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| column | value |
|---|---|
| 類別 | 藥政管理類,藥事法施行細則 |
| 法規性質 | 法規命令 |
| 法規名稱 | 藥事法施行細則 |
| 條文內容 | <p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則依藥事法</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">以下簡稱本法</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">第一百零五條規定訂定之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 2 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第七條，用詞定義如下：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一、新成分：指新發明之成分可供藥用者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二、新療效複方：指已核准藥品具有新適應症、降低副作用、改善療效強度、改善療效時間或改變使用劑量之新醫療效能，或二種以上已核准成分之複方製劑具有優於各該單一成分藥品之醫療效能者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三、新使用途徑：指已核准藥品改變其使用途徑者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 3 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第八條第二項所稱醫師處方藥品，係指經中央衛生主管機關審定，在藥品許可證上，載明須由醫師處方或限由醫師使用者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 4 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法所稱稽查，係指關於藥物有無經核准查驗登記及與原核准查驗登記或規定是否相符之檢查事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">本法所稱檢驗，係指關於藥品之性狀、成分、質、量或強度等化驗鑑定事項，或醫療器材之化學、物理、機械、材質等鑑定事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 5 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十條第一款所稱未經核准，擅自製造者，不包括非販賣之研究、試製之藥品。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">前項藥品應備有研究或試製紀錄，並以無商品化之包裝者為限。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 6 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十二條第二款所稱未經核准擅自輸入之藥品，係指該藥品未曾由中央衛生主管機關依本法第三十九條規定核發輸入許可證者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 7 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十三條第一款所稱使用，係指依標籤或仿單刊載之用法，作正常合理之使用者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 8 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十五條所稱標籤，包括直接標示於醫療器材上之文字、圖畫或記號。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 9 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十七條第二項規定藥商登記事項如左：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一、藥商種類。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二、營業項目。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三、藥商名稱。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">四、地址。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">五、負責人。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">六、藥物管理、監製或技術人員。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">七、其他應行登記事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 10 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第二十七條第一項規定申請藥商登記者，應填具申請書，連同執照費及下列文件，申請直轄市或縣（市）衛生主管機關核准：</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">一、依本法規定，應聘用藥物管理、監製或技術人員者，其所聘人員之執</span><span style="font-size: 14pt;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">業執照或證明文件。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">二、藥商為公司組織者，其公司登記、公司組織章程影本。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">三、藥物販賣業者，其營業地址、場所（貯存藥品倉庫）及主要設備之平面略圖。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">四、藥物製造業者，其工廠登記證明文件及其影本。但依工廠管理輔導法規定免辦理工廠登記者，免附。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">五、直轄市或縣（市）衛生主管機關所定之其他文件。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">新設立公司組織之藥商，得由衛生主管機關先發給籌設許可文件，俟取得公司登記或工廠登記證明文件後，再核發藥商許可執照。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 11 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請藥商登記者，其藥商種類及應載明之營業項目，應依本法第十四條至第十八條之規定。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">西藥販賣業者，由藥劑生駐店管理時，其營業項目應加註不販賣麻醉藥品。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商經營醫用放射性藥品者，應依有關法令規定，申請核准後始得販賣。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 12 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥品製造業者依本法第十六條規定在其製造加工之同一處所經營自製產品之批發、輸出、自用原料輸入及兼營自製產品之零售業務者，得由其監製人兼為管理之。但兼營非本藥商產品之販賣業務或分設處所經營各該業務者，應分別聘管理人員，並辦理藥品販賣業之藥商登記。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥品製造業者依本法第五十八條規定，委託他廠製造之產品，其批發、</span><span style="font-size: 14pt;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸出及零售，得依前項前段規定辦理。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 13 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">醫療器材製造業者依本法第三十二條規定應聘技術人員之醫療器材類別及其技術人員資格，依左列規定：</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">一、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造一般醫療設備、臨床檢驗設備及生物材料設備者，應聘國內公立或立案之私立專科以上學校或經教育部承認之國外專科以上學校理、工、醫、農等相關科、系、所畢業之專任技術人員駐廠監製。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">二、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造隱形眼鏡鏡片消毒藥水</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">錠</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">、移植器官保存液、衛生材料、衛生棉條業者，應聘專任藥師駐廠監製。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 14 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商許可執照、藥局執照，應懸掛於營業處所之明顯位</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">置。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 15 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第二十七條第一項所稱應辦理變更登記之事項，包括</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商登記事項之變更及自行停業、復業或歇業。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">前項應辦理變更登記事項，藥商應自事實發生之日起十五</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">日內，向原核准登記之衛生主管機關申請辦理變更登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 16 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商辦理變更登記，除遷址變更登記，應先向衛生主管機</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">關申請辦理外，其他公司組織或商業登記事項之變更，應</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">先向商業主管機關辦妥各該變更登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 17 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商依本法第二十八條或第二十九條規定聘用之管理或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">監製人員，或第三十一條、第三十二條規定聘用之技術人</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">員，因解聘、辭聘或其他原因不能執行其任務而未另行聘</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">置時，應即停止營業，並申請停業或歇業之登記。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 18 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥品販賣業者依本法第二十八條規定聘用之藥師、藥劑生</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">或中醫師，或本法第十九條規定親自主持藥局業務之藥</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">師、藥劑生，均應親自在營業場所執行業務，其不在場時，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">應於門口懸掛明顯標示。