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.
成都市公共安全技术防范管理办法
四川省成都市人民政府
成都市公共安全技术防范管理办法
(1997年12月31日 市政府令第65号发布)
第一条 为加强公共安全技术防范设施管理,保障国家、集体财产和公民生命财产的安全,根据国家有关规定,结合成都市实际,制定本办法。
第二条 本办法适用于本市行政区域内的机关、团体、企业事业单位及个体经营者。
第三条 本办法所称公共安全技术防范产品(以下简称技防产品)包括入侵探测器、闭路电视监控器材设备、出入口控制设备、报警控制器、传输器材、安全检查器材、专用锁具、防盗安全门、防盗保险柜等产品。
本办法所称公共安全技术防范工程(以下简称技防工程)是指以维护公共安全为目的,综合运用技防产品所组成的技术防范系统。
技防产品和技防工程统称为公共安全技术防范设施(以下简称技防设施)。
第四条 市公安局是本市公共安全技术防范工作的主管机关,其所属的公共安全技术防范管理机构负责具体实施工作。市建设、技术监督、工商、保密等行政管理部门应按照各自职责,各司其职,协同公安机关实施本办法。
第五条 机关、团体、企业事业单位的公共安全技术防范工作由本单位主管领导负责,保卫部门组织实施公共场所的公共安全技术防范工作由其主管部门负责;居民住宅区的公共安全技术防范工作由辖区公安派出所负责组织。
第六条 技防设施的建设,应具备报警、监控、应急呼救功能,实现系统化、网络化。
第七条 从事技防产品生产、销售,必须到公安机关登记。
从事技术防工程设计、施工,必须按中华人民共和国公共安全行业标准《安全防范工程程序与要求》(GA/T75-94),向公安机关申报取得相应证书,方可承接设计、施工业务。
从事技防产品生产、销售和技防工程的设计、施工,必须依法申请工商登记,领取营业执照,方能开业。
第八条 凡国家实行生产许可证或认证管理的技防产品,由市公安局上报上级公安机关,按国家技术监督局和公安部的规定办理。
第九条 外地技防产品进入本市销售,应当持产地公安机关有关证明,向市公安局登记备案。
外地企业在本市承接技防工程设计、施工,必须持设计、施工相应证书,到市公安局验证注册,经验证注册后,方可从事此项业务。
第十条 下列场所必须安装与公共安全技术防范要求相适应的技防设施:
(一)海关、出入境口岸、机场及主要火车站、长途客运汽车站;
(二)银行、证券交易场所等金融机构的金库、营业场所和邮政、电信枢钮及星级宾馆、饭店、大型商场和高层商住楼宇;
(三)枪支弹药库;
(四)国家机关存放秘密文件、档案、图纸的场所;
(五)储存易燃、易爆、剧毒危险品和病菌种、放射性物质的场所;
(六)货币、有价证券、票据的印刷、储存场所和运输货币、有价证券的工具;
(七)陈列、收藏国家级文物和经营金银珠宝的场所;
(八)重要物资仓库和存放重要物品、仪器的场所;
(九)室内大型停车场;
(十)经市政府同意的其他涉及公共安全的重点场所。
第十一条 汽车应当安装必要的防盗装置、设施。
第十二条 本办法第十条规定必须安装技防设施的场所,应当在新建、扩建和改建的总体设计中统筹安排,设置技防设施。按规定需进行初步设计阶段的建设项目,在进行初步设计审查时,涉及技防工程设计、施工的,由市公安局参加建设行政管理部门组织的会审,提出审查意见,经初步设计审查批准后方可实施。
第十三条 技防工程的建设,执行国家和地方有关设计、施工的技术标准、规范和规程。技防工程,须按规定程序验收合格后方能开通使用。
第十四条 机关、团体、企业事业单位应当在公安机关的指导下,做好本单位的公共安全技术防范工作。
已安装技防设施的单位,应建立技防设施的使用管理和值班值勤制度,经常检查,对不适应公共安全技术防范要求的,应及时整改、更换。
第十五条 居民住宅技防设施的建设,按建设部、公安部《城市居民住宅防范设施建设管理规定》执行。居民住宅建设必须同步规划技防设施。
第十六条 违反本办法有下列行为之一的,由市或区(市)县公安机关予以处罚;
(一)违反本办法第十条规定,拒绝安装技防设施的单位,责令其限期改正,可处以五百元以上一千元以下罚款。
(二)未经登记生产技防产品的,责令改正,可处一千元以上三千元以下罚款,并限期按规定办理手续。
(三)未经登记销售技防产品的,责令改正,可处一千元以上三千元下罚款,并限期按规定办理手续的。
(四)销售无技防产品登记手续的技防产品,处五百元以上二千元以下罚款。
(五)未取得相应证书,或者持有外地相应证书但未经市公安局验证注册从事技防工程设计、施工的,责令改正,处一千元以上三千元以下罚款。
第十七条 故意损坏、偷窃技防设施,依照《中华人民共和国治安管理处罚条例》处罚;构成犯罪的,依法追究刑事责任。
第十八条 公安机关的工作人员滥用职权、玩忽职守、徇私舞弊,由所在机关或有权机关予以行政处分;构成犯罪的,依法追究刑事责任。
第十九条 当事人对行政处罚决定不服的,可依法申请行政复议或依法提起行政诉讼。
第二十条 本办法具体应用中的问题由成都市公安局负责解释。
第二十一条 本办法自发布之日起施行。1989年1月经市政政府批准由市公安局发布的《成都市加强技术防范设施建设的规定》同时废止。