国家税务总局


中华人民共和国发票管理办法实施细则

国家税务总局令第25号


　　《中华人民共和国发票管理办法实施细则》已经2011年1月27日国家税务总局第1次局务会议审议通过，现予公布，自2011年2月1日起施行。　　
　　


国家税务总局局长：肖 捷　　
二○一一年二月十四日
　　

中华人民共和国发票管理办法实施细则　　

　　第一章 总 则
　　第一条　根据《中华人民共和国发票管理办法》(以下简称《办法》)规定，制定本实施细则。
　　第二条　在全国范围内统一式样的发票，由国家税务总局确定。
　　在省、自治区、直辖市范围内统一式样的发票，由省、自治区、直辖市国家税务局、地方税务局（以下简称省税务机关）确定。
　　第三条　发票的基本联次包括存根联、发票联、记账联。存根联由收款方或开票方留存备查；发票联由付款方或受票方作为付款原始凭证；记账联由收款方或开票方作为记账原始凭证。
　　省以上税务机关可根据发票管理情况以及纳税人经营业务需要，增减除发票联以外的其他联次，并确定其用途。
　　第四条　发票的基本内容包括:发票的名称、发票代码和号码、联次及用途、客户名称、开户银行及账号、商品名称或经营项目、计量单位、数量、单价、大小写金额、开票人、开票日期、开票单位(个人)名称(章)等。
　　省以上税务机关可根据经济活动以及发票管理需要，确定发票的具体内容。
　　第五条 有固定生产经营场所、财务和发票管理制度健全的纳税人，发票使用量较大或统一发票式样不能满足经营活动需要的，可以向省以上税务机关申请印有本单位名称的发票。
　　第二章　发票的印制
　　第六条 发票准印证由国家税务总局统一监制，省税务机关核发。
　　税务机关应当对印制发票企业实施监督管理，对不符合条件的，应当取消其印制发票的资格。
　　第七条 全国统一的发票防伪措施由国家税务总局确定，省税务机关可以根据需要增加本地区的发票防伪措施,并向国家税务总局备案。
　　发票防伪专用品应当按照规定专库保管，不得丢失。次品、废品应当在税务机关监督下集中销毁。
　　第八条　全国统一发票监制章是税务机关管理发票的法定标志，其形状、规格、内容、印色由国家税务总局规定。
　　第九条　全国范围内发票换版由国家税务总局确定；省、自治区、直辖市范围内发票换版由省税务机关确定。
　　发票换版时，应当进行公告。
　　第十条　监制发票的税务机关根据需要下达发票印制通知书，被指定的印制企业必须按照要求印制。
　　发票印制通知书应当载明印制发票企业名称、用票单位名称、发票名称、发票代码、种类、联次、规格、印色、印制数量、起止号码、交货时间、地点等内容。
　　第十一条　印制发票企业印制完毕的成品应当按照规定验收后专库保管，不得丢失。废品应当及时销毁。　　
　　第三章　发票的领购
　　第十二条　《办法》第十五条所称经办人身份证明是指经办人的居民身份证、护照或者其他能证明经办人身份的证件。　　
　　第十三条　《办法》第十五条所称发票专用章是指用票单位和个人在其开具发票时加盖的有其名称、税务登记号、发票专用章字样的印章。
　　发票专用章式样由国家税务总局确定。
　　第十四条　税务机关对领购发票单位和个人提供的发票专用章的印模应当留存备查。
　　第十五条 《办法》第十五条所称领购方式是指批量供应、交旧购新或者验旧购新等方式。
　　第十六条　《办法》第十五条所称发票领购簿的内容应当包括用票单位和个人的名称、所属行业、购票方式、核准购票种类、开票限额、发票名称、领购日期、准购数量、起止号码、违章记录、领购人签字(盖章)、核发税务机关(章)等内容。
　　第十七条 《办法》第十五条所称发票使用情况是指发票领用存情况及相关开票数据。
　　第十八条　税务机关在发售发票时，应当按照核准的收费标准收取工本管理费，并向购票单位和个人开具收据。发票工本费征缴办法按照国家有关规定执行。
