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.
天津市实施《军人抚恤优待条例》办法
天津市人民政府
天津市实施《军人抚恤优待条例》办法
1990年6月6日天津市人民政府第21号令发布
第一章 总 则
第一条 为了做好本市军人的抚恤优待工作，根据国务院《军人抚恤优待条例》（以下简称《条例》），结合本市实际情况，制定本办法。
第二条 本办法所称的抚恤优待对象和家属的范围，按照《条例》的规定执行。
第三条 本市一切国家机关、社会团体、企业事业单位和公民应当依照《条例》和本办法的规定履行各自应尽的职责和义务。
第四条 市民政部门主管全市的军人抚恤优待工作，区（县）民政部门主管本区（县）的军人抚恤优待工作。
在抚恤优待工作中成绩显著的单位和个人，由市、区（县）或乡（镇）人民政府给予表彰和奖励。
第二章 死亡抚恤
第五条 现役军人死亡，确定为革命烈士、因公牺牲军人或病故军人后，由其家属户口所在地的区（县）民政部门发给家属一次性抚恤金。具体标准按照民政部、财政部的规定执行。
第六条 一次性抚恤金发给的顺序为：
（一）有父母（或抚养人）无配偶的，发给父母（或抚养人）；
（二）有配偶无父母（或抚养人）的，发给配偶；
（三）既有父母（或抚养人）又有配偶的，各发半数；
（四）无父母（或抚养人）和配偶的，发给子女；
（五）无父母（或抚养人）、配偶、子女的，发给未满十八周岁的弟、妹；
无上述亲属的不发。
第七条 立功和获得荣誉称号的现役军人死亡，增发一次性抚恤金。增发比例按照《条例》第九条的规定执行。
第八条 符合下列条件的人员，经户口所在地的区（县）民政部门批准，核发《定期抚恤金领取证》，凭证领取定期抚恤金：
（一）革命烈士、因公牺牲军人、病故军人的父母、抚养人、配偶属于农业户口的；
（二）革命烈士、因公牺牲军人、病故军人的父母、抚养人、配偶属于非农业户口而无劳动能力和生活收入的，或虽有一定生活收入，但达不到当地一般群众生活水平的。
（三）革命烈士、因公牺牲军人、病故军人的未满十八周岁子女，或虽满十八周岁因在学或伤残而无生活来源的；
（四）革命烈士、因公牺牲军人、病故军人的未满十八周岁的弟、妹，且依靠军人生前供养的；
（五）革命烈士的配偶再婚后属于孤老的，或完全丧失劳动能力，无经济来源，不能维持生活的。
第九条 定期抚恤金的标准，由市民政局会同市财政局按照与城乡人民生活水平相适应的原则，并参照民政部、财政部制定的定期抚恤金标准制定。
第十条 曾被军区（方面军）以上机关授予荣誉称号的革命烈士的家属，以及革命烈士、因公牺牲军人、病故军人的家属是孤老或孤儿的，其定期抚恤金在基本标准之上再增发25％。
第十一条 享受定期抚恤金的人员死亡时，加发半年的定期抚恤金，作为丧葬补助费，同时注销《定期抚恤金领取证》。
第三章 伤残抚恤
第十二条 退出现役后没有参加工作的革命伤残军人的伤残抚恤金以及符合护理条件的护理费，由户口所在地的区（县）民政部门发给。
退出现役后参加工作的革命伤残军人的伤残保健金，由其工作单位所在地的区（县）民政部门发给；已离休、退休的，由户口所在地的区（县）民政部门发给，符合护理条件的，其护理费由发给离休、退休费的单位发给。
第十三条 伤残抚恤金和伤残保健金的具体标准，按照民政部、财政部的规定执行。
第十四条 退出现役的特等、一等革命伤残军人、分散供养的，由其家庭户口所在地的区（县）人民政府接收安置。
负责接收安置的区（县）人民政府应妥善安排他们的住房；对家居农村需要建房的，经费由区（县）财政解决。
本人、配偶及十八周岁以下子女（包括已超过十八周岁但仍在学或因残疾无劳动能力的），属于农业户口的，转为非农业户口；从本市农村择偶的，转为非农业户口，从外地农村择偶的，准予进津落户，并转为非农业户口。
配偶符合招工条件的，在同等条件下，由区（县）劳动部门优先介绍就业，招工单位应优先录用。
第十五条 领取伤残保健金人员的工作单位，不得因其伤残而解聘。确需解聘的，须征得所在地的区（县）民政部门同意。
第四章 优 待
