Regulations for Registration of Medicinal Products Article 50
The following documents are required for the application of changes in the Chinese or English product name.1.Application form of post-approval changes;2.The original copy of drug license;3.An assurance statement (A) should be submitted to certify the changes in the Chinese or English product names of a locally manufactured drug, or the change in the Chinese product name of an imported drug. If available, a photocopy of the trademark registration certificate or approval letter issued by the Bureau of Intellectual Property of the Ministry of Economic Affairs (MOEA) should be submitted; and4.The application of the change in the English product name of an imported drug should be accompanied with a notification letter of post-approval changes issued by the original manufacturer and the CPP from the manufacturing country.
中文原文 藥品查驗登記審查準則第50條
申請藥品中、英文品名變更登記，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、如係國產藥品之中、英文品名或輸入藥品之中文品名變更，應另附切結書（甲）；如持有經濟部智慧財產局商標註冊證或核准審定書者，得附其影本。
四、如係輸入藥品之英文品名變更，應另附原廠變更通知函與出產國許可製售證明。
一、藥品變更登記申請書。
二、藥品許可證正本。
三、如係國產藥品之中、英文品名或輸入藥品之中文品名變更，應另附切結書（甲）；如持有經濟部智慧財產局商標註冊證或核准審定書者，得附其影本。
四、如係輸入藥品之英文品名變更，應另附原廠變更通知函與出產國許可製售證明。