Prevention of Rare Diseases and Orphan Drug Act Article 14
Unless otherwise regulated in this Act, orphan drugs shall not be manufactured or imported without the registration and market approval, and drug permits issued, by the central competent authority.
中文原文 罕見疾病防治及藥物法第14條
除本法另有規定外，罕見疾病藥物非經中央主管機關查驗登記，並發給藥物許可證，不得製造或輸入。