Regulations for Registration of Medicinal Products Article 102
The following documents and data are required for post-approval changes in the indications, efficacy, administration, and dosage of a Chinese medicine product:1. Application form for post-approval changes;2. Original copy of the drug license; however, a photocopy is acceptable for applications for changes in administration and dosage;3. 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;4. Photocopy of the references that support the change.
中文原文 藥品查驗登記審查準則第102條
申請中藥適應症、效能、用法用量變更登記，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。
但申請變更用法用量者，檢附影本。
三、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。
四、變更依據影本。
一、藥品變更登記申請書。
二、藥品許可證正本。
但申請變更用法用量者，檢附影本。
三、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。
四、變更依據影本。