第十六条 义务兵入伍前是农业户口的，按照当地乡（镇）一个整劳力年均收入或人均收入的标准发给优待金。优待金由乡（镇）人民政府采取统筹平衡负担的办法筹集，统收统付，专款专用，当年兑现。
优待金从乡（镇）企业筹集的，在税前的10％补助社会性开支中列支。
义务兵在服役期间，获得荣誉称号或立功的，可适当增发优待金。具体办法由区（县）人民政府制定。
第十七条 义务兵入伍前是非农业户口且有工作的，按下列规定享受工资待遇：
（一）从企业单位入伍的，由原单位照发其标准工资（学徒工发原生活补贴，熟练工发熟练期工资）和五元副食品价格补贴；
（二）从机关事业单位入伍的，由原单位照发其基础工资、职务（岗位）工资和工龄津贴。
（三）义务兵入伍前是合同制工人，在服役期间原订合同期限已满的，原工作单位应根据服役证明仍按合同制工人对待，并按本条第（一）项或第（二）项的规定发给工资。
义务兵入伍前是非农业户口但无工作的，从义务兵批准入伍之月起，由原户口所在地的街道办事处或乡（镇）人民政府发给优待金。具体标准，由市民政局会同市财政局制定，优待金由市财政专款解决。
第十八条 农业户口的孤老优抚对象免除负担集体提留与统调工；现役军人不计入家庭人口摊派提留和负担义务工；二等乙级以上革命伤残军人免服义务工。
第十九条 革命伤残军人因伤残需要配置假肢，代步三轮车等辅助器械的，由所在地的区（县）民政部门负责审批、配置。
第二十条 优抚对象在与其他公民同等条件下，享受下列优先待遇：
（一）国家机关、企业事业单位及乡镇企业的职工录用；
（二）学校对学员的录取，幼儿园、托儿所对幼儿的入托；
（三）中等以上学校助学金待遇的取得；
（四）疾病治疗的挂号和就诊；
（五）扶持生产、社会救济款物的领取；
（六）各种贷款的取得；
（七）农业生产资料的供应；
（八）公有房屋的分配、购买；
（九）农村建房用地分配及建筑材料的购买。
第二十一条 革命烈士子女、革命伤残军人和荣立二等功以上的退伍军人报考中等学校、高等院校时，录取的文化或身体条件按照国家有关规定适当放宽并优先审查录取。
第二十二条 机关、团体、企业事业单位分配职工住房时，对服现役的义务兵应计算为家庭实有在津人口，复员退伍军人在部队服役的军龄和待分配时间应计算为在本单位的工作年限。
第二十三条 未随军的现役军官、志愿兵的家属住房困难，家属有工作单位的，由所在单位按本单位双职工待遇解决；家属无工作单位的，由区（县）人民政府统筹解决。
第二十四条 交通部门应给予革命伤残军人和现役军人优先购票的优待；有条件的车站、码头、机场应为革命伤残军人和现役军人设置专门的候车、候船或候机室（席）。
第二十五条 复员军人未参加工作，因年老体弱、生活困难的，按照规定的条件由区（县）民政部门发给定期定量补助。具体标准由市民政局会同市财政局制定。
第二十六条 义务兵在服役期间患精神病或其它慢性病，退役后未参加工作并生活困难的，由户口所在地的区（县）民政部门给予适当补助。
第二十七条 享受定期定量补助的复员退伍军人病故后，由区（县）民政部门增发半年定期定量补助金，作为一次性补助，同时注销定期定量补助领取证件。
第二十八条 优抚对象享受《条件》和本办法规定的抚恤、补助或优待金后，生活仍有困难，属于农业户口的，由所在乡（镇）人民政府给予优待照顾；属于非农业户口有工作的，由所在单位按照职工困难补助的有关规定从优解决；属于非农业户口无工作的，由所在街道办事处或乡（
镇）人民政府给予优待照顾。
第二十九条 革命烈士、因公牺牲军人、病故军人、现役军人家属以及带病回乡的复员退伍军人，不享受公费医疗待遇，因病治疗无力支付医疗费的，由当地卫生部门给予减免。具体办法由区（县）人民政府参照市民政局、卫生局、财政局的有关规定制定。
第五章 附 则
第三十条 本办法亦适用于中国人民武装警察部队。
第三十一条 因战伤亡的民兵、民工和因参加军事训练伤亡的民兵及其他人员，其抚恤参照《条例》和本办法的规定办理。
第三十二条 本办法未作规定的军人抚恤优待的其他事项，按照《条例》和民政部的解释执行。
第三十三条 本办法由市民政局负责解释。
第三十四条 本办法自一九九○年七月一日起施行。市人民政府以前颁布的有关军人抚恤和优待的规定，同本办法相抵触的，以本办法为准。
1990年6月6日
