Pharmaceutical Affairs Act Article 97-1
In the case that the examined medicament does not comply with information stated in applications submitted in accordance with the Regulations for Registration of Medicinal Products or the Regulations for Registration of Medical Devices, the central competent health authority shall not accept nor process new applications for other medicaments by the said manufacturers for six months, which shall commence from the date the incompliance is verified.In the case that the result of re-examination upon the application within the time limit for response still fails to comply, the central competent health authority shall not accept nor process new applications for other medicaments by the said manufacturers for one year, which shall commence from the date the incompliance is verified.
中文原文 藥事法第97-1條
依藥品查驗登記審查準則及醫療器材查驗登記審查準則提出申請之案件，其送驗藥物經檢驗與申請資料不符者，中央衛生主管機關自檢驗結果確定日起六個月內，不予受理其製造廠其他藥物之新申請案件。
前項情形於申復期間申請重新檢驗仍未通過者，中央衛生主管機關自重新檢驗結果確定日起一年內，不予受理其製造廠其他藥物之新申請案件。
前項情形於申復期間申請重新檢驗仍未通過者，中央衛生主管機關自重新檢驗結果確定日起一年內，不予受理其製造廠其他藥物之新申請案件。