Regulations for Registration of Medicinal Products｜第 76 條｜Food and Drug Administration｜Regulation｜In Force
第 三 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
The name of a Chinese medicine product shall comply with the following regulations: 1. Single ingredient preparations: Products are named by adding the manufacturer’s name, brand name or trademark, and dosage form to the name of the Chinese medicine. If a merchandise name is used, then the name of the Chinese medicine shall be added to the end of the product name in brackets. 2. Compound preparations: Products are named by adding the manufacturer’s name, brand name or trademark, and dosage form to the compound name indicated in a pharmacopoeia. If a merchandise name is used, then the compound name indicated in a pharmacopoeia shall be added to the end of the product name in brackets. If the name of a Chinese medicine product, as set forth in the preceding paragraph, is used for export only, the foregoing limitations shall not apply.
中藥之品名，應依下列規定定之： 一、單方製劑：以中藥材名，加冠廠名、品牌或註冊商標及劑型名稱；其以商品名加冠者，並於品名末處以括號加註中藥材名。 二、複方製劑：以原典成方名，加冠廠名、品牌或註冊商標及劑型名稱；其以商品名加冠者，並於品名末處以括號加註原典成方名。 前項中藥之品名，專供外銷者，不受前項之限制。