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| 類別 | 法規性質 | 法規名稱 | 條文內容 | 發佈日期 | 附件檔案 | |
|---|---|---|---|---|---|---|
| 1420609 | 藥政管理類,藥事法 | 行政解釋 | 公告廢止含propoxyphene成分藥品許可證共六件 | 詳如附件 | 2013-12-16 | |
| 1420610 | 藥政管理類,藥事法 | 行政解釋 | 公告廢止含strontium成分牙膏藥品許可證共2件 | 詳如附件 | 2013-12-16 | |
| 1420611 | 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記,指示藥品審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜合感冒藥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗過敏劑,指示藥品審查基準-一般皮膚外用劑,西藥及醫療器材查驗登記審查費收費標準,藥物資料公開辦法,新型流感疫苗查驗登記指引,核醫放射性藥品審查基準,生物相似性藥品查驗登記技術性資料審查重點表,新成分新藥查驗登記療效及安全性之考量重點,原料藥主檔案(DMF)核備及國產原料藥查驗登記精實送審文件資料,新藥查驗登記精簡審查程序,新藥查驗登記優先審查機制,國產創新藥品查驗登記專案試辦計畫 | 行政解釋 | 公告藥物、化粧品查驗登記案件廠商申請陳述意見之作業流程，自九十年一月一日起實施 | <p><span style="font-family: 新細明體, serif;">一、行政程序法已於八十八年二月三日總統令公布，將自九十年一月一日施行，該法規定，行政機關作成行政處分或從事行政行為，應通知相關之人陳述意見或給予相對人陳述意見之機會。</span> </p><p><span style="font-family: 新細明體, serif;">二、配合行政程序法之規定，訂定相關之作業流程如下：</span> </p><p><span style="font-family: 新細明體, serif;">（一）本署不准登記或要求補件之藥物、化粧品查驗登記案件，廠商均得申請當面陳述意見。本署受理後，應於十四日內，由承辦人會同科長與廠商進行當面溝通並作成紀錄。</span> </p><p><span style="font-family: 新細明體, serif;">（二）不准登記案件，廠商並得申請列席審議委員會當面陳述意見。本署受理後，應於一個月內，由廠商列席審議委員會當面陳述意見並作成紀錄。</span> </p><p><span style="font-family: 新細明體, serif;">三、藥物、化粧品查驗登記案件廠商申請陳述意見流程圖如附件。</span> </p> | 2013-12-16 | |
| 1420612 | 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記,指示藥品審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜合感冒藥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗過敏劑,指示藥品審查基準-一般皮膚外用劑,西藥及醫療器材查驗登記審查費收費標準,藥物資料公開辦法,新型流感疫苗查驗登記指引,核醫放射性藥品審查基準,生物相似性藥品查驗登記技術性資料審查重點表,新成分新藥查驗登記療效及安全性之考量重點,原料藥主檔案(DMF)核備及國產原料藥查驗登記精實送審文件資料,新藥查驗登記精簡審查程序,新藥查驗登記優先審查機制,國產創新藥品查驗登記專案試辦計畫 | 行政解釋 | 公告藥物或含藥化粧品許可證持有者，授權他人輸入各該產品，應向本署報備 | <p><span style="font-family: 新細明體, serif;">為配合通關自動化作業，並減少海關審核授權文件時判斷上之困擾或錯誤，報備程序，規定如下：</span> </p><p><span style="font-family: 新細明體, serif;">一、凡藥物許可證或含藥化粧品許可證之持有者，授權他人輸人各該產品時，均應檢具「授權輸入藥物或含藥化粧品報備申請書」，填妥藥物許可證或含藥化粧品許可證之字號、被授權者之藥商許可執照字號、被授權者之公司或工廠名稱、被授權者營利事業登記證統一編號、授權日期等資料，連同上述證照之影印本各乙份，申請本署核備，經本署核准簽審文件編號（十四碼）後，供為輸入通關使用。</span> </p><p><span style="font-family: 新細明體, serif;">二、短期授權、單次授權、授權終止或授權變更，均應依照前項規定申請本署核備。</span> </p><p><span style="font-family: 新細明體, serif;">三、輸入管制藥品者，應請逐批檢具授權輸入之相關資料，向本署管制藥品管理局，申請輸入同意書，並以輸入同意書編號（十四碼），作為簽審文件編號，依管制藥品管理條例相關規定，辦理輸入通關事宜。</span> </p> | 2013-12-16 | |
| 1420613 | 藥政管理類,藥事法 | 行政解釋 | 世界衛生組織函告有關「日本政府宣佈不適用藥品4,4'-DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE一種」令希知照轉飭加強注意。 | <p><span style="font-family: 新細明體, serif;">一、准世界衛生組織本年三月二十一日函，為日本政府提供有關</span><span style="font-family: calibri;">4,4'- DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE </span><span style="font-family: 新細明體, serif;">藥品不適用之報告，略以「一九七○年十一月日本健康福利部製藥組接獲其專門提供藥品反作用之一九二所醫院中之一所醫院報告，關於</span><span style="font-family: calibri;"> 4,4'- DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE </span><span style="font-family: 新細明體, serif;">藥品所引起如脂肪過多症……等等新的反作用，此類反應並經作動物實驗證實。又此項報告經通知各製藥商後均表重視，並決定將市面上此類藥品刪除，同時將此作用之報告提供政府。日本政府接獲製藥商及藥事審議委員會等之報告後，已決定不再核准此項藥品之許可證，各藥商亦決定在已核准之產品目錄中將該藥刪去。」等由。</span> </p><p><span style="font-family: 新細明體, serif;">二、茲為維護國民健康起見，檢發世界衛生組織來函之影印本一份，希即轉飭各有關醫療團體對該藥品</span><span style="font-family: calibri;"> 4,4'- DIETHYLAMINOETHOXYHEXESTROL DIHYDROCHLORIDE </span><span style="font-family: 新細明體, serif;">加強注意使用。</span> </p> | 2013-12-16 | |
| 1420614 | 藥政管理類,藥事法 | 行政解釋 | 司法院釋字第376號解釋文 | <span style="font-family: 新細明體, serif;">化學合成麻醉藥品類及其製劑為麻醉藥品管理條例所稱麻醉藥品之一種，為同條例第二條第四款所明定。安非他命係以化學原料合成而具有成癮性之藥品，行政院衛生署中華民國七十九年十月九日衛署藥字第九○四一四二號公告，將安非他命列入麻醉藥品管理條例所稱化學合成麻醉藥品類，係在公告確定其列為管理之項目，並非增列處罰規定或增加人民之義務，與憲法並無牴觸。</span> | 2013-12-16 | |
| 1420615 | 藥政管理類,藥事法 | 行政解釋 | 司法院釋字第404號解釋文 | <span style="font-family: 新細明體, serif;">憲法第十五條規定人民之工作權應予保障，故人民得自由選擇工作及職業，以維持生計。惟人民之工作與公共福祉有密切關係，為增進公共利益之必要，對於人民從事工作之方法及應具備之資格或其他要件，得以法律為適當之限制，此觀憲法第二十三條規定自明。醫師法為強化專業分工、保障病人權益及增進國民健康，使不同醫術領域之醫師提供專精之醫療服務，將醫師區分為醫師、中醫師及牙醫師。醫療法第四十一條規定醫療機構之負責醫師應督導所屬醫事人員依各該醫事專門職業法規規定執行業務，均屬增進公共利益所必要。中醫師之醫療行為應依中國傳統之醫術為之，若中醫師以「限醫師指示使用」之西藥製劑或西藥成藥處方，為人治病，顯非以中國傳統醫術為醫療方法，有違醫師專業分類之原則及病人對中醫師之信賴。行政院衛生署七十一年三月十八日衛署醫字第三七○一六七號函釋：「三、中醫師如使用『限醫師指示使用』之西藥製劑，核為醫師業務上之不正當行為，應依醫師法第二十五條規定論處。四、西藥成藥依藥物藥商管理法之規定，其不待醫師指示，即可供治療疾病。故使用西藥成藥為人治病，核非中醫師之業務範圍。」要在闡釋中醫師之業務範圍，符合醫師法及醫療法之立法意旨，與憲法保障工作權之規定，尚無牴觸</span> | 2013-12-16 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=535&type=0 |
| 1420616 | 藥政管理類,藥事法 | 行政解釋 | 市售及存庫舊包裝藥品，仍應於六十二年三月底前全部清點收回，一律改換新包裝，違者按其情節依法處理 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">62.01.31.</span><span style="font-family: 新細明體, serif;">省藥調總字第</span><span style="font-family: calibri;">008</span><span style="font-family: 新細明體, serif;">號申請書已悉。</span> </p><p><span style="font-family: 新細明體, serif;">二、查換證後之舊包裝藥品，原規定在新許可證生效一年內未售完者，應自第二年起換新包裝。而藥品許可證自五十八年開始換發以來，迄已歷時數載；即</span> <span style="font-family: 新細明體, serif;">貴會六十年九月間建議藥品舊包裝准予繼續使用一年，亦逾越限期。廠商業者，理應早日完成改換新包裝，詎目前市售藥品，發現仍有繼續使用舊包裝，影響藥政管理至鉅。茲為加強檢肅偽劣禁藥，維護國民健康，所請再予展延舊包裝藥品收回期限一節，未便同意。仍應切實照本署</span><span style="font-family: calibri;">61.12.27.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;"> 16490</span><span style="font-family: 新細明體, serif;">號令辦理。</span> </p><p><span style="font-family: 新細明體, serif;">三、副本抄送臺灣區製藥工業同業公會、臺北市藥品調製商業同業公會，抄發臺灣省政府衛生處、臺北市政府衛生局、本署藥政處。</span> </p> | 2013-12-16 | |
| 1420617 | 藥政管理類,藥事法 | 行政解釋 | 成公告含Gadolinium成分顯影劑藥品安全性再評估結果相關事宜 | 詳如附件 | 2013-12-16 | |
| 1420618 | 藥政管理類,藥事法 | 行政解釋 | 有關製造藥品標明有效期限一案復希知照 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">61.7.22.</span><span style="font-family: 新細明體, serif;">衛四字第</span><span style="font-family: calibri;">02074</span><span style="font-family: 新細明體, serif;">號呈件均悉。</span> </p><p><span style="font-family: 新細明體, serif;">二、查製造藥品，除抗生素及生物製劑須在包裝上刊載有效期間外，其他藥品尚無註明有效期限之規定，但仍須標明製造年月日或批號等，以利查核。</span> </p> | 2013-12-16 | |
| 1420619 | 藥政管理類,藥事法 | 行政解釋 | 行政院九十二年五月七日院授研管字第09200104262號函（公文書橫式書寫推動方案） | <p><span style="font-family: 新細明體, serif;">一、藥品、醫療器材、含藥化粧品和化粧品色素申請書表新規格：</span><span style="font-family: calibri;">A4</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">80</span><span style="font-family: 新細明體, serif;">磅模造紙，長二十九．七公分，寬二十一公分，內容為白底黑字直式橫書電腦正楷列印。</span> </p><p><span style="font-family: 新細明體, serif;">二、行政院衛生署藥品、醫療器材、含藥化粧品、化粧品色素許可證新規格為：</span><span style="font-family: calibri;">A4</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">150</span><span style="font-family: 新細明體, serif;">磅模造紙，長二十九．七公分，寬二十一公分，內容文為直式橫書電腦正楷列印，下方加蓋本署關防，證書背面為變更事項記錄。各類許可證顏色區分如下：藥品許可證為黃色、外銷專用藥品許可證為草綠色、細菌學免疫製品許可證為淺綠色、含藥化粧品許可證為粉紅色、第一等級醫療器材許可證為淺橘色、第二、三等級醫療器材許可證為橘色、外銷醫療器材許可證為淺淺橘色。</span> </p> | 2013-12-16 | |
| 1420620 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署93年2月25日衛署藥字第0930300018號函 | <p><span style="font-family: 新細明體, serif;">主 旨：修正「藥局設置作業注意事項」如附件，並自即日起實施。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、「藥局設置作業注意事項」經本署九十一年十月二十一日衛署藥字第○九一○○六四七一九號公告，九十二年五月六日衛署藥字第○九二○三一六五五○號修正公告在案。</span> </p><p><span style="font-family: 新細明體, serif;">二、九十一年十月二十一日公告前已設立之藥局，得繼續依原申請之規定辦理，不適用該注意事項。</span> </p><p><span style="font-family: 新細明體, serif;">附 件：</span> <span style="font-family: 新細明體, serif;">藥局設置作業注意事項</span> </p><p><span style="font-family: 新細明體, serif;">一、藥局設立，應依藥事法之規定，由藥師或藥劑生親自主持，依法執行藥品調劑、供應及兼營藥品零售業務。</span> </p><p><span style="font-family: 新細明體, serif;">二、藥局設置總面積需有十八平方公尺以上，其空間應有調劑處所、候藥區、受理處方箋與非處方藥品供應區及藥事諮詢服務區，但不包含廁所及倉庫等。</span> </p><p><span style="font-family: 新細明體, serif;">三、藥局設置之調劑處所，至少應有六平方公尺之作業面積，其環境設施應符合優良藥品調劑作業規範（</span><span style="font-family: calibri;">GDP</span><span style="font-family: 新細明體, serif;">）之規定。</span> </p><p><span style="font-family: 新細明體, serif;">四、藥局不得在醫療機構內，以隔間方式設置。</span> </p><p><span style="font-family: 新細明體, serif;">五、藥局申請設立，如與其他營業、執業單位或機構同一樓層或同一門牌地址，應具備各自獨立出入門戶及明顯區隔之條件，且藥事服務作業應獨立進行，民眾進出互不影響。</span> </p><p><span style="font-family: 新細明體, serif;">六、藥局設立應有明顯市招，如屬健保特約藥局，應有全民健康保險醫事服務機構標誌。</span> </p><p><span style="font-family: 新細明體, serif;">七、（刪除）</span> </p> | 2013-12-16 | |
| 1420621 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署96年1月23日衛署藥字第0950064131號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關貴公司函請釋示醫療院所直接購買</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">度酒精，再由藥師或藥劑生自行稀釋為</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">消毒酒精，作為肌膚、手部及器皿、器械等清潔、消毒、抗菌之用途，是否違反藥事法或其他相關法規之疑義乙案，復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴公司</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">08</span><span style="font-family: 新細明體, serif;">日祐字第</span><span style="font-family: calibri;">0951208302</span><span style="font-family: 新細明體, serif;">號函，兼復生發貿易股份有限公司</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">11</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">27</span><span style="font-family: 新細明體, serif;">日發字第</span><span style="font-family: calibri;">0951127102</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、案內</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">度酒精，不以人用藥品列管，其管理請參照財政部公布之「未變性酒精管理辦法」。</span> </p><p><span style="font-family: 新細明體, serif;">三、有關</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">酒精製劑之管理：</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">作為醫療用途，如殺菌、消毒、手術前消毒等用途之</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">消毒酒精製劑，應以藥品列管。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">若作為一般手部、皮膚清潔用途（非醫療用途），含</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">酒精產品，得以一般商品列管，惟不得宣稱醫療效能（如：殺菌、消毒等）。</span> </p><p><span style="font-family: 新細明體, serif;">四、</span><span style="font-family: calibri;">75%</span><span style="font-family: 新細明體, serif;">酒精基於醫療作業消毒抗菌程序之用，應由醫療之人員管控，其由醫院藥局以</span><span style="font-family: calibri;">95%</span><span style="font-family: 新細明體, serif;">酒精調配，應無不可。</span> </p> | 2013-12-16 | |
| 1420622 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署96年6月12日衛署藥字第0960321599號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關乙類成藥是否應開放由網路平台銷售乙案，請 惠賜卓見。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、依據○○數位整合股份有限公司</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">日康字第</span><span style="font-family: calibri;">960601</span><span style="font-family: 新細明體, serif;">號函辦理。</span> </p><p><span style="font-family: 新細明體, serif;">二、因乙類成藥係安全性較高之藥品，作用緩和，無積蓄性，耐久儲存，使用簡便，並明示其效能、用量、用法，標明成藥許可證字號，其使用不待醫師指示，即供治療疾病之用者。為便於民眾自主健康管理，是故，民國</span><span style="font-family: calibri;">81</span><span style="font-family: 新細明體, serif;">年修正之成藥及固有成方製劑管理辦法第</span><span style="font-family: calibri;">16</span><span style="font-family: 新細明體, serif;">條規定，乙類成藥得由百貨店、雜貨店及餐旅服務商兼營零售，自立法原意觀之，因當時並無網路銷售平台之概念，故應僅開放由實體店面販賣乙類成藥，然而時代進步，虛擬通路亦為市場經營行銷之一，得否開放網路平台銷售乙類成藥，請 惠賜卓見。</span> </p> | 2013-12-16 | |
