Provisions for Drug Insert Sheets and Labels
Commissioner of SFDA
Provisions for Drug Insert Sheets and Labels
(SFDA Decree No.24)
The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.
Shao Mingli
Commissioner of SFDA
March 15, 2006
Provisions for Drug Insert Sheets and Labels
Chapter I General Provisions
Article 1 The Provisions are enacted with a view to regulating drug insert sheets and labels in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.
Article 2 The insert sheets and labels of drugs marketed within the territory of the People’s Republic of China shall meet the requirements of the Provisions.
Article 3 Drug insert sheets and labels shall be reviewed and approved by the State Food and Drug Administration.
A drug shall be labeled on the basis of its insert sheet. The content of the label shall be within the scope of the insert sheet. Any words and marks with implied therapeutic effects, misleading information on usage, or inappropriate promotion of the product shall not be printed.
Article 4 A drug label shall be printed on or affixed to the drug package, and no other written words, audio and/or visual materials or other information are attached to introduce or publicize the product or the enterprise.
An insert sheet shall be attached to the smallest package provided by the drug manufacturer for marketing.
Article 5 The wording in drug insert sheets and labels shall be scientific, standardized and accurate. The insert sheet of a non-prescription drug shall be written intelligibly and convenient for patients to judge, choose and use the drug on their own.
Article 6 In the label or insert sheet, the letters or characters shall be clear and easy to be recognized and the marks shall be clear and distinctive. The label and insert sheet shall have no print faded and shall not be affixed unsteadily. Any addition or modification shall not be made by means of pasting, cutting or altering.
Article 7 Drug insert sheets and labels shall be written in standardized Chinese characters published by the National Language Commission. The versions in other languages shall comply with the Chinese version.
Article 8 With the aim to protect public health and direct the rational use of drugs, drug manufacturers may voluntarily apply to add warnings to drug insert sheets or labels. The State Food and Drug Administration may also request drug manufacturers to add warnings to drug insert sheets or labels.
Chapter II Drug Insert Sheet
Article 9 A drug insert sheet shall include the significant scientific data, conclusions and information concerning drug safety and efficacy in order to direct the safe and rational use of drugs. The specific format, content and writing requirements of drug insert sheet shall be prescribed and issued by the State Food and Drug Administration.
Article 10 Disease names, pharmaceutical terms, drug names, the names and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards.
Article 11 All the active ingredients or medicinal ingredients of traditional Chinese medicines in a prescription shall be listed in the insert sheet. For injections and non-prescription drugs, all excipients shall be listed as well.
The ingredients or excipients included in a prescription, which may cause severe adverse reaction, shall be specified.
Article 12 A drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely.
The State Food and Drug Administration may also require a drug manufacturer to make modification to the insert sheet on the basis of the results of adverse drug reaction monitoring and drug re-evaluation.
Article 13 After the modification to the insert sheet is approved, the drug manufacturer shall inform relevant drug distributors, drug users and other departments of the modified content immediately, and use the modified insert sheet and label timely as required.
Article 14 The insert sheet shall provide full information on adverse drug reaction and indicate the adverse reactions in detail. A drug manufacturer, who fails to timely modify the insert sheet on the basis of the safety and efficacy data of the marketed drug or to fully explain the adverse reaction in the insert sheet, shall be liable for all the consequences arising therefrom.
Article 15 The approval date and the modification date shall be distinctively shown in the insert sheet.
Chapter III Drug Labels
Article 16 Drug labels refer to the information printed or pasted on drug packaging, including inner labels and outer labels. Inner labels refer to those that appear on immediate packaging; outer labels are those on the other packaging outside of inner labels.
Article 17 The inner label shall bear such drug information as the adopted name in China, indications or functions, strength, dose and usage, production date, batch number, expiry date and manufacturer. If there is no enough space in the package to include all the information mentioned above, the adopted name in China, strength, batch number and expiry date shall be indicated at least.
Article 18 The outer label of a drug shall indicate such information as the adopted name in China, ingredients, description, indications or functions, strength, dose and usage, adverse reactions, contraindications, precautions, storage, production date, batch number, expiry date, approval number and manufacturer. Where indications or functions, dose and usage, adverse reactions, contraindications and precautions cannot be fully noted, main information plus a “See drug insert sheet for details.” notice shall be indicated.
Article 19 The label on the package for transportation and storage shall bear at least the adopted name in China, strength, storage, production date, batch number, expiry date, approval number and manufacturer. Other information such as packaging quantity, precautions for transportation or other marks may be included when necessary.
Article 20 The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied specifications, approval number and manufacturer. Other necessary information such as packaging quantity and precautions for transportation shall also be indicated.
Article 21 Where one drug produced by a manufacturer has the same drug strength and packaging specification, the content, format and color of its labels must be the same. Where one drug produced by a manufacturer has different drug strengths or packaging specifications, its labels shall be clearly distinguished from one another, or its specifications shall be notably marked in the corresponding specification items.
