Regulations for Medicament Contract Manufacture and Analysis Article 9
The contract party shall firstly find a contract manufacturer, then fill in an application and attach the contract for manufacturing signed by the two parties and related documents, and apply to the central competent health authority for approval.
中文原文 藥物委託製造及檢驗作業準則第9條
委託製造者應先覓妥受託廠,並填具申請書及檢附雙方簽立之委託製造契約等相關文件,向中央衛生主管機關申請核准。