【中英文对照版】药品网络销售监督管理办法.docx
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1、药品网络销售监督管理办法Measures for the Supervision and Administration of Online Saleof Medicinal Products发布部门:国家市场监督管理总局发文字号:国家市场监督管理总局令第58号发布日期:2022.08.03实施日期:2022.12.01效力级别:部门规章法规类别:药品管理Issuing Authority : State Administration for Market RegulationDocument Number: Order No. 58 of the State Administration fo
2、r Market RegulationDate Issued: 08-03-2022Effective Date: 12-01-2022Level of Authority: Departmental Rules药品网络销售监督管理办 法(2022年8月3日国家市 场监督管理总局令第58号 公布自2022年12月1 日起施行)Area of Law: Pharmaceutical AdministrationMeasures for the Supervision and Administration of Online Sale of Medicinal Products(Issued by
3、 Order No. 58 of the State Administration for Market Regulation on August 3, 2022 and shall come into force on December 1, 2022)第一章总则第一章总则第一条为了规范药 品网络销售和药品网络交Chapter I General PrinciplesArticle 1 For the purposes of regulating the online sale of medicinal products and the services onactivities of th
4、eir websites in a timely manner.页或者经营活动主页面公 开相应信息。第三章平台管理Chapter III Platform Management第十七条第三方平 台应当建立药品质量安全 管理机构,配备药学技术 人员承担药品质量安全管 理工作,建立并实施药品 质量安全、药品信息展 示、处方审核、处方药实 名购买、药品配送、交易 记录保存、不良反应报 告、投诉举报处理等管理 制度。第十七条第三方平 台应当建立药品质量安全 管理机构,配备药学技术 人员承担药品质量安全管 理工作,建立并实施药品 质量安全、药品信息展 示、处方审核、处方药实 名购买、药品配送、交易 记录
5、保存、不良反应报 告、投诉举报处理等管理 制度。Article 17 A third-party platform shall establish a medicinal products quality and safety management institution, assign pharmacy technicians to manage the quality and safety of medicinal products, and establish and implement the management systems for for quality and safety
6、of medicinal products, display of information on medicinal products, review of prescriptions, real-name purchase of prescription medicinal products, distribution of medicinal products, keeping of trading records, reporting of adverse reactions, and handling of complaints and tip-offs.第三方平台应当加强检 查,对入
7、驻平台的药品网 络销售企业的药品信息展 示、处方审核、药品销售 和配送等行为进行管理, 督促其严格履行法定义 务。A third-party platform shall strengthen inspections, manage the display of information on medicinal products, review of prescriptions, sale and distribution of medicinal products by enterprises selling medicinal products online settled on the
8、platform, and urge them to strictly perform their legal obligations.第十八条第三方平 台应当将企业名称、法定 代表人、统一社会信用代Article 18 A third-party platform shall submit the information such as an enterprises name, legal representative, unified social credit code, website name, and domain name to the medical products10码、网
9、站名称以及域名等 信息向平台所在地省级药 品监督管理部门备案。省 级药品监督管理部门应当 将平台备案信息公示。administrative department at the provincial level where the platform is located for recordation. The medical products administrative departments at the provincial level shall publicize platforms recordation information.第十九条第三方平 台应当在其网站首页或者 从事药品经
10、营活动的主页 面显著位置,持续公示营 业执照、相关行政许可和 备案、联系方式、投诉举 报方式等信息或者上述信 息的链接标识。Article 19 A third-party platform shall, in a prominent position on the home page or the main page for its drug business activities of its website, continuously publicize information such as business license, relevant administrative licen
11、se and recordation, contact information, methods for filing complaints and tip-offs, or the link logos of the aforesaid information.第三方平台展示药品信息 应当遵守本办法第十三条 的规定。To display information on medicinal products, a third-party platform shall comply with the provisions of Article 13 of these Measures.第二十条第三
12、方平 台应当对申请入驻的药品 网络销售企业资质、质量 安全保证能力等进行审 核,对药品网络销售企业 建立登记档案,至少每六 个月核验更新一次,确保 入驻的药品网络销售企业 符合法定要求。Article 20 A third-party platform shall review the qualifications, quality and safety assurance capabilities, etc. of an enterprise selling medicinal products online that applies for settlement, and create r
