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.
郑州市人民政府关于禁止随地吐痰乱扔乱倒废弃物的规定
河南省郑州市人民政府
郑州市人民政府关于禁止随地吐痰乱扔乱倒废弃物的规定
政府令第6号
《郑州市人民政府关于禁止随地吐痰乱扔乱倒废弃物的规定》业经一九九○年十月六日第五十三次市人民政府常务会议讨论通过，现予发布施行。
市 长 胡树俭
一九九○年十月九日
郑州市人民政府关于禁止随地吐痰乱扔乱倒废弃物的规定
为了加强市容卫生管理，维护市容整洁，纠正随地吐痰、乱扔乱倒废弃物等不文明、不卫生的陋习，保护人民群众身体健康，提高省会社会主义精神文明建设水平，根据国家法律、法规的有关规定，结合我市实际，制定如下规定：
一、在本市城区（含上街区）范围内的机关、团体、部队、企事业单位以及市场、商店、饭店、体育场（馆）、影剧院、车站、机场、公园、游览区、街道、广场等一切公共场所，严禁随地吐痰、乱扔瓜果皮核、食品包装、烟头、纸屑和其它废弃物、严禁随地便溺，乱倒垃圾、污水、（以下简称随地乱吐、乱扔、乱倒）。
二、对随地吐痰、便溺、乱扔废弃物者，在进行批评教育、令其擦净痰迹、便迹或清除废弃物的同时，对乱吐乱扔者，处以二元罚款；对随地便溺者，处以五元罚款。对拒不接受批评教育的，加处一至二倍的罚款。对阻碍执法人员依法执行公务或寻衅闹事、辱骂殴打执法人员的，由公安机关依照《治安管理处罚条例》的规定处理。触犯刑律的依法追究刑事责任。
三、清倒垃圾必须倒入指定的垃圾容器或垃圾点中，清运垃圾必须运往环卫部门指定的地点。凡违反规定者，除给予批评教育、责令清除并打扫干净外，每一簸箕罚款二元、每一架子车罚款二十元，拖拉机、汽车每车罚款五十至五百元，架子车、拖拉机和汽车并义务代运十车垃圾。
四、认真落实“门前三包”责任制，切实加强对乱吐、乱扔、乱倒行为的管理。对管理不善，造成室内外脏、乱、差的单位和个人，区政府和街道办事处要给予黄牌警告，并督促其限期整改，愈甚不改正者，处以二百元至五百元的罚款。
五、城管、环卫、市容卫生监督监察人员和佩戴统一标志的“门前三包”执勤人员，要认真履行职责，文明执法、秉公办事，所有罚款一律使用财政部门规定的统一票据。
六、本通告自发布之日起执行，市人民政府过去有关规定与本通告相抵触的，按本通告执行。
