Pharmaceutical Affairs Act｜第 80 條｜Food and Drug Administration｜Act｜In Force
第 八 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
本條規定藥物回收義務，適用對象為製造或輸入之業者。有六種情形應即通知醫療機構、藥局及藥商，並依規定期限收回市售品連同庫存品一併處理：原領有許可證經公告禁止製造或輸入；經依法認定為偽藥、劣藥或禁藥；經依法認定為不良醫療器材或未經核准而製造、輸入之醫療器材；藥物製造工廠經檢查發現其藥物確有損害使用者生命、身體或健康之事實或有損害之虞；製造、輸入藥物許可證未申請展延或不准展延；其他經中央衛生主管機關公告應回收。製造、輸入業者回收時，醫療機構、藥局及藥商應予配合。
If any of the following circumstances apply to any medicament, its manufacturer or importer shall immediately notify medical care institutions, pharmacies, and pharmaceutical firms and, within a prescribed time limit, shall recall the medicament in question from the market and dispose of it together with its stock of the medicament pursuant to the relevant provisions of this Act: I. Where the medicament has been granted a license but is subsequently prohibited by public announcement from being manufactured or imported. II. Where the drug has duly been deemed counterfeit, substandard, or prohibited in accordance with the law. III. Where the medical device has duly been deemed defective or has been manufactured or imported without approval in accordance with the law. IV. Medicaments produced by a medicament manufacturing factory are found, after inspection, to be damaging or likely to damage the life, body, or health of users. V. Where an application for extension of a medicament manufacture or import license previously granted has not been filed, or its approval has been denied. VI. Other medicaments whose recall has been publicly announced by the central competent health authority. Medical care institutions, pharmacies, and pharmaceutical firms shall cooperate with manufacturers or importers in recalling the medicaments set forth in the subparagraphs of the preceding paragraph. Regulations governing recalled medicaments under the provision of the first paragraph, such as classification, method of handling, recalling, and other matters to be complied with shall be prescribed by the central competent health and welfare authority.
依本條第一項，有下列情形之一者應即通知並依規定期限收回：一、原領有許可證，經公告禁止製造或輸入；二、經依法認定為偽藥、劣藥或禁藥；三、經依法認定為不良醫療器材或未經核准而製造、輸入之醫療器材；四、藥物製造工廠經檢查發現其藥物確有損害使用者生命、身體或健康之事實，或有損害之虞；五、製造、輸入藥物許可證未申請展延或不准展延；六、其他經中央衛生主管機關公告應回收。
依本條第二項，製造、輸入業者回收前項各款藥物時，醫療機構、藥局及藥商應予配合。