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Commit af348827 by 林家欣
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业务大厅下我是医疗企业切图

parent c9fad9b0
Showing with 727 additions and 23 deletions
src/components/layout/header/mock.js
......@@ -177,7 +177,7 @@ export const nav = [
name: "我还不是系统成员",
nameInHeaderNav: "我还不是系统成员",
index: 2,
link: "/Business",
link: "",
breadcrumb: [{ name: "业务大厅", path: "/Business" }, { name: "我还不是系统成员" }],
children: [
{
......@@ -202,6 +202,7 @@ export const nav = [
{ name: "操作指南" },
],
},
{
id: uuid("gs_nav"),
name: "我要申请商品条码",
......@@ -246,28 +247,7 @@ export const nav = [
{ name: "微信共享" },
],
},
{
id: uuid("gs_nav"),
name: "我要培训",
index: 2,
link: "/Business/Guide5",
breadcrumb: [
{ name: "业务大厅", path: "/Business" },
{ name: "操作指南", path: "/Business/Guide" },
{ name: "我要培训" },
],
},
{
id: uuid("gs_nav"),
name: "我要续展",
index: 2,
link: "/Business/Guide6",
breadcrumb: [
{ name: "业务大厅", path: "/Business" },
{ name: "操作指南", path: "/Business/Guide" },
{ name: "我要续展" },
],
},
{
id: uuid("gs_nav"),
name: "我要咨询",
......@@ -389,6 +369,41 @@ export const nav = [
{ name: "物流单元" },
],
},
],
},
{
id: uuid("gs_nav"),
name: "我是系统成员",
nameInHeaderNav: "我是系统成员",
index: 2,
link: "/Business",
breadcrumb: [{ name: "业务大厅", path: "/Business" }, { name: "我还不是系统成员" }],
children: [
{
id: uuid("gs_nav"),
name: "我要培训",
index: 2,
link: "/Business/Guide5",
breadcrumb: [
{ name: "业务大厅", path: "/Business" },
{ name: "操作指南", path: "/Business/Guide" },
{ name: "我要培训" },
],
},
{
id: uuid("gs_nav"),
name: "我要续展",
index: 2,
link: "/Business/Guide6",
breadcrumb: [
{ name: "业务大厅", path: "/Business" },
{ name: "操作指南", path: "/Business/Guide" },
{ name: "我要续展" },
],
},
{
id: uuid("gs_nav"),
name: "我要生成商品二维码",
......@@ -422,6 +437,48 @@ export const nav = [
{ name: "条码微站" },
],
},
],
},
{
id: uuid("gs_nav"),
name: "我是医疗企业",
nameInHeaderNav: "我是医疗企业",
index: 2,
link: "/Business",
breadcrumb: [{ name: "业务大厅", path: "/Business" }, { name: "我还不是系统成员" }],
children: [
{
id: uuid("gs_nav"),
name: "我要申请医疗器械唯一标识（UDI）",
index: 2,
link: "/Business/UDI",
breadcrumb: [
{ name: "业务大厅", path: "/Business" },
{ name: "我是医疗企业", path: "/Business/UDI" },
{ name: "我要申请医疗器械唯一标识（UDI）" },
],
},
{
id: uuid("gs_nav"),
name: "我要申请药品追溯码",
index: 2,
link: "/Business/ypzs",
breadcrumb: [
{ name: "业务大厅", path: "/Business" },
{ name: "我是医疗企业", path: "/Business/UDI" },
{ name: "我要申请药品追溯码" },
],
},
],
},
{
id: uuid("gs_nav"),
name: "办理其他业务",
nameInHeaderNav: "办理其他业务",
index: 2,
link: "/Business",
breadcrumb: [{ name: "业务大厅", path: "/Business" }, { name: "我还不是系统成员" }],
children: [
{
id: uuid("gs_nav"),
name: "办理全球位置码(GLN)",
......
