Pharmaceutical Affairs Act｜第 75 條｜Food and Drug Administration｜Act｜In Force
第 八 章｜衛生福利部 / 食品藥物管理署｜v107.01.31
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
The labels, use instructions, and packaging of medicaments shall indicate the following particulars as approved: 1. Name and address of the manufacturer; 2. Name of the medicament and license number; 3. Lot number; 4. Date of manufacture and period of validity or expiration date; 5. Active ingredients contents, dosage, and method of administration; 6. Main medical efficacy, functions, or indications; 7. Adverse reactions, contraindications, and other warnings and precautions; 8. Other particulars as required by relevant regulations. The particulars in Subparagraph 4 of the preceding paragraph may be omitted if such omission has been publicly announced by the central competent health authority. For the medicaments announced by the central competent health authority, the labels, use instructions, and packaging shall provide supplementary measures such as Braille characters or other sufficient information for reading along with the regulations prescribed in Paragraph 1. The indicated items, methods, and other requirements shall be established by the central competent health authority.