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| column | value |
|---|---|
| 類別 | 罕見疾病類,罕見疾病藥物,衛生福利部受理罕見疾病藥物查驗登記審查費收費標準 |
| 法規性質 | 行政解釋 |
| 法規名稱 | 衛生福利部受理罕病藥物查驗登記審查費收費標準 |
| 條文內容 | <p><span style="font-family: calibri;"> </span></p><table style="border-collapse: collapse;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; padding-top: 0cm;border: windowtext 1pt solid;" valign="top"> <p><span style="font-family: 新細明體,serif;">受理類別</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">定義與範圍</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">收費基準</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">備註</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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;">新罕見疾病藥品</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">罕見疾病防治及藥物法規定之新藥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">一○、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><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-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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;">生物製劑、類毒素及菌液等基因工程製劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">血液製劑、抗毒素、疫苗、利用基因工程製造之藥品</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">一○、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><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-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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;">臨床試驗</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.5pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">計畫書審核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 104.55pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">三、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 5.4pt; width: 105.05pt; padding-right: 5.4pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 19.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 19.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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;">原料藥</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">供藥廠製造罕見疾病藥品之原料</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">六、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 19.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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;">自用原料輸入</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 22.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 22.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><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;">罕見疾病用之新醫療器材</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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">六、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 22.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國內醫療器材廠</span><span style="font-family: calibri;"> GMP</span><span style="font-family: 新細明體,serif;">查核</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 21.75pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">國外醫療器材工廠備查</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">四、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 21.75pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 13.5pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 13.5pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><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;">藥品變更</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">新適應症、新用法用量、新類別、新賦形劑</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">二、四○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 13.5pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">委託製造、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></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、六○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">其他變更或許可證、標仿單遺失補發</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><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;">醫療器材變更</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">增加新適用範圍</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">二、四○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">委託製造、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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、六○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">其他變更或許可證、標仿單遺失補發</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">一、○○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><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;">展延</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">六○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">十</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">產地證明、</span><span style="font-family: calibri;">GMP </span><span style="font-family: 新細明體,serif;">查廠、醫療器材英文證明</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <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 style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr style="height: 20.25pt;"> <td style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;">(</span><span style="font-family: 新細明體,serif;">十一</span><span style="font-family: calibri;">) </span><span style="font-family: 新細明體,serif;">領證費用</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.5pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: calibri;"> </span></p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 104.25pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top"> <p><span style="font-family: 新細明體,serif;">三○○</span> </p> </td> <td style="border-bottom: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; border-top-color: #f0f0f0; padding-left: 1.4pt; width: 105.35pt; padding-right: 1.4pt; height: 20.25pt; border-left-color: #f0f0f0; border-right: windowtext 1pt solid; padding-top: 0cm;" valign="top" colspan="2"> <p><span style="font-family: 新細明體,serif;">新增項目</span> </p> </td> </tr> <tr> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 139px;border-color: #f0f0f0;"></td> <td style="background-color: transparent;border-color: #f0f0f0;"></td> <td style="background-color: transparent; width: 140px;border-color: #f0f0f0;"></td> </tr> </tbody></table><p><span style="font-family: calibri;"> </span></p><p><span style="font-family: calibri;"> </span></p> |
| 發佈日期 | 2013-12-05 |
| 附件檔案 |