Pharmaceutical Affairs Act｜第 74 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
Serums, antitoxins, vaccines, toxoids, and bacterial suspensions produced in accordance with microbiological and immunological principles may not be sold unless the central competent health authority has sampled from each batch after production or importation, conducted tests to verify their compliance, and affixed a seal indicating that the inspection has been completed. The inspection and lot release procedures shall be established by the central competent health authority. The importation of the drug substances for biological drugs referred to in the preceding paragraph shall be restricted to the biological drug manufacturers.