| 1420623 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署96年8月10日衛署藥字第0960031183號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關貴局檢送轄內○○企業有限公司銷售之「○○梅」產品（經本署藥物食品檢驗局檢驗結果檢出含</span><span style="font-family: calibri;">Sennoside 3.8mg/pack</span><span style="font-family: 新細明體, serif;">），函請釋疑其違規情事應依藥事法抑或食品衛生管理法相關規定處辦乙案，復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴局</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">7</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">10</span><span style="font-family: 新細明體, serif;">日北市衛藥食字第</span><span style="font-family: calibri;">09635313400</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、案內貴局函敘『……依案內產品標示使用已超過已超過該公告限量，惟案內產品為一般梅子之醃漬食品物並非大署函釋之「茶包」，謹請大署釋疑，本案將應依藥事法抑或食品衛生管理法相關規定處辦。』乙節，依據</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">「番瀉（</span><span style="font-family: calibri;">Cassia angustifolia Vahl</span><span style="font-family: 新細明體, serif;">）」其葉與莢部位可供為茶包、膳食調理包或經萃取後作為飲料、錠狀、膠囊狀、粉末狀、顆粒狀等食品之原料，惟其番瀉葉甘（</span><span style="font-family: calibri;">Sennoside</span><span style="font-family: 新細明體, serif;">）之每日使用劑量為</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">毫克以下。且產品應標示番瀉葉甘含量、每日建議食用量，及相關之警語。</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">本署</span><span style="font-family: calibri;">91</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">11</span><span style="font-family: 新細明體, serif;">日衛署藥字第</span><span style="font-family: calibri;">0910020787</span><span style="font-family: 新細明體, serif;">號公告：「番瀉葉茶包之管理產品標示或檢出含番瀉葉甘（</span><span style="font-family: calibri;">Sennoside</span><span style="font-family: 新細明體, serif;">）每日使用劑量為</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">毫克以上者，應以藥品管理……」</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)Sennosides</span><span style="font-family: 新細明體, serif;">列屬本署</span><span style="font-family: calibri;">93</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">15</span><span style="font-family: 新細明體, serif;">日衛署藥字第</span><span style="font-family: calibri;">0930309289</span><span style="font-family: 新細明體, serif;">號公告「指示藥品審查基準瀉劑」之有效成分之品項。綜上，案內產品應以藥品管理，顯無疑義，非因醃漬食品物與本署公告之「茶包」，有所更迭。</span> </p><p><span style="font-family: 新細明體, serif;">三、若就案內所述，該產品係由「黃金梅（一般梅子醃漬製成）」、「乳酸菌」、「藤黃果（羅夢果）」、「明日葉」、「普洱茶」等原料所製成，而無另外添加使用「番瀉（葉或莢）粉末或其萃取物」，則產品應不致檢出番瀉甘成分。若業者表示番瀉甘確為來自產品原料，而無添加「番瀉（葉或莢）粉末或其萃取物」，建請業者舉證說明係來自何種原料。</span> </p><p><span style="font-family: 新細明體, serif;">四、檢還原附之「○○梅」檢體乙份。</span> </p> | 2013-12-16 | |
| 1420624 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署96年9月7日衛署藥字第0960332676號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關 貴廠函詢藥事法及其施行細則中「自製產品」之意義乙案，復如說明段，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復 貴廠</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">8</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">27</span><span style="font-family: 新細明體, serif;">日永釋藥字第</span><span style="font-family: calibri;">096082701</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、藥品之製造、輸入應依藥事法第</span><span style="font-family: calibri;">39</span><span style="font-family: 新細明體, serif;">條之規定，申請本署查驗登記，經核准發給藥品許可證後，始得製造輸入。</span> </p><p><span style="font-family: 新細明體, serif;">三、復依藥事法第</span><span style="font-family: calibri;">16</span><span style="font-family: 新細明體, serif;">條、第</span><span style="font-family: calibri;">18</span><span style="font-family: 新細明體, serif;">條規定，藥品製造業者係指經營藥品之製造、加工與其產品批發、輸出及自用原料輸入之業者，藥品製造業者，得兼營自製產品之零售業務，亦即所稱「自製產品」係該業者依藥事法第</span><span style="font-family: calibri;">39</span><span style="font-family: 新細明體, serif;">條規定核准發給許可證，經核准製售之藥品成品。</span> </p> | 2013-12-16 | |
| 1420625 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署96年10月30日衛署藥字第0960045629號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關「○○西藥房」市招是否符合規定乙案，復如說明段，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復 貴局</span><span style="font-family: calibri;">96</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">10</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">日雲衛藥字第</span><span style="font-family: calibri;">0964000552</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、市招所載之文字係屬表見自由之範疇，其限制須符合法律保留及比例原則等，復查藥事法及其授權之法規，尚無就市招所載之文字內容有所限制，僅藥局設置作業注意事項第</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">點規定「藥局設立應有明顯市招，如屬健保特約藥局，應有全民健康保險醫事服務機構標誌。」，合先敘明。</span> </p><p><span style="font-family: 新細明體, serif;">三、若其市招內容涉虛偽不實或引人錯誤，為避免誤導消費者，宜請 貴局視實際情況輔導藥商改善。</span> </p> | 2013-12-16 | |
| 1420626 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署96年11月20日衛署藥字第0960321933號令 | <p><span style="font-family: 新細明體, serif;">依地方制度法第四條第二項之規定，臺北縣升格為準直轄市之後準用本署主管法規有關於直轄市規定者如後附，並自中華民國九十六年五月二十五日生效。</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">法規名稱</span> <span style="font-family: 新細明體, serif;">條、項、款、目</span> <span style="font-family: 新細明體, serif;">藥事法</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;">66</span><span style="font-family: 新細明體, serif;">條第</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">項、第</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">項、第</span><span style="font-family: calibri;">66</span><span style="font-family: 新細明體, serif;">條之</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">、第</span><span style="font-family: calibri;">102</span><span style="font-family: 新細明體, serif;">條第</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">項</span> <span style="font-family: 新細明體, serif;">藥事法施行細則</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;">38</span><span style="font-family: 新細明體, serif;">條、第</span><span style="font-family: calibri;">44</span><span style="font-family: 新細明體, serif;">條</span> <span style="font-family: 新細明體, serif;">化粧品衛生管理條例</span> <span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;">24</span><span style="font-family: 新細明體, serif;">條第</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">項、第</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">項</span> </p> | 2013-12-16 | |
| 1420627 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署97年1月2日衛署藥字第0960053982號函 | <p><span style="font-family: 新細明體, serif;">主</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">旨：檢陳轄內○○藥品有限公司販售之「</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三合一○○錠」產品（本</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">署藥物食品檢驗局檢驗結果檢出</span><span style="font-family: calibri;">7-Keto-dehydroepiandrosterone</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> Synephrine</span><span style="font-family: 新細明體, serif;">及</span><span style="font-family: calibri;">Caffeine</span><span style="font-family: 新細明體, serif;">等成分），函請釋示其產品屬性等乙案，復請 </span><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴局</span><span style="font-family: calibri;">95</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">14</span><span style="font-family: 新細明體, serif;">日北市衛藥食字第</span><span style="font-family: calibri;">09639071000</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、查案內「</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三合一○○錠」產品，業經本署藥物食品檢驗局檢驗結果：檢出</span><span style="font-family: calibri;">7-Keto-dehydroepiandrosterone</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">Synephrine</span><span style="font-family: 新細明體, serif;">及</span><span style="font-family: calibri;">Caffeine</span><span style="font-family: 新細明體, serif;">等成分，經查本署目</span> <span style="font-family: 新細明體, serif;">前對於含</span><span style="font-family: calibri;">dehydroepiandrosterone</span><span style="font-family: 新細明體, serif;">成分口服劑型之管理，經審慎評估，不以人用藥品列管，不得宣稱醫療效能；惟本件被檢出含</span><span style="font-family: calibri;">Caffeine</span><span style="font-family: 新細明體, serif;">及</span><span style="font-family: calibri;">Synephrine</span><span style="font-family: 新細明體, serif;">，依案內本署藥物食品檢驗局</span><span style="font-family: calibri;">96.11.12</span><span style="font-family: 新細明體, serif;">藥檢參字第</span><span style="font-family: calibri;">0960000920</span><span style="font-family: 新細明體, serif;">號報告書記載「</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三合一○○錠」標示含綠茶萃取物（</span><span style="font-family: calibri;">Green tea extract</span><span style="font-family: 新細明體, serif;">）及柑橘萃取物【</span><span style="font-family: calibri;">Citrus aurantium extract 200mg</span><span style="font-family: 新細明體, serif;">（</span><span style="font-family: calibri;">Octopamin 150mg Synephrine 50mg</span><span style="font-family: 新細明體, serif;">）】，是否為茶葉及柑橘（</span><span style="font-family: calibri;">Citrus aurantium</span><span style="font-family: 新細明體, serif;">）中之天然來源成分不明。倘若係天然來源之微量存在且未經純化精製者，不以藥品列管，不得宣稱醫療效能；若係外加者，依其作用，則以藥品列管。</span> </p><p><span style="font-family: 新細明體, serif;">三、檢還「</span><span style="font-family: calibri;">Octop</span><span style="font-family: 新細明體, serif;">三合一○○錠」產品檢體乙份。</span> </p> | 2013-12-16 | |
| 1420628 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署97年2月13日衛署藥字第0970002523號函 | <p><span style="font-family: 新細明體, serif;">主 旨：有關於「新世代產業</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">法（草案）」，本署意見，仍請 參採。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復 貴部</span><span style="font-family: calibri;">97</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">14</span><span style="font-family: 新細明體, serif;">日經授工字第</span><span style="font-family: calibri;">09600669950</span><span style="font-family: 新細明體, serif;">號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、有關產業發展基本法草案之法律位階，請參考行政院法規委員會</span><span style="font-family: calibri;">92</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">17</span><span style="font-family: 新細明體, serif;">日召開法規諮詢會議，關於「基本法」制定之必要性、法律位階及規範效力疑義案所作成之會議結論辦理。</span> </p><p><span style="font-family: 新細明體, serif;">三、產業整體思維當然有其必要，然產業之發展，常因涉及層面不同而有不同管轄，並非某一部會所能獨立完成。經查 貴部所擬之「新世代產業</span><span style="font-family: calibri;">3</span><span style="font-family: 新細明體, serif;">法」草案，亦將產業整體與個別之特性，列為各該法案重要內容，為達事權統一、專業分工以及簡化行政流程等項目的，本案建請仍以 貴部作為相關法律案之主管機關，再由 貴部會同目的事業主管機關，就個別產業之特殊性，共同擬定產業發展策略，協同建立合作機制，以利行政資源之統整與運用。如涉及機關角色之重新定位問題，並請衡酌各機關之特性，整體加以審慎考量。</span> </p> | 2013-12-16 | |
| 1420629 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署97年4月30日衛署藥字第0970304896號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關台灣柏朗藥品股份有限公司「肝素鈉注射液</span><span style="font-family: calibri;">5000</span><span style="font-family: 新細明體, serif;">國際單位／公撮（衛署藥輸字第</span><span style="font-family: calibri;">018198</span><span style="font-family: 新細明體, serif;">號）」藥品抽驗事宜，權責區分及管轄爭議乙案，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、關於藥事法稽查及取締之相關事項，應由藥商登記地之直轄市或縣（市）衛生主管機關管轄，有管轄權之地方衛生主管機關得依行政程序法之相關規定，請求行為或物品儲放地之地方衛生主管機關協助辦理，非有正當理由不能協助者不得拒絕。</span> </p><p><span style="font-family: 新細明體, serif;">二、至行為或物品儲放地之地方衛生主管機關認有必要時，得請求有管轄權之地方衛生主管機關陪同配合辦理。</span> </p> | 2013-12-16 | |
| 1420630 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署七十四年六月一日衛署藥字第五一七六○三號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">艾葉揉製成艾絨所作成之製品，而使用於針灸者，應以藥品管理，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：覆貴局七十四年二月十一日七四高市衛四字第○三三五一號函。</span> </p> | 2013-12-16 | |
| 1420631 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署九十一年三月十一日衛署藥字第○九一○○二○七八七號公告 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">為有效管理含番瀉葉（</span><span style="font-family: calibri;">sennosides</span><span style="font-family: 新細明體, serif;">）產品，重申產品標示或檢出含番瀉葉（</span><span style="font-family: calibri;">sennosides</span><span style="font-family: 新細明體, serif;">），每日使用劑量為十二毫克以上者，應以藥品管理。</span> </p><p><span style="font-family: 新細明體, serif;">依 據：藥事法第六條。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> <span style="font-family: 新細明體, serif;">番瀉葉茶包之管理，產品標示或檢出含番瀉葉（</span><span style="font-family: calibri;">sennosides</span><span style="font-family: 新細明體, serif;">），每日使用劑量為十二毫克以上者，應以藥品管理。上述處理原則，前經本署八十八年七月二十八日衛署藥字第八八○三七五七○號函知各縣、市衛生局在案，特再公告周知。</span> </p> | 2013-12-16 | |
