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Advertising AtlasJapan / Claims of efficacy

Claims of efficacy

Japan / MHLW

Expressions of the efficacy, effect or performance of a product requiring approval must not exceed the scope of the approved indications, whether explicit or implicit, and expressions guaranteeing efficacy or using superlatives are prohibited.

承認等を要する医薬品等の効能効果等についての表現は、明示的か暗示的かを問わず承認等を受けた効能効果等の範囲をこえてはならず、効能効果等が確実であるとの保証表現及び最大級の表現は禁止される。

Note
基準第4の3(1)(5)(6)。上位の法的根拠は薬機法第66条第1項(虚偽又は誇大な記事の広告等の禁止)で、これも e-Gov の条文で確認した。承認を要しない医薬品等・化粧品には別の範囲(第4の3(2))が適用される。
Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.