Regulations for Registration of Medicinal Products Article 81
The information contained on labels, package inserts, or packaging for Chinese medicine is subject to Article 75 of the Act. The contents and presentation shall comply with the following regulations, and the fonts shall be easy to read:1. Package inserts shall contain information on drug category, packaging, storage conditions and other necessary information.2. The information contained on package inserts is limited to the extent of the efficacy or indications. For compound preparations, the information is limited to the extent of the main pharmacological effects of their mixed active ingredients. Exaggerated terms and wordings are not allowed.3. A detailed description of contraindications, warnings, side effects, and precautions shall be provided on the package inserts, and shall be printed in red or in bold with a different font or, when necessary, with a red frame.4. For any Chinese medicine preparation that uses a merchandise name, the original formula name derived from a pharmacopeia shall be listed after the product name in the package inserts, or on the labels or outer boxes if no package inserts are provided.5. Unless otherwise provided, the Chinese fonts printed on package inserts shall not be smaller than DFKai-SB font size seven.6. Labels, package inserts, and packaging materials shall not include indecent or offensive images or wording or exaggerated descriptions of the efficacy and indications.7. If a distributor’s name is printed on the labels, package inserts, or packaging materials, the distributor shall have obtained a business license, and the font size of the distributor’s name shall not be larger than that of the name of the manufacturer (license holder).8. The font size of the Chinese product name shall not be smaller than that of any foreign letters. The font size of the Chinese product name shall not be lower than that of any foreign letters.9. For the font size of the product name, no character is allowed to be less than half of the size of any other characters. However, the font size of the manufacturer’s name, merchandise name, and dosage form will not be compared with each other.10. For OTC drugs, “OTC Drug” or “Class B OTC Drug” shall be printed in a significantly larger font on labels and packaging materials according to their categories. In the case of preparations for external use, “For External Use” shall be printed in red or in bold with a different font or, when necessary, with a red frame.11. The labeling of the smallest unit for single use, which is given or sold in its original package with the outer box remaining intact, should be at least labeled indicating Chinese product name, manufacturer’s name, and license number on the circumstances of the immediate package does not have enough space to include all required information.12. For drugs packed in aluminum blister foils, the Chinese product name, manufacturer’s name, and license number shall be printed on each sheet of foil. The same rule also applies to aluminum foil packets for refills used by medical institutions.13. Labels, packaging, or aluminum foil packets for refills used by medical institutions shall contain information in any of the following formats:(1) Batch number, manufacturing date, and effective period;(2) Batch number and expiry date; or(3) Batch number, manufacturing date and expiry date.14. The manufacturing date or expiry date, as required in the preceding paragraph, shall be printed in year-month-day format. The manufacturing date, effective period, and expiry date shall be printed in a manner understandable to consumers.15. In the case of imported drugs, such information as the importer’s name, address, license number, Chinese product name, and category may be provided on a sticker.16. The process of labeling or attaching stickers is subject to the GMP regulations. For imported drugs, labels or stickers shall be properly attached by the original manufacturers. Alternatively, a GMP certified manufacturer or a GMP certified medical product distribution center in Taiwan might be commissioned in accordance with the Regulations for Medicament Contract Manufacture and Analysis to carry out the packaging and labeling or sticker attaching processes after drugs are imported into Taiwan. However, labels indicating the foreign manufacturer’s name and address shall be properly attached by the original manufacturer.The package inserts, labels, stickers, outer boxes, aluminum blister foils, and other printed materials or drafts indicating the materials used, which conform to the regulations set forth in all subparagraphs of the preceding paragraph, shall be properly attached to the forms for sticking outer boxes, package inserts, and labels, as specified in Paragraph 2 of Article 3. However, the package insert is not required for any Chinese medicated patches with contents to be set forth in the preceding paragraph package insert fully indicated on the label or package.
