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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
25、al products online has illegal acts and requires a third-party platform to adopt measures to stop it, the third-party platform shall perform relevant obligations in a timely manner.第二十五条药品监 督管理部门开展监督检 查、案件查办、事件处置 等工作时，第三方平台应 当予以配合。药品监督管 理部门发现药品网络销售 企业存在违法行为，依法 要求第三方平台采取措施 制止的，第三方平台应当 及时履行相关义务。If a m
26、edical products administrative department provides information on sellers, sales records, pharmaceutical services, and traceability on a platform in accordance with the requirements of laws and administrative regulations, the third-party platform shall provide it in a timely manner.药品监督管理部门依照法 律、行政法
27、规要求提供有 关平台内销售者、销售记 录、药学服务以及追溯等 信息的，第三方平台应当 及时予以提供。Third-party platforms shall be encouraged to establish automated information reporting mechanisms in the form of open data interface with medical products administrative departments.鼓励第三方平台与药品监 督管理部门建立开放数据 接口等形式的自动化信息 报送机制。Chapter IV Supervision and
28、Inspection第四章监督检查14Article 26 The medical products administrative departments shall supervise and inspect third-party platforms and enterprises selling medicinal products online in accordance with laws, regulations, rules and other provisions, and according to the division of duties.第二十六条药品监 督管理部门应当
29、依照法 律、法规、规章等规定， 按照职责分工对第三方平 台和药品网络销售企业实 施监督检查。Article 27 When a medical products administrative department inspects third-party platforms and enterprises selling medicinal products online, it may adopt the following measures according to the law:第二十七条药品监 督管理部门对第三方平台 和药品网络销售企也进行 检查时，可以依法采取下 列措施：(1) C
30、onducting on-site inspections at the relevant premises for online sale of medicinal products and online platform services.（一）进入药品网络销售 和网络平台服务有关场所 实施现场检查；(2) Conducting sampling inspection of the medicinal products sold online.（二）对网络销售的药品 进行抽样检验；(3) Inquiring relevant personnel to learn about the rel
31、evant information on online sale of medicinal products.（三）询问有关人员，了 解药品网络销售活动相关 情况；(4) Consulting and duplicating trading data, contracts, bills, account books and other relevant materials in accordance with the law.（四）依法查阅、复制交 易数据、合同、票据、账 簿以及其他相关资料；(5) Adopting measures to seal up and detainmedicina
32、l products and their relevant materials with（五）对有证据证明可能 危害人体健康的药品及其15有关材料，依法采取查 封、扣押措施；evidence to prove that they may endanger human health.（六）法律、法规规定可 以采取的其他措施。(4) Other measures that may be adopted as prescribed by laws and regulations.必要时，药品监督管理部 门可以对为药品研制、生 产、经营、使用提供产品 或者服务的单位和个人进 行延伸检查。If nece
33、ssary, the medical products administrative department may conduct extended inspections of entities and individuals that provide products or services for development, production, distribution, and use of medicinal products.第二十八条对第三 方平台、药品上市许可持 有人、药品批发企业通过 网络销售药品违法行为的 查处，由省级药品监督管 理部门负责。对药品网络 零售企业违法行为的
34、查 处，由市县级药品监督管 理部门负责。Article 28 The medical products administrative departments at the provincial level shall be responsible for the investigation and handling of illegal sale of medicinal products online by third- party platforms, medicinal products marketing license holders, and medicinal products
35、wholesalers. The investigation and handling of illegal acts of online medicinal products retailers shall be in the charge of the medical products administrative departments at the municipal level and the county level.药品网络销售违法行为由 违法行为发生地的药品监 督管理部门负责查处。因 药品网络销售活动引发药 品安全事件或者有证据证 明可能危害人体健康的， 也可以由违法行为结果地
36、 的药品监督管理部门负 责。The medical products administrative department at the place where the illegal acts of online sale of medicinal products occur shall be responsible for investigating and handling illegal acts of online sale of medicinal products. Where medicinal products safety incidents are caused by o