src/router/index.js
......@@ -373,6 +373,22 @@ const routes = [
component: () => import("@/views/Business/BarcodeV.vue"),
},
{
path: "/Business/UDI",
name: "UDI",
meta: {
name: "我要申请医疗器械唯一标识（UDI）",
},
component: () => import("@/views/Business/UDI.vue"),
},
{
path: "/Business/ypzs",
name: "ypzs",
meta: {
name: "我要申请药品追溯码",
},
component: () => import("@/views/Business/ypzs.vue"),
},
{
path: "/Business/GLN",
name: "GLN",
meta: {
......
src/views/Business/UDI.vue 0 → 100644
<template>
<div class="corppay">
<cate :father="udiCate"></cate>
<div class="corppay-msg container">
<p>
中国物品编码中心（GS1 China）完全满足我国药监局发布的<a
href="https://www.nmpa.gov.cn/ylqx/ylqxggtg/ylqxqtgg/20190827092601750.html"
target="_blank"
>《医疗器械唯一标识系统规则》</a
>中对发码机构的要求并且已经在国内成功实施超过十五年。GS1也是欧美医疗器械监管部门认可的UDI发码机构，满足目前全球已发布的UDI相关法规要求。
</p>
<ul class="mainTxt">
<li>
<p><b>UDI实施步骤</b></p>
<div>
<p>
<b
>1.确定哪些产品属于国内UDI法规要求实施的范围，谁是注册人/备案人？</b
>
</p>
<p>
<b>2.申请成为GS1系统成员（即申请UDI-DI厂商识别代码）</b>
</p>
<p>
--<a href="/Business/Guide1" target="_blank"
>商品条码（厂商识别代码）在线申请</a
>
（也可通过微信公众号、小程序、中国编码APP申请）
</p>
<p>--咨询电话：400-7000-690</p>
<p>
<b
>3.UDI实施请访问<a
href="https://v4.gds.org.cn/#/udi/anccOpen"
target="_blank"
>“UDI一站式服务”</a
>或联系<a
href="http://www.gs1cn.org/Service/Partners/List.aspx"
target="_blank"
>GS1标准服务提供商</a
></b
>
</p>
</div>
</li>
<li>
<p><b>请注意</b></p>
<div>
<p>
<b>1.产品标识UDI-DI：</b
>医疗器械使用单元及各包装级别可通过GTIN-13或GTIN-14标识
</p>
<p>--确保GTIN在数据库中存储为14位，若使用GTIN-13应在前面补零</p>
<p>--物流包装如需编码可使用SSCC</p>
<p>
<b>2.生产标识UDI-PI：</b
>根据监管和实际应用需求，确定生产标识是否应包含医疗器械序列号、生产批号、生产日期、失效日期等
</p>
<p>--器械种类不同，生产标识可能不同</p>
<p>
<b>3.UDI载体和人工识读</b>
</p>
<p>
--根据器械类型和追溯需求等因素，确定最小销售单元和更高级别的包装使用的UDI载体类型（GS1-128、GS1
DataMatrix、EAN/UPC……）
</p>
<p>
--根据相关法规、标准、<a
href="https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specifications"
target="_blank"
>《GS1通用规范》</a
>以及<a
href="https://www.gs1.org/docs/healthcare/GS1_Healthcare_Implementation_Guideline.pdf"
target="_blank"
>《GS1医疗AIDC实施指南》</a
>等确定条码印制质量、人工识读内容和载体放置位置等细节。
</p>
<p>--确定是否需要直接标记</p>
<p>
--对条码印制质量进行检测（可联系<a
href="http://www.gs1cn.org/Service/jcyxz/Barcode.aspx"
target="_blank"
>中国物品编码中心质量检测部</a
>进行测试）
</p>
<p>
<b
>4.在国家药监局唯一标识注册系统、医疗器械唯一标识数据库（CUDID）中提交UDI数据</b
>
</p>
<p>
--申请首次注册、延续注册或者注册变更时，注册申请人/注册人应当在注册管理系统中提交其最小销售单元的产品标识
</p>
<p>
--上市销售前，注册人应当按照相关标准或者规范要求将最小销售单元、更高级别包装的产品标识和相关数据上传至医疗器械唯一标识数据库
</p>
<p>
<b>5.数据维护：</b
>当医疗器械产品最小销售单元产品标识的相关数据发生变化时，注册人应当在该产品上市销售前，在医疗器械唯一标识数据库中进行变更，实现数据更新。
</p>
<p>
<b>6.其他监管数据关联：</b
>做好医保、卫健委等相关平台上产品编码与UDI的关联。
</p>
</div>
</li>
</ul>
<div class="fileDownload">
<p>
<img src="../../assets/image/business/ico-download.png" alt="" />
参考资料：
</p>
<ul style="list-style: none">
