Regulations on Management of Medicament Samples and Gifts Article 8

For applications for medicament samples for non-clinical study or in vitro study use made in accordance with the stipulations of Article 2, Subparagraph 2, the following materials shall be submitted:I. Study protocol.II. Materials related to the medicament.
中文原文 藥物樣品贈品管理辦法第8條
依第二條第二款規定申請供非臨床研究或體外試驗研究用之藥物樣品,應檢附下列資料:
一、研究試驗計畫書。
二、藥物相關資料。

English translation for reference only; the Chinese text prevails. Not legal advice.