| Order of the State Administration for Market Regulation | | 国家市场监督管理总局令 |
| (N0. 21) | | （第21号） |
| The Interim Measures for the Administration of Censorship of Advertisements on Drugs, Medical Devices, Dietary Supplements and Formula Foods for Special Medical Purposes, as deliberated and adopted at the 16th executive meeting of the State Administration for Market Regulation on December 13, 2019, are hereby issued and shall come into force on March 1, 2020. | | 《药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理暂行办法》已于2019年12月13日经国家市场监督管理总局2019年第16次局务会议审议通过，现予公布，自2020年3月1日起施行。 |
| Director: Xiao Yaqing | | 局长 肖亚庆 |
| December 24, 2019 | | 2019年12月24日 |
| Interim Measures for the Administration of Censorship of Advertisements on Drugs, Medical Devices, Dietary Supplements and Formula Foods for Special Medical Purposes | | 药品、医疗器械、保健食品、特殊医学用途配方食品广告审查管理暂行办法 |
| (Issued by Order No. 21 of the State Administration for Market Regulation on December 24, 2019) | | （2019年12月24日国家市场监督管理总局令第21号公布） |
| Article 1 For purposes of enhancing the supervision and administration of advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes, regulating advertisement censorship, maintaining the order of the advertising market, and protecting the lawful rights and interests of consumers, these Measures are developed in accordance with the Advertising Law of the People's Republic of China and other laws and administrative regulations. | | 第一条 为加强药品、医疗器械、保健食品和特殊医学用途配方食品广告监督管理，规范广告审查工作，维护广告市场秩序，保护消费者合法权益，根据《中华人民共和国广告法》等法律、行政法规，制定本办法。 |
| Article 2 These Measures shall apply to the censorship of advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes. | | 第二条 药品、医疗器械、保健食品和特殊医学用途配方食品广告的审查适用本办法。 |
| No advertisement on any drug, medical device, dietary supplement, or formula food for special medical purpose may be published without undergoing censorship. | | 未经审查不得发布药品、医疗器械、保健食品和特殊医学用途配方食品广告。 |
| Article 3 Advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes shall be true and lawful, and shall not contain any false or misleading information. | | 第三条 药品、医疗器械、保健食品和特殊医学用途配方食品广告应当真实、合法，不得含有虚假或者引人误解的内容。 |
| An advertiser shall be responsible for the veracity and legality of the contents of its advertisement on a drug, a medical device, a dietary supplement, or formula food for special medical purpose. | | 广告主应当对药品、医疗器械、保健食品和特殊医学用途配方食品广告内容的真实性和合法性负责。 |
| Article 4 The State Administration for Market Regulation (“SAMR”) shall be responsible for organizing and guiding the censorship of advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes. | | 第四条 国家市场监督管理总局负责组织指导药品、医疗器械、保健食品和特殊医学用途配方食品广告审查工作。 |
| The market regulatory authorities and medical products administrations (hereinafter referred to as “advertisement censoring authorities”) of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the censorship of advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes and may authorize other administrative agencies to do the specific censorship. | | 各省、自治区、直辖市市场监督管理部门、药品监督管理部门（以下称广告审查机关）负责药品、医疗器械、保健食品和特殊医学用途配方食品广告审查，依法可以委托其他行政机关具体实施广告审查。 |
| Article 5 The contents of a drug advertisement shall be governed by the instructions approved by the medical products administration of the State Council. A drug advertisement involving the name, indications, and the functions and pharmaceutical effects, etc., of the drug shall not exceed the scope of the instructions. | | 第五条 药品广告的内容应当以国务院药品监督管理部门核准的说明书为准。药品广告涉及药品名称、药品适应症或者功能主治、药理作用等内容的，不得超出说明书范围。 |