<li>
<p>
<a
href="/Manage/down/基于商品条码（GS1）标准的医疗器械唯一标识（UDI）实施指南.pdf"
target="_blank"
>1.基于商品条码（GS1）标准的医疗器械唯一标识（UDI）实施指南</a
>
</p>
</li>
<li>
<p>
<a
href="/Manage/down/基于商品条码（GS1）标准的医疗器械唯一标识（UDI）系统实施常见问题.pdf"
target="_blank"
>2.基于商品条码（GS1）标准的医疗器械唯一标识（UDI）系统实施常见问题</a
>
</p>
</li>
<li>
<p>
<a
href="https://www.gs1.org/industries/healthcare/udi"
target="_blank"
>3.GS1总部UDI相关页面</a
>
</p>
</li>
</ul>
</div>
</div>
</div>
</template>
<script>
import cate from "../comps/cate.vue";
export default {
components: {
cate,
},
data() {
return {
udiCate: {
name: "我要申请医疗器械唯一标识（UDI）",
ico: "",
},
};
},
created() {
// console.log(this.$route.query.id)
},
};
</script>
<style lang="scss" scoped>
.corppay {
@include module-box;
.corppay-msg {
margin: 30px 0;
font-size: 14px;
.msg-title {
color: #008dbd;
margin-bottom: 20px;
&.actived {
color: #04408d;
}
}
p {
font-size: 14px;
text-indent: 25px;
}
a {
color: #008dbd;
text-decoration: none;
}
ul {
margin: 0;
padding: 0;
list-style-type: disc;
margin-block-start: 1em;
margin-block-end: 1em;
margin-inline-start: 0px;
margin-inline-end: 0px;
padding-inline-start: 40px;
}
.mainTxt, .fileDownload {
p {
text-indent: 0;
}
}
.fileDownload {
img {
width: 16px;
}
}
table {
table-layout: fixed;
font-size: 14px;
max-width: 100%;
background-color: transparent;
tbody {
tr {
&:nth-child(odd) {
td {
border-bottom: 0;
}
}
}
}
}
thead {
border: 1px solid #b2b2b8;
display: table-header-group;
vertical-align: middle;
box-sizing: border-box;
tr {
th {
text-align: center;
}
}
}
tbody {
border: 1px solid #b2b2b8;
display: table-row-group;
vertical-align: middle;
box-sizing: border-box;
tr:last-child {
td {
border-bottom: none;
}
}
}
tr {
border: 1px solid #b2b2b8;
box-sizing: border-box;
display: table-row;
vertical-align: inherit;
}
th {
border: 1px solid #b2b2b8;
text-align: center;
}
td {
border: 1px solid #b2b2b8;
text-align: center;
}
.text-explain {
li {
display: list-item;
list-style-type: disc;
}
}
.table {
tbody {
tr {
th {
border-top: none;
}
td {
border-top: none;
}
}
}
thead {
tr {
th {
border: none;
vertical-align: bottom;
}
}
&:first-child {
tr {
&:first-child {
th {
border-top: 0;
}
}
}
}
}
}
.table-striped {
tbody {
tr:nth-child(odd) {
th {
background-color: #f5f5f5;
}
td {
background-color: #f5f5f5;
}
}
}
}
}
}
</style>
\ No newline at end of file
src/views/Business/index.vue
......@@ -568,6 +568,24 @@ export default {
],
},
{
name: "我是医疗企业",
path: "",
active: "",
children: [
{
name: "我要申请医疗器械唯一标识（UDI）",
path: "/Business/UDI",
active: "UDI",
},
{
name: "我要申请药品追溯码",
path: "/Business/ypzs",
active: "ypzs",
},
],
},
{
name: "办理其他业务",
path: "",
active: "",
......