Where a drug produced by a manufacturer is administrated as prescription drug and non-prescription drug respectively, their packaging colors shall be distinctly different.
Article 22 For drugs with special requirements on storage, its requirements shall be marked in the notable place of the label.
Article 23 The expiry date in the drug label shall appear in the order of year, month and day, with year shown in four digits, month and day in two digits. Its specific format shall be “Valid till XXXX year XX month” or “Valid till XXXX year XX month XX day”. It may be presented with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till XXXX/XX/XX”.
For the preventive biological product, the expiry date shall be labeled according to the registration specifications approved by the State Food and Drug Administration. The expiry date of the biological product for therapeutic use shall be counted from the filling date. For other drugs, the expiry date shall be counted from the production date.
Where the expiry date is labeled to the day, it shall be marked as one day earlier than the actual expiry date; where the expiry date is labeled to the month, it shall be marked as one month earlier than the actual expiry month.
Chapter IV Use of Drug Name and Registered Trademark
Article 24 The drug name in insert sheets and labels shall conform to the nomenclature principles on the adopted name in China and trade name of drug announced by the State Food and Drug Administration, and shall be consistent with those appeared in the approval documents of the drug.
Article 25 The adopted name in China shall be conspicuous and prominent, and its typeface, size and color shall be consistent, and meet the following requirements:
(1) For horizontal labels, the adopted name in China shall appear in a prominent position within the area of the upper one-third of the label; for vertical labels, it shall appear in a prominent position within the area of the right one-third of the label;
(2) No such illegible typefaces as cursive characters and seal characters shall be used, and no such format as italics, margining and shading shall be used to modify the typefaces.
(3) The font color of the adopted name in China shall be black or white, in sharp contrast to the light-colored or dark-colored background respectively.
(4) Writing in separate lines shall be avoided unless limited by the packaging size.
Article 26 The trade name of a drug shall not be placed in the same line with the adopted name in China; its typeface and color shall be no more conspicuous than that of the adopted name in China, and its font area per character shall be no bigger than half of that of the adopted name in China.
Article 27 Unregistered trademarks and other drug names unapproved by the State Food and Drug Administration shall not be used in the drug insert sheets and labels.
Where a registered trademark is used in a drug label, it shall be printed in a corner of the label. Where a registered trademark contains characters, the font area per character shall be no bigger than a quarter of that of the adopted name in China.
Chapter V Other Provisions
Article 28 For narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive pharmaceuticals, drugs for topical use, non-prescription drugs and other drugs having special marks specified by the State, their special marks shall be printed in the drug insert sheets and labels.
