Pharmaceutical Affairs Act｜第 48 條｜Food and Drug Administration｜Act｜In Force
第 四 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
本條規定許可證有效期間內的重新評估機制：藥物於其製造、輸入許可證有效期間內，經中央衛生主管機關重新評估確定有安全或醫療效能疑慮者，得限期令藥商改善，屆期未改善者廢止其許可證；但安全疑慮重大者，得逕予廢止之。這說明輸入許可並非取得後即不可變動。
If there is a safety or medical efficacy concern of medicaments as re-evaluated and confirmed by the central competent health authority within the validity period of the manufacture or import license, pharmaceutical firms may be ordered to rectify any concerns within a time limit. For those who fail to make corrections within the given time limit, their licenses shall be revoked. Where there is a serious safety concern, the central competent health authority may revoke the license directly.
依本條，藥物於其製造、輸入許可證有效期間內，經中央衛生主管機關重新評估確定有安全或醫療效能疑慮者，得限期令藥商改善，屆期未改善者，廢止其許可證。
依本條但書，安全疑慮重大者，得逕予廢止之。