Regulations for Registration of Medicinal Products Article 109-1
The following documents and data are required for the applications set forth in Paragraph 1 of the preceding article:1. Application form for a drug license extension, otherwise which shall be applied by the drug license holder on the circumstances of contract manufacturing;2. Original copy of the drug license;3. If the “expiration date” field on the drug license is filled with extension stamps, the original copy of the application form for drug registration is also required;4. If the drug concerned is among those announced by the central health competent authority after it has conducted an evaluation in accordance with Article 48 of the Act, the documents required in the announcement shall be submitted for applications for extension;5. If the manufacturing of the drug concerned is outsourced to a domestic manufacturer, a manufacturing outsourcing agreement shall also be submitted;6. In the case of imported Chinese medicine, the original FSC from the country of origin, the authorization letter issued by the original manufacturer, and a photocopy of documents proving that the foreign manufacturer of imported medicines complies with the Good Manufacturing Practice for Medicinal Products are also required; if the applicant is not the holder of the documents proving the compliance with the Good Manufacturing Practice for Medicinal Products, the applicant may submit the authorization letter issued by the original manufacturer or the authorization letter issued by the domestic manufacturer that holds such documents and indicate the approval number instead.For Chinese medicine listed in the Taiwan Herbal Pharmacopeia, the testing specifications and methods for finished products as well as a photocopy of the approval letter for the latest change of the Taiwan Herbal Pharmacopeia, shall be otherwise submitted. However, if the testing specifications meet or are better than the latest edition of the Taiwan Herbal Pharmacopeia, the testing specifications and methods for finished products may be adopted instead.If any application for a license extension submitted involves concerns about the safety, efficacy, or indications of a product, the central health competent authority may request the applicant to submit relevant documents and data.
中文原文 藥品查驗登記審查準則第109-1條
前條第一項申請，應檢附下列文件、資料：
一、藥品許可證有效期間展延申請書；其藥品係委託製造者，由藥品許可證所有人提出申請。
二、藥品許可證正本。
三、藥品許可證有效期間欄位已蓋滿展延章戳者，另附藥品查驗登記申請書正本。
四、申請展延之藥品，屬中央衛生主管機關依本法第四十八條評估公告之藥品者，依公告規定檢附有關資料。
五、國產藥品委託製造者，並檢委託製造契約書。
六、屬輸入之中藥，並檢附出產國許可製售證明正本、原廠委託書及輸入藥品之國外製造廠符合藥品優良製造規範之證明文件影本。
符合藥品優良製造規範之證明文件持有者非申請人時，得以原廠授權函或持有證明文件之國內藥商授權函，並載明其核准文號替代之。
收載於臺灣中藥典之中藥製劑，應另檢附成品檢驗規格、方法，依臺灣中藥典最新版本變更之核准函影本。
但檢驗規格符合或優於臺灣中藥典最新版本者，得以成品檢驗規格及方法替代之。
辦理許可證展延申請，涉及產品安全或效能、適應症疑慮者，中央衛生主管機關得命提出相關證明文件、資料。
一、藥品許可證有效期間展延申請書；其藥品係委託製造者，由藥品許可證所有人提出申請。
二、藥品許可證正本。
三、藥品許可證有效期間欄位已蓋滿展延章戳者，另附藥品查驗登記申請書正本。
四、申請展延之藥品，屬中央衛生主管機關依本法第四十八條評估公告之藥品者，依公告規定檢附有關資料。
五、國產藥品委託製造者，並檢委託製造契約書。
六、屬輸入之中藥，並檢附出產國許可製售證明正本、原廠委託書及輸入藥品之國外製造廠符合藥品優良製造規範之證明文件影本。
符合藥品優良製造規範之證明文件持有者非申請人時，得以原廠授權函或持有證明文件之國內藥商授權函，並載明其核准文號替代之。
收載於臺灣中藥典之中藥製劑，應另檢附成品檢驗規格、方法，依臺灣中藥典最新版本變更之核准函影本。
但檢驗規格符合或優於臺灣中藥典最新版本者，得以成品檢驗規格及方法替代之。
辦理許可證展延申請，涉及產品安全或效能、適應症疑慮者，中央衛生主管機關得命提出相關證明文件、資料。