　　第十九条 《办法》第十六条所称书面证明是指有关业务合同、协议或者税务机关认可的其他资料。
　　第二十条 税务机关应当与受托代开发票的单位签订协议，明确代开发票的种类、对象、内容和相关责任等内容。
　　第二十一条　《办法》第十八条所称保证人，是指在中国境内具有担保能力的公民、法人或者其他经济组织。
　　保证人同意为领购发票的单位和个人提供担保的，应当填写担保书。担保书内容包括：担保对象、范围、期限和责任以及其他有关事项。
　　担保书须经购票人、保证人和税务机关签字盖章后方为有效。
　　第二十二条　《办法》第十八条第二款所称由保证人或者以保证金承担法律责任，是指由保证人缴纳罚款或者以保证金缴纳罚款。
　　第二十三条　提供保证人或者交纳保证金的具体范围由省税务机关规定。　　
　　第四章　发票的开具和保管
　　第二十四条　《办法》第十九条所称特殊情况下，由付款方向收款方开具发票，是指下列情况：
　　（一）收购单位和扣缴义务人支付个人款项时；
　　（二）国家税务总局认为其他需要由付款方向收款方开具发票的。
　　第二十五条　向消费者个人零售小额商品或者提供零星服务的，是否可免予逐笔开具发票，由省税务机关确定。
　　第二十六条　填开发票的单位和个人必须在发生经营业务确认营业收入时开具发票。未发生经营业务一律不准开具发票。
　　第二十七条　开具发票后，如发生销货退回需开红字发票的，必须收回原发票并注明“作废”字样或取得对方有效证明。
　　开具发票后，如发生销售折让的，必须在收回原发票并注明“作废”字样后重新开具销售发票或取得对方有效证明后开具红字发票。
　　第二十八条　单位和个人在开具发票时，必须做到按照号码顺序填开，填写项目齐全，内容真实，字迹清楚，全部联次一次打印，内容完全一致，并在发票联和抵扣联加盖发票专用章。
　　第二十九条　开具发票应当使用中文。民族自治地方可以同时使用当地通用的一种民族文字。
　　第三十条 《办法》第二十六条所称规定的使用区域是指国家税务总局和省税务机关规定的区域。
　　第三十一条　使用发票的单位和个人应当妥善保管发票。发生发票丢失情形时，应当于发现丢失当日书面报告税务机关，并登报声明作废。　　
　　第五章　发票的检查
　　第三十二条　《办法》第三十二条所称发票换票证仅限于在本县(市)范围内使用。需要调出外县(市)的发票查验时，应当提请该县(市)税务机关调取发票。
　　第三十三条　用票单位和个人有权申请税务机关对发票的真伪进行鉴别。收到申请的税务机关应当受理并负责鉴别发票的真伪；鉴别有困难的，可以提请发票监制税务机关协助鉴别。
　　在伪造、变造现场以及买卖地、存放地查获的发票，由当地税务机关鉴别。　　
　　第六章　罚 则
　　第三十四条　税务机关对违反发票管理法规的行为进行处罚，应当将行政处罚决定书面通知当事人；对违反发票管理法规的案件，应当立案查处。
　　对违反发票管理法规的行政处罚，由县以上税务机关决定；罚款额在2000元以下的，可由税务所决定。
　　第三十五条　《办法》第四十条所称的公告是指，税务机关应当在办税场所或者广播、电视、报纸、期刊、网络等新闻媒体上公告纳税人发票违法的情况。公告内容包括：纳税人名称、纳税人识别号、经营地点、违反发票管理法规的具体情况。
　　第三十六条 对违反发票管理法规情节严重构成犯罪的，税务机关应当依法移送司法机关处理。　　
　　第七章　附 则
　　第三十七条　《办法》和本实施细则所称“以上”、“以下”均含本数。
　　第三十八条 本实施细则自2011年2月1日起施行。
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　　分送：各省、自治区、直辖市和计划单列市国家税务局、地方税务局




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.