The Measures Regarding the Administration of Drug Information Service over the Internet | | 互联网药品信息服务管理办法 |
| (Promulgated by the Order No.9 of the State Food and Drug Administration on July 8, 2004; and amended in accordance with the Decision to Amend Certain Rules adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017) | | （2004年7月8日国家食品药品监督管理局令第9号公布 根据2017年11月7日国家食品药品监督管理总局局务会议《关于修改部分规章的决定》修正） |
| Article 1 These Measures are formulated under the P.R.C Drug Administration Law and the Measures Regarding the Administration of Information Service over the Internet with a view to strengthening the supervision and administration of drugs, regulating the drug information service over the Internet and guaranteeing the authenticity and accuracy of the drug information over the Internet. | | 第一条 为加强药品监督管理，规范互联网药品信息服务活动，保证互联网药品信息的真实、准确，根据《中华人民共和国药品管理法》《互联网信息服务管理办法》，制定本办法。 |
| Article 2 These Measures shall apply to the provision of drug information services over the Internet within the territory of the P. R. C. | | 第二条 在中华人民共和国境内提供互联网药品信息服务活动，适用本办法。 |
| For the purposes of these Measures, the term “drug information service over the Internet” means the provision of drugs (including medical appliances) information over the Internet for the internet users. | | 本办法所称互联网药品信息服务，是指通过互联网向上网用户提供药品（含医疗器械）信息的服务活动。 |
| Article 3 The drug information service over the Internet is divided into for-profit service and not-for-profit service. | | 第三条 互联网药品信息服务分为经营性和非经营性两类。 |
| The term “for-profit drug information service over the Internet” means the paid drug information service provided over the Internet for the Internet users. | | 经营性互联网药品信息服务是指通过互联网向上网用户有偿提供药品信息等服务的活动。 |
| The term “not-for-profit drug information service” means the public drug information service provide gratuitously for the Internet users to share. | | 非经营性互联网药品信息服务是指通过互联网向上网用户无偿提供公开的、共享性药品信息等服务的活动。 |
| Article 4 The China Food and Drug Administration shall implement the supervision and administration of such websites who provide drug information service over the Internet throughout China. | | 第四条 国家食品药品监督管理总局对全国提供互联网药品信息服务活动的网站实施监督管理。 |
| The food and drug administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government shall implement the supervision and administration of the websites providing drug information services over the Internet within their respective administrative region. | | 省、自治区、直辖市食品药品监督管理部门对本行政区域内提供互联网药品信息服务活动的网站实施监督管理。 |
| Article 5 Any website which proposes to provide drug information services over the Internet shall apply for a business license to the department in charge of information industry under the State Council or the administration of telecommunication at the provincial level or, prior to going through the procedures for recording, file an application with the food and drug administrative department of the province, autonomous region and municipality directly under the Central Government where the entity sponsoring the website is located under the principle of territorial supervision and, subject to the examination and approval, obtain the qualification of providing drug information services over the Internet. | | 第五条 拟提供互联网药品信息服务的网站，应当在向国务院信息产业主管部门或者省级电信管理机构申请办理经营许可证或者办理备案手续之前，按照属地监督管理的原则，向该网站主办单位所在地省、自治区、直辖市食品药品监督管理部门提出申请，经审核同意后取得提供互联网药品信息服务的资格。 |
| Article 6 The food and drug administrative departments of all provinces, autonomous regions and municipalities directly under the Central Government shall carry out the examination and approval of the Internet websites that apply for providing drug information services over the Internet within their respective jurisdiction and issue a Qualification Certificate for Drug Information Services over the Internet to such websites that comply with the conditions. | | 第六条 各省、自治区、直辖市食品药品监督管理部门对本辖区内申请提供互联网药品信息服务的互联网站进行审核，符合条件的核发《互联网药品信息服务资格证书》。 |
| Article 7 The format of the Qualification Certificate for Drug Information Services over the Internet shall be made uniformly by the China Food and Drug Administration. | | 第七条 《互联网药品信息服务资格证书》的格式由国家食品药品监督管理总局统一制定。 |
| Article 8 Such websites that provide drug information services over the Internet shall indicate the serial number of the Qualification Certificate for Drug Information Services over the Internet on an eye-catching position of its website home page. | | 第八条 提供互联网药品信息服务的网站，应当在其网站主页显著位置标注《互联网药品信息服务资格证书》的证书编号。 |
| Article 9 The drug information uploaded by such websites that provide the drug information services must be scientific and accurate and comply with the State laws, regulations and other relevant provisions of the State relating to the administration of drug and medical appliances. | | 第九条 提供互联网药品信息服务网站所登载的药品信息必须科学、准确，必须符合国家的法律、法规和国家有关药品、医疗器械管理的相关规定。 |
| All websites that provide the drug information services over the Internet shall not publish any information about any narcotic drugs, mental medicines, toxic medicines, radioactive medicines, anti-drug medicines or the preparation products of medical institutions. | | 提供互联网药品信息服务的网站不得发布麻醉药品、精神药品、医疗用毒性药品、放射性药品、戒毒药品和医疗机构制剂的产品信息。 |
| Article 10 Any advertisement for the drugs published by any website that provides drug information services over the Internet must be subject to the examination and approval of the food and drug administrative department. | | 第十条 提供互联网药品信息服务的网站发布的药品（含医疗器械）广告，必须经过食品药品监督管理部门审查批准。 |
| The advisement for drugs (including medical appliances) published by such a website that provides drug information services over the Internet shall indicate the approval document number of the advertisements. | | 提供互联网药品信息服务的网站发布的药品（含医疗器械）广告要注明广告审查批准文号。 |
| Article 11 Any website that applies for providing drug information services over the Internet shall fulfill the following conditions in addition to complying with the requirements set forth in the Measures Regarding the Administration of Information Service over the Internet: | | 第十一条 申请提供互联网药品信息服务，除应当符合《互联网信息服务管理办法》规定的要求外，还应当具备下列条件： |
| (1) The provider of drug information services over the Internet shall be an enterprise, institution or any other organization; | | （一）互联网药品信息服务的提供者应当为依法设立的企事业单位或者其他组织； |
| (2) It shall have professionals, facilities and relevant rules that suit the provision of drug information services over the Internet; and | | （二）具有与开展互联网药品信息服务活动相适应的专业人员、设施及相关制度； |
(3) It shall have more than two technical personnel in pharmaceutics and medical appliance who are familiar with the laws and regulations relating to the administration of medical appliances and the professional knowledge therein or certified according to the law.
．．．．．． | | （三）有两名以上熟悉药品、医疗器械管理法律、法规和药品、医疗器械专业知识，或者依法经资格认定的药学、医疗器械技术人员。
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