| 1420632 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署九十二年十一月四日署授藥字第○九二○○○二三五一號公告 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">公告處方內容含細辛之中藥藥品許可證，應自公告日起一個月內，向本署申請變更類別為中醫師處方用藥及應標示注意事項。</span> </p><p><span style="font-family: 新細明體, serif;">依 據：藥事法第八條、第四十八條及其施行細則第三條。</span> </p><p><span style="font-family: 新細明體, serif;">公告事項：</span> <span style="font-family: 新細明體, serif;">一、原核定為「成藥」之中藥藥品許可證，應檢附左列資料辦理變更手續：</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">變更登記申請書乙份：類別變更為「中醫師處方用藥」。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">藥品許可證正本。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">原核准並蓋有騎縫章之標籤、仿單核定本乙份。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">四</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">查驗登記申請書正本。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">標籤、仿單及外盒擬稿二份。</span> </p><p><span style="font-family: 新細明體, serif;">二、原核定為「中醫師處方用藥」之中藥藥品許可證，應自行於標籤、仿單及外盒，以粗黑字體或加紅框標示「本製劑含馬兜鈴酸，大量長期服用可能導致腎衰竭等副作用」之注意事項。不需向本署報備。</span> </p> | 2013-12-16 | |
| 1420633 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署九十年七月十九日衛署藥字第○九○○○四七二五六號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關台端函詢藥事法第六條第一項第一款所稱「公定之國家處方集」及第五十條第六條第一項第三款所稱「國民處方選集」為何？</span> </p><p><span style="font-family: 新細明體, serif;">目前本署認定之「公定之國家處方集」包括美國：</span><span style="font-family: calibri;">PDR</span><span style="font-family: 新細明體, serif;">（</span><span style="font-family: calibri;">Physician</span><span style="font-family: 新細明體, serif;">’</span><span style="font-family: calibri;">s Desk Reference</span><span style="font-family: 新細明體, serif;">）、英國：</span><span style="font-family: calibri;">British National Formula</span><span style="font-family: 新細明體, serif;">，</span><span style="font-family: calibri;">ABPI</span><span style="font-family: 新細明體, serif;">、日本：日本醫藥品集（</span><span style="font-family: calibri;">Drugs in Japan</span><span style="font-family: 新細明體, serif;">）、瑞士：</span><span style="font-family: calibri;">Arzneimitte-Kompendium der Schweiz</span><span style="font-family: 新細明體, serif;">、加拿大：</span><span style="font-family: calibri;">Compendium of Pharmaceuticals and Specialities</span><span style="font-family: 新細明體, serif;">、法國：</span><span style="font-family: calibri;">Dictionarie Vidale</span><span style="font-family: 新細明體, serif;">、澳洲：</span><span style="font-family: calibri;">MIM</span><span style="font-family: 新細明體, serif;">’</span><span style="font-family: calibri;">s</span><span style="font-family: 新細明體, serif;">、德國：</span><span style="font-family: calibri;">Rote List</span><span style="font-family: 新細明體, serif;">、比利時：</span><span style="font-family: calibri;">Repertoire Commente Des Medicaments</span><span style="font-family: 新細明體, serif;">、瑞典：</span><span style="font-family: calibri;">FASS</span><span style="font-family: 新細明體, serif;">（</span><span style="font-family: calibri;">Farmacevtiska specialiteteri Sverige</span><span style="font-family: 新細明體, serif;">），以上書籍可至醫學專業書局洽購；另本署於七十七年出版「國民處方選集」，該書籍未再出版，台端若有需要，可洽衛生署藥政處查詢。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：復台端九十年七月十一日未列字號號函。</span> </p> | 2013-12-16 | |
| 1420634 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署九十年二月二十一日衛署中會字第○九○○○一一七二七號公告 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">公告含廣防己、青木香、關木通、天仙藤及馬兜鈴等中藥材之中藥藥品許可證，應於九十一年二月二十八日前變更為中醫師處方用藥及標示注意事項。</span> </p><p><span style="font-family: 新細明體, serif;">依 據：藥事法第八條、第四十八條及藥事法施行細則第三條。</span> </p><p><span style="font-family: 新細明體, serif;">公告事項：</span> <span style="font-family: 新細明體, serif;">一、原核為「成藥」之中藥藥品許可證，應檢附左列資料辦理變更手續：</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">變更登記申請書乙份：類別變更為「中醫師處方用藥」。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">藥品許可證正本。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">原核准並蓋有騎縫章之標籤、仿單核定本乙份。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">四</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">查驗登記申請書正本。</span> </p><p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">五</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">標籤、仿單及外盒擬稿二份。</span> </p><p><span style="font-family: 新細明體, serif;">二、原核定為「中醫師處方用藥」之中藥藥品許可證，應自行於標籤、仿單及外盒，以粗黑字體或加紅框標示「本製劑含馬兜鈴酸，大量長期服用可能導致腎衰竭等副作用」之注意事項。不需向本署報備。</span> </p> | 2013-12-16 | |
| 1420635 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署九十年五月十六日衛署藥字第○九○○○二三五六四號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">貴局函詢抽驗自屈臣氏百佳股份有限公司之「乾洗潔手凝膠」產品，是否屬「乙類成藥」管理乙案，復如說明段二，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴局九十年四月十七日北市衛四字第九○二一五六七二○○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、案內製品「乾洗潔手凝膠“</span><span style="font-family: calibri;">Antibacterial Hand Gel</span><span style="font-family: 新細明體, serif;">”」含</span><span style="font-family: calibri;">Alcohol denatured</span><span style="font-family: 新細明體, serif;">成分，並宣稱</span><span style="font-family: calibri;">Antibacterial Hand Gel</span><span style="font-family: 新細明體, serif;">，應以藥品列管。依據本署八十九年四月五日衛署藥字第八九○一六九六○號函，函知各縣市衛生局，含有以</span><span style="font-family: calibri;">Ethyl alcohol</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">Isopropyl alcohol</span><span style="font-family: 新細明體, serif;">為主成分之皮膚外用製劑（乾洗手製品），經本署核定列屬「乙類成藥」管理。據此，本案產品應可比照列屬「乙類成藥」管理。</span> </p><p><span style="font-family: 新細明體, serif;">三、檢還所附檢體。</span> </p> | 2013-12-16 | |
| 1420636 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署八十九年十月二十四日衛署藥字第○八九○○二二四三六號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關貴局函詢貴轄進昌藥局除經營藥局業務外，並以「藥品供貨中心」之方式供應診所及其他藥局，是否違反藥事法或藥師法等相關法規乙案，復如說明段，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴局八十九年十月十六日八九雲衛四字第一九四一○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、按「藥品供貨中心」從事藥品批發，應屬藥事法所稱之西藥販賣業者，依藥事法應申請地方衛生主管機關核准登記，另設專任藥師駐店管理，惟二者設於同址時，商品應有明顯區隔。</span> </p> | 2013-12-16 | |
| 1420637 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署八十八年七月二十八日衛署藥字第八八○三七五七○號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關番瀉葉茶包之管理，茲重新規定如后，請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、番瀉葉茶包之管理，廣告優先處理，廣告如宣稱「減肥」，則以食品衛生管理法處罰。產品部分，如未標示主成分，僅稱減肥茶，以食品衛生管理法處理；如標示番瀉葉、莢果或麘者，則依標示之含量、用法、用量判定，每日使用劑量以番瀉葉麘（</span><span style="font-family: calibri;">Sennosides</span><span style="font-family: 新細明體, serif;">）計為十二毫克以上者，以藥品管理，每日使用劑量未達十二毫克，則不以藥品管理；如衛生局認有必要送驗時，檢驗結果亦依此原則判定。</span> </p><p><span style="font-family: 新細明體, serif;">二、上述處理原則，業經本署藥物食品協調會報第二十次會議討論確定。食品使用，則不得宣稱醫療效能，且應符合食品衛生管理法及相關法令之規定。</span> </p> | 2013-12-16 | |
| 1420638 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署八十六年九月二十二日衛署藥字第八六○四二三○九號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">關於貴局函請釋示西藥販賣業者依處方販售管制藥品應依何項法條規範處罰乙案，復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴局八十六年七月九日北市衛四字第八六二三六三三一○○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、西藥販賣業者依醫師處方供應管制藥品，應屬調劑範圍，而西藥販賣業者並未列有調劑營業項目，應依違反藥事法第二十七條之規定辦理。</span> </p> | 2013-12-16 | |
| 1420639 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署八十六年十一月十四日衛署藥字第八六○六一二○六號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">貴署檢送「源胚」二瓶、「肝功能改善劑</span><span style="font-family: calibri;">LAENNEC INJ.</span><span style="font-family: 新細明體, serif;">」壹盒及「怡偲胎盤精華液」壹盒，囑予鑑定乙節。復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴署八十四年十月九日士檢會八六偵九五六五字第二一九五○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、胎盤素製品之管理，如為牛、羊動物之胎盤萃取精製（又稱抽出物），則以藥品列管；若為牛、羊動物之胎盤直接磨粉製成，且不添加其他藥品成分者，則以食品管理，惟不得宣稱療效；另若以「人」之胎盤萃取精製或直接磨粉製成，均以藥品列管。是以若經核屬藥品管理，則須申領藥品許可證後，始得製造或輸入；違者，依偽藥或禁藥論處。</span> </p><p><span style="font-family: 新細明體, serif;">三、經查前開檢體，</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">「源胚」製品，係自「人」之胎盤萃取精製，且標示涉及療效詞句，應以藥品管理，與本署八十四年三月三十一日衛署食字第八四○一四八八○號所核准之內容不符，併予敘明；</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">日本產製肝臟機能改善劑「</span><span style="font-family: calibri;">LAENNEC INJ. 2ML</span><span style="font-family: 新細明體, serif;">×</span><span style="font-family: calibri;">10 AMP.</span><span style="font-family: 新細明體, serif;">」注射劑，係屬藥品；</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">「怡偲胎盤精華液」製品，依其使用須知，將「</span><span style="font-family: calibri;">LANNEC INJ.</span><span style="font-family: 新細明體, serif;">」</span><span style="font-family: calibri;">2ML</span><span style="font-family: 新細明體, serif;">×</span><span style="font-family: calibri;">2AMP.</span><span style="font-family: 新細明體, serif;">注射劑加入</span><span style="font-family: calibri;">120ML</span><span style="font-family: 新細明體, serif;">液體瓶裝中，搖晃均勻使用之，係屬藥品管理，該涉案三種藥品，均未經本署核准藥品登記，仍請查明其來源予以審酌。</span> </p> | 2013-12-16 | |
| 1420640 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署八十六年六月十四日衛署藥字第八六○二七八五二號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">關於輸入及經銷管制藥品之藥商，得否依醫師處方販售供應該藥商輸入經銷之管制藥品，復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：</span> </p><p><span style="font-family: 新細明體, serif;">一、復貴局八十六年五月十三日北市衛四字第八六二二六九二五○○號函。</span> </p><p><span style="font-family: 新細明體, serif;">二、依藥事法第十五條之規定，西藥販賣業者，係指經營西藥批發、零售、輸入及輸出之業者；西藥之調劑，係為同法第十九條藥局之業務範圍。管制藥品係屬醫師處方藥品，依同法第五十條第一項前段，須由醫師處方之藥品，非經醫師處方，不得調劑供應；復據該條但書規定，同業藥商之批發、販賣，則不在此限。</span> </p><p><span style="font-family: 新細明體, serif;">三、綜上，西藥販賣業者，不得依醫師處方「販售」管制藥品。</span> </p> | 2013-12-16 | |
| 1420641 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署八十四年七月二十四日衛署藥字第八四○四四六○九號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">有關「青草湯」廣告乙案，查以民間青草藥作成茶包，得不以藥品管理，惟不得宣稱療效，復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：復貴處八十四年七月十三日</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">八四</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">衛四字第○五五○三八號函。</span> </p> | 2013-12-16 | |
| 1420642 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署六十五年三月八日衛署藥字第一○一四一五號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">以「杭菊」製成之耐存飲料，按食品管理，准予製售，惟同時摻用其他中藥材或藥品者，應依藥品管理，復請 查照。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：復貴處六十五年一月二十三日衛四字第○七一一七號函。</span> </p> | 2013-12-16 | |
| 1420643 | 藥政管理類,藥事法 | 行政解釋 | 行政院衛生署六十四年四月二日衛署藥字第六二八一五號函 | <p><span style="font-family: 新細明體, serif;">主 旨：</span> <span style="font-family: 新細明體, serif;">樟腦及其系列品為「中華藥典」所收載，但亦為一般工業原料，非以醫藥之目的而加工或販賣者，不宜比照藥品管理。</span> </p><p><span style="font-family: 新細明體, serif;">說 明：復貴處六十四年三月七日衛四字第一二五一一號函。</span> </p> | 2013-12-16 | |