| A drug advertisement shall conspicuously indicate the restrictions and adverse reactions; an advertisement on a prescription drug shall conspicuously indicate: “This advertisement is intended for medical and pharmaceutical professionals only”; and an advertisement on an over-the-counter (OTC) drug shall further be conspicuously marked with the logo for OTC drugs and indicate: “Please follow the instructions of the drug or purchase and use the drug under the direction of a pharmacist.” | | 药品广告应当显著标明禁忌、不良反应，处方药广告还应当显著标明“本广告仅供医学药学专业人士阅读”，非处方药广告还应当显著标明非处方药标识（OTC）和“请按药品说明书或者在药师指导下购买和使用”。 |
| Article 6 The contents of an advertisement on a medical device shall be governed by the contents of the registration certificate or filing certificate approved by, or the product instructions registered or filed with, the medical products administration. An advertisement on a medical device involving the name, scope of application, mechanism of action, structure and ingredients, etc., of the medical device shall not exceed the scope of the registration certificate or filing certificate, or the registered or filed product instructions. | | 第六条 医疗器械广告的内容应当以药品监督管理部门批准的注册证书或者备案凭证、注册或者备案的产品说明书内容为准。医疗器械广告涉及医疗器械名称、适用范围、作用机理或者结构及组成等内容的，不得超出注册证书或者备案凭证、注册或者备案的产品说明书范围。 |
| An advertisement on a medical device recommended for personal use shall conspicuously indicate: “Please carefully read the product instructions or purchase and use the product under the direction of medical professional.” Where there are any contraindications or precautions in the registration certificate of a medical device, the advertisement shall conspicuously indicate: “Please see the instructions for details on contraindications or precautions.” | | 推荐给个人自用的医疗器械的广告，应当显著标明“请仔细阅读产品说明书或者在医务人员的指导下购买和使用”。医疗器械产品注册证书中有禁忌内容、注意事项的，广告应当显著标明“禁忌内容或者注意事项详见说明书”。 |
| Article 7 The contents of an advertisement on a dietary supplement shall be governed by the registration certificate or filing certificate approved by or the product instructions registered or filed with the market regulatory authority, and shall not mention disease prevention or treatment functions. An advertisement on a dietary supplement involving any health protection functions, product's functionality ingredients or marker ingredients and the content thereof, appropriate groups of people or consumption amount, etc., shall not exceed the scope of the registration certificate or filing certificate, or the registered or filed product instructions. | | 第七条 保健食品广告的内容应当以市场监督管理部门批准的注册证书或者备案凭证、注册或者备案的产品说明书内容为准，不得涉及疾病预防、治疗功能。保健食品广告涉及保健功能、产品功效成分或者标志性成分及含量、适宜人群或者食用量等内容的，不得超出注册证书或者备案凭证、注册或者备案的产品说明书范围。 |
| An advertisement on a dietary supplement shall conspicuously indicate: “Dietary supplements are not drugs, and cannot used in the treatment of diseases as substitutes for drugs,” state that the product is not a substitute for drugs, and conspicuously indicate the logo of dietary supplements, appropriate groups of people, and inappropriate groups of people. | | 保健食品广告应当显著标明“保健食品不是药物，不能代替药物治疗疾病”，声明本品不能代替药物，并显著标明保健食品标志、适宜人群和不适宜人群。 |
| Article 8 The contents of an advertisement on a formula food for special medical purpose shall be governed by the registration certificates and products labels and instructions approved by the SAMR. An advertisement on a formula food for special medical purpose involving the name, formula, nutritional characteristics, appropriate groups of people of the product shall not exceed the scope of the registration certificates and products labels and instructions approved by the SAMR. | | 第八条 特殊医学用途配方食品广告的内容应当以国家市场监督管理总局批准的注册证书和产品标签、说明书为准。特殊医学用途配方食品广告涉及产品名称、配方、营养学特征、适用人群等内容的，不得超出注册证书、产品标签、说明书范围。 |
