Regulations for Registration of Medicinal Products Article 105
Except for the situations mentioned in the preceding two articles, applications for registration of changes in the packaging of Chinese medicine preparations shall comply with the following regulations:1. The following documents and information are required for applications for changes in the maximum packaging size, provided that there are no changes in the packaging materials:(1) Application form for post-approval changes;(2) Original copy of the drug license.2. The following documents and information are required for changes in the packaging materials:(1) Application form for post-approval changes;(2) Original copy of the drug license;(3) Documentation procedures and reports of stability tests;(4) Photocopy of batch records.If the changes in the packaging materials mentioned in the preceding paragraph involve changes in labels, package inserts, or packaging, two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead shall also be submitted.In case of imported Chinese medicine preparations, on top of the provisions in the two preceding paragraphs, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required.
中文原文 藥品查驗登記審查準則第105條
前二條規定以外國產中藥製劑包裝之變更，應依下列規定申請變更登記：
一、包裝材質不變更，僅申請變更包裝限量者，檢附下列文件、資料：
（一）藥品變更登記申請書。
（二）藥品許可證正本。
二、包裝材質變更者，檢附下列文件、資料：
（一）藥品變更登記申請書。
（二）藥品許可證正本。
（三）安定性試驗書面作業程序及其報告。
（四）批次製造紀錄影本。
前項包裝材質之變更，涉及標籤、仿單或包裝變更者，並應加具原外盒、仿單及標籤核定本與擬變更之外盒、仿單及標籤黏貼表各二份。
輸入之中藥製劑，除前二項規定外，應另檢附原廠變更通知函及出產國許可製售證明正本。
一、包裝材質不變更，僅申請變更包裝限量者，檢附下列文件、資料：
（一）藥品變更登記申請書。
（二）藥品許可證正本。
二、包裝材質變更者，檢附下列文件、資料：
（一）藥品變更登記申請書。
（二）藥品許可證正本。
（三）安定性試驗書面作業程序及其報告。
（四）批次製造紀錄影本。
前項包裝材質之變更，涉及標籤、仿單或包裝變更者，並應加具原外盒、仿單及標籤核定本與擬變更之外盒、仿單及標籤黏貼表各二份。
輸入之中藥製劑，除前二項規定外，應另檢附原廠變更通知函及出產國許可製售證明正本。