Regulations for Medicament Contract Manufacture and Analysis Article 11
Extension of the effective term of the license for a drug (medicinal) product that has been approved for contract manufacturing shall be carried out by the holder of the license in accordance with the provisions of the Act, related laws and regulations.
中文原文 藥物委託製造及檢驗作業準則第11條
經核准委託製造之藥物，其許可證有效期間之展延，應由許可證持有者依本法及有關法令規定辦理。