{"billNo":"1090923070200200","提案單位/提案委員":"本院委員何志偉等29人","議案名稱":"「藥事法第二十三條條文修正草案」，請審議案。","相關附件":[{"網址":"https://ppg.ly.gov.tw/ppg/download/agenda1/02/pdf/10/02/03/LCEWA01_100203_00018.pdf","名稱":"關係文書PDF"},{"網址":"https://ppg.ly.gov.tw/ppg/download/agenda1/02/word/10/02/03/LCEWA01_100203_00018.doc","名稱":"關係文書DOC"}],"關連議案":[],"提案人":["何志偉","羅美玲"],"連署人":["陳亭妃","蔡易餘","邱議瑩","吳思瑤","余天","邱志偉","賴香伶","張其祿","賴惠員","黃秀芳","伍麗華Saidhai‧Tahovecahe","趙天麟","蘇巧慧","周春米","賴瑞隆","賴品妤","洪申翰","沈發惠","吳玉琴","范雲","吳秉叡","羅致政","吳琪銘","張宏陸","陳素月","鍾佳濱","莊競程"],"議案狀態":"交付審查","議案流程":[{"會期":"10-02-03","院會/委員會":"院會","狀態":"排入院會 (交社會福利及衛生環境委員會)","日期":["2020-10-06","2020-10-13"],"會議代碼":"院會-10-2-3"},{"會期":"10-02-03","院會/委員會":"院會","狀態":"交付審查","日期":["2020-10-06","2020-10-13"],"會議代碼":"院會-10-2-3"}],"mtime":"2024-01-18T18:33:19+08:00","屆期":10,"first_time":"2020-10-06","last_time":"2020-10-13","議案類別":"法律案","提案來源":"委員提案","meet_id":"院會-10-2-3","會期":2,"字號":"院總第775號委員提案第25059號","laws":["02510"],"提案編號":"775委25059","案由":"本院委員何志偉、羅美玲等29人，有鑑於口罩國家隊頻頻出現摻雜他國製造口罩混充之情事，但藥事法卻僅有對藥品有定義將他人產品抽換或摻雜而無醫療器材混充之定義，不利醫療器材管理，爰提案「藥事法第二十三條條文修正草案」。是否有當？敬請公決。","說明":"根據現行藥事法第二十三條不良醫材之定義並無將他人產品抽換或摻雜者，造成衛生主管機關無法有效管理不肖業者，嚴重打擊國人防疫信心，且損及國家防疫能量，爰新增不良醫材之定義，將他人產品抽換或摻雜者明確定義為不良醫材。","對照表":[{"law_id":"02510","law_name":"藥事法","立法種類":"修正條文","title":"藥事法第二十三條條文修正草案對照表","rows":[{"現行":"第二十三條　本法所稱不良醫療器材，係指醫療器材經稽查或檢驗有左列各款情形之一者：\n\n一、使用時易生危險，或可損傷人體，或使診斷發生錯誤者。\n\n二、含有毒質或有害物質，致使用時有損人體健康者。\n\n三、超過有效期間或保存期限者。\n\n四、性能或有效成分之質、量或強度，與核准不符者。","說明":"新增不良醫材之定義，將他人產品抽換或摻雜者明確定義為不良醫材。","修正":"第二十三條　本法所稱不良醫療器材，係指醫療器材經稽查或檢驗有左列各款情形之一者：\n\n一、使用時易生危險，或可損傷人體，或使診斷發生錯誤者。\n\n二、含有毒質或有害物質，致使用時有損人體健康者。\n\n三、超過有效期間或保存期限者。\n\n四、性能或有效成分之質、量或強度，與核准不符者。\n\n五、將他人產品抽換或摻雜者。"}]}],"ppg_url":"https://ppg.ly.gov.tw/ppg/bills/1090923070200200/details"}