Regulations for Registration of Medicinal Products Article 104
In any of the following situations, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations without any changes in the originally approved text:1. Changing the graphic design or colors; however, the graphic design shall not be offensive, indecent, or misleading;2. Proportionally resizing the originally approved graphic design or text, or repositioning the originally approved graphic design or text;3. Changing the fonts; however, the font size of the English product name shall not be larger than that of the Chinese product name;4. Adding or changing the symbol for the corporate identity system;5. Printing labels on outer boxes instead of sticking labels on them;6. Additionally providing outer boxes that display the same text and graphic design as those on the original labels.In case of any of the following changes in the originally approved text without affecting drug quality or medication safety, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations:1. Adding or changing the barcode, NHI code, ID code, “GMP” wording, names of ingredients of the formula in foreign languages, copyright registration number, trademark registration certificate number, or patent certificate number;2. Adding or changing the suggested retail price or the customer service hotline;3. Changing the name or address of the drug company, or adding or changing the telephone number, fax number, and contacts;4. Adding or changing the distributor’s name and address; the font size of the distributor’s name shall not be larger than that of the drug company’s name;5. Adding or changing seal labels for outer boxes or price labels;6. Adding “For use by XX Hospital or hospitals only; no resale is allowed” or similar wordings on the originally approved packaging;7. Changing the manufacturer’s name that was added to the English product name;8. Changing the measurement unit of formulas in order to comply with the Taiwan Herbal Pharmacopoeia; or9. Changing the terms used in describing the storage methods without altering the original storage methods; the terms shall be consistent with those used in the Taiwan Herbal Pharmacopoeia or Chinese Pharmacopoeia.If any changes in the text involves the addition of directions for use in order to ensure drug quality and medication safety, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations.For domestically manufactured Chinese medicine preparations to be exported, manufacturers may, at their own discretion, change the font of the product name, font of the distributor’s name, or the terms for storage method, or add an “export only” label, package insert, or packaging, without being subject to the restrictions set out in the provisos of Subparagraph 3 of Paragraph 1, and Subparagraphs 4 and 9 of Paragraph 2.The changes or addition of an “export only” label, package insert, or packing set forth in the preceding four paragraphs shall conform to the Good Manufacturing Practices for Pharmaceuticals specified in the Pharmaceutical Good Manufacturing Practice Regulations, and records shall be made and retained by the manufacturers for recording purposes.
中文原文 藥品查驗登記審查準則第104條
國產中藥製劑標籤、仿單或包裝，有下列情形之一，而未變更原核准文字內容者，得自行變更：
一、圖樣或色澤變更。
但不得有涉及猥褻、有傷風化或誤導效能之圖樣。
二、依比例縮小或放大原核准之圖文，或變更原核准圖文之版面位置。
三、字體變更。
但其品名英文字體不得大於中文字體。
四、企業識別系統標誌之加印或變更。
五、標籤黏貼變更為於外包裝直接印刷。
六、增加與原標籤文字、圖樣設計相同之外盒。
國產中藥製劑標籤、仿單或包裝，有下列原核准文字內容變更情形之一，而不涉及藥品品質或用藥安全者，得自行變更：
一、增印或變更條碼、健保代碼、識別代碼、GMP字樣、處方原料之外文名、著作權登記字號、商標註冊證字號或專利證書字號。
二、增印、變更建議售價或消費者服務電話。
三、變更藥商名稱或地址，或增印、變更電話、傳真、連絡處。
四、增印或變更經銷商名稱、地址。
但經銷商名稱之字體不得大於藥商名稱之字體。
五、增加或變更外盒封口標示、價位標示。
六、原核定包裝加註「本藥限由某醫院或限供醫院使用，不得轉售」或其他類似用語。
七、英文品名之廠名變更。
八、處方之單位標示以符合臺灣中藥典之方式變更。
九、未變更原貯藏法，僅變更貯藏法之用詞。
但其用詞應符合臺灣中藥典或中華藥典。
國產中藥製劑標籤、仿單或包裝，有為維護藥品品質及用藥安全，而加註使用方法之文字內容變更者，得自行變更。
國產中藥製劑有外銷需求者，其品名字體、經銷商名稱字體或貯藏法用詞，得自行變更，或增加外銷專用標籤、仿單或包裝，不受第一項第三款但書、第二項第四款但書及同項第九款但書規定之限制。
前四項變更或增加外銷專用標籤、仿單或包裝，應符合藥物優良製造準則所定之藥品優良製造規範，並作成紀錄留廠備查。
一、圖樣或色澤變更。
但不得有涉及猥褻、有傷風化或誤導效能之圖樣。
二、依比例縮小或放大原核准之圖文，或變更原核准圖文之版面位置。
三、字體變更。
但其品名英文字體不得大於中文字體。
四、企業識別系統標誌之加印或變更。
五、標籤黏貼變更為於外包裝直接印刷。
六、增加與原標籤文字、圖樣設計相同之外盒。
國產中藥製劑標籤、仿單或包裝，有下列原核准文字內容變更情形之一，而不涉及藥品品質或用藥安全者，得自行變更：
一、增印或變更條碼、健保代碼、識別代碼、GMP字樣、處方原料之外文名、著作權登記字號、商標註冊證字號或專利證書字號。
二、增印、變更建議售價或消費者服務電話。
三、變更藥商名稱或地址，或增印、變更電話、傳真、連絡處。
四、增印或變更經銷商名稱、地址。
但經銷商名稱之字體不得大於藥商名稱之字體。
五、增加或變更外盒封口標示、價位標示。
六、原核定包裝加註「本藥限由某醫院或限供醫院使用，不得轉售」或其他類似用語。
七、英文品名之廠名變更。
八、處方之單位標示以符合臺灣中藥典之方式變更。
九、未變更原貯藏法，僅變更貯藏法之用詞。
但其用詞應符合臺灣中藥典或中華藥典。
國產中藥製劑標籤、仿單或包裝，有為維護藥品品質及用藥安全，而加註使用方法之文字內容變更者，得自行變更。
國產中藥製劑有外銷需求者，其品名字體、經銷商名稱字體或貯藏法用詞，得自行變更，或增加外銷專用標籤、仿單或包裝，不受第一項第三款但書、第二項第四款但書及同項第九款但書規定之限制。
前四項變更或增加外銷專用標籤、仿單或包裝，應符合藥物優良製造準則所定之藥品優良製造規範，並作成紀錄留廠備查。