Regulations for Registration of Medicinal Products Article 103
The following documents and data are required for post-approval changes in the product or license category for a Chinese medicine product:1. Application form for post-approval changes;2. Original copy of the drug license;3. Application form for drug review and registration;4. 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;5. Photocopy of the references that support the change.
中文原文 藥品查驗登記審查準則第103條
申請中藥類別、證別變更登記，應檢附下列文件、資料：
一、藥品變更登記申請書。
二、藥品許可證正本。
三、查驗登記申請書正本。
四、原外盒、仿單及標籤核定本及擬變更之外盒、仿單及標籤黏貼表各二份。
五、變更依據影本。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、查驗登記申請書正本。
四、原外盒、仿單及標籤核定本及擬變更之外盒、仿單及標籤黏貼表各二份。
五、變更依據影本。