山东省人民政府


山东省政府信息公开办法

(山东省人民政府令第225号)




　　《山东省政府信息公开办法》已经2010年5月7日省政府第72次常务会议通过，现予发布，自2010年7月1日起施行。

　　省　长　　姜大明　　　　
　　　　　　　　　　　　　　　　　　　　　　　　　　　　二○一○年五月二十八日　

　　山东省政府信息公开办法

　　第一章　总　则

　　第一条　为了保障公民、法人和其他组织的知情权和监督权，建立公开透明的行政管理体制，促进依法行政，依据《中华人民共和国政府信息公开条例》和其他有关法律、法规，结合本省实际，制定本办法。

　　第二条　本办法所称政府信息，是指行政机关在履行职责过程中制作或者获取的，以纸质、电磁介质以及其他载体形式予以记录、保存的信息。

　　第三条　行政机关公开政府信息，应当遵循公平、公正、及时、便民的原则。

　　第四条　各级人民政府应当加强对政府信息公开工作的组织领导，建立健全政府信息公开发布制度和监督保障机制。

　　省人民政府办公厅为全省政府信息公开工作的主管部门，负责推进、指导、协调、监督全省的政府信息公开工作。

　　设区的市、县(市、区)人民政府办公室(厅)为本行政区域政府信息公开工作的主管部门，负责推进、指导、协调、监督本行政区域的政府信息公开工作。

　　乡(镇)人民政府、街道办事处具体负责本行政区域的政府信息公开工作的推进和组织实施。

　　实行垂直管理的行政机关应当根据上级业务主管行政机关的统一安排做好政府信息公开工作，并接受所在地政府信息公开工作主管部门的指导。

　　第五条　行政机关应当建立健全政府信息公开工作制度，并指定机构(以下统称政府信息公开工作机构)负责本机关政府信息公开的日常工作，具体职责是：

　　(一)维护和更新本机关主动公开的政府信息；

　　(二)受理和处理向本机关提出的政府信息公开申请；

　　(三)对拟公开的政府信息进行保密审查；

　　(四)组织编制本机关的政府信息公开指南、目录和年度工作报告；

　　(五)履行本机关规定的与政府信息公开有关的其他职责。

　　第六条　政府信息公开工作主管部门和其他行政机关，应当建立和完善政府信息发布协调与处理机制，保证政府信息的准确一致。

　　第七条　行政机关公开政府信息，不得危及国家安全、公共安全、经济安全和社会稳定。

　　第二章　公开的范围和主体

　　第八条　行政机关应当按照《中华人民共和国政府信息公开条例》第九条、第十条、第十一条、第十二条的规定，在各自职责范围内确定主动公开的政府信息的具体内容和重点公开的政府信息。

　　重点公开的政府信息目录，应当按照规定报本级政府信息公开工作主管部门备案。

　　第九条　行政机关拟定地方性法规、规章、规范性文件和有关政策、措施、标准，或者编制相关规划、计划、方案、预案，涉及公民、法人和其他组织的重大利益，或者有重大社会影响的，在拟定、编制过程中，应当将草案主动向社会公开，充分听取公众意见。

　　除前款所列的行政机关主动公开征求意见的草案外，其他属于调查、讨论、处理过程中的有关信息，因其内容不确定，不予公开。

　　行政机关发现影响或者可能影响社会稳定、扰乱社会管理秩序的虚假或者不完整信息的，应当根据职责权限范围发布准确的政府信息予以澄清；无权进行澄清的，应当报请有权机关予以澄清，或者报告本级政府信息公开工作主管部门进行处理。

