Regulations for Registration of Medicinal Products Article 58
The following documents are required for changes of immediate packaging materials:1.Application form for post-approval changes;2.Original copy of drug license;3.The Stability study report4.For injections or liquid dosage forms, the testing specifications, methods and certificate of analysis of finished products. For injections packed in syringes or soft bags, the testing specifications, methods and certificate of analysis and leachables and/or extractables assessments of containers;5.For locally manufactured injections, a photocopy of formulation basis. If the formulation basis is not available, the applicant should provide the safety data of packaging and go through the testing procedure as requested by the central health competent authority.6.For imported drugs, a notification letter of post-approval changes issued by the original manufacturer;7.If soft bags are added as a new packaging material of injections, Standard Manufacturing and Control Procedures and the amount of all starting materials in the batch record or the batch record of the same lot as the finished product should be submitted.
中文原文 藥品查驗登記審查準則第58條
申請藥品直接包裝材質變更登記，應檢附下列資料：
一、藥品變更登記申請書。
二、藥品許可證正本。
三、安定性試驗報告。
四、如係注射劑或液體劑型，應另附成品檢驗規格、方法及檢驗成績書；並應附該容器之檢驗規格、方法、檢驗成績書及可滲出物、可萃出物評估資料。
五、如係國產注射劑，應另附處方依據影本。
如未能提出處方依據者，應檢附包裝材質安全性資料，並依中央衛生主管機關通知辦理送驗手續。
六、如係輸入藥品，應另附原廠變更通知函。
七、如係注射劑增加軟袋包裝，應另附製造管制標準書及批次製造紀錄中之下料量或與成品同批次之批次製造紀錄。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、安定性試驗報告。
四、如係注射劑或液體劑型，應另附成品檢驗規格、方法及檢驗成績書；並應附該容器之檢驗規格、方法、檢驗成績書及可滲出物、可萃出物評估資料。
五、如係國產注射劑，應另附處方依據影本。
如未能提出處方依據者，應檢附包裝材質安全性資料，並依中央衛生主管機關通知辦理送驗手續。
六、如係輸入藥品，應另附原廠變更通知函。
七、如係注射劑增加軟袋包裝，應另附製造管制標準書及批次製造紀錄中之下料量或與成品同批次之批次製造紀錄。