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 19 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 20 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 21 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 22 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 22-1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第三十九條第二項規定申請輸入試製藥品原料</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥者，應繳納費用，並填具申請書及檢附下列資料，送</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">請中央衛生主管機關核辦：</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、藥商許可執照。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、試製計畫書。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三、經濟部工廠登記證明文件。但研發單位，免附。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">四、委託其他藥商辦理輸入試製藥品原料藥者，其委託</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">書、委託者及受委託者之藥商許可執照。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 23 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 23-1 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">中央衛生主管機關對於藥物之查驗，得委託衛生財團法</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">人或其他相關團體、機構辦理學術性研究、安全、臨床</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">試驗等技術性資料之審查業務。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 24 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第三十九條、第四十條所稱藥物查驗登記事項如左：</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、藥物中文及外文品名。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、藥品處方及藥品劑型。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三、醫療器材成分、材料、結構及規格。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">四、藥物標籤、仿單及包裝。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五、藥品之直接包裝。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">六、適應症、效能、性能、用法、用量及類別。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">七、藥物製造方法、檢驗規格及檢驗方法。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">八、藥商名稱。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">九、製造廠廠名及廠址。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一○、其他經中央衛生主管機關指定登記事項。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 25 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 26 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 27 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">國內製造之藥物，其標籤、仿單、包裝應以中文為主，所</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">附外文文字應小於中文。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">國外輸入之藥物，除應加附中文仿單外，其標籤、包裝均</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">應另以中文載明品名、類別、許可證字號及輸入藥商名</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">稱、地址，且應以中文或依習慣能辨明之方式刊載有效期</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">間或保存期限；其中文品名之文字不得小於外文。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 28 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥商名稱之變更，涉及權利之移轉者，應由雙方共同提出</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 29 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 30 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 31 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸出藥物為應輸出地區購買者之要求，須變更藥物名稱、</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">標籤、仿單、包裝或附加外文者，應檢附其所變更之實樣</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">各二份，申請中央衛生主管機關核定。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">前項經變更名稱、標籤、仿單、包裝或附加外文之藥物，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">不得用於內銷。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 32 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 33 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第四十九條所稱不得買賣，包括不得將藥物供應非藥</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">局、非藥商及非醫療機構。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 34 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第五十三條第二項為輸入原料藥之分裝，應由輸入</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之藥商於符合優良藥品製造規範之藥廠分裝後，填具申請</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">書，連同藥品許可證影本、海關核發之進口報單副本、原</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">廠檢驗成績書、檢驗方法及其他指定文件，申請中央衛生</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">主管機關備查。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">經分裝之原料藥，以銷售藥品製造業者為限；所使用之標</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">籤應分別刊載左列事項：</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、廠商名稱及地址。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、品名及許可證字號。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三、效能或適應症。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">四、批號。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五、分裝藥商名稱及地址。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">六、分裝日期。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">七、製造日期及有效期間或保存期限。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">八、其他依規定應刊載事項。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">前項第七款經中央衛生主管機關明令公告免刊載者，不在</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">此限。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 35 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">生物藥品之容器、標籤、仿單及包裝，除應依本法第七十</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">五條規定刊載外，含有防腐劑者，應標明防腐劑含量。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 36 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本法第七十四條所規定辦理之藥品檢驗封緘，其審查或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">檢驗結果為不合格者，國外輸入藥品應由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關派員監督原輸入藥商限期退運；本國製造藥</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">品可改製使用者，由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;">(</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關派員監</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">督原製造廠商限期改製。屆期未能退運或改製，或不能改</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製者，應予以銷燬。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 37 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物有本法第八十條第一項第一款至第四款所列情形之</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一者，藥商、藥局及醫療機構，應自公告或依法認定之日</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">起，立即停止輸入、製造、批發、陳列、調劑、零售；其</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造或輸入之業者，並應於回收期限內回收市售品，連同</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">庫存品依本法第七十九條規定處理；回收期限由中央衛生</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">主管機關依個案性質決定，最長不得超過二個月。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物有本法第八十條第一項第五款或第六款情形之一</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">者，其製造或輸入之業者，應自藥物許可證到期或包裝、</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">標籤、仿單經核准變更之日起六個月內收回市售品，連同</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">庫存品送經直轄市或縣（市）衛生主管機關驗章後，始得</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">販賣。