Pharmaceutical Affairs Act Article 8
The term “pharmaceutical preparations,” as used in this Act, shall refer to drugs that are processed and compounded from active pharmaceutical ingredients into a specific pharmaceutical form and dosage.Pharmaceutical preparations are classified into medicines to be prescribed by physicians; medicines designated by physicians, pharmacists, and/or assistant pharmacists; general sale medicines; and pharmaceutical preparations of inherited formulations.Regulations governing the clarification and review of general sale medicines and the manufacturing and sale of inherited formulation set forth in the preceding paragraph, and regulations governing the management of the sale of general sale medicines and inherited formulations and other matters requiring compliance shall be formulated by the central competent health authority.
中文原文 藥事法第8條
本法所稱製劑，係指以原料藥經加工調製，製成一定劑型及劑量之藥品。
製劑分為醫師處方藥品、醫師藥師藥劑生指示藥品、成藥及固有成方製劑。
前項成藥之分類、審核、固有成方製劑製售之申請、成藥及固有成方製劑販賣之管理及其他應遵行事項之辦法，由中央衛生主管機關定之。
製劑分為醫師處方藥品、醫師藥師藥劑生指示藥品、成藥及固有成方製劑。
前項成藥之分類、審核、固有成方製劑製售之申請、成藥及固有成方製劑販賣之管理及其他應遵行事項之辦法，由中央衛生主管機關定之。