Regulations on Management of Medicament Samples and Gifts Article 7
For applications for samples of drugs or medical devices for the improvement of manufacturing technology made in accordance with the stipulations of Article 2, Subparagraph 1, the following materials shall be submitted:I. A photocopy of the certificate issued by the academic research agency implementing the improvement of manufacturing technology, or a photocopy of the pharmaceutical license of the drug manufacturer or medical device manufacturer.II. An affidavit stating that the approved drug sample or medical device sample will absolutely not be resold or used for other purpose and clinical purpose.III. Information related to technical improvement.
中文原文 藥物樣品贈品管理辦法第7條
依第二條第一款規定申請供改進製造技術用之藥品或醫療器材樣品，應檢附下列資料：
一、執行改進製造技術之學術研究單位證明或藥品製造業、醫療器材製造業藥商許可執照影本。
二、載明經核准之藥品或醫療器材樣品絕不轉售、轉供他用及供臨床使用之切結書。
三、改進技術相關資料。
一、執行改進製造技術之學術研究單位證明或藥品製造業、醫療器材製造業藥商許可執照影本。
二、載明經核准之藥品或醫療器材樣品絕不轉售、轉供他用及供臨床使用之切結書。
三、改進技術相關資料。