Regulations for Registration of Medicinal Products Article 47
Applications of post-approval changes of imported drugs should provide a notice of changes issued by the original manufacturer. The notice should be issued by the registered original manufacturer or its headquarters, or authorized license holders in other countries; and the notice should be within its one-year validity. The manufacturer’s name and address stated on the notice should be identical to those on the approval. The notice should not be issued by affiliates, agencies or distributors or in the form of telegram, price quotation statement, or electronic media.
中文原文 藥品查驗登記審查準則第47條
申請輸入藥品變更登記須檢附之原廠變更通知函，應由原登記製造廠或其總公司、或國外許可證持有者出具證明函正本，並限出具日起一年內有效，且其所載之廠名、廠址均應與原核定相符，不得以關係企業、代理商、經銷商出具，或持電報、報價單或電傳資料替代。