Regulations Governing Delegation or Commission of Medicaments Spot-check and Test Article 3

The commissioned authorized agency (institution) for enforcement of medicaments spot-check (referred to as “ commissioned spot-check agency ” hereunder) shall be government authority (institution) or approved juridical persons established in accordance with the laws, and qualified with the following conditions:1. Possessed with related facilities, equipments and place for specimen storage.2. Established operation procedure and quality assurance plan to the commissioned business.3. Personnel who have medicaments related background with spot-check working experience and personnel who have studied courses of Criminal Code, Civil Code, Code of Criminal Procedure, Code of Civil Procedure and Administrative Law and completed with at least 15 credits in domestic university. All of the courses shall be received more than 0 points of the score and credit certificate shall be offered.
中文原文 藥物抽查及檢驗委任或委託作業辦法第3條
受委託辦理藥物抽查之機關(構)(以下稱受託抽查者),應為政府機關(構)或依法設立登記之法人,並具備下列條件:
一、具相關設備及檢體儲存場所。
二、對受託之抽查業務訂有作業程序及品質保證計畫。
三、聘有藥物相關領域抽查經驗之抽查人員及修習國內大學所開設刑法、民法、刑事訴訟法、民事訴訟法及行政法總計十五個學分以上且其中不得有一門科目學分數為零,並領有學分證明之人員。

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