効能・効果の表現
スイス / Swissmedic
専門家向け広告のすべての記載はスイスメディックが最後に承認した医薬品情報と一致していなければならず、承認された効能・使用法のみを広告でき、記載は正確・均衡・客観的に正しく立証可能で誤解を招いてはならず、最新の科学的知見に基づいてこれを反映しなければならない(一般向け広告にも同じ一致の要請がかかる)。
All statements in professional advertising must be consistent with the medicinal product information last approved by Swissmedic and only indications and uses approved by Swissmedic may be advertised; the statements must be accurate, balanced, factually correct, substantiable and not misleading, and must be based on and reflect the current state of scientific knowledge, with the same consistency requirement applying to advertising to the public.
注記
Read in German on Fedlex. The Fedlex ELI landing page (https://www.fedlex.admin.ch/eli/cc/2001/519/de) is a JavaScript application that returns no text to a plain fetch, so the consolidated HTML was taken from the Fedlex filestore URL cited here. Art. 5 Abs. 5 further requires that advertising claims refer only to clinical trials conducted under GCP and published or accepted for publication, and to data collections such as meta-analyses or practice reports published in a scientifically recognised medium, quoted verbatim, in full and with a precise source. Art. 5 Abs. 6 and Art. 16 Abs. 4 allow a product, indication, dosage, dosage form or pack to be promoted as 'new' for eighteen months after first authorisation in Switzerland. I swept every monthly consolidation date from January 2020 to December 2026 on the Fedlex filestore and found no version later than 1 January 2020.
Read in German on Fedlex. The Fedlex ELI landing page (https://www.fedlex.admin.ch/eli/cc/2001/519/de) is a JavaScript application that returns no text to a plain fetch, so the consolidated HTML was taken from the Fedlex filestore URL cited here. Art. 5 Abs. 5 further requires that advertising claims refer only to clinical trials conducted under GCP and published or accepted for publication, and to data collections such as meta-analyses or practice reports published in a scientifically recognised medium, quoted verbatim, in full and with a precise source. Art. 5 Abs. 6 and Art. 16 Abs. 4 allow a product, indication, dosage, dosage form or pack to be promoted as 'new' for eighteen months after first authorisation in Switzerland. I swept every monthly consolidation date from January 2020 to December 2026 on the Fedlex filestore and found no version later than 1 January 2020.
補足 ── 当方未検証
下記は 提供文書『世界の医薬品広告規制、承認内外の境界を読み解く』(2026-09-23) に記載のある内容です。出典の記載はありますが、当方で原典に当たって確かめていません。上の検証済みの記述とは区別してお読みください。
- AWV 第5条(1)は専門家向け広告について、全ての記載が Swissmedic が最後に承認した Arzneimittelinformation と整合しなければならず、承認された適応・用法のみを広告できると定める。