13、egistration files for the enterprise selling medicinal products online, which shall be verified and updated at least every six months to ensure that the settled enterprise selling medicinal products online satisfies the statutory requirements.第三方平台应当与药品网络销售企业签订协议,明A third-party platform shall enter
14、into an agreement with the entei-prise selling medicinal products online11to specify the responsibilities of both parties for quality and safety of medicinal products.确双方药品质量安全责 任。Article 21 A third-party platform shall keep information such as display of medicinal products, trading records, complai
15、nts and tip-offs, for not less than five years, and not less than one year after the expiry of the validity period of medicinal products. A third-party platform shall ensure the authenticity and integrity of relevant materials, information and data, and provide convenience for the settled enterprise
16、 selling medicinal products online to save data by themselves.第二十一条第三方 平台应当保存药品展示、 交易记录与投诉举报等信 息。保存期限不少于5 年,且不少于药品有效期 满后1年。第三方平台应 当确保有关资料、信息和 数据的真实、完整,并为 入驻的药品网络销售企业 自行保存数据提供便利。Article 22 A third-party platform shall establish an inspection and monitoring system for online sale of medicinal products
17、. If a settled entei*prise selling medicinal products online is found to have illegal acts, it shall stop it in a timely manner and report to the local medical products administrative department at the county level immediately.第二十二条第三方 平台应当对药品网络销售 活动建立检查监控制度。 发现入驻的药品网络销售 企业有违法行为的,应当 及时制止并立即向所在地 县级药品
18、监督管理部门报 告。Article 23 A third-party platform finding the following serious violations shall immediately stop providing online trading platform services and stop displaying information on medicinal products:第二十三条第三方 平台发现下列严重违法行 为的,应当立即停止提供 网络交易平台服务,停止 展示药品相关信息:12(三)超过药品经营许可 范围销售药品的;(四)因违法行为被药品 监督管理部门责
19、令停止销 售、吊销药品批准证明文 件或者吊销药品经营许可 证的;Those who are not qualified for selling medicinal (一)不具备资质销售药 products.品的;(1) Medicinal products under special administration (二)违反本办法第八条 of die state are sold in violation of the provisions of 规定销售国家实行特殊管 Article 8 of these Measures,理的药品的;Medicinal products are sold
20、beyond the scope of business license of medicinal products.(2) Being ordered to cease sale, and being subject to revocation of the medicinal products approval certificate or business license for medicinal products by the medical products administrative department due to illegal acts.(3) Other seriou
21、s illegal acts.(五)其他严重违法行为 的。药品注册证书被依法撤 销、注销的,不得展示相 关药品的信息。第二十四条出现突 发公共卫生事件或者其他 严重威胁公众健康的紧急 事件时,第三方平台、药 品网络销售企业应当遵守 国家有关应急处置规定, 依法采取相应的控制和处 置措施。If a medicinal product registration certificate is revoked or canceled in accordance with the law, the information on the relevant medicinal product shall n
22、ot be displayed.Article 24 In the event of public health emergencies or other emergencies that seriously threaten public health, third-party platforms and enterprise selling medicinal products online shall comply with the relevant rules of the state on emergency response, and adopt corresponding con
23、trol and disposal measures in accordance with the law.13Where a medicinal products marketing license holder recalls a medicinal product in accordance with the law, third-party platforms and enterprise selling medicinal products online shall actively cooperate with it.药品上市许可持有人依法 召回药品的,第三方平 台、药品网络销售企
24、业应 当积极予以配合。Article 25 If a medical products administrative department conducts supervision and inspection, case investigation and handling, incident handling, etc., third-party platforms shall cooperate with it. If a medical products administrative department finds that an enterprise selling medicin
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