Regulations Governing the Determination of Patent Term Extension Article 5
When requesting patent term extension for pharmaceuticals or their manufacturing procedures, the following documents shall be provided:1. document(s) of proof and a list regarding the time period of domestic and/or foreign clinical trials and the commencement and expiration thereof;2. document(s) of proof regarding the examination period for domestic regulatory approval and the commencement and expiration thereof; and3. a photocopy of the pharmaceutical approval.
中文原文 專利權期間延長核定辦法第5條
申請延長醫藥品或其製造方法專利權期間者，應備具下列文件：
一、國內外臨床試驗期間與起、訖日期之證明文件及清單。
二、國內申請藥品查驗登記審查期間及其起、訖日期之證明文件。
三、藥品許可證影本。
一、國內外臨床試驗期間與起、訖日期之證明文件及清單。
二、國內申請藥品查驗登記審查期間及其起、訖日期之證明文件。
三、藥品許可證影本。