　　第十条　除行政机关主动公开的政府信息外，公民、法人或者其他组织还可以根据自身生产、生活、科研等特殊需要，向行政机关申请获取相关政府信息。

　　行政机关一般不承担为申请人汇总、加工或者重新制作政府信息，以及向其他行政机关和公民、法人或者其他组织搜集信息的义务。

　　第十一条　行政机关不得公开下列政府信息：

　　(一)涉及国家秘密的；

　　(二)涉及商业秘密的；

　　(三)涉及个人隐私的。但是，经权利人同意公开或者行政机关认为不公开可能对公共利益造成重大影响的涉及商业秘密、个人隐私的政府信息，可以予以公开。须经权利人同意公开的，权利人对是否同意公开的意见征询未向行政机关作答复的，视为不同意公开。

　　第十二条　行政机关应当建立健全政府信息发布保密审查机制，明确审查的程序和责任。

　　行政机关在公开政府信息前，应当依法进行保密审查，并相应明确主动公开、依申请公开或者不予公开的情形。确定不予公开的，还应当注明理由。

　　政府信息的保密审查，由行政机关内部负责制作或者获取该信息的机构提出意见，经政府信息公开工作机构会同保密机构等审核后，报行政机关负责人决定。

　　第十三条　行政机关制作的政府信息，由制作该政府信息的行政机关负责公开；行政机关从公民、法人或者其他组织获取的政府信息，由保存该政府信息的行政机关负责公开；两个以上行政机关制作或者获取的政府信息，由为主的行政机关负责公开。

　　负有政府信息公开义务的行政机关被撤销、合并或者发生变更的，由承担其职责的行政机关负责原行政机关政府信息的公开。

　　法律、法规、规章对政府信息公开的权限另有规定的，从其规定。

　　第三章　公开的方式和程序

　　第十四条　属于主动公开范围的政府信息，行政机关应当自该政府信息形成或者变更之日起20个工作日内，采取便于公众知晓并符合该信息特点的方式予以公开。法律、法规对政府信息公开的期限另有规定的，从其规定。

　　第十五条　各级人民政府及政府部门应当将主动公开的政府信息在本单位的政府网站上全部公开。本单位尚未设立政府网站的，应当通过本级或者上级人民政府的政府网站公开。

　　第十六条　县级以上人民政府应当建立健全政府公报制度。

　　政府规章、规范性文件和有关政策、规划、计划等，应当及时在政府公报上全文登载。

　　第十七条　县级以上人民政府应当建立健全政府新闻发言人制度。定期或者不定期向新闻媒体及社会发布重要新闻，通报重要工作安排及工作进展情况，回答新闻媒体就本地区、本单位工作提出的询问。

　　第十八条　对重大公共事件、公共预警信息以及其他需要公众及时知晓的政府信息，应当通过政府网站、新闻发布会或者广播、电视等其他方式及时公开发布。

　　第十九条　行政机关依照本办法第九条第一款的规定，需要将有关草案向社会公开，充分听取公众意见的，应当通过政府网站、新闻报刊或者其他便于公众及时知晓的方式发布。

　　第二十条　各级人民政府应当在当地国家档案馆、公共图书馆(室)或者政务大厅设置政府信息查阅场所，并配备相应的设施、设备，为公民、法人和其他组织获取政府信息提供便利。行政机关应当及时向当地国家档案馆、公共图书馆(室)以及政务大厅提供主动公开的政府信息。

　　行政机关依法向国家档案馆移交的档案涉及政府信息的，应当将该政府信息属于主动公开、依申请公开或者不予公开的情况书面告知国家档案馆。

　　第二十一条　行政机关可以根据需要，设置公共查阅室、资料索取点、信息公告栏、电子信息屏等场所、设施，方便公众检索、查询、复制政府信息。

　　第二十二条　行政机关公开政府信息前，应当对该政府信息的准确性进行检查、核实；政府信息涉及其他行政机关或者其他有关单位、个人，且对该政府信息的准确性难以确定的，应当事先与其进行沟通、确认。

