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.
山东省血液管理暂行办法
山东省人民政府
山东省血液管理暂行办法
山东省政府
第一章 总 则
第一条 为加强血液管理，保证医疗用血，保障公民身体健康，促进社会主义精神文明建设，根据国家有关规定，结合我省实际情况，制定本办法。
第二条 本办法所称血液管理是指对献血、采血、供血、输血和用血的管理。
第三条 我省实行公民义务献血制度。凡居住在山东省行政区域内的适龄公民，均有献血的义务。提倡和鼓励公民无偿献血。
我省行政区域内的机关、团体、企事业单位及其他组织和个人，均应遵守本办法。
第四条 血液管理工作，实行统一管理血源、统一采血和统一供血（以下简称“三统一”）的制度。
第五条 各级人民政府应加强对血液管理工作的领导。
各级卫生行政部门主管本行政区域内的血液管理工作。
各级红十字会应配合卫生行政部门搞好义务献血的宣传、组织和动员工作。
新闻出版、广播电视、文化教育等有关部门，应向社会做好义务献血、血液科学知识的宣传教育工作。
第二章 管理机构及其职责
第六条 省卫生行政部门的职责：
（一）贯彻执行国家对血液管理的法律法规和方针政策，制定有关的规定和技术规范；
（二）制定全省公民义务献血规划和年度献血要求；
（三）审批、颁发《采供血许可证》；
（四）监督、检查全省的血液管理工作；
（五）负责与外省的血液调剂工作。
第七条 山东省血液中心和各级血站受同级卫生行政部门委托，具体办理本行政区域内血液管理的日常工作。
省血液中心负责全省血液工作的业务指导和省会驻地的“三统一”工作。
第三章 献血管理
第八条 男性20至50周岁，女性20至45周岁的健康公民，均应自愿履行献血的义务。
公民献血前由采血单位按照国家有关规定进行健康检查，检查合格者方可献血。
第九条 各单位必须依照卫生行政部门提出的献血要求，做好组织工作，按时完成献血任务。
中央和外省、市、自治区驻鲁单位应按所在地献血要求组织献血。
完成献血要求的单位，发给《完成献血证》。
第十条 有工作单位的公民由所在单位根据献血要求和血站的安排统一组织献血；无工作单位的公民，由街道办事处或村民委员会根据献血要求和血站的安排组织献血。
第十一条 自愿定期献血的公民，须携带身份证到当地血站办理献血登记手续。
第十二条 公民一次献血量为200至400毫升，两次献血间隔时间不得少于3个月。
第十三条 公民献血后，由采血单位发给《公民义务献血证》和国家规定的献血营养补助费、茶点费，献血的当日和次日享受公假，公假期间不影响工资、奖金及其他应有的福利待遇。
第十四条 公民参加无偿献血后，由采血单位发给《无偿献血证》和“无偿献血纪念章”。
第十五条 任何单位和个人不得以介绍公民献血为名进行牟利活动，不得雇佣他人代替单位或个人献血。
第四章 采血、供血管理
第十六条 各级血站是采血、供血的专业机构。其采血、供血工作必须取得省卫生行政部门颁发的《采供血许可证》后，方可进行。其他任何单位不得从事采供血。
第十七条 生产血液制品，需经省卫生行政部门批准，血源由所在地血站统一安排。
教学、科研用血、血浆和血液成分，由所在地血站负责供给。
第十八条 各级血站应当严格执行献血体检标准和采血、供血技术规范，保护献血公民健康，保证血液质量。
第五章 输血、用血管理
第十九条 各级医疗单位对病人用血时，应严格执行输血技术规范和操作规程，确保输血安全。推广成分输血，节约用血。
第二十条 公民因伤、病医疗需要用血时，享有用血的权利。
第二十一条 无偿献血的公民医疗用血时，可免费享受与无偿献血等量的医疗用血。
第六章 奖励与处罚
第二十二条 有下列情况之一的，由人民政府、卫生行政部门和红十字会给予表彰或奖励：
（一）无偿献血累计1000毫升以上的个人；
（二）当年符合献血条件的人员全部做到无偿献血的单位；
（三）在血液管理工作中做出显著成绩的单位或个人。
第二十三条 单位未完成献血要求的，由卫生行政部门给予警告，并限期完成献血要求；在限期内仍未完成要求的，建议当地人民政府予以通报批评。
第二十四条 违反本《办法》规定，有下列行为之一的，由卫生行政部门视情节轻重，给予警告、通报批评、没收非法所得，并可处以非法所得5倍以下的罚款。构成犯罪的，由司法机关依法追究刑事责任：
（一）未经卫生行政部门批准擅自采血的；
（二）雇佣他人冒名顶替献血的；
（三）组织他人卖血从中牟利的；
（四）采血单位不按规定采血、供血或者供应质量不合格血液的；
（五）伪造、涂改、转让献血有关证件的；
（六）扰乱献血秩序，对献血者敲诈勒索的。
第二十五条 罚没收入一律上缴同级财政部门。
第二十六条 献血管理机构的工作人员、医务人员滥用职权，玩忽职守，徇私舞弊的，由其所在单位或者上级主管部门追究行政责任；构成犯罪的，由司法机关依法追究刑事责任。
第二十七条 医务人员在采血、输血时造成医疗事故的，按照国家和本省医疗事故处理的规定严肃处理。
第二十八条 当事人对卫生行政部门作出的处罚不服的，可在接到处罚决定书之日起15日内向上一级卫生行政部门申请复议。复议机关应当在收到复议申请书之日起1个月内作出复议决定。对复议决定不服的，可在接到复议决定书之日起15日内向人民法院提起诉讼。当事人也可以
直接向人民法院提起诉讼。当事人既不执行处罚决定，又不申请复议，也不向人民法院提起诉讼的，卫生行政部门可以申请人民法院强制执行。
第七章 附 则
第二十九条 本办法由山东省卫生厅负责解释。
第三十条 本办法自发布之日起施行。
1992年12月21日
