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.
平顶山市雷电灾害风险评估管理办法
河南省平顶山市人民政府办公室
平顶山市人民政府办公室关于印发平顶山市雷电灾害风险评估管理办法的通知
平政办〔2011〕17号
各县(市、区)人民政府,市人民政府各部门,有关单位:
《平顶山市雷电灾害风险评估管理办法》已经2011年3月21日市政府第32次常务会议研究通过,现印发给你们,请认真贯彻执行。
平顶山市人民政府办公室
二○一一年三月三十一日
平顶山市雷电灾害风险评估管理办法
第一条 为了防御和减轻雷电灾害,保护人民生命财产安全,根据《中华人民共和国气象法》、《防雷减灾管理办法》、《河南省人民政府关于加强气象灾害防御工作的意见》(豫政〔2007〕74号)等法律、法规和文件精神,结合我市实际,就建设工程项目开展雷电灾害风险评估工作制定本办法。
第二条 本办法所称雷电灾害风险评估是指以实现系统防雷为目的,运用科学的原理方法,对系统可能遭受雷电灾害的概率及雷电灾害产生后的严重程度进行分析计算,提出相应技术防范措施。
第三条 市气象主管机构负责全市雷电灾害风险评估的监督管理工作。县(市)气象主管机构负责本辖区内雷电灾害风险评估的监督管理工作。新华区、卫东区、湛河区、石龙区辖区内雷电灾害风险评估的监督管理工作由市气象主管机构负责。市和县(市)气象主管机构的主要职责是:
(一)负责编制本行政区域内的雷电灾害防御规划并监督实施。
(二)负责对承担雷电灾害风险评估工作机构的监督。
(三)负责对各建设工程项目单位及设计单位执行雷电灾害风险评估情况的检查、监督。(四)负责对违反雷电灾害风险评估法律、法规的单位和个人进行依法查处。
第四条 各级发展改革、住房和城乡建设、城乡规划、安全监管等行政主管部门应当按照各自职责,协同气象主管机构做好雷电灾害风险评估监督管理工作。
第五条 以下新建、扩建和改建工程项目应进行雷电灾害风险评估:(一)各类化工厂、易燃仓储、输送贮存油气等易燃易爆场所。(二)供水、供气、供电、供热等生命线工程。(三)各类体育场馆、影剧院、大型商场超市、宾馆、医院、学校、汽车站、火车站等人员密集公共场所。(四)各类发射塔、高耸观光塔、高层建筑、国家级重点文物保护建筑、通讯枢纽、码头泊位等特殊工程。
第六条 凡属本办法第五条所列举的建设工程项目,建设单位(项目业主)在项目可行性研究阶段,应同步做好雷电灾害风险评估;设计单位应当把《雷电灾害风险评估报告》列入施工图的设计依据,同时,根据报告要求、防雷技术规范和标准进行防雷装置设计。
第七条 对于已投入使用的易燃易爆场所及煤炭、化工等企业,在按照有关法律、法规要求定期进行安全评价时,需将雷电灾害风险评估作为一项重要参考依据。
第八条 凡属本办法第五条所列建设工程项目,建设单位(项目业主)在项目可行性研究阶段或初步设计时应同步做好雷电灾害风险评估工作。办理程序如下:(一)气象主管机构接受建设单位(项目业主)填报的“建设工程项目雷电灾害风险评估表”。(二)市、县(市)气象主管机构根据建设工程项目类型、类别在3个工作日内作出该项目是否需要进行雷电灾害风险评估的书面意见。(三)需要进行雷电灾害风险评估的项目,由建设单位(项目业主)与雷电灾害风险评估工作承担机构签订有关合同。(四)雷电灾害风险评估结果由建设单位(项目业主)报市、县(市)气象主管机构备案。
第九条 承担雷电灾害风险评估工作的机构,必须严格执行建设工程雷电灾害风险评估技术规范等相关标准,并对评估结论负责。
第十条 各建设和设计单位应主动配合气象主管机构做好雷电灾害风险评估工作,自觉接受本行政区域内的气象主管机构的监督、检查。
第十一条 对于违反本办法规定的单位和个人,将按照有关法律、法规规定进行处罚。
第十二条 本办法自2011年5月1日起施行。