　　已公开的政府信息涉及两个以上行政机关，且公开的内容不一致的，由相关行政机关进行协调、确认和更正。相关行政机关对公开的内容意见不一致的，应当报请本级政府信息公开主管部门协调解决。依照国家和省有关规定，拟发布的政府信息需要批准的，行政机关在发布前应当获得批准；未经批准，不得发布。

　　第二十三条　公民、法人或者其他组织向行政机关申请获取其他未主动公开的政府信息的，应当提交载明下列内容的申请书：

　　(一)申请人的姓名或者名称、联系方式；

　　(二)申请公开的政府信息的内容描述；

　　(三)申请公开的政府信息的形式要求。

　　申请人能够提供政府信息的名称、文号或者其他特征的，应当在申请书上载明。

　　第二十四条　申请人书写政府信息公开申请书确有困难的，可以口头提出申请，由接收申请的行政机关工作人员代为填写申请书，并由申请人签字或者盖章确认。

　　申请人描述政府信息的内容及其特征确有困难，或者存在阅读、视听等方面障碍的，行政机关应当为其提供必要的引导和帮助。

　　第二十五条　行政机关可以设立接收申请的窗口，方便公民、法人和其他组织申请公开政府信息。具备条件的县级以上人民政府，可以设立集中接收申请窗口。

　　第二十六条　对公民、法人或者其他组织提出的政府信息公开申请，行政机关应当按照下列规定分别作出书面告知：

　　(一)属于公开范围的，应当告知申请人获取该政府信息的方式和途径；

　　(二)属于不予公开范围的，应当告知申请人并说明理由；

　　(三)申请内容不属于本办法规定的政府信息范围的，应当告知申请人并说明有关情况；

　　(四)申请公开的政府信息属于本机关职责权限范围，但本机关未制作或者获取的，应当告知申请人该政府信息不存在；

　　(五)申请公开的政府信息不属于本机关职责权限范围的，应当及时告知申请人，能够确定公开机关的，还应当告知申请人该机关的名称、联系方式；

　　(六)申请公开的政府信息中含有不应当公开的内容，但能够区分处理的，应当告知申请人可以部分公开以及获取的方式和途径，对不予公开的部分，应当说明理由；

　　(七)申请公开的政府信息涉及商业秘密、个人隐私，但符合本办法第十一条第二款规定，可以公开的，应当告知申请人获取该政府信息的方式和途径；

　　(八)申请内容不明确的，应当告知申请人在15个工作日内补正，申请人逾期未补正的，视为放弃申请；

　　(九)同一申请人无正当理由重复向同一行政机关申请公开同一政府信息，行政机关已经作出答复的，应当告知申请人不再重复受理；

　　(十)申请公开项目较多的，受理机关可以按照一个政府信息公开申请只对应一个政府信息公开项目的方式，告知申请人加以调整。

　　第二十七条　行政机关收到政府信息公开申请，能够当场答复的，应当当场予以答复；不能当场答复的，应当自收到申请之日起15个工作日内予以答复；需要延长答复期限的，应当经政府信息公开工作机构负责人同意，并告知申请人。延长答复的期限最长不得超过15个工作日。

　　因不可抗力或者其他法定事由，致使行政机关不能在规定的期限内答复申请人或者向申请人提供政府信息的，期限中止。中止时间不计算在前款规定的期限内。中止事由消除后，期限恢复计算。期限的中止和恢复，应当及时通知申请人。

　　第二十八条　公民、法人或者其他组织向行政机关申请提供与其自身相关的税费缴纳、社会保障、医疗卫生、证照办理、款项和物品拨付等政府信息的，应当出示有效身份证件或者证明文件。

　　公民、法人或者其他组织有证据证明行政机关提供的与其自身相关的政府信息记录不准确的，有权要求该行政机关予以更正；该行政机关无权更正的，应当转送有权更正的行政机关处理，并告知申请人。