| 1420644 | 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記,指示藥品審查基準,胃腸製劑,眼用製劑,解熱鎮痛劑,綜合感冒藥,瀉藥,鎮咳祛痰劑,驅蟲劑,鎮暈劑,抗過敏劑,指示藥品審查基準-一般皮膚外用劑,西藥及醫療器材查驗登記審查費收費標準,藥物資料公開辦法,新型流感疫苗查驗登記指引,核醫放射性藥品審查基準,生物相似性藥品查驗登記技術性資料審查重點表,新成分新藥查驗登記療效及安全性之考量重點,原料藥主檔案(DMF)核備及國產原料藥查驗登記精實送審文件資料,新藥查驗登記精簡審查程序,新藥查驗登記優先審查機制,國產創新藥品查驗登記專案試辦計畫 | 法規命令 | 行政院衛生署受理藥物、化粧品查驗登記審查費收費標準 | <p><span style="font-family: 新細明體, serif;">所</span> <span style="font-family: 新細明體, serif;">有</span> <span style="font-family: 新細明體, serif;">條</span> <span style="font-family: 新細明體, serif;">文</span><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 1 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">新藥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">藥事法規定之新藥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">成分、新療效複方或新使用途徑製劑之藥品</span><span style="font-family: calibri;">)</span></p> </td> <td style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">國內新設工廠、新劑型設立查核</span> </p> </td> <td style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 新細明體, serif;">國外製藥工廠資料備查</span> </p> </td> <td style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 2 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">新藥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">監視新藥</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">期中、期滿</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">、新劑型、新劑量、控釋劑型等製劑之藥品</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">35,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內新設工廠、新劑型設立查核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外製藥工廠資料備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 3 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">一般製劑</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">非屬新藥一、二之藥品</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內新設工廠、新劑型設立查核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外製藥工廠資料備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 4 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">四</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">生物製劑、類毒素及菌液等、基因工程製劑</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span><span style="font-family: calibri;">(一)</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體, serif;">血液製劑、抗毒素、疫苗。</span> </p> <p><span><span style="font-family: calibri;">(二)</span><span style="font: 7pt times new roman;"> </span></span><span style="font-family: 新細明體, serif;">利用基因工程製造之藥品</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內新設工廠、新劑型設立查核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外製藥工廠資料備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 5 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">臨床試驗</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">計畫書審核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">15,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 6 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">六</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">生體可用率／生體</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">相等性</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">計畫書審核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">5,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 7 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">原料藥</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">供藥廠製造藥品之原料</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">30,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 8 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">八</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">自用原料輸入</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內藥廠輸入自用之報備</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 9 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">九</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">新醫療器材</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">含新醫療效能</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">須檢附臨床、安全性試驗報告等之新醫療器材。</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">50,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">列管查核</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">須查驗或不須查驗之判定</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內醫療器材廠ＧＭ</span><span style="font-family: calibri;">P</span><span style="font-family: 新細明體, serif;">查核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr style="height: 27.75pt;"> <td valign="top" style="border-top: #f0f0f0; height: 27.75pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; height: 27.75pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: #f0f0f0; padding-right: 1.4pt; width: 139.5pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外醫療器材工廠資料備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; height: 27.75pt; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: #f0f0f0; padding-right: 1.4pt; width: 139.25pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 10 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一○</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">一般醫療器材</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">列管之醫療器材</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">列管查核</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">須查驗或不須查驗之判定</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國內醫療器材廠Ｇ</span><span style="font-family: calibri;">M</span><span style="font-family: 新細明體, serif;">Ｐ查核</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">國外醫療器材工廠資料備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 11 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一一</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">新發明或新化粧品</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">含藥化粧品、化粧品色素</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">須檢附研究報告、含配方禁忌之安全試驗報告</span> </p> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">臨床報告之新化粧品</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">20,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 12 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一二</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">含藥化粧品、化粧品色素</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">含藥品成分之化粧品、化粧品用色素</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">8,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 13 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一三</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">一般化粧品</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">含藥品成分之化粧品備查</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">3,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 14 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一四</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">藥品變更</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">新適應症、新用法用量、新類別或新賦形劑</span><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">12,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">委託製造、移轉、合併、產地變變更、遷廠</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">以廠次計</span><span style="font-family: calibri;">)</span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">8,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">其化變更或委託包裝、許可證、標仿遺失補發</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">5,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 15 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一五</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">醫療器材變更</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">增加新適用用範圍</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">12,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: #f0f0f0; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">二</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">移轉、合併、產地變更、遷廠</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">以廠次計</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">、增加規格</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">8,000</span></p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">三</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">其他變更或許可證、標仿遺失補發</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">5,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 16 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一六</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">化粧品變更</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">含藥化粧品、化粧品色素許可證、一般化粧品備查函內容變更、化粧品分裝或改裝備查。</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">3,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 17 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一七</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">展延</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">原核准許可證、備查函有效期間展延</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">3,000</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 18 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一八</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">產地證明、ＧＭＰ藥廠、醫療器材英文證明及查驗登記函詢案件</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: 新細明體, serif;">第</span><span style="font-family: calibri;"> 19 </span><span style="font-family: 新細明體, serif;">條</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">行政院衛生署受理藥物、化粧品查驗登記審查費收費標準</span> </p><p><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">單位：新台幣</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">元</span> </p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;border: windowtext 1pt solid;"> <p><span style="font-family: 新細明體, serif;">受理類別</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">定義與範圍</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">收費標準</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: windowtext 1pt solid; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: 新細明體, serif;">一九</span><span style="font-family: calibri;"> </span><span style="font-family: 新細明體, serif;">領證費用</span> </p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.35pt; background-color: transparent;"> <p><span style="font-family: calibri;"> </span></p> </td> <td valign="top" style="border-top: #f0f0f0; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 5.4pt; border-left: #f0f0f0; padding-right: 5.4pt; width: 139.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-family: calibri;">1,500</span></p> </td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p> | 2013-12-16 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6089&type=0 |
| 1420645 | 查驗登記類,西藥及醫療器材查驗登記審查費收費標準 | 法規命令 | 西藥及醫療器材查驗登記審查費收費標準 | <table width="614" style="border-collapse: collapse; width: 460.4pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;border: white 1pt solid;"> <p><span style="font-family: 標楷體;">第一條 本標準依藥事法第一百零四條之二第二項規定訂定之。 </span></p> </td> </tr> <tr> <td style="border-top: #f0f0f0; border-right: white 1pt solid; border-bottom: white 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: white 1pt solid; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;"> <p><span style="font-family: 標楷體;">第二條 西藥及醫療器材辦理查驗登記者，每件應繳納之審查費如下： </span></p> <p><span style="font-family: 標楷體;">一、新藥 </span></p> <p><span style="font-family: 標楷體;">（一）新成分製劑之藥品查驗登記，新臺幣六十萬元。 </span></p> <p><span style="font-family: 標楷體;">（二）新療效複方或新使用途徑製劑之藥品查驗登記，新臺幣五萬元。 </span></p> <p><span style="font-family: 標楷體;">（三）國內新設工廠或新劑型設立查核，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（四）國外製藥工廠資料備查，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（五）新劑型、新使用劑量、新單位含量或控釋劑型、相同成分相同投與途徑不同劑量之新成分新藥等製劑產品之查驗登記，新臺幣三萬五千元。 </span></p> <p><span style="font-family: 標楷體;">二、一般製劑 </span></p> <p><span style="font-family: 標楷體;">（一）監視藥品之學名藥品查驗登記，新臺幣三萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（二）非屬監視藥品之學名藥品查驗登記，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（三）國內新設工廠或新劑型設立查核，新臺幣二萬元。<span style="text-decoration: underline;"> </span></span></p> <p><span style="font-family: 標楷體;">（四）國外製藥工廠資料備查，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（五）外銷專用藥品查驗登記，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">三、生物藥品 </span></p> <p><span style="font-family: 標楷體;">（一）血液製劑、抗毒素或疫苗查驗登記，新臺幣六十萬元。 </span></p> <p><span style="font-family: 標楷體;">（二）利用基因工程製造之藥品查驗登記，新臺幣六十萬元。 </span></p> <p><span style="font-family: 標楷體; text-decoration: underline; text-underline: none;">（三）國內新設工廠或新劑型設立查核，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（四）國外製藥工廠資料備查，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（五）</span><span style="font-family: 標楷體;">已審查過之生物藥品，其不同劑量包裝、不同產地之查驗登記，新臺幣三萬五千元。</span> </p> <p><span style="font-family: 標楷體;">四、臨床試驗 </span></p> <p><span style="font-family: 標楷體;">（一）臨床試驗計畫書審核，新臺幣一萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（二）臨床試驗報告書查核，新臺幣一萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（三）銜接性試驗評估，新臺幣一萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（四）臨床試驗相關函詢，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">五、生體可用率及生體相等性試驗 </span></p> <p><span style="font-family: 標楷體;">（一）生體可用率試驗計畫書審核，新臺幣五千元。 </span></p> <p><span style="font-family: 標楷體;">（二）生體相等性試驗計畫書審核，新臺幣五千元。 </span></p> <p><span style="font-family: 標楷體;">（三）非監視成分之生體可用率試驗報告書審核，新臺幣一萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（四）非監視成分之生體相等性試驗報告書審核，新臺幣一萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（五）非監視成分口服劑型藥品之溶離率曲線比對報告書審核，新臺幣五千元。 </span></p> <p><span style="font-family: 標楷體;">六、原料藥 </span></p> <p><span style="font-family: 標楷體;">（一）供藥廠製造藥品之原料藥查驗登記，新臺幣三萬元。 </span></p> <p><span style="font-family: 標楷體;">（二）輸入自用原料藥備查，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（三）輸入試製藥品原料藥備查，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">七、醫療器材 </span></p> <p><span style="font-family: 標楷體;">（一）新原理、新結構、新材料、新效能或經中央衛生主管機關審查認定屬新醫療器材之查驗登記，新臺幣三萬元。 </span></p> <p><span style="font-family: 標楷體;">（二）一般及外銷專用醫療器材查驗登記，新臺幣一萬元。 </span></p> <p><span style="font-family: 標楷體;">（三）醫療器材列管查核，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（四）國內醫療器材製造工廠查核或其後續稽核，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（五）國外醫療器材製造工廠品質系統文件審查或其後續稽核，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（六）優良醫療器材製造工廠認可登錄增加登錄品項或遷廠之變更，新臺幣二萬元。 </span></p> <p><span style="font-family: 標楷體;">（七）優良醫療器材製造工廠認可登錄之其他變更，新臺幣八千元。 </span></p> <p><span style="font-family: 標楷體;">（八）第一等級體外診斷試劑備查函，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（九）第三等級體外診斷試劑查驗登記（新增品項），新臺幣五萬元。 </span></p> <p><span style="font-family: 標楷體;">（十）第三等級體外診斷試劑查驗登記（類似品項），新臺幣三萬五千元。 </span></p> <p><span style="font-family: 標楷體;">（十一）醫療器材半成品備查，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">八、藥品登記事項變更 </span></p> <p><span style="font-family: 標楷體;">（一）新適應症、新用法用量、新類別或新賦形劑變更，新臺幣一萬二千元。 </span></p> <p><span style="font-family: 標楷體;">（二）委託製造、移轉、合併、產地或遷廠變更，新臺幣八千元。 </span></p> <p><span style="font-family: 標楷體;">（三）前目以外之其它變更，新臺幣五千元。 </span></p> <p><span style="font-family: 標楷體;">九、醫療器材登記事項變更 </span></p> <p><span style="font-family: 標楷體;">（一）增加新適用範圍變更，新臺幣一萬二千元。 </span></p> <p><span style="font-family: 標楷體;">（二）增加規格、移轉、合併、產地或遷廠變更，新臺幣八千元。 </span></p> <p><span style="font-family: 標楷體;">（三）其它變更或申請委託包裝，新臺幣五千元。 </span></p> <p><span style="font-family: 標楷體;">（四）許可證、標籤或仿單之遺失補發，新臺幣五千元。 </span></p> <p><span style="font-family: 標楷體;">十、藥物原核准許可證有效期間展延，新臺幣三千元。 </span></p> <p><span style="font-family: 標楷體;">十一、證明書及備查函 </span></p> <p><span style="font-family: 標楷體;">（一）中文產地證明書，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（二）英文產地證明書，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（三）中文優良藥品製造證明書，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（四）英文優良藥品製造證明書，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（五）中文優良醫療器材製造證明書，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（六）英文優良醫療器材製造證明書，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（七）中文備查函證明，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">（八）英文備查函證明，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">十二、藥物許可證領證，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">十三、案件函詢，新臺幣一千五百元。 </span></p> <p><span style="font-family: 標楷體;">十四、國外藥品製造工廠實地查核 </span></p> <p><span style="font-family: 標楷體;">（一）工廠資料經衛生署准予備查者， 新臺幣五十萬元。 </span></p> <p><span style="font-family: 標楷體;">（二）工廠資料未經衛生署准予備查者，新臺幣五十六萬元。 </span></p> <p><span style="font-family: 標楷體;">十五、國外醫療器材製造工廠實地查核 </span></p> <p><span style="font-family: 標楷體;">（一）實地查核或其後續稽核，新臺幣五十萬元。 </span></p> <p><span style="font-family: 標楷體;">（二）增加登錄品項之查核，新臺幣五十萬元。 </span></p> <p><span style="font-family: 標楷體;">（三）遷廠之查核，新臺幣五十萬元。 </span></p> <p><span style="font-family: 標楷體;">前項第八款第二目及第九款第二目之變更申請，每件以一廠次為限。 </span></p> <p><span style="font-family: 標楷體;">第一項第十一款證明書及備查函之申請，每件以一式五份為限。 </span></p> <p><span style="font-family: 標楷體;">第一項第十四款，每件每增加一劑型之收費如下： </span></p> <p><span style="font-family: 標楷體;">一、非無菌製劑之同一廠房、空調、水系統，加收新臺幣三萬五千元。</span> </p> <p><span style="font-family: 標楷體;">二、非無菌製劑之同一廠房不同空調或水系統，加收新臺幣五萬元。 </span></p> <p><span style="font-family: 標楷體;">三、無菌製劑之同一廠房不同空調或水系統，加收新臺幣八萬八千元。 </span></p> <p><span style="font-family: 標楷體;">四、非無菌製劑之同一廠房不同空調系統且不同水系統，加收新臺幣七萬元。 </span></p> <p><span style="font-family: 標楷體;">五、無菌製劑之同一廠房不同空調系統且不同水系統，加收新臺幣十萬五千元。 </span></p> <p><span style="font-family: 標楷體;">六、非無菌製劑之不同廠房，加收新臺幣十萬五千元。 </span></p> <p><span style="font-family: 標楷體;">七、無菌製劑之不同廠房，加收新臺幣十萬五千元。 </span></p> <p><span style="font-family: 標楷體;">第一項第十五款，每件每增加一醫療器材品項製程之收費如下： </span></p> <p><span style="font-family: 標楷體;">一、同一廠房，加收新臺幣三萬五千元。 </span></p> <p><span style="font-family: 標楷體;">二、不同廠房，加收新臺幣十萬五千元。 </span></p> <p><span style="font-family: 標楷體;">第一項第十五款，每件每增加一不同滅菌製程，加收新臺幣十萬五千元。 </span></p> <p><span style="font-family: 標楷體;">第一項第一款第一目、第三款第一目及第二目</span><span style="font-family: 標楷體;">自中華民國九十六年一月一日施行。</span> </p> </td> </tr> <tr> <td valign="top" style="border-top: #f0f0f0; border-right: white 1pt solid; border-bottom: white 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: white 1pt solid; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;"> <p><span style="font-family: 標楷體;">第三條 辦理本標準第二條第十四款及第十五款之查核人員臨場費，應比照國外出差旅費報支要點所定標準，由中央衛生主管機關向被查核者收取。 </span></p> </td> </tr> <tr> <td style="border-top: #f0f0f0; border-right: white 1pt solid; border-bottom: white 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: white 1pt solid; padding-right: 1.4pt; width: 460.4pt; background-color: transparent;"> <p><span style="font-family: 標楷體;">第四條 本標準</span><span style="font-family: 標楷體;">除已另定施行日期者外，</span><span style="font-family: 標楷體;">自發布日施行。 </span></p> <p><span style="font-family: 標楷體;"> </span></p> </td> </tr> </tbody></table><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p><p style="text-align: justify; text-justify: inter-ideograph; line-height: 23pt;"> </p> | 2013-12-16 | |
| 1420646 | 藥政管理類,藥事法 | 行政解釋 | 含diclofenac成分藥品之仿單修訂事宜diclofenac皮膚外用劑型仿單 | <p><b><span style="font-family: 標楷體; font-size: 14pt;">修訂Diclofenac成分藥品（皮膚外用劑型）之仿單內容－包括用法用量、禁忌、警語、注意事項、副作用、藥物交互作用、特殊族群及過量</span></b><span style="font-family: 標楷體; font-size: 13pt;">(</span><span style="font-family: 標楷體; font-size: 13pt;">劃線為新增部分)</span></p><p><span style="font-family: 標楷體; font-size: 14pt;">【用法用量】 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">增加『本製劑不建議使用於12歲以下之兒童』。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">【注意事項】 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">1. </span><span style="font-family: 標楷體; font-size: 14pt;">本製劑只能用於完整皮膚，不可用於裂開的皮膚或開放性傷口。本製劑不要與眼睛及黏膜接觸。本品僅供外用，不可口服。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">2. </span><span style="font-family: 標楷體; font-size: 14pt;">須置於小孩接觸不到之處。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">3. </span><span style="font-family: 標楷體; font-size: 14pt;">避免陽光直射，宜保存於陰涼之處。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">4. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">懷孕:尚未有研究報告顯示關於孕婦使用本製劑之安全性，因此本製劑於懷孕期間不應使用。由於可能造成子宮無力（Uterine inertia）和/或胎兒動脈導管過早閉合，因此在懷孕第三期使用本製劑為禁忌。動物研究尚未顯示任何直接或間接對於在懷孕期間胚胎/胎兒發展、分娩或產後發展的不良影響。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">5. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">授乳:</span><span style="font-family: 標楷體; color: black; font-size: 14pt; text-decoration: underline;">本製劑</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">是否分泌至人類乳汁中尚屬未知，因此本製劑於授乳期間不建議使用。若為不得已使用，本製劑不得用於乳房部位或大面積投予，更不可長期使用。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">6. </span><span style="font-family: 標楷體; font-size: 14pt;">除非醫師或藥師、藥劑生指示，本製劑勿使用於大面積之體表或皮膚深部感染。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">7. </span><span style="font-family: 標楷體; font-size: 14pt;">請勿超過建議劑量，若有副作用產生，應立即停藥就醫。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">8. </span><span style="font-family: 標楷體; font-size: 14pt;">使用後自覺狀況未改善或更惡化，應立即停藥並就醫。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">9. </span><span style="font-family: 標楷體; font-size: 14pt;">除非醫師或藥師、藥劑生指示，非類固醇抗發炎藥劑不可連續使用超過二星期。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">【警語】 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">1.</span><span style="font-family: 標楷體; font-size: 14pt;">癬類或其他皮膚感染症，應使用抗感染劑，單獨使用非類固醇抗發炎藥劑會使病情惡化。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">2.</span><span style="font-family: 標楷體; font-size: 14pt;">皮膚的黴菌感染有時不易與其他皮膚炎區分，誤用非類固醇抗發炎藥劑會使病情惡化並造成日後診斷及治療之困難。 </span></p><p class="Default"><span style="font-family: 標楷體; font-size: 14pt;">3.</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">使用本品，仍有極少數引起肝功能異常之報告。</span><span style="font-family: 標楷體; font-size: 14pt;"> </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">【禁忌】 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">1. </span><span style="font-family: 標楷體; font-size: 14pt;">Diclofenac sodium, Acetylsalicylic acid</span><span style="font-family: 標楷體; font-size: 14pt;">及其他非類固醇抗發炎藥物，或對Propylene glycol有過敏反應者禁用本藥。 </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">2. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">懷孕第三期禁用本藥。</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;"> </span></p><p><span style="font-family: 標楷體; font-size: 14pt;">【副作用】</span> </p><p><span style="font-size: 14pt;">1. </span><span style="font-family: 標楷體; font-size: 14pt;">偶有搔癢、灼熱感、局部發紅、過敏性皮膚炎。</span> </p><p><span style="font-size: 14pt;">2. Diclofenac </span><span style="font-family: 標楷體; font-size: 14pt;">局部治療期間發生全身反應與出現副作用的可能性較口服給與的機率小。假如長期大面積使用本製劑，不能完全排除全身性反應的可能性。</span> </p><p><span style="font-size: 14pt;">3. </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">不良反應依器官系統分類和發生頻率詳列於下表。發生頻率之定義為</span><span style="font-size: 14pt; text-decoration: underline;">: </span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">極常見</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/10)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">、常見</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/100 ~ < 1/10)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">、不常見</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/1,000 ~ < 1/100)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">、罕見</span><span style="font-size: 14pt; text-decoration: underline;">(</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">≧</span><span style="font-size: 14pt; text-decoration: underline;">1/10,000 ~ < 1/1,000)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">、極罕見</span><span style="font-size: 14pt; text-decoration: underline;">(< 1/10,000)</span><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">。在各組發生頻率中，依不良反應的嚴重度降冪排列。