Regulations for the Management of Drug Safety Surveillance Article 13
The central competent health authority may send personnel to inspect the drug safety surveillance process or request the provision of relevant data. The pharmaceutical dealer shall not evade, impede or refuse such inspection or request.The central competent health authority may invite scholars, experts, or relevant agencies (institutions) to take part in the inspection or review of the data as indicated in the preceding paragraph.
中文原文 藥物安全監視管理辦法第13條
中央衛生主管機關得派員查核藥商之藥品安全性監視作業或要求提供相關資料，藥商不得規避、妨礙或拒絕。
中央衛生主管機關執行前項查核或審視前項資料，得邀請學者、專家或相關機關（構）參與。
中央衛生主管機關執行前項查核或審視前項資料，得邀請學者、專家或相關機關（構）參與。