act requires that people be informed they are interacting with AI — clearly and distinguishably, at the latest at the first interaction. The obligation applies from 2 August 2026.
- No digital promotional outreach without prior permission.
- ePrivacy rules require opt-in consent for automated promotional contact, and the EFPIA Code requires prior permission or an HCP-initiated request — and promotion must never be disguised.
- No gifts; samples under strict conditions.
- Gifts and benefits beyond the inexpensive-and-relevant are barred. Samples are permitted only under strict cumulative conditions, including a signed, dated request from the prescriber.
- Every suspected adverse reaction, recorded.
- Serious suspected adverse reactions are reported within 15 days; non-serious within 90. Recording is not optional at any severity.
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 EU ruleset maps them onto the requirements above and ships with EU deployment, after counsel review and productization.
Off-label is declined and routed to a documented medical-information path — the product routes those questions; it does not answer them. Conversations are judged by purpose, so a scientific frame never smuggles promotion, and prescription-product content is held to HCP audiences. (Requirements 4–6.)
Claims trace to SmPC-approved material, and quoted data is reproduced faithfully with its source. (Requirements 1–3.)
Essential safety information is paired with promotional content by default. (Requirements 2–3.)
Every exchange is documented and reviewable, and adverse-event mentions are captured for the 15- and 90-day clocks. (Requirements 5 and 10.)
A zenrep discloses its AI identity at the first interaction on the gated text channels — the platform's default behavior, and the behavior the AI Act requires from August 2026. No outreach happens without recorded prior permission, no gifts are offered, and sample requests are never fulfilled in conversation — the signed-request process stays with your team. (Requirements 7–9.)