Regulations for Medicament Contract Manufacture and Analysis Article 14
The contract party shall firstly find a party, willing to undertake the contract analysis, then fill in an application form and attach the contract analysis agreement ,related documentation and apply to the central competent health authority for the approval.The central competent health authority may carry out an on-site analysis of the contract inspector as it deems necessary in accordance with the actual conditions.
中文原文 藥物委託製造及檢驗作業準則第14條
委託者應先覓妥受託檢驗者，並填具申請書及檢附雙方簽立之委託檢驗契約等相關文件，向中央衛生主管機關申請核准。
中央衛生主管機關得視實際需要，對受託者進行現場查核。
中央衛生主管機關得視實際需要，對受託者進行現場查核。