Enforcement Rules for the Controlled Drugs Act Article 2
Institutions or business with registration licenses, whose medical or educational researchers are making application to dispense controlled drugs in accordance with Article 6 Paragraph 2 of this Act shall prepare said application, with a copy of documents proving identity of the researchers and relevant project materials, and submit same to the Food and Drug Administration, Ministry of Health and Welfare (hereinafter "FDA"). Applicants shall not commence the project until permission is granted by the Central Health authority.
中文原文 管制藥品管理條例施行細則第2條
領有管制藥品登記證之機構或業者，其醫藥教育研究試驗人員依本條例第六條第二項規定申請使用管制藥品，應由該機構或業者備具申請書，檢附醫藥教育研究試驗人員身分證明文件影本及其相關研究試驗計畫資料，向衛生福利部食品藥物管理署（以下簡稱食品藥物署）申請，經中央衛生主管機關核准後，始得為之。