Pharmaceutical Affairs Act Article 9
The term “general sale medicines” as used in this Act shall refer to drugs that are processed and manufactured from active pharmaceutical ingredients without retaining their original names, with the drugs contained therein being limited to a level not in excess of the limitations of use thereof as specified by the central competent health authority, and characterized by mild action, non-accumulativeness, long storage life, and easy administration, and duly indicated with their efficacy, dosage, and use, and the serial number of permit for general sale medicines indicated, and which can be used for the treatment of illnesses without requiring the instructions of physicians.
中文原文 藥事法第9條
本法所稱成藥，係指原料藥經加工調製，不用其原名稱，其摻入之藥品，不超過中央衛生主管機關所規定之限量，作用緩和，無積蓄性，耐久儲存，使用簡便，並明示其效能、用量、用法，標明成藥許可證字號，其使用不待醫師指示，即供治療疾病之用者。