Precleared material, and nothing but.
Canadian HCP advertising runs on preclearance and an off-label posture among the strictest of the four jurisdictions on these pages. A zenrep fits the regime natively: it speaks only from your approved, precleared material, holds efficacy content to HCP audiences, and does not improvise — even when the question invites it.
- Health Canada
- PAAB — Pharmaceutical Advertising Advisory Board
- CRTC (CASL)
What the regulator requires
Nine requirements govern promotional communication to Canadian HCPs. They are the specification the Canadian ruleset enforces.
- Fair balance is statutory.
- The Food and Drugs Act (s.9(1)) prohibits advertising that is false, misleading, deceptive, or likely to create an erroneous impression about a drug's merit or safety. In Canada, balance is not an industry courtesy — it is the statute itself.
- Off-label is advertising an unauthorized use.
- The Food and Drug Regulations prohibit advertising any use outside the Notice of Compliance and Product Monograph.
- Even a solicited off-label question cannot be answered by sales.
- Health Canada guidance and the industry code are aligned: off-label responses must never come from sales or marketing personnel. Only a genuinely unsolicited request, handled by the medical function, qualifies — among the strictest off-label postures of the four jurisdictions on these pages.
- Efficacy claims are HCP-only.
- Public advertising of prescription drugs is restricted to name, price, and quantity — no therapeutic claims to the public, full stop.
- Balanced benefit and risk, consistent with the market authorization.
- Health Canada's test for HCP-directed advertising is explicit: not false or misleading, balanced in its benefit-risk representation, and consistent with the terms of market authorization.
- Preclearance is how Canadian HCP advertising works.
- PAAB is the Health-Canada-recognized preclearance body for HCP-directed advertising, and precleared copy carries the authorization-consistent safety profile in the body of the message.
- Adverse events on a 15-day clock, records for 25 years.
- Serious adverse drug reactions must be reported within 15 days, and adverse-event records are retained for 25 years.
- Outbound consent is a hard gate.
- CASL requires express consent, sender identification, and a working unsubscribe for commercial electronic messages. It applies to HCPs, and the sender bears the burden of proving consent.
- No inducements; samples only on a signed order.
- The industry conduct rules bar any gift or reward for prescribing, and samples require a practitioner's signed order, with records kept.
How the receipt answers the regulator
On the gated text channels — web chat and Telegram — every reply ships with the four-check receipt: in scope, grounded in approved material, fair-balanced, audit-recorded. Here is what each check holds, in PAAB and Health Canada terms.
Off-label is refused outright in the promotional conversation and routed away from the commercial channel — sales personnel never answer it, and neither does a zenrep. Efficacy content is held to HCP audiences, honoring the public-advertising near-ban. (Requirements 3 and 4.)
A zenrep speaks only from your approved, precleared material — it does not generate novel promotional claims, the thing no preclearance regime can cover. (Requirements 2, 5, and 6.)
Safety context travels with every benefit claim, matching the statutory no-erroneous-impression standard. (Requirements 1 and 5.)
Every conversation leaves a reviewable record, and adverse-event mentions are captured and forwarded in time for the 15-day clock. (Requirement 7.)
AI identity is disclosed at the start of the conversation — a deliberate default rather than a Canadian statutory demand, and one aligned with the EU's binding standard. No gifts or value are ever offered, and sample requests are never fulfilled in conversation — the signed-order process stays with your team, where it belongs. (Requirements 8–9.)