src/views/Business/ypzs.vue 0 → 100644
<template>
<div class="corppay">
<cate :father="ypzsCate"></cate>
<div class="corppay-msg container">
<p>
<b>政策背景</b>
</p>
<p>
2019年12月1日，《中华人民共和国药品管理法》和《中华人民共和国疫苗管理法》正式施行，药品管理法要求药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当建立并实施药品追溯制度，按照规定提供追溯信息，保证药品可追溯。疫苗管理法要求疫苗上市许可持有人应当建立疫苗电子追溯系统，与全国疫苗电子追溯协同平台相衔接，实现生产、流通和预防接种全过程最小包装单位疫苗可追溯、可核查。
</p>
<p>
商品条码系列标准（GS1标准）完全满足NMPABT
1002—2019《药品追溯码编码要求》标准中的相关要求。GS1标准的药品编码也得到了世界卫生组织WHO、联合国儿童基金会UNICEF等众多国际组织的推荐，在70多个国家/地区得到广泛应用。
</p>
<ul class="mainTxt">
<li>
<p><b>药品追溯码实施步骤</b></p>
<div>
<p>
<b
>1.确定哪些产品属于药品追溯要求实施的范围，谁是上市许可持有人、生产企业？</b
>
</p>
<p>
<b>2.申请厂商识别代码</b>
</p>
<p>
--<a
href="/Business/Guide1"
target="_blank"
>商品条码（厂商识别代码）在线申请</a
>
（也可通过微信公众号、小程序、中国编码APP申请）
</p>
<p>
--<a
href="http://www.gs1cn.org/service/notice/article.aspx?id=603&amp;codeid=7"
target="_blank"
>编码中心分支机构药品追溯联系人</a
>
</p>
<p>
<b>3.药品标识码：</b>根据<a
href="https://www.gs1.org/standards/gs1-healthcare-gtin-allocation-rules-standard/current-standard"
target="_blank"
>GS1医疗GTIN分配规则</a
>为药品各级销售包装单元分配GTIN-13或GTIN-14
</p>
<p>--确保GTIN在数据库中存储为14位，若使用GTIN-13应在前面补零</p>
<p>--物流包装如需编码可使用SSCC</p>
<p>
<b>4.生产标识码：</b
>为药品编制单品序列号，并根据实际需求，包含药品生产批号、生产日期、有效期或失效期等信息（国际上药品追溯码普遍采用GTIN、失效日期、批号和序列号的组合）
</p>
<p>
<b>5.药品追溯码载体和人工识读</b>
</p>
<p>
--确定药品各级销售包装单元使用的药品追溯码载体类型（国际上普遍采用GS1
DataMatrix二维码）
</p>
<p>
--根据相关法规、标准、<a
href="https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specifications"
target="_blank"
>《GS1通用规范》</a
>以及<a
href="https://www.gs1.org/docs/healthcare/GS1_Healthcare_Implementation_Guideline.pdf"
target="_blank"
>《GS1医疗AIDC实施指南》</a
>等确定条码印制质量、人工识读内容和载体放置位置等细节。
</p>
<p>
--对条码印制质量进行检测（可联系<a
href="http://www.ancc.org.cn/Service/jcyxz/Barcode.aspx"
target="_blank"
>中国物品编码中心质量检测部</a
>进行测试）
</p>
<p>
<b>6.做好各级销售包装单元药品追溯码之间的关联</b>
</p>
<p style="text-align: center; font-size: 14px; margin-top: 0px">
<b>药品追溯码要素及相应的GS1标准</b>
</p>
<table class="table table-striped table-hover">
<thead>
<tr>
<th>药品追溯码要素</th>
<th>适用的GS1标准</th>
</tr>
</thead>
<tbody>
<tr>
<td>药品标识码</td>
<td>GS1全球贸易项目代码（GTIN）</td>
</tr>
<tr>
<td>生产标识码</td>
<td>GS1应用标识符（AI）</td>
</tr>
<tr>
<td>载体</td>
<td>GS1-128条码、GS1 DataMatrix条码、EPC标签</td>
</tr>
<tr>
<td>人眼识读</td>
<td>供人识读字符HRI</td>
</tr>
</tbody>
</table>
</div>
</li>
