甘肃省人民代表大会常务委员会议事规则
甘肃省人大常委会
甘肃省人民代表大会常务委员会议事规则
甘肃省人大常委会
（1988年9月20日甘肃省第七届人民代表大会常务委员会第四次会议通过）
目 录
第一章 会议的召开
第二章 议题、议案的提出和审议
第三章 询问与质询
第四章 发言和表决
根据《中华人民共和国宪法》、《中华人民共和国地方各级人民代表大会和地方各级人民政府组织法》以及甘肃省人民代表大会常务委员会的工作实际，制定本规则。
第一章 会议的召开
第一条 常务委员会审议议案、决定问题，实行民主集中制的原则。在常务委员会会议上的发言和表决，受法律保护。
第二条 常务委员会会议每两个月至少举行一次；根据实际需要，主任会议可以决定临时召集常务委员会会议。
常务委员会会议一般应在省会所在地兰州举行。
常务委员会会议由主任召集并主持。主任可以委托副主任主持会议。
第三条 常务委员会会议必须有常务委员会全体组成人员的过半数出席，才能举行。每次会议召开前七天，办公厅应将常委会组织人员能否参加会议的人数报告主任会议。
第四条 主任会议依照地方组织法的规定拟订常务委员会会议议程草案，提请常务委员会全体会议决定。
已经通过的常务委员会会议议程，一般不作变动，如需变动时，仍应经过全体会议决定；会议日程的变动，可由主任会议决定。
第五条 常务委员会举行会议，一般应当在会议举行十日以前，将开会日期，建议会议审议的主要事项，通知常务委员会组成人员、列席会议的有关单位；对会议审议的有关议案草案至迟也应在会议举行十日以前发给常务委员会组成人员。
因特殊需要，有二分之一以上的常委会组成人员参加，可以召集临时的常务委员会会议，会后应将会议的文件发给没有出席会议的组成人员。
第六条 常务委员会举行会议的时候，常务委员会组成人员除因病或者其他特殊原因请假的以外，都应当出席会议。
对因病因事请假没有出席会议的常务委员会组成人员，会后应发给会议文件。
第七条 常务委员会举行会议的时候，省人民政府组成人员和省高级人民法院院长、省人民检察院检察长列席会议。因故不能列席会议的，也可由副职列席。
常务委员会副秘书长、各工作部门的负责人列席会议。
各自治州、省辖市的人民代表大会常务委员会和常务委员会各地区联络处主任或副主任列席会议。
地区所辖的各市、县、自治县人民代表大会常务委员会负责人轮流列席会议。
常务委员会举行会议的时候，可以邀请在我省的部分全国人民代表大会代表和部分省人民代表大会代表列席会议。
常务委员会举行会议时，还可以允许部分公民旁听会议。
第八条 常务委员会举行会议的时候，分别召开全体会议、分组会议和联组会议。
第九条 常务委员会分组或联组会议对议案或者有关的工作报告进行审议的时候，应当通知有关部门派人到会，听取意见，回答询问。
第二章 议题、议案的提出和审议
第十条 常务委员会会议议题，一般应按照省人大常委会年度工作要点有计划地提出。
省人民政府、省高级人民法院和省人民检察院、常委会各工作委员会至迟应在每次常委会议举行十日之前，主动提出下次常务委员会会议的议题，由主任会议确定，提交常委会审议。
第十一条 常务委员会会议的议题，重点应放在监督法律、行政法规和地方性法规的贯彻实施和需要审议通过或批准的法规及所要作出的决议、决定方面。
第十二条 要列入常务委员会会议议程的法规案，由提案部门在一个月前向常务委员会书面上报法规草案及说明和有关资料。
第十三条 主任会议可以向常务委员会提出属于常务委员会职权范围内的议案，由常务委员会会议审议。
常务委员会各工作委员会、办公厅，受主任会议委托，也可以拟订议案草案，经主任会议讨论决定向常务委员会会议提出议案，并作说明。
省人民政府、省高级人民法院、省人民检察院，可以向常务委员会提出属于常务委员会职权范围内的议案，由常务委员会有关的工作委员会、办公厅研究提出意见，由主任会议决定提请常务委员会会议审议。
