Health and Medicinal Claim Review Before Campaign Launch

Advertising a prescription-only medicine to the public is prohibited across the Union under Article 88 of Directive 2001/83/EC, and advertising an over-the-counter medicine to the public in Italy needs prior authorisation from the Ministero della Salute under Article 118 of D.Lgs 219/2006, with the authorisation number shown in the advertisement itself. Most of what reaches us is neither: a supplement, a device, a clinic or an insurer whose marketing has drifted into a medicinal claim without anyone having decided to make one. The remedy is the claim. It is almost never the disclaimer. How a claim gets ruled: Line by line, against the register that governs it rather than against a general sense of caution. Nutrition and health claims on foods and supplements resolve to Regulation (EC) 1924/2006 and the EU Register: an authorised wording, a botanical still on hold, or nothing. Article 10(3) is where campaigns fail most often, because a general wellbeing statement in a headline is permitted only when a specific authorised claim travels with it, and headlines are written by people who have never been shown that rule. Disease prevention and treatment claims on a food are closed rather than negotiable. Devices resolve to Article 7 of the Medical Device Regulation. Every line returns green, amend or drop, with the authority cited, so your regulatory affairs lead can overrule us on evidence we have not seen. The platform layer sits on top of the law: A claim can be lawful and still unrunnable. Google's healthcare and medicines policy gates pharmacy and telehealth advertising behind LegitScript certification country by country and restricts what may be said about over-the-counter products even where national law permits it. Meta prohibits creative implying knowledge of a personal health attribute, and that rule kills before-and-after imagery and second-person body copy far more often than any medicines law does. We review against both and we tell you which of the two is stopping a line, because the two have different remedies and only one of them is negotiable. Italy: The Codice di Autodisciplina and the IAP Comitato di Controllo move faster than any regulator, and an injunction to desist arrives long before an AGCM proceeding would have opened. AGCM handles misleading practice under the Codice del Consumo, where exposure is turnover-linked rather than reputational. We mark which of the two a given line invites, since the same sentence rarely invites both. Insurance and health cover: Policy marketing that describes clinical outcomes, screening benefits or wellness programmes reads as a health claim even though the product is a contract. This is the corner of the field we know best, and it is usually where a creative team has never been told that the rules apply to them at all. What we are not: We are not your regulatory affairs function. We do not write or assess clinical substantiation, we do not build dossiers, we sign nothing that goes to AIFA, and we do not decide whether your evidence supports a claim. We decide whether the claim as written is permitted, given the evidence you tell us you hold. What we turn down: Weight-loss, sexual performance and cognitive enhancement funnels. Unregistered telemedicine. Any brief framed as finding a wording that survives review rather than a wording that is true. Work that starts after the campaign is live and the letter has arrived, which is defence work and belongs with your litigators. Delivered: A ruling table covering every claim in the set, with authority and platform verdict on each line, rewritten alternatives for the amends, and a short note on the two or three habits in your creative process that produced the drops, so the next brief starts closer to the line instead of over it.