Regulations for the Inspection and Examination of Imported Medicaments Article 12
In the event the medicaments applied for inspection correspond to one of the following situations, the competent authority may require the obligatory inspection applicant to provide written documentation before a given date, to explain the reasons for non-conformance, and a proposed improvement plan with preventative measures:1. Same product applied for batch-by-batch examination by the same obligatory examination applicant does not conform to regulations for the second time.2. Products belong to the same origin of medicaments permit license, and whose inspection results do not conform to regulations for three times within 180 days.3. Chinese medicine materials belonging to the same origin, same country and same commodity classification code of the Republic of China, and whose inspection results do not conform to regulations for three times within 180 days.
中文原文 輸入藥物邊境抽查檢驗辦法第12條
輸入藥物有下列情形之一，中央衛生主管機關得要求報驗義務人限期提供書面資料，說明不合格原因與改善計畫及其預防措施：
一、同一報驗義務人申請屬逐批檢驗之同一輸入藥物，經二次輸入檢驗不合格者。
二、同一許可證字號之藥物，自發生查驗不合格日起一百八十日內，查驗不合格達三次者。
三、同產地或國家相同輸入貨品分類號列之中藥材，自發生查驗不合格日起一百八十日內，查驗不合格達三次者。
一、同一報驗義務人申請屬逐批檢驗之同一輸入藥物，經二次輸入檢驗不合格者。
二、同一許可證字號之藥物，自發生查驗不合格日起一百八十日內，查驗不合格達三次者。
三、同產地或國家相同輸入貨品分類號列之中藥材，自發生查驗不合格日起一百八十日內，查驗不合格達三次者。