| An advertisement on formula foods for special medical purposes shall conspicuously indicate: appropriate groups of people, “Not applicable to not-targeted groups of people,” and “Please use under the direction of a doctor or clinical nutritionist.” | | 特殊医学用途配方食品广告应当显著标明适用人群、“不适用于非目标人群使用”“请在医生或者临床营养师指导下使用”。 |
| Article 9 Advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes shall conspicuously indicate the approval numbers of advertisements. | | 第九条 药品、医疗器械、保健食品和特殊医学用途配方食品广告应当显著标明广告批准文号。 |
| Article 10 The fonts and colors of the contents that shall be conspicuously indicated in advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes must be plainly visible and easily discernible, and they shall be continuously displayed in video advertisements. | | 第十条 药品、医疗器械、保健食品和特殊医学用途配方食品广告中应当显著标明的内容，其字体和颜色必须清晰可见、易于辨认，在视频广告中应当持续显示。 |
| Article 11 Advertisements on drugs, medical devices, dietary supplements and formula foods for special medical purposes shall not violate Articles 9, 16, 17, 18 and 19 of the Advertising Law of the People's Republic of China, and be prohibited from: | | 第十一条 药品、医疗器械、保健食品和特殊医学用途配方食品广告不得违反《中华人民共和国广告法》第九条、第十六条、第十七条、第十八条、第十九条规定，不得包含下列情形： |
| (1) using, or using in a disguised form, the name or image of any state authority or any of its staff member, or any military entity or military personnel, or using any military equipment, facility, etc. for publicity or advertisements; | | （一）使用或者变相使用国家机关、国家机关工作人员、军队单位或者军队人员的名义或者形象，或者利用军队装备、设施等从事广告宣传； |
| (2) using any recommendation or certification in the name or image of any scientific research entity, academic institution, industry association or expert, scholar, physician, pharmacist, clinical nutritionist, or patient; | | （二）使用科研单位、学术机构、行业协会或者专家、学者、医师、药师、临床营养师、患者等的名义或者形象作推荐、证明； |
| (3) violating the laws of science, expressing or suggesting that it can treat all diseases, adapt to all symptoms, adapt to all people, or necessary for normal life and treatment of illness; | | （三）违反科学规律，明示或者暗示可以治疗所有疾病、适应所有症状、适应所有人群，或者正常生活和治疗病症所必需等内容； |
| (4) containing any content causing the public to have unnecessary concerns and fears about their health conditions and diseases, or any content causing the public to misunderstand that they would get sick or their diseases would be aggravated if they don't use this drug; | | （四）引起公众对所处健康状况和所患疾病产生不必要的担忧和恐惧，或者使公众误解不使用该产品会患某种疾病或者加重病情的内容； |
| (5) containing any indication such as “safe,” “no toxic or side effects” or “negligible toxic or side effects;” or containing any explicit or implicit indication that the safety is guaranteed as the ingredients are “natural.” | | （五）含有“安全”“安全无毒副作用”“毒副作用小”；明示或者暗示成分为“天然”，因而安全性有保证等内容； |
(6) containing any inductive content that “the product is a hot sale, a panic buy or the product is for free trial use,” or of “home essentials, free treatment, or free gift,” any comprehensive assessment information as “being appraised, ranked, recommended, appointed, selected or prize-winning”, any content guaranteeing “refund in case of no efficacy” and “being insured by an insurance company,” or any content instigating consumers' abuse or excessive use of drugs, dietary supplements and formula food for special medical purpose;
．．．．．． | | （六）含有“热销、抢购、试用”“家庭必备、免费治疗、免费赠送”等诱导性内容，“评比、排序、推荐、指定、选用、获奖”等综合性评价内容，“无效退款、保险公司保险”等保证性内容，怂恿消费者任意、过量使用药品、保健食品和特殊医学用途配方食品的内容；
．．．．．． |
|
Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.
1. To become a premium member, please call 400-810-8266 Ext. 171.
2. Binding to the account with access to this database.
3. Apply for a trial account.
4. To get instant access to a document, you can Pay Amount 【￥600.00】 for your single purchase. | |
您好：您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户；您可通过网上支付进行单篇购买，支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
|
| | | |
| | | |