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.


河南省人民政府


河南省饲料管理办法
河南省人民政府


现发布《河南省饲料管理办法》，自发布之日起施行。


第一条 为加强对饲料行业的管理，保证饲料产品质量，维护生产经营者和用户的合法权益，促进养殖业的发展，制定本办法。
第二条 在本省行政区域内生产、经营、使用饲料和饲料产品的单位和个人，必须遵守本办法。
第三条 本办法所称饲料包括饲料原料、饲料产品及饲料添加剂。
本办法所称饲料原料，是指用来生产饲料产品，以动物、植物、微生物或矿物质为来源的物质。
本办法所称饲料产品，是指通过工业化生产手段生产，作为商品销售的配合饲料、混合饲料、精料补充料、浓缩饲料、饲料添加剂、添加剂预混料等产品。
本办法所称饲料添加剂（不含饲料药物添加剂），是指为满足特殊需要而加入饲料中的少量、微量物质。
第四条 各级人民政府应当加强对饲料生产经营活动的领导和管理，并在资金、物资和政策等方面对饲料工业的发展予以扶持。
第五条 省畜牧行政主管部门负责全省饲料行业的监督和管理工作，其主要职责是：
（一）贯彻执行国家有关饲料方面的法律、法规、政策和本办法，依法对饲料工业进行行业管理。
（二）制定本省饲料工业发展规划、计划并组织实施；
（三）负责组织对饲料产品质量进行行业监督，协助组织本省饲料质量监测和检验工作；
（四）负责审批饲料产品的生产；
（五）依法查处违反饲料管理规定的违法行为。
第六条 各级饲料行业主管部门以及其他有关部门，应当采取措施，多方面筹措资金，逐步建立健全饲料科学研究、技术推广和质量监测体系，加强对饲料产品的科学研究和先进生产技术的引进、推广工作，依靠科学技术进步开。?
第七条 市地、县（市）人民政府指定的饲料行业主管部门负责本行政区域内的饲料行业管理工作。
第八条 凡符合国家产业政策的饲料产品生产技术改造项目、饲料新产品开发项目，享受国家和本省的有关优惠政策。
第九条 对新建、改建的饲料产品生产项目和饲料新产品开发项目，计划或者经济贸易部门在批准立项、竣工验收时，应当经同级饲料行业主管部门审查同意。
第十条 鼓励单位和个人引进国内外的资金、先进技术和设备生产经营饲料产品，开发利用饲料资源。
第十一条 从事饲料产品生产的企业，必须具备以下条件：
（一）具有保证产品质量需要的厂房、设备、工艺、贮运条件；
（二）有保证饲料产品质量的检验手段或接受其委托具有检验资格的代检单位；
（三）有健全的企业管理制度，并拥有与生产相适应的专业技术人员；
（四）生产环境和设备符合国家环境保护法规规定的要求。
第十二条 凡属国家实行工业产品生产许可证管理的饲料产品，生产者必须在领取工业产品生产许可证后方可进行生产。
生产饲料添加剂、添加剂预混料、浓缩饲料、配合饲料，必须取得省饲料行业主管部门核发的产品批准文号。
第十三条 饲料生产企业必须严格按照产品标准组织生产，建立健全生产记录和留样观察制度，按规定填报生产报表。
第十四条 饲料添加剂、添加剂预混料、浓缩饲料、配合饲料等饲料产品，应当符合产品质量标准并有产品标签和产品质量合格证。
第十五条 生产配合、浓缩饲料和添加剂预混料，不得使用未经国家批准的饲料添加剂。
第十六条 饲料经营者禁止经销下列产品：
（一）标签不符合国家规定的标准，没有产品质量检验合格证的产品；
（二）超过保质期、霉坏变质、掺杂使假的饲料或者受到有毒有害物质污染的饲料；
（三）改变所经销产品成份的产品；
（四）没有产品批准文号的饲料添加剂、添加剂预混料、浓缩饲料、配合饲料；
（五）含有未经国家批准使用的饲料添加剂产品。
第十七条 新研制的饲料添加剂，在报送国家饲料行业行政主管部门约定审批前，应制定企业标准，并报省技术监督部门和省饲料行业主管部门备案。
第十八条 饲料产品的包装，必须符合保证饲料产品质量和安全、卫生的要求，便于贮藏、运输和使用。
第十九条 饲料生产企业必须执行国家、行业或地方的有关标准，没有上述标准的，应当制定相应的企业标准作为组织生产的依据，并报当地技术监察部门和饲料行业主管部门备案。
第二十条 饲料产品的质量监督检验工作，由同级技术监察部门授权认可的饲料产品质量监督检验机构负责。饲料产品质量监督检验机构接受同级技术监督、饲料行业主管部门的业务指导。
饲料产品质量监督检验机构可以派员到生产、经营和使用单位调查饲料产品的质量情况、抽检样品和索取有关质量资料，有关单位和个人应当予以配合。
第二十一条 饲料生产企业的质量检验员、化验员应当经过培训、考核合格，持证上岗。对不符合质量标准的原料、辅料，质量监督检验人员有权制止进货，对不合格的产品有权制止出厂。
第二十二条 饲料产品质量监督检验机构及其工作人员，应当依法行使职权，坚持原则，秉公办事，不得营私舞弊，玩忽职守。
饲料产品质量监督检验机构及其工作人员应当对生产企业提供的质量技术资料保密。
第二十三条 进口的饲料原料或产品，必须符合国家规定的饲料卫生标准、饲料产品质量标准。进口饲料产品或原料中含有未经国家批准进口的饲料添加剂的，必须取得国家农业行政主管部门签发的《登记许可证》。
出口饲料产品，按照国家有关规定办理。
第二十四条 进出口饲料的检疫和质量检验，按照《中华人民共和国进出口商品检验法》和国家有关规定办理。
第二十五条 违反本办法规定，有下列行为之一的，根据其情节轻重，由县级以上饲料行业主管部门责令停止违法行为，并可处以警告和罚款；处以罚款的，按下列标准执行：
（一）未取得产品批准文号生产饲料添加剂、添加剂预混料、浓缩饲料、配合饲料的，处以2000元以上5000元以下的罚款；
（二）使用未经国家批准的饲料添加剂生产配合饲料、浓缩饲料和添加剂预混料的，处以2000元以上1万元以下罚款；
（三）违反第二十三条第一款规定，进口饲料原料或产品的，处以5000元以上2万元以下的罚款。
第二十六条 饲料生产经营者在生产经营活动中，违反标准化、产品质量规定和工商行政管理法律、法规、规章的，县级以上饲料行业主管部门可建议技术监督或工商行政管理机关对其依法予以处罚。
第二十七条 当事人对行政处罚不服的，可以依法申请复议，也可直接向人民法院起诉。逾期不申请复议、不起诉，又不履行处罚决定的，做出处罚决定的机关可向人民法院申请强制执行。
第二十八条 本办法的具体应用问题由省畜牧行政主管部门负责解释。
第二十九条 本办法自发布之日起施行。



1997年1月9日