兽药广告审查办法（1998年修正）
国家工商行政管理总局 农业部
兽药广告审查办法（修正）
国家工商行政管理局 农业部
1995年4月7日中华人民共和国国家工商行政管理局、中华人民共和国农业部令第29号发布 根据1998年12月22日中华人民共和国国家工商行政管理局、农业部令第88号修正
第一条 根据《中华人民共和国广告法》、《兽药管理条例》的有关规定，制定本办法。
第二条 凡利用各种媒介或者形式发布用于预防、治疗、诊断畜禽等动物疾病，有目的地调节其生理机能并规定作用、用途、用法、用量的物质（含饲料药物添加剂）的广告，包括企业产品介绍材料等，均应当按照本办法进行审查。
第三条 兽药广告审查的依据：
（一）《中华人民共和国广告法》；
（二）《兽药管理条例》、国家有关兽药管理的规定及兽药技术标准；
（三）国家有关广告管理的法规及广告监督管理机关制定的广告审查标准；
第四条 国务院农牧行政管理机关和省、自治区、直辖市农牧行政管理机关（以下简称省级农牧行政管理机关），在同级广告监督管理机关的监督指导下，对兽药广告进行审查。
第五条 利用重点媒介（见目录）发布的兽药广告，以及保护期内新兽药、境外生产的兽药的广告，需经国务院农牧行政管理机关审查，并取得广告审查批准文号后，方可发布。
其它兽药广告需经生产所在地的省级农牧行政管理机关审查，并取得广告审查批准文号后，方可发布。需在异地发布的兽药广告，须持所在地农牧行政管理机关审查的批准文件，经广告发布地的省级农牧行政管理机关换发广告发布地的兽药广告批准文号后，方可发布。
第六条 兽药广告审查的申请
（一）申请审查境内生产的兽药的广告，应当填写《兽药广告审查表》，并提交下列证明文件：
1、生产者的营业执照副本以及其它生产、经营资格的证明文件；
2、农牧行政管理机关核发的兽药产品批准文号文件；
3、省级兽药监察所近期（三个月内）出具的产品检验报告单。
4、经农牧行政管理机关批准、发布的兽药质量标准，产品说明书。
5、法律、法规规定的及其他确认广告内容真实性的证明文件。
（二）申请审查境外生产的兽药的广告，应当填写《兽药广告审查表》，并提交以下证明文件及相应的中文译本：
1、申请人及生产者的营业执照副本或者其他生产、经营资格的证明文件；
2、《进口兽药登记许可证》；
3、该兽药的产品说明书；
4、境外兽药生产企业办理的兽药广告委托书；
5、中国法律、法规规定的及其他确认广告内容真实性的证明文件。
提交本条规定的证明文件的复印件，应当由原出证机关签章或者出具所在国（地区）公证机构的公证文件。
第七条 申请兽药广告审查，可以委托中国的兽药经销者或者广告经营者代为办理。
第八条 兽药广告的审查
（一）初审
兽药广告审查机关对申请人提供的证明文件的真实性、有效性、合法性、完整性和广告制作前文稿的真实性、合法性进行审查，并于受理申请之日起十日内做出初审决定，发给《兽药广告初审决定通知书》。
（二）广告申请人凭初审合格决定，将制作的广告作品送交原广告审查机关，广告审查机关在受理之日起十日内做出终审决定。对终审合格者，签发《兽药广告审查表》及广告审查批准号；对终审不合格者，应当通知广告申请人，并说明理由。
（三）广告申请人可以直接申请终审，广告审查机关应当在受理审查之日起十五日内做出终审决定。
第九条 兽药广告审查机关发出的《兽药广告初审决定通知书》和带有广告审查批准号的《兽药广告审查表》，应当由广告审查机关负责人签字，并加盖兽药广告审批专用章。
兽药广告审查机关应当将带有广告审查批准号的《兽药广告审查表》寄送同级广告监督管理机关备查。
第十条 兽药广告审查批准号的有效期为一年。
《兽药生产许可证》、《兽药经营许可证》的有效期限不足一年的，兽药广告审查批准号的有效期以上述许可证有效期限为准。
第十一条 经审查批准的兽药广告，有下列情况之一的，广告审查机关可以调回复审：
（一）该兽药在使用中发生畜禽死亡，以及造成一定经济损失的；
（二）兽药广告审查依据发生变化的；
（三）兽药产品标准发生变化的；
（四）国务院农牧行政管理机关认为省级农牧行政管理机关的批准决定不妥的；
（五）广告监督管理机关或者发布地省级农牧行政管理机关提出复审建议的；
（六）广告审查机关认为应当调回复审的其他情况；
复审期间，广告停止发布。
第十二条 广告发布地的广告审查机关对生产者所在地的审查机关做出的终审决定持有异议的，应当提请上级广告审查机关进行裁定，并以裁定结论为准。
第十三条 经审查批准的兽药广告，有下列情况之一的，应重新申请审查：
（一）广告审查批准号有效期满的；
（二）广告内容需要改动的；
第十四条 经审查批准的兽药广告，有下列情况之一的，原广告审查机关应当收回《兽药广告审查表》，其广告审查批准号作废：
（一）兽药生产、经营者被吊销《兽药生产许可证》或《兽药经营许可证》的；
（二）兽药产品在使用中发生严重问题而被撤销生产批准文号的；
（三）被国家列为淘汰或者禁止生产、使用的兽药产品的；
（四）兽药广告审查批准号有效期内，经国务院农牧行政管理机关统计兽药抽检不合格次数累计达三批次以上的；
（五）广告复审不合格的；
（六）应当重新申请审查而未申请或者重新审查不合格的；
第十五条 广告审查批准号作废后，兽药广告审查机关应当将有关材料送同级广告监督管理机关备查。
第十六条 兽药广告经审查批准后，应当将广告审查批准号列为广告内容，同时发布。未注明广告审查批准号或者批准号已过期、被撤销的兽药广告，广告发布者不得发布。
第十七条 广告发布者发布兽药广告，应当查验《兽药广告审查表》原件或者经原审查机关签章的复印件，并保存一年。
第十八条 对违反本办法规定发布兽药广告的，按照《中华人民共和国广告法》第四十三条和《兽药管理条例》的规定予以处罚。
第十九条 广告审查机关对违反广告审查依据的广告做出审查批准决定，致使违法广告得以发布的，由国家广告监督管理机关向国务院农牧行政管理机关通报情况，按照《中华人民共和国广告法》第四十五条的规定予以处理。
第二十条 本办法自发布之日起施行。
1998年12月22日发布
为了贯彻《行政处罚法》和《国务院关于贯彻实施〈中华人民共和国行政处罚法〉的通知》精神，促进依法行政，国家工商行政管理局、农业部对《兽药广告审查办法》中超越《行政处罚法》规定处罚权限的内容进行了修改。现将修改内容予以公布，自公布之日起施行。
第十四条改为“经审查批准的兽药广告，有下列情况之一的，原广告审查机关应当收回《兽药广告审查表》，其广告审查批准号作废：
……。”
第十五条改为“广告审查批准号作废后，兽药广告审查机关应当将有关材料送同级广告监督管理机关备查。”
1995年4月7日
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.
