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  2. 藥品法規條文資料集
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類別 藥政管理類,藥事法
法規性質 行政解釋
法規名稱 公告申請本署藥物、含藥化粧品查驗登記暨變更案件，請檢附產品仿單、標籤之電子圖像檔案相關事宜
條文內容 <p><span style="font-family: 新細明體, serif;">一、自民國</span><span style="font-family: calibri;">98</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;">1</span><span style="font-family: 新細明體, serif;">日起，廠商申請藥物或含藥化粧品之查驗登記暨涉及仿單、標籤、外盒及藥物外觀變更之案件時，請檢附產品仿單、標籤、外盒及藥物外觀之電子圖像檔案。以利藥物資料公開之推動與執行。</span> </p><p><span style="font-family: 新細明體, serif;">二、前述電子圖像檔案規格需求如下列：</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;">藥物、含藥化粧品之仿單、標籤及外盒電子圖像：</span> </p><p><span style="font-family: 新細明體, serif;">１、依照閱讀順序掃描成每張解析度至少</span><span style="font-family: calibri;">300dpi</span><span style="font-family: 新細明體, serif;">之</span><span style="font-family: calibri;">JPEG</span><span style="font-family: 新細明體, serif;">圖像檔案，色彩管理使用</span><span style="font-family: calibri;">sRGB</span><span style="font-family: 新細明體, serif;">色域空間。</span> </p><p><span style="font-family: 新細明體, serif;">２、</span><span style="font-family: calibri;">JPEG</span><span style="font-family: 新細明體, serif;">圖像檔命名為阿拉伯數字</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">碼：前</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">碼為證別、中</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">碼為證號、末</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">碼為張數順序</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以藥品為例：衛署藥輸字第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔名設為</span><span style="font-family: calibri;">020123450001</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">020123450002&amp;hellip;</span><span style="font-family: 新細明體, serif;">；以醫療器材為例：衛署醫器輸字第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔名設為</span><span style="font-family: calibri;">060123450001</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">060123450002&amp;hellip;)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">３、以許可證字號為單位設立資料夾，其內部設立兩個子資料夾將</span><span style="font-family: calibri;">&amp;rdquo;</span><span style="font-family: 新細明體, serif;">仿單</span><span style="font-family: calibri;">&amp;rdquo;</span><span style="font-family: 新細明體, serif;">及</span><span style="font-family: calibri;">&amp;rdquo;</span><span style="font-family: 新細明體, serif;">標籤、外盒</span><span style="font-family: calibri;">&amp;rdquo;</span><span style="font-family: 新細明體, serif;">之圖像檔分別存放，並燒製成光碟檢附於申請案件中。</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;">藥物外觀電子圖像，使用印有</span><span style="font-family: calibri;">50mm</span><span style="font-family: 新細明體, serif;">尺規</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">實體比例</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">：</span><span style="font-family: calibri;">1)</span><span style="font-family: 新細明體, serif;">的灰色紙作為背景紙，拍攝規格如後：</span> </p><p><span style="font-family: 新細明體, serif;">１、紙張、尺規、藥品拍攝比例皆為</span><span style="font-family: calibri;">1</span><span style="font-family: 新細明體, serif;">：</span><span style="font-family: calibri;">1(</span><span style="font-family: 新細明體, serif;">不可縮小放大鏡頭</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">２、製成</span><span style="font-family: calibri;">JPEG</span><span style="font-family: 新細明體, serif;">檔案後，每張圖像解析度須有</span><span style="font-family: calibri;">180dpi</span><span style="font-family: 新細明體, serif;">以上，色彩管理使用</span><span style="font-family: calibri;">sRGB</span><span style="font-family: 新細明體, serif;">色域空間。</span> </p><p><span style="font-family: 新細明體, serif;">３、須能區別藥品正反面，藥品擺放以尺規</span><span style="font-family: calibri;">25mm</span><span style="font-family: 新細明體, serif;">處為中點</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">圖例如附件</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">４、錠劑以尺規中點為基準，正反面左右擺放</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">長圓柱形錠劑除外</span><span style="font-family: calibri;">)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">５、長圓柱形錠劑之中點與尺規中點對齊，依正反面上下擺放。</span> </p><p><span style="font-family: 新細明體, serif;">６、膠囊上下蓋接合處與尺規中點成一直線，依序上下擺放。</span> </p><p><span style="font-family: 新細明體, serif;">７、檔案命名為阿拉伯數字</span><span style="font-family: calibri;">12</span><span style="font-family: 新細明體, serif;">碼：前</span><span style="font-family: calibri;">2</span><span style="font-family: 新細明體, serif;">碼為證別、中</span><span style="font-family: calibri;">6</span><span style="font-family: 新細明體, serif;">碼為證號、末</span><span style="font-family: calibri;">4</span><span style="font-family: 新細明體, serif;">碼為張數順序</span><span style="font-family: calibri;">(</span><span style="font-family: 新細明體, serif;">以藥品為例：衛署藥輸字第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔名設為</span><span style="font-family: calibri;">020123450001</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">020123450002&amp;hellip;</span><span style="font-family: 新細明體, serif;">；以醫療器材為例：衛署醫器輸字第</span><span style="font-family: calibri;">012345</span><span style="font-family: 新細明體, serif;">號，其檔名設為</span><span style="font-family: calibri;">060123450001</span><span style="font-family: 新細明體, serif;">、</span><span style="font-family: calibri;">060123450002&amp;hellip;)</span><span style="font-family: 新細明體, serif;">。</span> </p><p><span style="font-family: 新細明體, serif;">８、完成之電子圖像檔以光碟燒錄後附於申請案件中。</span><span style="font-family: calibri;">&lt;/font&gt;&lt;/p&gt;</span></p>
發佈日期 2013-12-16
附件檔案