Regulations for Registration of Medicinal Products Article 33
After a drug license was revoked or cancelled due to drug efficacy or safety reasons, the first application of drug with identical active ingredient, dosage form and contents should follow the regulations for the new drug registration. If the reasons for license revocation or cancelation are irrelevant to drug efficacy or safety issues, then the first application shall follow the regulations of generic drugs.
中文原文 藥品查驗登記審查準則第33條
中央衛生主管機關曾核准相同有效成分、劑型、劑量之藥品許可證，如其廢止或註銷之原因與藥品療效安全性有關者，日後首家申請案應依新成分新藥規定辦理查驗登記；如其廢止或註銷之原因與藥品療效安全性無關者，日後首家申請案得依學名藥規定辦理查驗登記。