Regulations for Registration of Medicinal Products｜第 5 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
The term “authorization letter” mentioned in this Chapter refers to the documents issued by the foreign manufacturer, headquarters or the license holder of an imported drug to authorize the application of drug registration. The above-mentioned authorization letter is effective for one year from the issuance date. The authorization letter should include the names and addresses of the manufacturer and the agent, as well as drug name, dosage form and contents. The information should be consistent with those stated in the application form. If the authorization letter is in neither Chinese nor English, a Chinese or English translation should be provided additionally. If the original license holder has a branch office in Taiwan, the authorization letter can be issued by either the manufacturer’s headquarters or the head office in Asia.