Regulations for Registration of Medicinal Products｜第 81 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 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.