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">製造或輸入業者執行藥物回收作業前，應訂定回收作業計</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">畫書，載明回收程序、回收期限、執行成果報告書報備之</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">期限及其他相關事項報中央衛生主管機關備查後，依該計</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">畫書執行；並於執行結束後，製作回收報告書，報各級衛</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">生主管機關備查。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 38 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">取締偽藥、劣藥、禁藥、不良醫療器材及未經許可製造或</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸入之醫療器材，直轄市衛生主管機關得設置查緝中心；</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關得設置查緝小組。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 39 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發偽藥、劣藥、禁藥、不良醫療器材或未經核准製造或</span><span style="font-size: 14pt; font-family: calibri;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">輸入之醫療器材經緝獲者，應由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">管機關依左列標準計點核發獎金：</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">一、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發製造或輸入偽藥、禁藥或未經核准製造或輸入醫療器材</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">者：四至十點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">二、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發以批發方式轉售</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">讓</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">偽藥、禁藥或未經核准製造或輸入醫療器材者：二至五點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">三、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發零售、運送、儲</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">寄</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藏、牙保或意圖販賣而陳列偽藥、禁藥或未經核准製造或輸入醫療器材者：二至三點。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">四、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">舉發製造、輸入、販賣劣藥或不良醫療器材者：二至</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">三點。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">每點獎金之數額，由直轄市或縣</span><span style="font-size: 14pt; font-family: calibri;"> (</span><span style="font-size: 14pt; font-family: 新細明體,serif;">市</span><span style="font-size: 14pt; font-family: calibri;">) </span><span style="font-size: 14pt; font-family: 新細明體,serif;">衛生主管機關視情</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">況訂定，並編列預算支應之。中央衛生主管機關於必要時，</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">得編列緝獲獎金補助之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 40 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二人以上聯名舉發前條之案件，其獎金應由原舉發人聯名</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">具領。二人以上分別舉發案件而有相同部分者，其獎金應</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">發給最先舉發者；如無法分別先後時，平均分發之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 41 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">協助查緝機關緝獲偽藥、劣藥、禁藥、不良醫療器材及未</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">經核准製造或輸入之醫療器材者，其獎勵準用關於舉發人</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之規定。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 42 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">依本細則應發給獎金者，應由緝獲偽藥、劣藥、禁藥、不</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">良醫療器材及未經核准製造或輸入醫療器材之機關敘明</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">事實申請之。但同時符合</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則或其他法令規定給予獎勵者，不得重複給獎。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 43 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">對於舉發人或協助緝獲偽藥、劣藥、禁藥、不良醫療器材</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">及未經核准製造或輸入醫療器材者之姓名，應嚴予保密，</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">不得洩漏。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 44 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">登載或宣播藥物廣告，應由領有藥物許可證之藥商，填具</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">申請書，連同藥物許可證影本、核定之標籤、仿單或包裝</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">影本、廣告內容及審查費，申請中央或直轄市衛生主管機</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">關核准後為之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 45 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告所用之文字圖畫，應以中央衛生主管機關所核定</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之藥物名稱、劑型、處方內容、用量、用法、效能、注意</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">事項、包裝及廠商名稱、地址為限。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">中藥材之廣告所用文字，其效能應以本草綱目所載者為</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">限。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 46 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告應將廠商名稱、藥物許可證及廣告核准文件字</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">號，一併登載或宣播。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 47 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">藥物廣告之內容，具有左列情形之一者，應予刪除或不予</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">核准：</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">一、涉及性方面之效能者。</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">二、利用容器包裝換獎或使用獎勵方法，有助長濫用藥物</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">之虞者。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">三、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">表示使用該藥物而治癒某種疾病或改進某方面體質</span><span style="font-size: 14pt;"> </span></p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">及健康或捏造虛偽情事藉以宣揚藥物者。</span> </p><p><span style="font-size: 14pt;"><span style="font-family: calibri;">四、</span><span style="font: 7pt times new roman;"> </span></span><span style="font-size: 14pt; font-family: 新細明體,serif;">誇張藥物效能及安全性者。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 48 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 49 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 50 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法第一百零二條第二項所稱醫療急迫情形，係指醫師於</span> </p><p><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">醫療機構為急迫醫療處置，須立即使用藥品之情況。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 51 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 52 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條（刪除）</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 53 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本法及本細則所定文書格式，由中央衛生主管機關定之。</span> </p><p><span style="font-size: 14pt; font-family: 新細明體,serif;">第</span><span style="font-size: 14pt; font-family: calibri;"> 54 </span><span style="font-size: 14pt; font-family: 新細明體,serif;">條</span><span style="font-size: 14pt; font-family: calibri;"> </span><span style="font-size: 14pt; font-family: 新細明體,serif;">本細則自發布日施行。</span> </p> |
| 發佈日期 | 2013-12-05 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6068&type=0 |