Regulations for Registration of Medicinal Products Article 67
Concerning locally manufactured drugs for exportation, the following documents are required for the applications for changes or additions in immediate packaging materials, maximum package size, labels, package inserts, outer boxes, drug names, indications, excipients, testing specifications, methods and appearance:1.Application form for post-approval changes;2.Original copy of drug license for the application of changes in drug name, indications, immediate packaging materials and maximum package size;3.Photocopy of the front and back of drug license for the application of changes or addition of labels, package inserts, outer boxes, excipients, testing specifications, methods, and product appearance ;4.Assurance statement for drug exportation;5.Two copies of the drafts of package inserts, labels, outer boxes and aluminium blister foil for changes of in package inserts, labels, outer boxes and aluminium blister foil;6.For changes of testing specifications and methods, a description of the differences in specifications before and after the changes. The new testing specifications, methods and certificate of analysis should be retained by the manufacturer for future inspection.
中文原文 藥品查驗登記審查準則第67條
申請外銷專用之國產藥品變更或增加外銷專用直接包裝材質、包裝限量、標籤、仿單、外盒、藥品名稱、適應症、賦形劑、檢驗規格、方法、外觀者，應檢附下列資料：
一、藥品變更登記申請書。
二、如申請藥品名稱、適應症、直接包裝材質、包裝限量之變更者，應檢附藥品許可證正本。
三、如申請標仿單外盒、賦形劑、檢驗規格、方法、外觀變更或增加者，應檢附藥品許可證正、反面影本。
四、外銷專用切結書。
五、如係仿單、標籤、外盒、鋁箔之變更者，應檢附仿單、標籤、外盒、鋁箔擬稿各二份。
六、如係檢驗規格、方法、外觀之變更者，應說明新舊二規格之差異。
另變更後之藥品檢驗規格、方法及檢驗成績書，應留廠商備查。
一、藥品變更登記申請書。
二、如申請藥品名稱、適應症、直接包裝材質、包裝限量之變更者，應檢附藥品許可證正本。
三、如申請標仿單外盒、賦形劑、檢驗規格、方法、外觀變更或增加者，應檢附藥品許可證正、反面影本。
四、外銷專用切結書。
五、如係仿單、標籤、外盒、鋁箔之變更者，應檢附仿單、標籤、外盒、鋁箔擬稿各二份。
六、如係檢驗規格、方法、外觀之變更者，應說明新舊二規格之差異。
另變更後之藥品檢驗規格、方法及檢驗成績書，應留廠商備查。