Pharmaceutical Affairs Act Article 45-1
Medical care institutions, pharmacies, and pharmaceutical firms shall report any serious adverse reactions caused by medicaments. Regulations regarding reporting method, content, and other matters to be complied with shall be established by the central competent health authority.
中文原文 藥事法第45-1條
醫療機構、藥局及藥商對於因藥物所引起之嚴重不良反應，應行通報；其方式、內容及其他應遵行事項之辦法，由中央衛生主管機關定之。