不得网上销售！加强这些药品管理→
<div class="wx_rich_media_content" id="jsWxContainer"><section><p><br></p></section><section><section style='padding-right: 10px; padding-left: 10px; outline: 0px; max-width: 100%; box-sizing: border-box; font-size: 15px; color: rgb(0, 3, 4); font-family: PingFangSC-light; letter-spacing: 1.8px; line-height: 1.8; visibility: visible;'><section powered-by="xiumi.us" style='margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; box-sizing: border-box; justify-content: flex-start; display: flex; flex-flow: row nowrap; visibility: visible;'><section style='outline: 0px; max-width: 100%; box-sizing: border-box; display: inline-block; width: 657px; vertical-align: top; background-color: rgb(240, 246, 255); align-self: flex-start; flex: 0 0 auto; visibility: visible;'><section powered-by="xiumi.us" style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><section style='outline: 0px; max-width: 100%; box-sizing: border-box; display: inline-block; width: 30px; height: 30px; vertical-align: top; overflow: hidden; border-width: 0px; border-radius: 0px 0px 136px; border-style: none; border-color: rgb(62, 62, 62); background-color: rgb(255, 255, 255); visibility: visible;'><section powered-by="xiumi.us" style='margin-top: 4px; margin-bottom: -4px; outline: 0px; max-width: 100%; box-sizing: border-box; transform: translate3d(6px, 0px, 0px); visibility: visible;'><section style='outline: 0px; max-width: 100%; box-sizing: border-box; display: inline-block; width: 9px; height: 9px; vertical-align: top; overflow: hidden; border-width: 0px; border-radius: 78px; border-style: none; border-color: rgb(62, 62, 62); background-color: rgb(252, 209, 206); visibility: visible;'><svg viewBox="0 0 1 1" style='float: left;line-height: 0;width: 0px;vertical-align: top;visibility: visible;'></svg></section></section></section></section><section powered-by="xiumi.us" style='margin-bottom: 25px; outline: 0px; max-width: 100%; box-sizing: border-box; text-align: center; visibility: visible;'><section style='padding-right: 10px; padding-left: 10px; outline: 0px; max-width: 100%; box-sizing: border-box; text-align: justify; visibility: visible;'><p style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'>2月13日，国家药监局网站发布《国家药监局综合司 公安部办公厅 国家邮政局办公室关于进一步加强复方地芬诺酯片等药品管理的通知》。全文如下↓↓↓</p></section></section></section></section><p powered-by="xiumi.us" style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'></p><section powered-by="xiumi.us" style='outline: 0px; max-width: 100%; box-sizing: border-box; text-align: center; visibility: visible;'><p style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'>国家药监局综合司 公安部办公厅 国家邮政局办公室关于进一步加强复方地芬诺酯片等药品管理的通知</strong></p></section><section powered-by="xiumi.us" style='margin-top: 7px; margin-bottom: 20px; outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><section style='outline: 0px; max-width: 100%; box-sizing: border-box; border-top: 4px solid rgb(236, 211, 201); visibility: visible;'><svg viewBox="0 0 1 1" style='float: left;line-height: 0;width: 0px;vertical-align: top;visibility: visible;'></svg></section><section style='margin-top: 3px; outline: 0px; max-width: 100%; box-sizing: border-box; border-top: 1px solid rgb(236, 211, 201); visibility: visible;'><svg viewBox="0 0 1 1" style='float: left;line-height: 0;width: 0px;vertical-align: top;visibility: visible;'></svg></section></section><section powered-by="xiumi.us" style='outline: 0px; max-width: 100%; box-sizing: border-box; text-align: center; font-size: 12px; color: rgba(81, 81, 81, 0.54); visibility: visible;'><p style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'>药监综药管〔2023〕13号</p></section><p powered-by="xiumi.us" style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'></p><section powered-by="xiumi.us" style='margin-top: 10px; margin-bottom: 10px; outline: 0px; max-width: 100%; box-sizing: border-box; justify-content: flex-start; display: flex; flex-flow: row nowrap; visibility: visible;'><section style='padding: 20px 11px; outline: 0px; max-width: 100%; box-sizing: border-box; display: inline-block; width: 657px; vertical-align: top; background-color: rgb(255, 247, 244); align-self: flex-start; flex: 0 0 auto; visibility: visible;'><section powered-by="xiumi.us" style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><section style='outline: 0px; max-width: 100%; box-sizing: border-box; text-align: justify; visibility: visible;'><p style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; letter-spacing: 1.8px; visibility: visible;'>各省、自治区、直辖市药品监督管理局、公安厅、邮政管理局，新疆生产建设兵团药品监督管理局、公安局：</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'>近期，我国部分地区出现<span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8); visibility: visible;'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box; visibility: visible;'>复方地芬诺酯片、复方曲马多片、氨酚曲马多片以及右美沙芬口服单方制剂、依托咪酯注射剂</strong></span>的滥用问题,且滥用人群以青少年为主，严重危害公众特别是青少年的身心健康和生命安全。