Regulations for Registration of Medicinal Products Article 71
The following documents are required for the renewal or reissuance of damaged or lost drug licenses:1.Application form for post-approval changes;2.A photocopy of drug license (front and back sides). Original drug license is required, if the application is filed due to damages to licenses;3.Original copy of the application form for drug registration;4.Assurance statement certifying the loss of drug licenses. This document would not be required for cases of damaged licenses.5. For locally manufactured drugs appling for changes in license number, one copy each of the originally approved copy of labels and package inserts and two copies of the form for sticking label and package insert. The affixing form can be exempted, if the documents said in the preceding paragraph are submitted via the electronic submission platform.6.For imported drugs, the original copy of an authorization letter issued by the original manufacturer. The letter has to be authenticated by the R.O.C. foreign affairs offices.
中文原文 藥品查驗登記審查準則第71條
藥品許可證遺失或污損，申請補發或換發，應檢附下列資料：
一、藥品變更登記申請書。
二、藥品許可證正、反面影本。
但申請許可證污損換發者，應附許可證正本。
三、藥品查驗登記申請書正本。
四、藥品許可證遺失切結書。
但申請許可證污損換發者，免附。
五、涉換字號之國產藥品，應另附原核准之標仿單核定本一份及外盒、仿單、標籤黏貼表二份；其以線上平台提交者，得免附黏貼表。
六、如係輸入藥品，應另附原廠委託書正本。
一、藥品變更登記申請書。
二、藥品許可證正、反面影本。
但申請許可證污損換發者，應附許可證正本。
三、藥品查驗登記申請書正本。
四、藥品許可證遺失切結書。
但申請許可證污損換發者，免附。
五、涉換字號之國產藥品，應另附原核准之標仿單核定本一份及外盒、仿單、標籤黏貼表二份；其以線上平台提交者，得免附黏貼表。
六、如係輸入藥品，應另附原廠委託書正本。