国家外汇管理局关于印发《进口付汇差额核销管理办法》的通知
国家外汇管理局
国家外汇管理局关于印发《进口付汇差额核销管理办法》的通知
（2004年12月3日 国家外汇管理局发布）
汇发[2004]116号
国家外汇管理局各省、自治区、直辖市分局、外汇管理部，深圳、大连、青岛、厦门、宁波市分局：
为进一步完善进口付汇核销管理，规范进口付汇差额核销业务操作，提高进口付汇核销管理工作效率，国家外汇管理局制定了《进口付汇差额核销管理办法》（以下简称《办法》，见附件），现印发给你们，并就有关问题通知如下： 一、 对进口付汇核销报审业务实行差额核销管理，是对现行进口核销管理规定的有效补充,旨在解决因客观原因造成进口单位对外付汇金额与实际到货金额之间存在差额而不能办理进口付汇核销报审手续的问题，以进一步推进贸易便利化，减轻进口单位和外汇局的工作负担。国家外汇管理局各分支局（以下简称“外汇局”）应注意向进口单位做好宣传、解释工作，确保《办法》的顺利实施。
二、外汇局在为进口单位办理进口付汇差额核销报审业务时，应认真审核差额核销所依据的相关资料，并做好档案保存工作。
三、外汇局应结合本地区的实际情况，制定有关差额核销分级授权审批管理的内控制度。
四、《办法》于2005年2月1日起实施。在《办法》实施前，总局将对进口付汇核销计算机系统进行修改和升级，升级后的计算机系统将实现对差额核销数据的查询、统计、监管等功能。计算机系统的具体升级日期，总局将另行通知。
各分局收到本通知后，应尽快转发辖内中心支局。执行中如遇问题，请及时向国家外汇管理局反馈。
附件：《进口付汇差额核销管理办法》
附件：
进口付汇差额核销管理办法
第一条 为进一步完善进口付汇核销管理，规范进口付汇差额核销业务操作，提高进口付汇核销管理工作效率，根据《贸易进口付汇核销监管暂行办法》及相关规定，制定本办法。
第二条 本办法所称“核销差额”系指进口单位报审付汇金额与实际进口到货金额（即海关进口货物报关单中货物单价与数量乘积）间的差额。
核销差额分为多到货核销差额和少到货核销差额两种类型。实际进口到货金额大于报审付汇金额的为多到货核销差额，实际进口到货金额小于报审付汇金额的为少到货核销差额。
第三条 本办法适用以下情况的进口付汇核销报审业务：
（一）单笔合同项下一次付汇、一次到货、一次报审业务；
（二）单笔合同项下一次付汇、多次到货、一次报审业务；
（三）单笔合同项下多次付汇、一次到货、一次报审业务；
（四）单笔合同项下多次付汇、多次到货、一次报审业务。
对进口单位差额核销报审业务实行按合同管理。对于单笔合同项下多次报审的业务，只有当合同执行完毕，在最终一次报审时，进口单位方可申请办理差额核销报审手续。
第四条 对于单笔合同项下核销差额不超过等值5000美元（含5000美元）的，或核销差额虽超过5000美元但占合同金额的比例不超过2%（含2%）的进口付汇核销报审业务，国家外汇管理局各分支局（以下简称“外汇局”）可以直接凭企业差额核销说明函、进口合同及其他核销单证办理差额核销报审手续。 第五条 对于单笔合同项下核销差额超过等值5000美元且核销差额占合同金额的比例超过2%的进口付汇核销差额报审业务，进口单位应按照本办法第七条、第八条的要求提供其他相关材料，申请办理差额核销报审手续。
第六条 进口单位每月申请办理差额核销业务的累计差额（包括限额以上和限额以下的所有核销差额，多到货金额作为负数参与累加）原则上不得超过等值10万美元（含10万美元）。外汇局可以结合本地区的实际情况对限额进行适当调整。
第七条 对于单笔合同项下少到货核销差额超过等值5000美元且核销差额占合同金额的比例超过2%的进口付汇差额核销报审业务，进口单位在办理差额核销报审手续时，除需向外汇局提交相关的核销单证外，还需提供单位法人代表签字并加盖单位公章的差额核销说明函、进口合同，并视以下不同情况提供相应证明材料：
（一）因国外商品市场行情变动产生的核销差额，提供有关商会出具的证明或经有关交易所或交易所会员单位证明的行情报价材料。
（二）因进口商品质量产生的核销差额，提供与出口商的有关往来函电及商检机构证明材料。由于客观原因无法提供商检证明的，可提供相关质量证明材料、书面保函。
（三）因动物及鲜货产品变质、腐烂、非正常死亡或损耗产生的核销差额，提供与出口商的有关往来函电及商检机构证明材料。由于客观原因无法提供商检证明的，可提供相关质量证明材料、书面保函。
（四）因自然灾害、战争、国家紧急政策等不可抗力因素产生的核销差额，提供我国驻出口商所在国使领馆商务处出具的证明文件。
（五）因出口商破产、关闭、解散等原因产生的核销差额，提供新闻媒体的报道材料或我国驻出口商所在国使领馆商务处出具的证明文件或相关法律文件。
（六）因汇率变动产生的核销差额，提供付汇银行当日牌价。
（七）因溢短装产生的核销差额，提供商品检验证明、提单或货运单等证明材料。
（八）进口合同中已约定运保费、杂费等贸易从属费用包含在合同总货款内对外支付的，因运保费、杂费等贸易从属费原因产生的核销差额，提供进口合同、税务凭证、运保费单证及有关商业单证（进口货物报关单已标明运保费、杂费金额的除外）。
（九）因金属矿砂等大宗散装货物进口项下产生的核销差额，提供进口合同、海关出具的进口货物报关单情况证明、补税证明及相应商业单证。
（十）因其他原因产生的核销差额，提供外汇局要求的有效凭证。
第八条 对于实际进口到货金额大于进口付汇金额的多到货差额核销报审业务，进口单位在办理多到货差额核销报审手续时，应在《贸易进口付汇到货核销表》中对进口货物报关单的余额情况加以注明，并在“备注”栏内标注“留用”或“核销结案”字样。
对于单笔合同项下多到货核销差额超过等值5000美元且核销差额占合同金额的比例超过2%的进口付汇差额核销报审业务，进口单位还需向外汇局提供加盖单位公章的差额核销说明函。
第九条 外汇局在为进口单位办理多到货差额核销报审业务时，需在“中国电子口岸�进口付汇系统”中对进口单位标注“核销结案”的进口货物报关单电子底账做核销结案处理。
第十条 货到汇款结算方式项下进口付汇自动核销和转口贸易、境外工程使用物资以及进口退汇等项下凭收汇凭证办理进口付汇核销报审手续的进口付汇核销报审业务，暂不适用本办法。
第十一条 外汇局在为进口单位办理差额核销手续时，需按规定严格审核差额核销相关凭证，并在《贸易进口付汇到货核销表》上标注差额核销金额及日期，加盖“已报审”印，按规定留存相关凭证。
第十二条 外汇局应结合本地区实际情况，建立健全进口付汇差额核销分级授权管理内控制度。
第十三条 国家外汇管理局各分局应做好本地区差额核销情况的汇总、统计工作，并于每月前五个工作日内向总局报送进口付汇差额核销报审业务电子报表。
第十四条 本办法由国家外汇管理局负责解释。
第十五条 本办法自2005年2月1日起施行。其他规定与本办法规定相抵触的，以本办法的规定为准。
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.