中文原文 藥品查驗登記審查準則第81條
中藥之標籤、仿單或包裝之刊載事項，應符合本法第七十五條規定；刊載之方式及內容，其字體應易於辨識，並符合下列規定：
一、仿單載明藥品類別、包裝、儲藏及其他應刊載之必要事項。
二、仿單記載事項，不得超出其效能或適應症。
複方製劑，以各有效成分混合使用之主要藥理作用為範圍，不得有誇大字樣。
三、仿單詳實刊載禁忌、警語、副作用及注意事項，使用紅字或粗黑異體字，必要時，並得加印紅框。
四、使用商品名為品名之中藥製劑，於仿單之品名後加註原典成方名。
無仿單者，標示於標籤或外盒。
五、中文仿單之字體大小規格，除另有規定外，不得小於標楷體七號字。
六、標籤、仿單或包裝，不得刊印涉及猥褻、有傷風化或誇大效能、適應症之圖案或文字。
七、標籤、仿單或包裝，刊載經銷商名稱時，經銷商應取得藥商許可執照，且其上刊載經銷商名稱之字體不得大於許可證持有藥商名稱之字體。
八、中文品名之字體，不得小於外文字體，且單一中文品名字體高度不得小於單一外文字母。
九、藥品名稱字體大小，每個字不得小於另一個字一倍以上；廠名、商品名及劑型名之間，不互比對。
十、成藥之標籤及包裝，依其類別，加印明顯大號「成藥」或「乙類成藥」，其字體為正楷；其屬外用製劑者，加印「外用」，使用紅字或粗黑異體字，必要時，並得加印紅框。
十一、藥品最小單位包裝（直接包材之包裝）受限於面積，且以原包裝給藥或販售之藥品，於給藥或販售時不單獨將外盒拆封者，至少應標示中文品名、廠名及許可證字號。
十二、鋁箔片盒裝之每一片鋁箔紙，均應刊載中文品名、廠名及許可證字號；供醫療機構使用之鋁箔袋裝補充包，亦同。
十三、標籤、包裝，或供醫療機構使用之鋁箔袋裝補充包，依下列方式之一刊載：
（一）批號、製造日期及有效期間。
（二）批號及保存期限。
（三）批號、製造日期及保存期限。
十四、依前款規定刊載製造日期或保存期限時，以年、月、日標明；製造日期、有效期間及保存期限，以消費者易於辨識之方式為之。
十五、輸入藥品之藥商名稱、地址、許可證字號、中文品名及類別，得以小籤條標示。
十六、貼標籤或小籤條，依藥品優良製造規範之作業程序為之；輸入藥品於原廠貼妥，或依藥物委託製造及檢驗作業準則之規定，於輸入國內後委託國內符合藥品優良製造規範之藥廠或醫藥物流中心為藥品包裝及貼標籤或小籤條作業。
但國外製造廠之名稱及地址，應於原廠貼妥。
第三條第二項所定外盒、仿單及標籤黏貼表，應貼妥符合前項各款規定之仿單、標籤或小籤條、外盒、鋁箔紙及其他標示材料之已印妥實體或擬稿。
但已於標籤或包裝完整標示前項仿單應刊載事項之中藥藥膠布劑，得免附仿單。
一、仿單載明藥品類別、包裝、儲藏及其他應刊載之必要事項。
二、仿單記載事項，不得超出其效能或適應症。
複方製劑，以各有效成分混合使用之主要藥理作用為範圍，不得有誇大字樣。
三、仿單詳實刊載禁忌、警語、副作用及注意事項，使用紅字或粗黑異體字，必要時，並得加印紅框。
四、使用商品名為品名之中藥製劑，於仿單之品名後加註原典成方名。
無仿單者，標示於標籤或外盒。
五、中文仿單之字體大小規格，除另有規定外，不得小於標楷體七號字。
六、標籤、仿單或包裝，不得刊印涉及猥褻、有傷風化或誇大效能、適應症之圖案或文字。
七、標籤、仿單或包裝，刊載經銷商名稱時，經銷商應取得藥商許可執照，且其上刊載經銷商名稱之字體不得大於許可證持有藥商名稱之字體。
八、中文品名之字體，不得小於外文字體，且單一中文品名字體高度不得小於單一外文字母。
九、藥品名稱字體大小，每個字不得小於另一個字一倍以上；廠名、商品名及劑型名之間，不互比對。
十、成藥之標籤及包裝，依其類別，加印明顯大號「成藥」或「乙類成藥」，其字體為正楷；其屬外用製劑者，加印「外用」，使用紅字或粗黑異體字，必要時，並得加印紅框。
十一、藥品最小單位包裝（直接包材之包裝）受限於面積，且以原包裝給藥或販售之藥品，於給藥或販售時不單獨將外盒拆封者，至少應標示中文品名、廠名及許可證字號。
十二、鋁箔片盒裝之每一片鋁箔紙，均應刊載中文品名、廠名及許可證字號；供醫療機構使用之鋁箔袋裝補充包，亦同。
十三、標籤、包裝，或供醫療機構使用之鋁箔袋裝補充包，依下列方式之一刊載：
（一）批號、製造日期及有效期間。
（二）批號及保存期限。
（三）批號、製造日期及保存期限。
十四、依前款規定刊載製造日期或保存期限時，以年、月、日標明；製造日期、有效期間及保存期限，以消費者易於辨識之方式為之。
十五、輸入藥品之藥商名稱、地址、許可證字號、中文品名及類別，得以小籤條標示。
十六、貼標籤或小籤條，依藥品優良製造規範之作業程序為之；輸入藥品於原廠貼妥，或依藥物委託製造及檢驗作業準則之規定，於輸入國內後委託國內符合藥品優良製造規範之藥廠或醫藥物流中心為藥品包裝及貼標籤或小籤條作業。
但國外製造廠之名稱及地址，應於原廠貼妥。
第三條第二項所定外盒、仿單及標籤黏貼表，應貼妥符合前項各款規定之仿單、標籤或小籤條、外盒、鋁箔紙及其他標示材料之已印妥實體或擬稿。
但已於標籤或包裝完整標示前項仿單應刊載事項之中藥藥膠布劑，得免附仿單。