Regulations for Reporting Serious Adverse Reactions of Medicaments Article 8
The central competent health authority may forward relevant reporting information to pharmaceutical firms upon receiving a serious adverse drug reaction report from medical care institutions and pharmacies.Pharmaceutical firms that receive such forwarding from the central competent health authority and have new, updated, or supplementary reporting information shall comply with the provisions of Paragraphs 1 and 2 of Article 3, and the preceding article regarding reporting.
中文原文 嚴重藥物不良反應通報辦法第8條
中央衛生主管機關接獲醫療機構及藥局通報藥品嚴重不良反應後，得將相關通報資料轉知藥商。
藥商接獲中央衛生主管機關前項轉知後，有新增、更新或補充通報資料者，準用第三條第一項、第二項及前條關於通報之規定。
藥商接獲中央衛生主管機關前項轉知後，有新增、更新或補充通報資料者，準用第三條第一項、第二項及前條關於通報之規定。