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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.


安徽省宿州市人民政府办公室


关于印发宿州市工业发展专项资金使用管理暂行办法的通知

宿政办发〔2009〕56号


各县、区人民政府，市政府有关部门：
市财政局、市经济和信息化委制定的《宿州市工业发展专项资金使用管理暂行办法》已经市政府同意，现印发给你们，请遵照执行。


二○○九年十一月十七日　

　　　
宿州市工业发展专项资金使用管理暂行办法
（市财政局　市经济和信息化委）

一　　总　　则

第一条　为进一步加快工业化进程，增强工业经济对全市经济发展的支撑能力和带动作用，规范工业经济发展专项资金的使用和管理，提高资金的使用效益，促进全市工业经济又好又快发展，根据《中共宿州市委　宿州市人民政府关于实施工业五年扩张战略的意见》（宿发〔2009〕14号），制定本办法。
第二条　本办法所称工业发展专项资金（以下简称专项资金）是指市级财政预算安排的专项用于支持工业经济发展的财政性资金。
第三条　专项资金的使用和管理，坚持体现公平、公正、透明的原则；坚持有利于改善工业经济发展环境，促进工业企业健康发展的原则；坚持鼓励企业做大做强的原则；坚持统筹安排、突出重点和规范运作的原则。
第四条　对当年已获得中央和省财政资金支持的项目，一般不予重复支持。


二　　基本条件和资金使用范围

第五条　申报专项资金的项目单位必须同时具备以下条件：
（一）具有独立的法人资格，法人治理结构规范；
（二）领导班子素质较高，经营管理能力较强，并富有创新意识；
（三）财务管理制度健全，会计核算真实、完整，并按照《企业财务通则》等规定及时向财政部门报送会计报表；
（四）近年来有良好的经营业绩，照章纳税；
（五）申报的项目能够成为我市经济新的增长点，节能降耗、保护环境成效显著；
（六）项目真实，资金落实；
（七）其他应具备的相关条件。
第六条　专项资金的使用范围包括技术改造项目，重大工业项目，企业技术创新项目，中小企业发展项目和工业五年扩张战略的各项考评奖励等。主要划分为：
（一）技改专项资金。重点支持市政府调度的企业技术改造项目。兼顾支持高新技术产业化项目、采用先进适用技术改造传统产业项目，促进产业结构、产品结构、技术结构优化升级的项目。
（二）企业技术创新专项资金。重点支持促进产业结构调整和技术升级的关键技术、共性技术、重点产品和重大装备的研发项目、产学研合作项目、企业技术中心创新能力建设项目、企业信息化项目等。
（三）中小企业发展专项资金。优先扶持市重点调度骨干企业，重点支持成长性好、主业突出、主导产品市场前景好、发展有后劲的“专、精、特、新”中小企业、中小企业服务体系、新型乡村工业园（工业集聚区）建设和创业扶持等。
（四）工业五年扩张战略的各项考评奖励。按照《中共宿州市委　宿州市人民政府关于实施工业五年扩张战略的意见》（宿发〔2009〕14号）的要求，支持列入市重点调度的重大项目建设以及企业上规模、创名牌等，由市级财政给予的各项奖励。

三　　支持方式及额度

第七条　专项资金采取补助或贴息的支持方式。
第八条　申报专项资金补助的额度，按企业自有资金的投入额度，给予一定数量的补助。申报专项资金贷款贴息的额度，根据项目贷款额度及人民银行公布的同期贷款利率研究确定。

四　　项目申报和资金拨付

第九条　项目申报程序：
（一）市经济和信息化委会同市财政局根据本办法的规定，组织专项资金的申报、评审工作。
（二）符合条件的市级项目单位直接向市经济和信息化委、财政局提出申请。市级以下项目单位向所在县（区）工业委、财政局提出申请。
（三）各县（区）工业委会同财政局对申请企业的材料进行初审，初审合格后联合行文上报市经济和信息化委、市财政局。
第十条　市经济和信息化委会同市财政局按照项目申报相关要求，对推荐上报的项目材料进行审核。按照公开、公正、公平的原则，组织相关专家对审核合格的项目进行评审。
第十一条　项目申报材料包括：
（一）项目资金申请报告；
（二）专项资金申请表；
（三）法人营业执照副本（复印件）；
（四）项目审批、核准或备案文件；
（五）项目资金证明材料，自有资金有效凭证和项目贷款合同，已发生的银行贷款凭证及结息单等资料；
（六）生产经营情况；
（七）经会计师事务所审计的上一年度会计报表及截至项目申报前一个月的会计报表。
第十二条　依据专家评审意见，按照择优原则，市经济和信息化委会同市财政局确定拟扶持项目，报市政府同意后，确定最终扶持项目及资金安排计划。
第十三条　市财政局会同市经济和信息化委下发补助或贴息资金计划。市财政局将补助或贴息资金及时拨付到项目单位。
第十四条　项目单位收到财政部门的资金后，应按国家有关财务规定进行账务处理。

五　　监督与检查

第十五条　专项资金必须专款专用，项目支出必须与项目申报预算口径一致，在项目执行过程中因特殊原因需改变资金用途的，须经市经济和信息化委和市财政局批准。
第十六条　市财政局会同市经济和信息化委或共同委托有关中介机构对专项资金的使用和管理情况进行监督检查。项目单位要严格遵守国家有关财经纪律和财务会计制度，自觉接受审计、监察部门的审计和监督。
第十七条　专项资金实行责任追究制度。对弄虚作假骗取专项资金，截留、挪用、挤占专项资金等违反财经纪律行为，一经发现，市财政局立即收回全部专项资金，并按照国家有关法律法规予以严肃处理，同时取消项目申报资格。

六　　附　　则

第十八条　本办法由市财政局会同市经济和信息化委负责解释。
第十九条　本办法自发布之日起执行。