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.


北京市人民政府


北京市人民政府《关于同意调整本市国内单位土地增值税纳税地点有关问题的批复》
北京市人民政府




市地税局、市财政局：
你们《关于改变我市国内单位土地增值税纳税地点的请示》（京地税二〔1998〕533号）收悉。现批复如下：
一、同意对本市范围内的国内单位土地增值税纳税地点进行调整，自1999年1月1日起，凡在本市转让在京房地产的国内单位，由向原房地产座落地的地方主管税务机关申报纳税，改为向转让项目的企业核算地或行政事业单位、社会团体税务注册登记地的地方主管税务机关申报纳
税。其他纳税人申报纳税仍按《北京市人民政府关于征收土地增值税有关政策问题的通知》（京政发〔1996〕7号）的有关规定执行。
二、本市国内单位土地增值税纳税地点调整后，原税款划分方式不变，每年年终通过市财政与区、县财政结算调整区、县税款交叉入库。纳税人应按规定自觉履行纳税义务；各级地方主管税务机关要认真做好有关工作，保证本市土地增值税征管工作的顺利进行。



第一条 为加强收费管理，规范收费行为，根据中共中央、国务院有关规定，制定本办法。
第二条 本办法适用于实施收费的国家机关、事业单位及非企业组织。
第三条 《收费许可证》由国务院价格主管部门负责统一制定样式，中央和省两级价格主管部门印制，各级价格主管部门分别核发。
第四条 《收费许可证》分正本和副本。正本用于收费单位悬挂，购买票据；副本用于亮证收费、年审及其它用途。
第五条 在京中央国家机关及其所属事业单位、非企业组织，凭合法有效的收费批准文件到国务院价格主管部门申领《收费许可证》；京外中央国家机关及其所属事业单位、非企业组织，凭合法有效的收费批准文件到省级价格主管部门申领《收费许可证》。省及省以下国家机关及其所
属事业单位、非企业组织《收费许可证》的具体核发办法由各省、自治区、直辖市人民政府价格主管部门会同同级财政部门制定，报国家发展计划委员会、财政部备案。
第六条 《收费许可证》实行一点一证。具有法人资格、财务独立核算、直接实施收费的单位为基本领证单位。有直接收费行为，但不具有法人资格、不实行财务独立核算的单位的收费点，由符合规定的领证单位统一申请办理《收费许可证》副本。
第七条 申领《收费许可证》按下列程序进行：
（一）申领单位到当地价格主管部门领取《收费许可证申请表》一式两份，按表列内容逐项填写并提供申请表所要求的资料；
（二）将填写好的申请表加盖本单位公章，负责人签名后送其上级主管部门确认，签署意见并加盖公章；
（三）价格主管部门对《收费许可证申请表》及批准收费的文件等进行审核，核准后颁发《收费许可证》。
《收费许可证申请表》由国务院价格主管部门统一样式，中央和省两级价格主管部门分别印制。
第八条 收费单位应于实施收费前20日申请核发《收费许可证》。
收费单位改变名称，增加收费项目、调整收费标准或收费范围，应于批准后20日内持批准文件到原发证机关办理《收费许可证》变更手续。
收费单位合并、分立、迁移或停业时，应于批准后20日内持批准文件到原发证机关办理《收费许可证》变更或注销手续。
收费单位丢失、损坏《收费许可证》时，应公告作废并及时到原发证机关申请补发新证。
第九条 收费单位申领《收费许可证》时，须提供下列资料：
（一）合法有效的批准收费的文件；
（二）法人资格证明或机构编制及经费来源情况的文件；
（三）政府或业务主管部门批准执业的文件；
（四）其它相关资料。
第十条 《收费许可证》有效期3年。
对临时性、一次性收费可核发临时收费许可证，并依实施收费情况注明有效期限，但最长不得超过1年。临时收费许可证发放的具体办法由各省、自治区、直辖市人民政府价格主管部门会同同级财政部门制定。
第十一条 《收费许可证》是收费单位依法收费的凭证。各收费单位要做到亮证收费，自觉接受价格、财政主管部门和社会各界的监督。
第十二条 价格主管部门要按照国家有关规定，严格办证手续，按照批准的收费项目和收费标准，详细填写《收费许可证》，并建立《收费许可证》管理档案。
第十三条 价格主管部门对经过审查符合本办法规定的收费单位，应在收到《收费许可证申请表》后15日之内核准发证；对不符合规定的收费亦应于收到《收费许可证申请表》后15日内通知申领单位不得收费并说明理由。
第十四条 《收费许可证》实行审验制度。经审验合格的，由发证机关加盖年度审验章后方可继续使用。
《收费许可证》审验内容包括：
（一）《收费许可证》中填列的单位、收费项目、收费标准、收费范围、收费对象、计算单位等与实际执行是否一致；
（二）是否继续保留该项收费或维持原有的收费标准；
（三）有无违法记录。
审验中发现有违反国家收费管理规定的，由价格主管部门依法处理。
第十五条 下级价格主管和部门核发《收费许可证》不符合国家有关政策规定的，上级价格主管部门可责令其改正。
第十六条 价格、财政主管部门负责对收费单位的《收费许可证》制度执行情况进行监督检查。各收费单位必须向价格、财政主管部门如实提供有关资料，自觉接受监督检查。
收费单位有违反收费管理规定的乱收费行为，由价格、财政主管部门根据国家有关规定查处。
第十七条 收费单位有涂改、转借《收费许可证》行为的，价格主管部门可暂扣或吊销其《收费许可证》。
第十八条 《收费许可证》工本费标准由省级以上人民政府价格主管部门报同级财政部门核定后执行。
第十九条 自本法实施之日起3个月内，原发旧证废止，收费单位须按本办法规定的条件和程序重新换领新证。
第二十条 本办法自1999年1月1日起施行。



1999年1月1日