Pharmaceutical Affairs Act｜第 22 條｜Food and Drug Administration｜Act｜In Force
第 一 章｜衛生福利部 / 食品藥物管理署｜v107.01.31
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
本條界定藥事法所稱「禁藥」，是判斷藥品能否輸入的核心條文。禁藥指兩種情形：一、經中央衛生主管機關明令公告禁止製造、調劑、輸入、輸出、販賣或陳列之毒害藥品；二、未經核准擅自輸入之藥品。第二款設有明文例外：旅客或隨交通工具服務人員攜帶自用藥品進口者，不在此限。該自用藥品之限量，依本條第二項由中央衛生主管機關會同財政部公告之。要留意的是，此例外限於旅客或隨交通工具服務人員「攜帶」進口，且須在公告限量內。
The term “prohibited drugs” as used in this Act shall refer to any of the following: 1. The poisonous or harmful drugs that are prohibited by an order publicly announced by the central competent health authority from manufacturing, dispensing, importing, exporting, selling, or displaying; or 2. The drugs that are imported without prior approval, except the drugs that are carried into this country for personal use by passengers or service personnel on board during transportation. Quotas regarding the personal-use pharmaceuticals referred to in Subparagraph 2 of the preceding paragraph shall be determined by the central competent health authority in conjunction with the Ministry of Finance.
依本條第一項，禁藥指藥品有下列情形之一：一、經中央衛生主管機關明令公告禁止製造、調劑、輸入、輸出、販賣或陳列之毒害藥品；二、未經核准擅自輸入之藥品。
依本條第一項第二款但書，旅客或隨交通工具服務人員攜帶自用藥品進口者，不在此限。惟依同條第二項，該自用藥品之限量由中央衛生主管機關會同財政部公告之，超出公告限量者不在但書適用範圍。