Prevention of Rare Diseases and Orphan Drug Act Article 20
When orphan drugs are determined to be hazardous to human health, or are suspected of being hazardous to human health, the central competent authority may order pharmaceutical firms or ad hoc applicants to recall said drugs within a specified deadline. Where necessary, the permits for said drugs may be revoked.
中文原文 罕見疾病防治及藥物法第20條
罕見疾病藥物經認定有危害人體健康之情事或有危害之虞者，中央主管機關得命藥商或專案申請者於期限內回收。
必要時，並得廢止該藥物之許可。
必要時，並得廢止該藥物之許可。