</span><span style="text-decoration: underline;"> </span></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; padding-top: 0cm;border: black 1pt solid;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">感染和寄生蟲感染</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">:</span> <span style="font-family: 標楷體; font-size: 14pt;">膿皰性發疹</span> </p> </td> </tr> <tr> <td valign="top" style="border-bottom: black 1pt solid; border-left: black 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: black 1pt solid; padding-top: 0cm;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">免疫系統的異常</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">過敏</span><span style="font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">包含蕁麻疹</span><span style="font-size: 14pt;">)</span><span style="font-family: 標楷體; font-size: 14pt;">、血管性水腫</span> </p> </td> </tr> <tr> <td valign="top" style="border-bottom: black 1pt solid; border-left: black 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: black 1pt solid; padding-top: 0cm;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">呼吸道、胸部及縱膈的異常</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">氣喘</span> </p> </td> </tr> <tr> <td valign="top" style="border-bottom: black 1pt solid; border-left: black 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 456.35pt; padding-right: 5.4pt; border-top: #f0f0f0; border-right: black 1pt solid; padding-top: 0cm;"> <p><b><span style="font-family: 標楷體; font-size: 14pt; text-decoration: underline;">皮膚和皮下組織的異常</span></b><b><span style="text-decoration: underline;"> </span></b></p> <p><span style="font-family: 標楷體; font-size: 14pt;">常見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">皮膚炎</span><span style="font-size: 14pt;">(</span><span style="font-family: 標楷體; font-size: 14pt;">包含接觸性皮膚炎</span><span style="font-size: 14pt;">)</span><span style="font-family: 標楷體; font-size: 14pt;">、紅疹、紅斑、濕疹、搔癢</span> </p> <p><span style="font-family: 標楷體; font-size: 14pt;">罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">水泡性皮膚炎</span> </p> <p><span style="font-family: 標楷體; font-size: 14pt;">極罕見</span><span style="font-size: 14pt;">: </span><span style="font-family: 標楷體; font-size: 14pt;">光敏感反應</span> </p> </td> </tr> </tbody></table><p><span style="font-family: 標楷體; font-size: 14pt;">【交互作用】</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;">至今未有本製劑的交互作用報告。</span> </p><p><span style="font-family: 標楷體; font-size: 14pt;">【過量】</span> </p><p><span style="font-size: 14pt;">Diclofenac </span><span style="font-family: 標楷體; font-size: 14pt;">局部使用的全身性吸收低，不易發生過量。如使用不當及無意的過量（如用於兒童），可能產生顯著的全身性反應，此時要採取一般的非</span><span style="font-family: 標楷體; font-size: 14pt;">類固醇抗發炎藥中毒救治措施以治療過量。</span> </p> | 2013-12-16 | |
| 1420647 | 藥政管理類,藥事法 | 行政解釋 | 含diclofenac成分藥品之仿單修訂事宜公告PDF檔 | 詳如附件 | 2013-12-16 | |
| 1420648 | 藥政管理類,藥事法 | 行政解釋 | 含diclofenac成分藥品之仿單修訂事宜增修全身性Diclofenac成分藥品 | <p><b><span style="font-family: 標楷體; font-size: 13pt;">修訂Diclofenac成分藥品（口服、注射及栓劑劑型）之仿單內容－包括禁忌、警語、注意事項、副作用、藥物交互作用、特殊族群及過量</span></b><span style="font-family: 標楷體; font-size: 13pt;">(</span><span style="font-family: 標楷體; font-size: 13pt;">劃線為新增部分)</span></p><p><span style="font-family: 標楷體;">【禁忌】 </span></p><p><span style="font-family: 標楷體;">1.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">對Diclofenac過敏之患者。 </span></p><p><span style="font-family: 標楷體;">2.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">消化性潰瘍患者。 </span></p><p><span style="font-family: 標楷體;">3.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">重症之血液異常患者。 </span></p><p><span style="font-family: 標楷體;">4.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">重症之肝障害患者。 </span></p><p><span style="font-family: 標楷體;">5.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">重症之腎障害患者。 </span></p><p><span style="font-family: 標楷體;">6.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">服用aspirin或其他非類固醇類消炎藥之後曾發生氣喘、蕁麻疹或其他過敏反應者。此類病人曾有嚴重(極少數為致死性)類過敏反應(anaphylactic-like reaction)發生之報告。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">7.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">於冠狀動脈繞道(CABG)手術期間投予作為止痛之用。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">8.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體; text-decoration: underline;">懷孕第三期婦女禁用本藥。 </span></p><p><span style="font-family: 標楷體;">【注意事項】 </span></p><p><span style="font-family: 標楷體;">1.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用消炎鎮痛劑治療，乃為對症療法非原因療法。 </span></p><p><span style="font-family: 標楷體;">2.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">使用於治療慢性疾患（慢性風濕性關節炎、僵直性脊髓炎）時應考慮以下事項： </span></p><p><span style="font-family: 標楷體;">（1）長期投與時，須定期作臨床檢查（尿檢查、血液檢查、肝功能檢查）遇有異常現象發生時，則須採取減量或停藥等適當措施。 </span></p><p><span style="font-family: 標楷體;">（2）考慮非藥物性療法。 </span></p><p><span style="font-family: 標楷體;">3. </span><span style="font-family: 標楷體;">使用於治療急性疾患時，應考慮以下事項： </span></p><p><span style="font-family: 標楷體;">（1）對於急性炎症須考慮其病痛及發熱程度而給藥。 </span></p><p><span style="font-family: 標楷體;">（2）原則上應避免長期使用同一類藥品。 </span></p><p><span style="font-family: 標楷體;">（3）如有原因療法則應採用。 </span></p><p><span style="font-family: 標楷體;">4. </span><span style="font-family: 標楷體;">須仔細觀察患者之狀況，留意有否副作用發生。 </span></p><p><span style="font-family: 標楷體;">5. </span><span style="font-family: 標楷體;">本藥可能遮蔽感染症狀之顯現，因此用於治療感染所引起之炎症時，必須合併使用適當之抗菌劑，同時仔細觀察，慎重投與。 </span></p><p><span style="font-family: 標楷體;">6. </span><span style="font-family: 標楷體;">儘量避免與其它消炎、鎮痛劑合併使用。 </span></p><p><span style="font-family: 標楷體;">7. </span><span style="font-family: 標楷體;">對小兒及高齡患者，尤其注意有否副作用出現，並以最低之有效劑量來慎重投予。 </span></p><p><span style="font-family: 標楷體;">8. </span><span style="font-family: 標楷體;">diclofenac</span><span style="font-family: 標楷體;">可能導致胎兒動脈導管過早閉合，因此於懷孕後期應避免使用。 </span></p><p><span style="font-family: 標楷體;">9. </span><span style="font-family: 標楷體;">對以下患者須慎重投與： </span></p><p><span style="font-family: 標楷體;">（1）患有肝障礙或曾有該病史之患者。 </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext;">（2）曾有過敏性病史之患者。</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">從未接觸過diclofenac的病人亦有可能發生類過敏反應(Anaphylactoid Reactions)。具有aspirin三症狀(aspirin triad)的病人不可投予diclofenac治療。這種複合症狀主要發生在患有鼻炎(無論具有鼻息肉與否)的氣喘病人，或是使用aspirin或其他非類固醇類消炎藥之後會發生嚴重而可能致死之支氣管痙攣的病人。一旦類過敏反應發生，應立即就醫診治。 </span></p><p><span style="font-family: 標楷體;">（3）支氣管氣喘之患者。</span><span style="font-family: 標楷體; text-decoration: underline;">氣喘病人可能具有aspirin敏感性氣喘。此類病人投予aspirin曾出現嚴重而可能致死的支氣管痙攣。由於aspirin與其他非類固醇消炎藥在此類病人中曾有交叉反應性的報告，因此此類aspirin過敏病人不可使用diclofenac，而對於原患有氣喘之病人也應謹慎投予。 </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">10. </span><span style="font-family: 標楷體; text-decoration: underline;">皮質類固醇藥物治療：diclofenac不能取代皮質類固醇或治療皮質類固醇不足。貿然停用皮質類固醇可能造成皮質類固醇反應性疾病的惡化。長期接受皮質類固醇治療的病人，若決定停藥，應緩慢減低劑量。 </span></p><p><span style="font-family: 標楷體;">11.</span><span style="font-family: 標楷體; text-decoration: underline;"> diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">抗發炎及退燒的藥理作用會降低利用這些診斷徵象來偵測感 染性併發症發生於一些本來推論為非感染性疼痛情形的機會。 </span></p><p><span style="font-family: 標楷體;">12.</span><span style="font-family: 標楷體; text-decoration: underline;">實驗室檢驗：由於嚴重的胃腸道潰瘍及出血可能沒有預警症狀，醫師應監測是否有胃腸出血的徵象或症狀。長期使用非類固醇類消炎藥的病人，應定期做全血球計數(CBC)及生化檢查。若肝功能或腎功能檢驗異常的情形維持或惡化，應立即停藥。 </span></p><p><span style="font-family: 標楷體;">【警語】 </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">1. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">心血管作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">栓塞性心血管事件</span></i><i><span style="font-family: arial, sans-serif; text-decoration: underline;"> (Cardiovascular Thrombotic Events)</span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">使用非類固醇類消炎藥治療可能使發生嚴重而可能致死之栓塞性心血管事件、心肌梗塞與中風的危險性增加。對於患有心血管疾病或具有心血管疾病危險因子的病人應使用最低有效劑量，並作為期最短的治療。病人應被告知嚴重心血管毒性的徵象與症狀，及萬一發生時所應採取的步驟。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">沒有一致的證據證明同時使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">aspirin</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">能夠減少使用非類固醇類消炎藥時的嚴重栓塞性心血管事件風險。而同時使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">aspirin</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">與</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">確實會增加嚴重胃腸道事件的危險性。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">兩個大型對照性臨床試驗中，發現選擇性</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">COX-2</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">之非類固醇類消炎藥在</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">CABG</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">手術後</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">10-14</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">天用於止痛，會增加其心肌梗塞和中風之發生率。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">高血壓</span></i><i><span style="text-decoration: underline;"> </span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">投予非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療可能導致新的高血壓發病或使原有的高血壓惡化。使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">thiazides</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">利尿劑或環利尿劑的病人，在服用非類固醇類消炎藥期間對這些利尿劑的反應可能會減弱。對於高血壓之病人應謹慎投予</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">，治療期間應密切監測血壓。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">充血性心衰竭與水腫</span></i><i><span style="text-decoration: underline;"> </span></i></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">有些病人接受非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療後曾發生體液滯留及水腫的現象。對於體液滯留或心衰竭之病人應謹慎投予。</span><span style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">2. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">胃腸道作用－胃腸潰瘍、出血及穿孔之危險性</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">可能引起胃、小腸或大腸發炎、出血、潰瘍及穿孔等嚴重而可能致死之腸胃道不良反應。接受非類固醇類消炎藥治療的病人隨時可能出現這些嚴重的不良事件，且不一定有預警症狀。對於有消化性潰瘍疾病或胃腸道出血病史之病人應謹慎投予。其他會增加使用非類固醇類消炎藥治療時發生胃腸道出血的危險因子包括同時使用口服皮質類固醇或抗凝血劑、長期使用非類固醇類消炎藥、吸煙、喝酒、年長及整體健康狀況不佳等。為了降低胃腸道不良反應的潛在危險，病人應使用最低有效劑量，並作為期最短的治療。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><b><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">3. </span></b><b><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">肝臟作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">投予</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療期間可能發生一種或多種肝功能指數升高的現象。持續治療時，這些檢驗值異常可能會惡化、保持不變或僅為短暫的現象。</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">依據上市後藥物安全監測報告，</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">引起之肝毒性不良反應包括肝臟壞死、黃疸、猛暴性肝炎（無論具有黃疸與否）及肝衰竭。其中一些通報案例導致死亡或肝臟移植。長期使用</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療的病人應定期檢測肝臟轉氨酶（</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">transaminases</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">），依據臨床試驗數據和上市後經驗，應於治療後的第</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">4</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">到第</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">8</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">週内進行檢測。然而，嚴重肝毒性不良反應可能發生在以</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療的任何時間。</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;"> </span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">若肝功能指數異常的情形維持或惡化，或出現與肝病一致的臨床徵象與症狀，或出現全身性反應</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">如嗜伊性白血球增多、皮疹、腹痛、腹瀉、褐色尿液等</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">時應立即停藥。為了降低肝臟不良反應的潛在危險，病人應使用最低有效劑量，並作為期最短的治療。同時投予具有潛在肝毒性的藥物</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">例如抗生素、抗癲癇藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">治療時須特別注意。</span><span style="text-decoration: underline;"> </span></p><p class="Default"><b><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">4. </span></b><b><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">腎臟作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">長期投予非類固醇類消炎藥可能導致腎乳頭壞死及其他腎臟損傷。對於發生這類反應的高危險族群</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">年長者、腎功能受損、心衰竭、肝功能不全及使用利尿劑與</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">ACE</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">抑制劑的病人</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">應謹慎投予。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">重症腎臟疾病</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">目前之對照性臨床試驗中尚未有關於重症腎臟疾病病人使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenec</span><span style="font-family: 標楷體; text-decoration: underline;">的資料，因此不建議此類病人使用。