Regulations for Medicament Contract Manufacture and Analysis Article 5
An application shall be submitted to and approved by the central competent health authority prior to any contracted manufacturing or analysis of medicinal products.Only a pharmaceutical firm that currently holds a drug license or has applied for registration and market approval for a given medicinal product may make an application for contract manufacturing and analysis of medicinal products.
中文原文 藥物委託製造及檢驗作業準則第5條
委託製造或檢驗藥物，應事先申請中央衛生主管機關核准。
申請藥物委託製造及檢驗，限持有藥物許可證或申請藥物查驗登記之藥商。
申請藥物委託製造及檢驗，限持有藥物許可證或申請藥物查驗登記之藥商。