Regulations for the Inspection and Examination of Imported Medicaments Article 20
In the event the medicaments fail to conform to regulations, a notification of noncompliance for medicaments will be issued.The obligatory inspection applicant can apply for re-examination to the original inspection authority within 15 days after receipt of the notification of results. Applications for re-examination is limited to one time only, and are performed by the original testing laboratory using remaining samples for the re-testing. For medical devices, if the remaining samples are not adequate for re-examination, additional sampling may be done according to Article 15.Remaining samples of products that do not conform to regulations shall be destroyed after the end of the period of application for re-examination, unless otherwise stated by law.
中文原文 輸入藥物邊境抽查檢驗辦法第20條
輸入藥物查驗不合格者，查驗機關應核發輸入不合格之通知予報驗義務人。
報驗義務人於收受前項通知之次日起十五日內，得向查驗機關申請複驗，但以一次為限，複驗時由查驗機關就原抽取餘存樣品為之。
如係醫療器材其餘存之樣品不足供複驗者，得依第十五條規定，再行辦理抽樣。
前項查驗不合格之輸入藥物，其餘存之樣品，除法律另有規定者外，於申請複驗之期限屆至後，應予銷毀。
報驗義務人於收受前項通知之次日起十五日內，得向查驗機關申請複驗，但以一次為限，複驗時由查驗機關就原抽取餘存樣品為之。
如係醫療器材其餘存之樣品不足供複驗者，得依第十五條規定，再行辦理抽樣。
前項查驗不合格之輸入藥物，其餘存之樣品，除法律另有規定者外，於申請複驗之期限屆至後，應予銷毀。