Regulations for Registration of Medicinal Products Article 59
The following documents are required for changes in the filling quantity of injections (under conditions of no changes in unit strength and container materials):1.Application form for post-approval changes;2.Original copy of drug license;3.For locally manufactured drugs, a photocopy of the reference of drug administration and dosage; for imported drugs, a notification letter of post-approval changes issued by the original manufacturer;4.The stability study data in situation where the filling quantity is reduced.
中文原文 藥品查驗登記審查準則第59條
申請注射液充填量之變更，以單位含量不變及容器材質不變為限，其變更登記應檢附資料如下：
一、藥品變更登記申請書。
二、藥品許可證正本。
三、如係國產藥品，應另附用法用量依據影本；如係輸入藥品，應另附原廠變更通知函。
四、如係充填量變小者，應另附安定性試驗資料。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、如係國產藥品，應另附用法用量依據影本；如係輸入藥品，應另附原廠變更通知函。
四、如係充填量變小者，應另附安定性試驗資料。