37、nline sale of medicinal products or there is evidence to prove that human health may be endangered, the medical products administrative department at the place where the illegal acts are conducted may also be responsible therefor.16第二十九条药品监 督管理部门应当加强药品 网络销售监测工作。省级 药品监督管理部门建立的 药品网络销售监测平台， 应当与国家药品网络销售
38、 监测平价实现数据对接。第二十九条药品监 督管理部门应当加强药品 网络销售监测工作。省级 药品监督管理部门建立的 药品网络销售监测平台， 应当与国家药品网络销售 监测平价实现数据对接。Artide 29 The medical products administrative department shall strengthen monitoring of online sale of medicinal products. The platforms for monitoring online sale of medicinal products established by the med
39、ical products administrative departments at the provincial level shall realize data connection with the national platform for monitoring online sale of medicinal products.药品监督管理部门对监测 发现的违法行为，应当依 法按照职责进行调查处 置。The medical products administrative departments shall investigate and handle illegal acts fo
40、und in monitoring according to the law.药品监督管理部门对网络 销售违法行为的技术监测 记录资料，可以依法作为 实施行政处罚或者采取行 政措施的电子数据证据。The technical monitoring records of the medical products administrative department on illegal acts of online sale may be used as electronic data evidence for implementing administrative penalties or ado
41、pting administrative measures in accordance with the law.第三十条对有证据 证明可能存在安全隐患 的，药品监督管理部门应 当根据监督检查情况，对 药品网络销售企业或者第 三方平台等采取告诫、约 谈、限期整改以及暂停生 产、销售、使用、进口等 措施，并及时公布检查处 理结果。Article 30 If there is evidence to prove that there is possible hidden safety risk, the medical products administrative department shal
42、l, according to the supervision and inspection situation, adopt measures such as warnings, holding interviews, rectification within a prescribed time limit and suspension of production, sale, use, and import against enterprises selling medicinal products online and third-party platforms, and announc
43、e the inspection results in a timely manner.17Article 31 The medical products administrative department shall strictly keep the personal information and business secrets provided by enterprise selling medicinal products online or third- party platforms confidential, and shall not disclose, sell or i
44、llegally supply them to any other.第三十一条药品监 督管理部门应当对药品网 络销售企业或者第三方平 台提供的个人信息和商业 秘密严格保密，不得泄 露、出售或者非法向他人 提供。Chapter V Legal Liability第五章法律责任Article 32 Where laws and administrative regulations have provisions on penalties for illegal online sale of medicinal products, such provisions shall be followed.
45、 If the medical products administrative department finds that the illegal online sale of medicinal products is suspected of a crime, it shall transfer the case to the public security organ in a timely manner.第二十一条.律 行政法面对药品网络销鲁 违法行为的处罚有规定 的，依照其规定。药品监 督管理部门发现药品网络 销售违法行为涉嫌犯罪 的，应当及时将案件移送 公安机关。Article 3
46、3 For online sale of medicinal products under special management of the state in violation of the provisions of paragraph 2 of Article 8 of these Measures, if there have been provisions in laws and administrative regulations, penalties shall be imposed upon in accordance with the provisions of the l
47、aws and administrative regulations. If there are no provisions in laws and administrative regulations,第三十三条违反本 办法第八条第二款的规 定，通过网络销售国家实 行特殊管理的药品，法 律、行政法规已有规定 的，依照法律、行政法规 的规定处罚。法律、行政18法规未作规定的，责令限 期改正，处5万元以上10 万元以下罚款；造成危害 后果的，处10万元以上 20万元以下罚款。第三十四条违反本 办法第九条第一款、第二 款的规定，责令限期改 正，处3万元以上5万元 以下罚款；情节严重的， 处5万元以
48、上10万元以下 罚款。the violator shall be ordered to take corrective action within a prescribed time limit and be subject to a fine of not less than 50,000 yuan nor more than 100,000 yuan; and if harmful consequences have been caused, it shall be subject to a fine of not less than 100,000 yuan nor more than 200,00() yuan.Article 34 For violation of the provisions of paragraphs 1 and 2 of Article 9 of these Measures, the violator shall be ordered to take co