Where there are special provisions issued by the State for drug insert sheets and labels, they shall prevail.
Article 29 The labeling provisions for Chinese crude drugs and prepared slices of Chinese crude drugs shall be formulated separately by the State Food and Drug Administration.
Article 30 Where drug insert sheets and labels are not in compliance with the Provisions, a punishment shall be imposed in accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China.
Chapter VI Supplementary Provisions
Article 31 These Provisions shall come into force as of June 1, 2006. the Provisions for Drug Packaging, Labels and Insert Sheets (Provisional) issued by State Food and Drug Administration on October 15, 2005 shall be annulled therefrom.
十堰市户外广告管理暂行办法
湖北省十堰市人民政府
十 堰 市 人 民 政 府 文 件
十政发[2002]27号
十堰市人民政府关于印发
《十堰市户外广告管理暂行办法》的通知
各县市区人民政府，白浪开发区管委会，市政府各部门，各县级事业单位，各大中型企业，驻市各单位：
《十堰市户外广告管理暂行办法》已经市政府第54次常务会议讨论通过，现印发给你们，请认真执行。
二○○二年九月二十六日
十堰市户外广告管理暂行办法
第一条 为了优化配置城市空间资源，美化城市环境，进一步加强我市户外广告经营管理，促进广告业的健康发展，保护广告主、广告经营者、广告发布者和消费者的合法权益，根据《中华人民共和国广告法》、中华人民共和国国务院令《城市市容和环境卫生管理条例》、《湖北省户外广告管理实施办法》、《湖北省实施〈中华人民共和国广告法〉办法》、《湖北省城市建设监察条例》等法律法规的规定,结合我市经营城市的实际,特制定本办法。
第二条 本办法所称户外广告，是指由商品生产经营者或服务者，利用城市（城镇）空间和建（构）筑物，直接或间接介绍商品或服务的下列广告：
（一）利用公有、自有或他人所有的建（构）筑物、场地、空间等设置的路牌、霓虹灯、电子显示屏、电子翻板装置、灯箱、实物模型、招牌以及张贴广告；
（二）利用车、船（包括各种水上漂浮物和空中飞行物）等交通工具设置、绘制、张贴的广告；
（三）以其它形式在户外设置的广告。
第三条 鼓励法人、其他经济组织和个人依照国家法律、法规及本办法的规定，设计、制作、发布有利于改善经济环境、美化城乡面貌、有利公民身心健康的户外广告。
第四条 城市（城镇）空间是政府的资源。利用城区空间设置户外广告的所有权属市人民政府；利用县（市）城镇空间设置户外广告的所有权属同级人民政府。
第五条 政府运用市场手段，配置户外广告资源，建立有偿占用城市（城镇）空间设置户外广告的机制。对已经开始市场化运作的户外广告，要进行清理、备案，在规定期限内继续运作；对没有开始市场化运作的户外广告，采取拍卖经营权的办法，从现在开始市场化运作（经批准的公益性广告除外）。
第六条 政府把户外广告经营权拍卖给具有广告经营资格的广告经营业主，经营业主必须依法经营。需要设置公益广告的，报经同级人民政府批准后，由相关部门组织落实。
第七条 县级以上工商行政管理部门主管本行政区域内的户外广告的管理工作，负责户外广告的登记，对户外广告的真实性、合法性等进行审核。城市规划、公安、交通等部门依法根据各自的职责，协助做好户外广告的相关工作。
第八条 县级以上人民政府应根据城市发展总体规划，组织工商、规划、交通等部门制定户外广告的设置专项规划。专项规划经同级人民政府批准后实施。
第九条 政府授权的单位根据批准的户外广告专项规划，组织户外广告位经营权的招标拍卖工作。
第十条 户外广告拍卖的基准价（标的）包括：场地占用费、设置管理费、工商管理费等。
第十一条 户外广告收入实行财政专户管理，政府、单位、个人按比例获取收益的管理办法。
城区设置户外广告的收益由市财政部门统一收取，为市财政收入；县（市）城镇设置户外广告的收益由县（市）乡镇财政部门收取，为同级财政收入。在企业、事业单位、个人建筑物上设置的户外广告，其收益分配办法由物价、财政部门按有关规定另行制定。
第十二条 户外广告内容必须有利公民身心健康，促进商品和服务质量的提高，保护消费者的合法权益，符合社会公德，维护国家的尊严和利益，不得以任何形式欺骗和误导消费者。
第十三条 户外广告应当符合下列条件：
（一）内容真实、合法、健康、清晰、明白；
（二）结构坚固、外形美观、容貌整洁；
（三）文字及书写规范。
第十四条 有下列情况之一者，不得设置户外广告：
（一）影响市政公用设施、园林绿化设施使用的；
（二）妨碍生产、人民群众生活、损害市容市貌的；
（三）国家机关、文物保护单位和名胜景区的建筑控制地带；
（四）利用交通标志和交通安全设施的；
（五）县级以上人民政府禁止设置户外广告的区域。
第十五条 申请经营户外广告业务的单位或个人，必须经工商行政管理部门核准，并颁发《广告经营许可证》，取得广告经营资格；未取得广告经营资格的，不得从事广告经营业务，不得参加城区户外广告经营权的竞拍活动。
第十六条 任何单位和个人发布户外广告，必须经工商行政管理部门登记，领取《户外广告登记证》；属临时性广告活动的，领取《临时性广告经营许可证》，并办理相关广告登记。活动结束后7日内拆除所发布的广告。
第十七条 办理户外广告登记，应向工商行政管理部门提交下列证件或资料：
（一）参加竞拍取得户外广告位经营使用权的证明或场地使用权、建（构）筑物所有权或使用权证明（含场租合同）；
（二）城市规划部门的设置审查批准意见；
（三）《广告经营许可证》和《营业执照》及其有效复印件；
（四）《广告业务发布合同》；
（五）证明广告内容真实、合法、有效的文件；
（六）其他有关证件。
第十八条 设置户外广告必须按照登记的地点、形式、规格、时间以及工商行政主管部门登记的内容据实发布，并标明户外广告审批登记证号、设置者、使用期限（霓虹灯、实物模型广告除外）。
第十九条 户外广告设置期限一般不超过三年，电子显示屏（牌）一般不超过六年。在有效期内，任何单位和个人不得擅自拆除、遮盖、损坏。确因建设需要撤除户外广告设施的，应当书面通知发布者拆除，建设单位应当对发布者予以补偿；经书面通知，发布者拒不拆除的，审批部门可指定单位代为拆除，费用由发布者承担。
第二十条 广告设施的制作、安装、设置，应当符合相应的技术质量和安全规范标准。广告主、广告经营者、广告发布者应当依照拍卖合同及有关规定，适时对户外广告进行维修，确保户外广告整洁、安全、美观。
第二十一条 禁止在本市城区发布布标、条幅、横幅等商业广告。确因特殊需要发布的，必须报经市政府批准。
第二十二条 本办法适用于十堰市行政区域内的户外广告经营管理。对违反本办法规定的，应由相关部门依照有关法律、法规进行处罚。
第二十三条 本办法由十堰市工商行政管理部门负责解释。
第二十四条 本办法自公布之日后三十日执行。同时，十堰市人民政府办公室于2001年2月23日发布的《十堰市户外广告管理实施办法》（十政办发〔2001〕30号）废止。