若必須開始</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療，建議應該密切監測病人的腎功能。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">5. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">皮膚反應</span></b><b><span style="text-decoration: underline;"> </span></b></p><p class="Default"><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">非類固醇類消炎藥</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">包括</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">在內</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">可能引發嚴重而可能致死的皮膚不良反應，例如剝落性皮膚炎、</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">史蒂文生氏</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">-</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">強生症候群</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(SJS)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">和毒性表皮壞死溶解</span><span style="font-family: arial, sans-serif; color: windowtext; text-decoration: underline;">(TENS)</span><span style="font-family: 標楷體; color: windowtext; text-decoration: underline;">。一旦出現皮疹或其他過敏徵象時應立即停藥。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">6. </span></b><b><span style="font-family: 標楷體; text-decoration: underline;">血液作用</span></b><b><span style="text-decoration: underline;"> </span></b></p><p><span style="font-family: 標楷體; text-decoration: underline;">接受非類固醇類消炎藥治療的病人有時會發生貧血。長期使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療的病人若出現任何貧血或失血的徵象或症狀，應進行血紅素及血比容之檢測。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">非類固醇類消炎藥會抑制血小板凝集，某些病人可能出現出血時間延長的情形。患有凝血疾病或正在使用抗凝血劑的病人應密切監測血小板功能。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">【不良反應】</span> </p><p><span style="font-family: 標楷體; text-decoration: underline;">使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">治療之病人較為常見的不良反應為</span><span style="font-family: 標楷體; text-decoration: underline;">胃腸道的影響，包括腹痛、便祕、腹瀉、消化不良、脹氣、大出血</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">穿孔、心灼熱感、噁心、胃腸道潰瘍</span><span style="font-family: arial, sans-serif; text-decoration: underline;">(</span><span style="font-family: 標楷體; text-decoration: underline;">胃</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">十二指腸</span><span style="font-family: arial, sans-serif; text-decoration: underline;">)</span><span style="font-family: 標楷體; text-decoration: underline;">與嘔吐。其他反應包括腎功能異常、貧血、頭暈、水腫、肝酵素升高、頭痛、延長出血時間、搔癢、紅疹及耳鳴。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">曾在治療期間被報告過的不良反應包括：</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">全身：發燒、感染、敗血症。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">心血管系統：充血性心衰竭、高血壓、心搏過速、暈厥。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">消化系統：口乾、食道炎、胃</span><span style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span style="font-family: 標楷體; text-decoration: underline;">腸潰瘍、胃炎、胃腸出血、舌頭發炎、吐血、肝炎、黃疸。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">血液及淋巴系統：瘀血、嗜伊性白血球增多、白血球過低、黑便、紫斑、直腸出血、口腔炎、血小板過低。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">代謝及營養：體重改變。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">神經系統：焦慮、衰弱、精神錯亂、憂鬱、作夢異常、</span><span style="font-family: 標楷體; text-decoration: underline;">睏倦、</span><span style="font-family: 標楷體; text-decoration: underline;">失眠、疲倦、緊張、感覺異常、嗜睡、顫抖、眩暈。</span><span style="font-family: arial, sans-serif; text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">呼吸系統：氣喘、呼吸困難。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">皮膚及附屬組織：禿髮、光敏感、排汗增加。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">特殊感官：視力模糊。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">泌尿系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">膀胱炎、排尿困難、血尿、間質性腎炎、少尿</span><span class="longtext1" style="font-family: arial, sans-serif; text-decoration: underline;">/</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">多尿、蛋白尿、腎衰竭。</span><span style="text-decoration: underline;"> </span></p><p><i><span style="font-family: 標楷體; text-decoration: underline;">其他少見之不良反應包括：</span></i><i><span style="text-decoration: underline;"> </span></i></p><p><span style="font-family: 標楷體; text-decoration: underline;">全身：過敏反應、食欲改變、死亡。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">心血管系統：心律不整、低血壓、心肌梗塞、心悸、血管炎。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">消化系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">結腸炎、噯氣、肝衰竭、胰臟炎。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">血液及淋巴系統：顆</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">粒性白血球缺乏、溶血性貧血、再生不良性貧血、淋巴結病變、全血球減少。</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">代謝及營養：高血糖。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">神經系統：</span><span style="font-family: 標楷體; text-decoration: underline;">痙攣<span class="longtext1">、昏迷、幻覺、腦膜炎。</span></span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">呼吸系統：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">呼吸抑制、肺炎。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">皮膚及附屬組織：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">血管性水腫、毒性表皮壞死溶解、多形性紅斑，</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="font-family: arial, sans-serif; text-decoration: underline;"><br /></span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">剝落性皮膚炎、</span><span style="font-family: 標楷體; text-decoration: underline;">史蒂文生氏</span><span style="font-family: arial, sans-serif; text-decoration: underline;">-</span><span style="font-family: 標楷體; text-decoration: underline;">強生症候群、</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">蕁麻疹。</span><span class="longtext1" style="text-decoration: underline;"> </span><span style="text-decoration: underline;"></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">特殊感官：</span><span class="longtext1" style="font-family: 標楷體; text-decoration: underline;">結膜炎、聽覺受損。 </span></p><p><span style="font-family: 標楷體;">【藥物交互作用】 </span></p><p><b><span style="font-family: 標楷體;">1.<span style="text-decoration: underline;"> Aspirin</span></span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">由於可能增加不良反應(包括腸胃道出血)發生的風險，一般而言不 </span></p><p><span style="font-family: 標楷體; text-decoration: underline;">建議同時使用aspirin與diclofenac進行治療。 </span></p><p><span style="font-family: 標楷體;">2.</span><span style="font-family: 標楷體;">抗凝血劑：<span style="text-decoration: underline;">抗凝血劑(如warfarin)與非類固醇類消炎藥對胃腸道出血的影響 </span></span></p><p><span style="font-family: 標楷體; text-decoration: underline;">是加成性的，合併使用這兩類藥品的病人發生嚴重胃腸道出血之風險較單獨使用任一類藥品者為高。 </span></p><p><b><span style="font-family: 標楷體; text-decoration: underline;">3.ACE</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">抑制劑：</span></b><span style="font-family: 標楷體; text-decoration: underline;">非類固醇類消炎藥會減弱血管張力素轉換酶(angiotensin c onverting enzyme (ACE))抑制劑的降血壓作用。同時投予非類固醇類消炎藥與ACE抑制劑時應考慮二者間可能發生之交互作用。 </span></p><p><span style="font-family: 標楷體;">4.</span><span style="font-family: 標楷體;">利尿劑：臨床研究指出，有些病人在同時接受非類固醇類消炎藥治療時，會使得furosemide及thiazides的利鈉尿作用減弱。<span style="text-decoration: underline;">合併使用期間應密切觀察是否有腎衰竭之徵象，</span>並確保利尿劑之效用。 </span></p><p><span style="font-family: 標楷體;">5.<span style="font: 7pt times new roman;"> </span></span><span style="font-family: 標楷體;">鋰鹽：<span style="text-decoration: underline;">非類固醇類消炎藥可能提高鋰鹽的血漿中濃度及降低其腎排除。合併使用期間應密切觀察是否有鋰鹽中毒之徵象。<b> </b></span></span></p><p><span style="font-family: 標楷體;">6.<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; text-decoration: underline;">Methotrexate</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">非類固醇類消炎藥可能使methotrexate毒性增加，合併使用期間須特別注意。<b> </b></span></p><p><span style="font-family: 標楷體;">7.<span style="font: 7pt times new roman;"> </span></span><b><span style="font-family: 標楷體; text-decoration: underline;">Cyclosporine</span></b><b><span style="font-family: 標楷體; text-decoration: underline;">：</span></b><span style="font-family: 標楷體; text-decoration: underline;">合併使用diclofenac治療時可能會增加cyclosporine之腎毒性，同時投予時須特別注意。 </span></p><p><b></b></p><p><b><span style="font-family: 標楷體;">【特殊族群】 </span></b></p><ol> <li><span style="font-family: 標楷體;">孕婦及授乳婦人之投與：對孕婦及授乳婦人之安全性尚未建立。對於孕婦及可能懷孕之婦女或授乳之婦人，須判斷其治療效益超過危險性時，方予投與。 </span></li> <li><span style="font-family: 標楷體;">懷孕最後3個月的婦女使用本品須特別注意（因可能造成子宮收縮無 </span></li></ol><p><span style="font-family: 標楷體;">力及/或胎兒動脈閉鎖過早）。 </span></p><p><span style="font-family: 標楷體;">3. FDA Pregnancy Category</span><span style="font-family: 標楷體;">（懷孕用藥級數）：C</span> </p><p><b><span style="font-family: arial, sans-serif;">4. </span></b><span style="font-family: 標楷體; text-decoration: underline;">兒童使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">的安全性及有效性尚未建立。</span><span style="text-decoration: underline;"> </span></p><p><b><span style="font-family: arial, sans-serif; text-decoration: underline;">5. </span></b><span style="font-family: 標楷體; text-decoration: underline;">臨床研究中老年與年輕受試者之有效性或安全性並無整體差異，然而不能排除某些老年人會對非類固醇類消炎藥的作用更加敏感。由於老年人的腎功能可能較差，在使用</span><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">時須特別注意監測腎功能。</span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">【過量】</span> </p><p><span style="font-family: arial, sans-serif; text-decoration: underline;">diclofenac</span><span style="font-family: 標楷體; text-decoration: underline;">過量之症狀通常侷限於嗜睡、疲倦、噁心、嘔吐及上腹痛，一般予以支持性照護後可恢復。</span><span style="font-family: 標楷體;">另可能發生胃腸道出血、高血壓、急性腎衰竭、呼吸抑制和昏迷。<span style="text-decoration: underline;">服藥過量時亦可能發生類過敏反應。</span></span><span style="text-decoration: underline;"> </span></p><p><span style="font-family: 標楷體;">若有</span><span style="font-family: arial, sans-serif;">diclofenac</span><span style="font-family: 標楷體;">過量並導致顯著全身性副作用時，建議採取催吐或洗胃。<span style="text-decoration: underline;">強迫利尿措施理論上有助益，而透析或血液灌洗的效用則尚未證實。</span>除支持性措施外，口服活性碳可能幫助減低</span><span style="font-family: arial, sans-serif;">diclofenac</span><span style="font-family: 標楷體;">的吸收。對於併發症如腎衰竭、痙攣、胃腸道刺激及呼吸抑制等，應給予支持療法與症狀處理。</span> </p> | 2013-12-16 | |
| 1420649 | 藥政管理類,藥事法 | 行政解釋 | 含雙磷酸鹽類(Bisphosphonates)成分藥品再評估結果相關事宜公告PDF檔 | 詳如附件 | 2013-12-16 | |
| 1420650 | 藥政管理類,藥事法 | 行政解釋 | 事 由︰為中國味精公司申請進口盤尼西林一案復請查照 | <p><span style="font-family: 新細明體, serif;">一、本年十月十三日陸拾國貿貳發字第</span><span style="font-family: calibri;">9980</span><span style="font-family: 新細明體, serif;">號函為中國味精公司申請進口盤尼西林</span><span style="font-family: calibri;">(PENICILLIN G BALK)</span><span style="font-family: 新細明體, serif;">作以加工味精、麩酸之用一事敬悉。</span> </p><p><span style="font-family: 新細明體, serif;">二、關於抗生素原料曾奉行政院</span><span style="font-family: calibri;">(50</span><span style="font-family: 新細明體, serif;">經字</span><span style="font-family: calibri;">3517</span><span style="font-family: 新細明體, serif;">號</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">令示應限由製造該項抗生素之藥廠輸入，並不得轉讓。惟據稱該項盤尼西林係屬製造味精公司進口有案，情形較為特殊，擬姑准比照前例由輸入之代理商與使用該藥之味精製造工廠聯名以專案向本署提出申請，同時附具切結以輸入該藥係專供味精加工之用，如有轉售</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">讓</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">或作其他用途，願受「藥物商管理法」有關規定處分，經核准後，再予辦理輸入，以利配合藥政管理。</span> </p> | 2013-12-16 | |
