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.
西宁市暂住人口治安管理办法
青海省西宁市人民政府
西宁市暂住人口治安管理办法
西宁市人民政府令第22号
《西宁市暂住人口治安管理办法》已经市人民政府 第１１次常务会议审议通过，现予发布，自１９９９年３月１日起施行。
市 长 李津成
一九九九年二月十三日
西宁市暂住人口治安管理办法
第一条 为加强暂住人口管理，保障暂住人口的合法权益，维护社会治安秩序，根据《中华人民共和国户口登记条例》等法律、法规的规定，结合本市实际，制定本办法。
第二条 本办法适用于本市行政区。
外国人、无国籍人、华侨和台、港、澳居民的暂住管理，按有关规定办理。
第三条 本办法所称的暂住人口，是指离开常住户口所在地，在本市行政区域内居住３日以上的人员。
第四条 市公安局是本市暂住人口治安管理的主管机关。
区公安分局、大通县公安局负责本辖区内暂住人口的治安管理工作，公安派出所负责暂住人口的登记、发证等日常治安管理工作。工商、计划生育、卫生、劳动、教育、民政、房产、物价、财政、税务等部门及街道办事处，应当按照职责分工，协同公安机关做好暂住人口的治安管理工作。
第五条 机关、团体、部队、学校、企事业单位以及个体工商户、居（村）民，应当按照“谁主管谁负责、谁用工谁负责、谁留住谁负责”的原则，配合公安机关和有关部门做好对暂住人口的管理、教育和服务工作。居（村）民委员会应当协助所在地公安派出所做好暂住人口管理工作。
第六条 拟在本市暂住３日以上的人员，应在到达本市３日内，按下列规定申报暂住登记：
（一）暂住在居（村）民家中的，由户主或暂住人持户主的户口簿和暂住人的居民身份证或其他身份证明到暂住地公安派出所办理；
（二）暂住在国家机关、社会团体、部队、企业、事业单位的，由留住者持暂住人的居民身份证或其他身份证明到暂住地公安派出所办理；
（三）暂住在出租房屋的，由房屋出租人或房屋代管人持房屋租赁合同和暂住人口居民身份证明到暂住地公安派出所办理；
（四）暂住在宾馆、饭店、招待所等旅馆的，按照旅馆业治安管理有关规定办理旅客住宿登记；
（五）暂住在宗教场所或其他场所的宗教职业人员，应到暂住所在地宗教主管部门及公安派出所办理。
暂住在其直系亲属家中的，由其亲属告知暂住地居（村）民委员会或本单位保卫部门，不办理暂住登记。
第七条 正在服刑的劳改、劳教人员经监狱、劳动教养机关批准回家探亲的，由本人持批准证明，在到达本市２４小时内，到当地公安派出所申报暂住登记。
第八条 城市流浪乞讨人员，由民政部门按有关规定收容遣送。
第九条 拟在本市暂住１个月以上、年满１６周岁从事劳务和生产经营活动的人员及宗教职业人员，在申报暂住登记的同时，还应当申领《暂住证》。
第十条 公安派出所在签发《暂住证》前，应当查看育龄人员《流动人口计划生育证明》以及依照国家和省有关规定暂住人应当持有的其他证明；对证件齐全，符合暂住规定的，应当于申请当日登记，签发《暂住证》。
第十一条 暂住证为一人一证，有效期限不超过１２个月。有效期满需要继续暂住的，应在期满前３日按照本办法第六条、第十条的规定申请延期，延期不超过１２个月；延期期满后继续暂住的，应当重新申领《暂住证》。
《暂住证》在本市范围内有效。暂住人在本市范围内变更暂住地的，应当持《暂住证》到现居住地公安派出所办理变更登记手续。
《暂住证》遗失、损毁的，暂住人应当向公安派出所报告，补领《暂住证》。
第十二条 《暂住证》由市公安局统一印制。禁止转借、转让、买卖、骗取、冒领、伪造、涂改《暂住证》。
第十三条 暂住人应当遵守下列规定：
（一）遵守国家法律、法规、规章和有关规定；
（二）接受公安机关的查验，服从当地的治安管理；
（三）协助公安机关做好治安防范和案件查处工作；
（四）离开本市时，应当到当地公安派出所办理注销暂住手续，交回《暂住证》。
第十四条 暂住人的合法权益受法律保护，除公安机关依照规定可以收缴《暂住证》以外，任何单位和个人不得非法扣押暂住人的《暂住证》和其他身份证件。
第十五条 用工单位、外来务工单位、社会办学单位及个体业主不得雇用、招收未申领《暂住证》的暂住人员。
单位及个体业主应当协助公安机关做好暂住人员的治安管理工作，发现暂住人有违反治安管理行为的，应当及时向暂住地公安派出所报告。
第十六条 劳动、卫生、工商、税务等部门为暂住人办理有关证照或登记手续时，应当查看其《暂住证》。
第十七条 暂住人在暂住地死亡，留住人或有关人员应当及时报告暂住地公安派出所。暂住地公安派出所注销死者暂住登记，并通知其常住户口所在地公安机关。
第十八条 公安机关应当履行下列职责：
（一）制定暂住人口管理制度，培训暂住人口管理人员，对暂住人口开展法制教育；
（二）检查督促有关单位和责任人落实管理责任和措施；
（三）依法查处涉及暂住人口的刑事案件、治安案件和违反暂住人口管理规定以及侵害暂住人口合法权益的行为；
（四）依据有关规定做好暂住人口统计工作，向有关部门提供有关情况；
（五）依照有关法律、法规、规章的规定，配合做好暂住人口计划生育等方面的管理工作。
第十九条 违反本办法规定，有下列情形之一的，由公安机关予以处罚：
（一）不按规定申报暂住登记的，对直接责任人或者暂住人处以警告或者５０元以下罚款；
（二）不按规定申领《暂住证》或者不按规定办理《暂住证》变更、延期、补领手续的，责令有关责任人或者暂住人限期补办，逾期不办的，处以警告或者２００元以下罚款；
（三）转借、转让、买卖、骗取、冒领、伪造、涂改《暂住证》的，收缴《暂住证》，对有关责任人处以警告或者２００元以上５００元以下罚款；
（四）单位或个体业主雇用、招收未申领《暂住证》的暂住人员的，责令限期改正，逾期不改正的可对单位负责人或者直接责任人处以５００元以上１０００元以下罚款；
（五）非法扣押暂住人《暂住证》和其他身份证件的，对单位主要负责人或者直接责任人处以警告或者１０００元以下罚款。
违反本办法构成违反治安管理行为的，依照《中华人民共和国治安管理处罚条例》予以处罚；构成犯罪的，依法追究刑事责任。
第二十条 当事人对公安机关作出的行政处罚决定不服的，可以依法申请行政复议或提起行政诉讼。
第二十一条 暂住人口管理人员玩忽职守、徇私舞弊、索贿受贿或者有意刁难暂住人的，由其所在单位或者上级主管机关给予行政处分；构成犯罪的，依法追究刑事责任。
第二十二条 本办法应用中的具体问题由西宁市公安局负责解释。
第二十三条 本办法自１９９９年３月１日起施行。１９９６年４月９日市人民政府办公厅印发的《西宁市暂住人口管理暂行办法》（宁政办〈１９９６〉４５号）同时废止。