</ul>
<div class="fileDownload">
<p>
<img src="../../assets/image/business/ico-download.png" alt="" />
参考资料：
</p>
<ul style="list-style: none">
<li>
<p>
<a
href="http://ancc.org.cn/Application/appArticle_yl.aspx?id=9379&amp;classid=17"
target="_blank"
>药品追溯码标准发布，如何用GS1实施？</a
>
</p>
</li>
</ul>
</div>
</div>
</div>
</template>
<script>
import cate from "../comps/cate.vue";
export default {
components: {
cate,
},
data() {
return {
ypzsCate: {
name: "我要申请药品追溯码",
ico: "",
},
};
},
created() {
// console.log(this.$route.query.id)
},
};
</script>
<style lang="scss" scoped>
.corppay {
@include module-box;
.corppay-msg {
margin: 30px 0;
font-size: 14px;
.msg-title {
color: #008dbd;
margin-bottom: 20px;
&.actived {
color: #04408d;
}
}
p {
font-size: 14px;
text-indent: 25px;
}
a {
color: #008dbd;
text-decoration: none;
}
ul {
margin: 0;
padding: 0;
list-style-type: disc;
margin-block-start: 1em;
margin-block-end: 1em;
margin-inline-start: 0px;
margin-inline-end: 0px;
padding-inline-start: 40px;
}
.mainTxt, .fileDownload {
p {
text-indent: 0;
}
}
.fileDownload {
img {
width: 16px;
}
}
table {
table-layout: fixed;
font-size: 14px;
max-width: 100%;
background-color: transparent;
tbody {
tr {
&:nth-child(odd) {
td {
border-bottom: 0;
}
}
}
}
}
thead {
border: 1px solid #b2b2b8;
display: table-header-group;
vertical-align: middle;
box-sizing: border-box;
tr {
th {
text-align: center;
}
}
}
tbody {
border: 1px solid #b2b2b8;
display: table-row-group;
vertical-align: middle;
box-sizing: border-box;
tr:last-child {
td {
border-bottom: none;
}
}
}
tr {
border: 1px solid #b2b2b8;
box-sizing: border-box;
display: table-row;
vertical-align: inherit;
}
th {
border: 1px solid #b2b2b8;
text-align: center;
}
td {
border: 1px solid #b2b2b8;
text-align: center;
}
.text-explain {
li {
display: list-item;
list-style-type: disc;
}
}
.table {
tbody {
tr {
th {
border-top: none;
}
td {
border-top: none;
}
}
}
thead {
tr {
th {
border: none;
vertical-align: bottom;
}
}
&:first-child {
tr {
&:first-child {
th {
border-top: 0;
}
}
}
}
}
}
.table-striped {
tbody {
tr:nth-child(odd) {
th {
background-color: #f5f5f5;
}
td {
background-color: #f5f5f5;
}
}
}
}
}
}
</style>
\ No newline at end of file
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