Pharmaceutical Affairs Act Article 74
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.
中文原文 藥事法第74條
依據微生物學、免疫學學理製造之血清、抗毒素、疫苗、類毒素及菌液等，非經中央衛生主管機關於每批產品輸入或製造後，派員抽取樣品，經檢驗合格，並加貼查訖封緘，不得銷售。
檢驗封緘作業辦法，由中央衛生主管機關定之。
前項生物藥品之原液，其輸入以生物藥品製造業者為限。
檢驗封緘作業辦法，由中央衛生主管機關定之。
前項生物藥品之原液，其輸入以生物藥品製造業者為限。