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关于印发乌鲁木齐市重大行政处罚决定备案审查办法的通知

作者:法律资料网 时间:2024-06-29 15:58:50  浏览:9405   来源:法律资料网
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关于印发乌鲁木齐市重大行政处罚决定备案审查办法的通知

新疆维吾尔自治区乌鲁木齐市人民政府


关于印发乌鲁木齐市重大行政处罚决定备案审查办法的通知
文号:乌政发[2003]53

乌鲁木齐县、各区人民政府,乌鲁木齐经济技术开发区、高新技术产业开发区管委会,市属各委、局、办,各县级事业单位:
《乌鲁木齐市重大行政处罚决定备案审查办法》已经市人民政府同意,现予公布施行。

乌鲁木齐市人民政府
二○○三年六月九日



《乌鲁木齐市重大行政处罚决定备案审查办法》

第一条 为了加强对行政执法工作的监督,保证行政处罚的合法与适当,规范行政执法文书,促进行政机关依法行政,维护公民、法人和其他组织的合法权益,根据《中华人民共和国行政处罚法》和《乌鲁木齐市行政执法条例》及其他有关法律、法规,结合本市实际,制定本办法。
第二条 本市各级行政执法机关,法律、法规授权的组织,受委托的组织的重大行政处罚决定备案审查适用本办法。
第三条 市人民政府法制办公室负责全市重大行政处罚决定备案审查工作的监督、指导和协调。
第四条 下列重大行政处罚决定应当报送备案:
(一) 责令停产停业的;
(二) 吊销许可证或者执照的;
(三) 对公民处1000元以上、对法人或者其他组织处3万元以上罚款的;
(四) 没收违法所得或者没收非法财物价值1万元以上的;
(五) 市人民政府认为应当备案审查的其他重大行政处罚决定。
第五条 作出重大行政处罚决定的机关(以下简称报备部门)应当在重大行政处罚决定作出后7日内依照下列规定报送备案:
(一)市人民政府所属行政执法机关作出的重大行政处罚决定报送市人民政府法制办公室备案;
(二)区(县)人民政府所属行政执法机关作出的重大行政处罚决定报送区(县)人民政府法制机构备案,同时报送上级业务主管部门;
(三)法律、法规授权的具有管理公共事务职能的组织在法定授权范围内作出的重大行政处罚决定,报送本级人民政府法制机构备案;
(四)依法受委托组织在委托范围内,以委托行政机关名义作出的重大行政处罚决定,由委托行政机关报本级人民政府法制机构备案;
(五)乌鲁木齐经济技术开发区管理委员会、乌鲁木齐高新技术产业开发区管理委员会所属工作部门作出的重大行政处罚决定分别报两管委会备案。
第六条 报备部门备案时应当向有备案管辖权的机关(以下简称备案部门)提交备案报告和行政处罚决定书。备案报告的格式由市人民政府法制办公室统一规定。
第七条 备案部门应在收到备案材料之日起30日内对材料进行审查,审查事项包括:
(一) 执法主体是否合法;
(二) 处罚程序是否合法;
(三) 适用的依据是否正确;
(四) 行政执法文书是否规范;
(五) 需要进行审查的其他内容。
第八条 备案部门在备案案件审查过程中,根据情况可以调阅报备部门的案卷材料或者要求案件承办人说明情况,报备部门不得拒绝。
第九条 备案部门在审查中发现报备部门作出的重大行政处罚决定不合法或者显失公正的,提请本级人民政府制发《重大行政处罚决定备案处理决定书》,责令其限期撤销、改变原处罚决定;需重新作出行政处罚决定的,应当重新作出(当事人提起行政复议、行政诉讼的案件除外)。
重大行政处罚决定书不规范的,由备案部门制发《重大行政处罚决定备案审查建议书》,建议报备部门以后改正。
第十条 报备部门应当在接到《重大行政处罚决定备案处理决定书》或者《重大行政处罚决定备案审查建议书》之日起30日内,将办理结果报告备案部门。
第十一条 建立重大行政处罚案件统计报表上报制度,报备部门应当于每年的一月底和七月底以前,将上一年度下半年和本年度上半年所处理的重大行政处罚案件统计表报送备案部门。
第十二条 备案部门应加强对报备部门的监督检查,对检查中发现的下列情形,应当对报备部门予以通报批评并责令改正,情节严重的,对负有责任的主管人员给予行政处分:
(一) 在规定期限内应备案而不备案的;
(二) 备案报告不符合规定格式的;
(三) 不按规定报送重大行政处罚案件统计表的;
(四) 拒绝调阅案件材料或说明案件情况的;
(五) 拒不执行备案部门作出的处理决定的。
第十三条 本办法自公布之日起施行。


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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.


国家物价局对《中华人民共和国价格管理条例》第二十九条第(一)项价格时效解释给四川省物价局的复文

国家物价局


国家物价局对《中华人民共和国价格管理条例》第二十九条第(一)项价格时效解释给四川省物价局的复文

1989年10月23日 [1989]价政字755号

你省物价检查所十月六日来函询问《中华人民共和国价格管理条例》第二十九条第(一)项中有关国家定价的时效问题,现解释如下:
该《条例》第二十九条第(一)项及其他项中所称的国家定价、国家指导价(均含收费标准)是指买卖双方成交当时必须执行的由国家有关部门按照价格管理权限所规定的价格。凡卖方已按成交当时的价格向买方开票并结清价款,尔后价格又进行调整(调高或调低)的,双方都不再退补价差款。对卖方向买方补收价差款的,应按《条例》第二十九条第(一)项规定的价格违法行为进行处罚。
但是,卖方由于事前获悉调低价格的机密而提前强行向买方增拨商品,以转嫁调价损失的,则属于价格违法行为。其强行增拨部分,应按新价结算并视情节对卖方给予处罚。



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