Regulations for Reporting Serious Adverse Reactions of Medicaments Article 10
Medical care institutions, pharmacies, and pharmaceutical firms shall retain relevant documents and data related to serious adverse drug reactions for the following periods:1. Medical care institutions and pharmacies: At least 5 years.2. Pharmaceutical firms: Until 5 years after the drug manufacturing or importing approval expires.The central competent health authority may request medical care institutions, pharmacies, and pharmaceutical firms to provide the documents and data specified in the preceding paragraph. Medical care institutions, pharmacies, and pharmaceutical firms shall not evade, obstruct, or refuse to provide such information.
中文原文 嚴重藥物不良反應通報辦法第10條
醫療機構、藥局及藥商應保存藥品嚴重不良反應相關文件、資料；其保存期間如下：
一、醫療機構及藥局：至少五年。
二、藥商：至藥品製造或輸入許可效期屆滿後五年。
中央衛生主管機關得要求醫療機構、藥局及藥商提供前項文件、資料；醫療機構、藥局及藥商不得規避、妨礙或拒絕。
一、醫療機構及藥局：至少五年。
二、藥商：至藥品製造或輸入許可效期屆滿後五年。
中央衛生主管機關得要求醫療機構、藥局及藥商提供前項文件、資料；醫療機構、藥局及藥商不得規避、妨礙或拒絕。