Regulations for the Inspection and Examination of Imported Medicaments Article 13
In the event the medicaments applied for inspection correspond to one of the following situations, the competent authority may temporarily suspend the application for inspection from the same manufacturer, same origin, or same country:1. Products mentioned in the preceding article and the written documentations provided are not approved upon review.2. Products mentioned in the preceding article requiring written documentations are not provided before the given date or the following imported products applied for inspection still do not conform to regulations by the given date.
中文原文 輸入藥物邊境抽查檢驗辦法第13條
輸入藥物有下列情形之一,中央衛生主管機關得暫停受理該產品同製造廠、同產地或同輸出國產品查驗申請:
一、前條書面資料經審核未通過者。
二、未於前條之期限內提供書面資料,或於限期內再次申請,經查驗仍不合格者。
一、前條書面資料經審核未通過者。
二、未於前條之期限內提供書面資料,或於限期內再次申請,經查驗仍不合格者。