为进一步强化监管，严厉打击违法违规行为，有效遏制上述药品滥用和流入非法渠道，保障公众用药安全，根据《中华人民共和国药品管理法》《中华人民共和国禁毒法》《麻醉药品和精神药品管理条例》等法律法规，现将有关事宜通知如下：</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>一、</strong></span><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>严格控制药品生产量。</strong></span>药品监管部门审批生产复方地芬诺酯片、复方曲马多片、氨酚曲马多片所需盐酸地芬诺酯原料药、盐酸曲马多原料药需用计划时，应当认真审核申请单位资质证明文件，严格控制计划量，原则上相关企业本年度盐酸地芬诺酯原料药、盐酸曲马多原料药需用计划量不得高于上一年度。对在非法渠道查获数量较大的复方地芬诺酯片、复方曲马多片和氨酚曲马多片的生产企业，适度削减其相应品种需用计划。涉案药品生产企业被公安机关立案侦查的，侦查期间暂停执行该企业相应品种的需用计划。</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>二、加强药品生产环节监管。</strong></span><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>药品监管部门要督促药品上市许可持有人、药品生产企业严格按照经核准的药品注册标准和生产工艺进行生产，保证药品生产全过程持续符合法定要求。要加强复方地芬诺酯片、复方曲马多片、氨酚曲马多片生产所需原料药使用和储存的管理，严防流入非法渠道。<span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>复方地芬诺酯片、复方曲马多片、氨酚曲马多片等含麻醉药品复方制剂和含精神药品复方制剂不得委托生产。</strong></span></span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>三、强化药品经营环节监管。</strong></span><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>药品监管部门要督促药品上市许可持有人、药品批发企业切实落实主体责任，严格审核购买方资质，不得将药品销售至不具备相应资质的企业、机构或个人，严格药品出入库的复核和查验工作，严防发生伪造资质骗购、套购药品行为。要将药品储存、运输过程纳入经营管理范围，保证全过程符合药品经营质量管理规范有关要求。督促药品零售企业严格执行凭处方销售处方药的规定。<span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>复方地芬诺酯片、复方曲马多片、氨酚曲马多片、右美沙芬口服单方制剂、依托咪酯注射剂不得在网络上销售。</strong></span></span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>四、加强寄递渠道查验。</strong></span><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>邮政管理部门要督促寄递企业严格遵守国家法律法规规定，严格落实“实名收寄、收寄验视、过机安检”制度。对个人交寄的要认真查验药品处方，对单位交寄的要查验药品生产许可证、药品经营许可证、医疗机构执业许可证等证明文件，严防非正当用途的复方地芬诺酯片、复方曲马多片、氨酚曲马多片、右美沙芬口服单方制剂、依托咪酯注射剂等药品通过寄递渠道流通扩散。督促寄递企业加强从业人员的培训和教育，增强责任意识和安全意识。</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box; color: rgba(245, 106, 75, 0.8);'><strong style='outline: 0px; max-width: 100%; box-sizing: border-box;'>五、严厉打击违法违规行为。</strong></span><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>药品监管部门、邮政管理部门要加强药品生产、经营、寄递等环节的监督检查，对监督检查中发现的违反《中华人民共和国药品管理法》《麻醉药品和精神药品管理条例》等法律法规，导致药品流入非法渠道，引发药物滥用或造成危害的，要依法从严从重处理；构成犯罪的，要及时移交公安机关。公安机关对此类案件要始终保持严打高压态势，对属于公安机关管辖的违法线索和涉嫌犯罪案件，要认真开展调查，并及时向相关部门通报涉案企业和药品信息。</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box;'><br style='outline: 0px; max-width: 100%; box-sizing: border-box;'></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box; text-align: right;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>国家药监局综合司 公安部办公厅</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box; text-align: right;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>国家邮政局办公室</span></p><p style='outline: 0px; max-width: 100%; box-sizing: border-box; text-align: right;'><span style='outline: 0px; max-width: 100%; box-sizing: border-box;'>2023年2月3日</span></p></section></section><section powered-by="xiumi.us" style='margin-top: 20px; margin-bottom: 10px; outline: 0px; max-width: 100%; box-sizing: border-box;'><section style='outline: 0px; max-width: 100%; box-sizing: border-box; border-top: 1px solid rgb(236, 211, 201);'><svg viewBox="0 0 1 1" style='float:left;line-height:0;width:0;vertical-align:top;'></svg></section><section style='margin-top: 3px; outline: 0px; max-width: 100%; box-sizing: border-box; border-top: 4px solid rgb(236, 211, 201);'><svg viewBox="0 0 1 1" style='float:left;line-height:0;width:0;vertical-align:top;'></svg></section></section></section></section></section><p style='outline: 0px; max-width: 100%; color: rgb(34, 34, 34); font-family: system-ui, -apple-system, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; letter-spacing: 0.544px; text-align: right; box-sizing: border-box !important;'><br></p></section><p><br></p>转载声明：本文转载自「眉山市场监管」</div><p></p>
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