Enforcement Rules of Veterinary Drugs Control Act Article 3

The terms “ without government approval ” in Section 4.1 and “ without a permit ” in Section 5.1.2 of the Act refer to the situation that a veterinary drug is not approved in accordance with Section 12.1 of the Act.
中文原文 動物用藥品管理法施行細則第3條
本法第四條第一款及第五條第一項第二款所稱未經核准,指未依本法第十二條第一項規定取得動物用藥品許可證者。

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