| 1420651 | 藥政管理類,藥事法 | 行政解釋 | 前規定應繳銷之感冒口服液及含有影響中樞神經藥類( 含咖啡因成分在五十公絲以下者不在此限 )之藥品許可證，尚有部分藥商仍未繳銷，茲再限於本(62)年 5月31日前將是項藥品許可證繳銷，並不得繼續製造，否則除予撤銷許可證外，並應調查其有無違規製售及庫存情形。 | <span style="font-family: 新細明體, serif;">本案係依據本署</span><span style="font-family: calibri;">61.5.24.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令及</span><span style="font-family: calibri;">61.7.11.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;">06241</span><span style="font-family: 新細明體, serif;">號令規定，治療感冒口服液及含有影響中樞神經藥類口服液</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">含咖啡因成分在五十公絲以下者不在此限</span><span style="font-family: calibri;"> )</span><span style="font-family: 新細明體, serif;">，於</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">年十二月底前應繳銷是項藥品許可證，不得繼續製造，並定於</span><span style="font-family: calibri;">(62)</span><span style="font-family: 新細明體, serif;">年七月一日起一律禁止出售，屬於中藥製劑，仍照本署</span><span style="font-family: calibri;">61.7.11.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;">06241</span><span style="font-family: 新細明體, serif;">號令規定切實辦理。</span> | 2013-12-16 | |
| 1420652 | 藥政管理類,藥事法 | 行政解釋 | 為「紅參精」標示療效等字樣，應以藥品管理，復希知照 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">61.08.10.</span><span style="font-family: 新細明體, serif;">北市衛四字第</span><span style="font-family: calibri;">13421</span><span style="font-family: 新細明體, serif;">號函開成企業有限公司副本已悉。</span> </p><p><span style="font-family: 新細明體, serif;">二、查以中藥藥材製成之各類露液茶等而標明用量用法治療效能及含量者應以藥品管理，業經本署</span><span style="font-family: calibri;">60.11.11.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;">06112</span><span style="font-family: 新細明體, serif;">號令飭遵在卷。案內「紅參精」一項於外盒仿單上標示主要成分、效能、用法用量等字樣，仍應依照本署前令指示依法處理。</span> </p> | 2013-12-16 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1072&type=0 |
| 1420653 | 藥政管理類,藥事法 | 行政解釋 | 為「薄荷膏」及「薄荷筒」應否申請查驗登記一案核復知照由 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">60.7.14.</span><span style="font-family: 新細明體, serif;">衛四字第</span><span style="font-family: calibri;">01961</span><span style="font-family: 新細明體, serif;">號呈暨附件均悉。</span> </p><p><span style="font-family: 新細明體, serif;">二、所請核示「薄荷膏」及「薄荷筒」應否申請查驗登記一節，經核該兩種產品所使用之原料，均屬藥典記載藥品，應依照「藥物藥商管理法」第四十三條之規定辦理查驗登記，經核准發給許可證後，始得製售。</span> </p> | 2013-12-16 | |
| 1420654 | 藥政管理類,藥事法 | 行政解釋 | 為工業原料行販賣「重曹」等應於包裝上標明「工業用」或「化工用」字樣一案希知照。 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">61.1.22.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;">08292</span><span style="font-family: 新細明體, serif;">號函經濟部副本計達。</span> </p><p><span style="font-family: 新細明體, serif;">二、案准經濟部</span><span style="font-family: calibri;">61</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;"> 2</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">10</span><span style="font-family: 新細明體, serif;">日經</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">工字第</span><span style="font-family: calibri;"> 04508</span><span style="font-family: 新細明體, serif;">號令臺灣省政府建設廳、臺北市政府建設局副本：「</span><span style="font-family: calibri;">1.</span><span style="font-family: 新細明體, serif;">准行政院衛生署本</span><span style="font-family: calibri;">(61)</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;"> 1</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;">22</span><span style="font-family: 新細明體, serif;">日衛署藥字第</span><span style="font-family: calibri;">8292</span><span style="font-family: 新細明體, serif;">號函略以『重曹』</span><span style="font-family: calibri;">( </span><span style="font-family: 新細明體, serif;">碳酸</span> <span style="font-family: 新細明體, serif;">氫鈉</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『硼酸』『石碳酸』</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">酚</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『凡士林』</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">石脂</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『硫苦』</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">硫酸鎂</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『柳酸』</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">水楊酸</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">『樟腦』『甘油』『橄欖油』『硼砂』</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">硼酸鈉</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">等均為藥典收載之藥品，其屬工業級原使用於『工業』或『化工』者，應於包裝上標明『工業用』或『化工用』等字樣，以資與藥品有所區別，而利管理等由到部。</span><span style="font-family: calibri;"> 2.</span><span style="font-family: 新細明體, serif;">為維護國民健康，應予照辦。</span><span style="font-family: calibri;"> 3.</span><span style="font-family: 新細明體, serif;">希遵照並轉知製造及販賣業者遵辦」。</span> </p> | 2013-12-16 | |
| 1420655 | 藥政管理類,藥事法 | 行政解釋 | 為世界衛生組織函稱有關「西德衛生部宣佈初步為期一年規定〞PHENTERMIN”藥品須由醫師處方使用令希遵照轉飭知照由 | <p><span style="font-family: 新細明體, serif;">一、准世界衛生組織本年二月二十一日函節開</span><span style="font-family: calibri;">:</span><span style="font-family: 新細明體, serif;">「西德衛生部提供有關</span><span style="font-family: calibri;">:PHENTERMIN(</span><span style="font-family: 新細明體, serif;">α</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體, serif;">α</span><span style="font-family: calibri;">-DIMETHYLPHENETHYLAMINE)</span><span style="font-family: 新細明體, serif;">藥品資料稱</span><span style="font-family: calibri;">,</span><span style="font-family: 新細明體, serif;">接獲由於服用該項</span><span style="font-family: calibri;">"PHENTERMIN"</span><span style="font-family: 新細明體, serif;">可能引起</span><span style="font-family: calibri;"> PRIMARY VASCULAR PULMONARY HYPERTENSION</span><span style="font-family: 新細明體, serif;">病例之報告，乃決定自</span><span style="font-family: calibri;">1971</span><span style="font-family: 新細明體, serif;">年</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">月</span><span style="font-family: calibri;"> 2</span><span style="font-family: 新細明體, serif;">日開始實施初步以一年為期之規定，使用〞</span><span style="font-family: calibri;">PHENTERMIN</span><span style="font-family: 新細明體, serif;">”必須由醫師處方使用。在停止配售含有</span><span style="font-family: calibri;">AMINORE (2-AMINO-5-PHENYL-2-OXAZOLINE)</span><span style="font-family: 新細明體, serif;">特效成份之食慾抑制劑之同時，亦應考慮其他以</span><span style="font-family: calibri;"> "AMPHETAMINE" </span><span style="font-family: 新細明體, serif;">或其衍化物為主成份之食慾抑制劑對於循環亦可能有類似影響而發生〞</span><span style="font-family: calibri;">PRIMARY VASCULARPULMONARY HYPERTENSION</span><span style="font-family: 新細明體, serif;">〞情形。在規定含〞</span><span style="font-family: calibri;">PHENTERMIN</span><span style="font-family: 新細明體, serif;">〞藥品須由醫師處方使用之一年期間內對於是否需再繼續限定將在作決定」等由。</span> </p><p><span style="font-family: 新細明體, serif;">二、查〞</span><span style="font-family: calibri;">PHENTERMIN</span><span style="font-family: 新細明體, serif;">〞與〞</span><span style="font-family: calibri;">DIETHYLPROPION</span><span style="font-family: 新細明體, serif;">〞之化學構造式極為相似，均屬</span> <span style="font-family: 新細明體, serif;">〞</span><span style="font-family: calibri;">AMPHETAMINE TYPE</span><span style="font-family: 新細明體, serif;">〞之食慾抑制劑，為維護國民建康起見，凡使用上述食慾抑制劑</span><span style="font-family: calibri;">(APPETITE DEPRESSANTS)</span><span style="font-family: 新細明體, serif;">藥品，必須限醫師處方使用並應加強注意。</span> </p><p><span style="font-family: 新細明體, serif;">三、隨令檢發世界衛生組織來函影本一份，令希遵照並希轉飭各有關醫療團體知照為要。</span> </p> | 2013-12-16 | |
| 1420656 | 藥政管理類,藥事法 | 行政解釋 | 以製藥廠商名義可否兼製食品飲料疑義一案令覆知照由 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">61.10.6.</span><span style="font-family: 新細明體, serif;">衛四字第</span><span style="font-family: calibri;">27884</span><span style="font-family: 新細明體, serif;">號呈悉。</span> </p><p><span style="font-family: 新細明體, serif;">二、查藥品使用於診斷、治療減輕或預防人類疾病，關係國民健康至鉅，因此製藥工廠設置標準規定，製藥工廠廠址應選擇於環境清潔、空氣新鮮之地帶，並應與住宅或公共場所隔離，亦即表示製造藥品不得與其他事物發生摻雜。復查食品範圍至為廣泛，其製造過程各有不同，為顧慮藥品品質之安全計，藥品與食品不得在同一廠址內製造，以免環境被污染而影響藥品品質。</span> </p> | 2013-12-16 | |
| 1420657 | 藥政管理類,藥事法 | 行政解釋 | 為加強止痛消炎類及荷爾蒙類原料藥管理案，請查照辦理 | <p><span style="font-family: 新細明體, serif;">一、</span><span style="font-family: calibri;">PREDNISOLONE, PHENYLBUTAZONE, OXYPHENBUTAZONE, DEXAMETHAZONE</span><span style="font-family: 新細明體, serif;">等止痛消炎類藥品及</span><span style="font-family: calibri;">TESTOSTERONE, METHYLTESTOSTERONE</span><span style="font-family: 新細明體, serif;">荷爾蒙類藥品效果固稱良好，但如使用失當，亦可能發生副作用。邇來曾發現少數藥商未經核准擅將該項藥品摻入製劑情事，除分別依法嚴處外，對該項原料藥之製造、輸入及銷售，亟應嚴格加強管理，以及可能少量攜帶走私亦應注意查緝，俾防止流為不正當用</span> <span style="font-family: 新細明體, serif;">途，藉以維護國民健康。</span> </p><p><span style="font-family: 新細明體, serif;">二、檢附上述藥品產銷</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">輸入及銷售</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">數量月報表及銷售狀況報告表格式各一份，希即分函各有關藥業團體轉知會員切實遵照辦理，自本</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">六十三</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">年七月十日起填送六月份報表，並由地方衛生主管機關嚴密查核，違者依法嚴究。</span> </p> | 2013-12-16 | |
| 1420658 | 藥政管理類,藥事法 | 行政解釋 | 為加強藥品管理特再分別規定含有影響中樞神經藥類口服液劑之處理要點令仰遵照 | <p><span style="font-family: 新細明體, serif;">一、本署</span><span style="font-family: calibri;">61. 5.24.</span><span style="font-family: 新細明體, serif;">衛署藥字第</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令為加強管理含有影響中樞神經藥類口服液劑藥品一案計達，茲再分別規定有關該類藥品處理要點如次：</span> </p><p><span style="font-family: calibri;">1.</span><span style="font-family: 新細明體, serif;">治療感冒藥品及不屬於下列各款之藥品而含有影響中樞神經之口服液，均應按照本署</span><span style="font-family: calibri;">61.5.24.</span><span style="font-family: 新細明體, serif;">衛署藥字</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令之規定處裡。</span> </p><p><span style="font-family: calibri;">2.</span><span style="font-family: 新細明體, serif;">感冒糖漿製劑，原則上不再核准登記，前經核准許可有案者，其含糖量濃度應在</span><span style="font-family: calibri;">55% </span><span style="font-family: 新細明體, serif;">以上</span><span style="font-family: calibri;"> (</span><span style="font-family: 新細明體, serif;">與該項標準不符者應申請變更登記並且不得使用糖精</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體, serif;">，其最小包裝不得少於二天份劑量，</span><span style="font-family: calibri;"> 60</span><span style="font-family: 新細明體, serif;">公撮以上者准由原廠商在其藥品許可證有效期間內製售，必要時本署對於該類藥品成分含量按照國產藥品審查基準，重新予以審查。</span><span style="font-family: calibri;"> 3.</span><span style="font-family: 新細明體, serif;">維他命及強肝類口服液，其所含咖啡因成分在</span><span style="font-family: calibri;">50MG</span><span style="font-family: 新細明體, serif;">以上者，不再核准登記，如係前經核准有案者，應依本署</span><span style="font-family: calibri;">61. 5.24.</span><span style="font-family: 新細明體, serif;">衛署藥字</span><span style="font-family: calibri;">04185</span><span style="font-family: 新細明體, serif;">號令之規定申請將該成分含量改為</span><span style="font-family: calibri;">50MG</span><span style="font-family: 新細明體, serif;">以下，至於所含咖啡因成分在</span><span style="font-family: calibri;">20MG</span><span style="font-family: 新細明體, serif;">至</span><span style="font-family: calibri;">50MG</span><span style="font-family: 新細明體, serif;">範圍以內者，須在仿單、標籤註明「不得連續服用」字樣</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以示警惕</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。各級衛生機關應加強抽查上項口服液劑。</span> </p><p><span style="font-family: calibri;">4.</span><span style="font-family: 新細明體, serif;">中藥口服液原則上不再核准登記，如係以前核准登記許可有案者，僅准由原廠在其藥品許可證有效期間內製售，該局</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">處</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">及所屬衛生機關應加強抽查是類藥品有無擅自摻入西藥或其他超越核准登記事項。</span> </p><p><span style="font-family: calibri;">5.</span><span style="font-family: 新細明體, serif;">口服液劑型多屬較易變質之藥品，為求安全及便於管理計，茲規定嗣後製售之口服液藥品，均應標明製造年月日及批號。</span> </p><p><span style="font-family: calibri;">6.</span><span style="font-family: 新細明體, serif;">中藥與西藥複合製劑，其以西藥</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">影響中樞神經類</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">摻入中藥固有方劑者，原則上不再核准登記，如係前經核准登記許可有案者，僅准由原廠在其藥品許可證有效期間內製售。</span> <span style="font-family: 新細明體, serif;">以上第二款、第四款、第六款所稱前已經核准登記許可有案者，其製品均限定各該藥品許可證有效期間屆滿六個月後，一律不得買賣或供使用。</span> </p> | 2013-12-16 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=1087&type=0 |