常务委员会组成人员五人以上联名，可以提出属于常务委员会职权范围内的议案，由主任会议决定提请常务委员会审议。
第十四条 对列入常务委员会会议议程的议案，提出议案的机关、常务委员会有关工作委员会、办公厅，应当提供与该议案有关的资料。
人事任免案的提出的审议按省人大常委会人事任免暂行办法办理。
第十五条 常务委员会全体会议听取提案机关关于议案的说明。
常务委员会全体会议听取议案说明后，分组或联组会议进行审议，并由有关的工作委员会、办公厅进行研究，报告主任会议决定，是否交付常务委员会全体会议进行表决。
第十六条 列入会议议程的法规草案，常务委员会听取说明，初步审议后，主任会议根据审议情况，决定是否交付常务委员会会议进行表决。
第十七条 提议案的机关负责人、提案人，可以在常务委员会全体会议、联组会议上对议案作补充说明。
第十八条 向常务委员会提出的议案，在交付表决前，提案人或者提案的机关要求撤回的，经主任会议同意，对该议案的审议即行终止。
第十九条 对提请常务委员会审议的议案，如果还有重大问题需要进一步研究，经主任会议讨论决定，本次会议可以暂不付表决，交有关工作委员会、办公厅进一步研究，提出报告，也可以组织专门的调查委员会或小组进行调查、论证，向常务委员会提出报告。
第二十条 省人民政府、省高级人民法院、省人民检察院按照地方组织法的有关规定，在两个月或者半年内应主动向常务委员会提出属于常务委员会职权范围内的综合的、或者单项的工作报告。向常务委员会提出的工作报告，主任会议根据实际情况决定是否列入常务委员会会议议程。
第三章 询问与质询
第二十一条 在常务委员会会议期间，常务委员会组成人员和列席会议的全国人大代表和省人民代表，可以对会议审议的议案和工作汇报提出询问。有关负责人应当到会回答询问。
询问的问题，应属省人民政府及其所属部门、省高级人民法院、省人民检察院以及辖属的地区中级人民法院、地区人民检察分院职责范围的较大问题，也可以是“一府两院”向常务委员会报告中不清楚的问题。
第二十二条 在常务委员会会议期间，常务委员会组成人员五人以上联名，可以向常务委员会书面提出对省人民政府及其有关的所属部门、省高级人民法院、省人民检察院以及辖属的地区中级人民法院、地区检察分院的质询案。
质询案的内容，应属“一府两院”及其有关部门职责范围内的重大的、严重违宪违法的、不执行省人大及其常委会决议的以及常委会组成人员认为需要质询的其他重大问题。
第二十三条 质询案必须写明质询对象、质询的问题和内容以及质询的理由。
第二十四条 质询案由主任会议研究后，提请常务委员会会议审议。
第二十五条 质询案由主任会议决定，交由受质询机关的负责人在常务委员会会议上口头答复或者书面答复。
质询案以书面答复的，应当由被质询机关负责人签署。
常务委员会组成人员如果对被质询机关的答复不满意时，可以要求被质询机关补充答复。
第二十六条 主任会议认为必要的时候，可以组织对质询案问题的调查委员会或小组，对调查的情况向主任会议作出报告。
第四章 发言和表决
第二十七条 常务委员会组成人员和列席会议的人员在全体会议上的发言，要紧紧围绕议题，抓住重点，简明扼要地表述自己的意见。发言一般不超过十分钟；在联组会议上，第一次发言一般不超过十五分钟，第二次对同一问题补充发言一般不超过十分钟；小组会上的一次发言，一般
不超过三十分钟。
第二十八条 表决议案由常务委员会全体组成人员的过半数通过。
表决结果由会议主持人当场宣布。
第二十九条 常务委员会通过议案等事项时，对表决的决议、决定、法规案，如有原则的、较重大的，较多处的修改，要作出修改说明，然后全文宣读后进行表决。
表决可以采用无记名投票方式或举手表决的方式，也可以采用其他方式进行表决。
第三十条 本规则自公布之日起施行。
1988年9月20日
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.