　　第二十九条　行政机关依申请公开政府信息，无法按照申请人要求的形式提供的，可以通过安排申请人查阅相关资料、提供复制件或者其他适当形式提供。

　　第三十条　行政机关应当依照《中华人民共和国政府信息公开条例》第十九条的规定，及时编制、更新本机关的政府信息公开指南和公开目录，并向社会公布。

　　行政机关应当将政府信息公开指南和公开目录在政府网站刊登，并在当地国家档案馆、公共图书馆(室)或者政务大厅的政府信息查阅场所和其他查阅场所的醒目位置予以摆放。

　　第三十一条　行政机关依申请向公民、法人和其他组织提供政府信息，除可以收取实际发生的检索、复制、邮寄等成本费用外，不得收取其他任何费用。检索、复制、邮寄等成本费用的标准，按照国家有关规定执行。收取的检索、复制、邮寄等费用，应当全部上缴本级财政。

　　申请人属于城乡居民最低生活保障对象或者确有其他经济困难的，经本人申请，政府信息公开机构负责人审核同意，可以减免相关费用。

　　行政机关不得通过其他组织、个人以有偿服务方式提供政府信息。

　　第四章　监督和保障

　　第三十二条　县级以上人民政府应当建立健全政府信息公开工作考核制度、社会评议制度和责任追究制度，加强对政府信息公开工作的考核、评议，及时对违法或者不当的行为进行纠正和处理。

　　政府信息公开工作主管部门和监察机关负责对行政机关政府信息公开的实施情况进行监督检查。

　　第三十三条　政府信息公开工作主管部门和监察机关应当会同有关部门，加强对下一级人民政府和本级人民政府各部门政府信息公开工作的考核，并适时组织开展社会评议。考核结果和社会评议结果应当作为行政机关绩效考核的内容之一，并予以公布。

　　第三十四条　各级行政机关应当于每年3月31日前，编制、公布上年度本机关政府信息公开工作报告，并报送本级和上一级政府信息公开工作主管部门和监察机关。

　　政府信息公开工作年度报告应当包括下列内容：

　　(一)行政机关主动公开政府信息的情况；

　　(二)公民、法人或者其他组织申请公开政府信息的情况；

　　(三)行政机关同意公开、部分公开和不予公开政府信息的分类情况；

　　(四)政府信息公开工作中行政复议、行政诉讼及投诉情况和处理结果；

　　(五)政府信息公开的收费及减免收费的情况；

　　(六)政府信息公开工作存在的主要问题及改进情况；

　　(七)其他需要报告的事项。

　　第三十五条　公民、法人或者其他组织认为行政机关不依法履行政府信息公开义务的，可以向上级行政机关、监察机关或者政府信息公开工作主管部门举报。收到举报的机关应当予以调查处理。

　　公民、法人或者其他组织认为行政机关在政府信息公开工作中的具体行政行为侵犯其合法权益的，可以依法申请行政复议或者提起行政诉讼。

　　第三十六条　行政机关未按照规定建立健全政府信息发布保密审查机制的，由监察机关、上一级行政机关责令改正；情节严重的，对行政机关主要负责人依法给予处分。

　　第三十七条　行政机关有下列情形之一的，由监察机关、上一级行政机关责令改正；情节严重的，对直接负责的主管人员和其他直接责任人员依法给予处分；涉嫌犯罪的，移送司法机关依法处理：

　　(一)不依法履行政府信息公开义务的；

　　(二)不及时更新公开的政府信息内容、政府信息公开指南和目录的；

　　(三)不按规定向当地国家档案馆、公共图书馆送交政府信息公开指南、目录或者属于主动公开范围的政府信息的；

　　(四)违反规定收取费用的；

　　(五)通过其他组织、个人以有偿服务方式提供政府信息的；

　　(六)公开不应当公开的政府信息的；

　　(七)在政府信息公开工作中隐瞒或者捏造事实的；

　　(八)其他滥用职权、徇私舞弊、玩忽职守的行为的。

　　第三十八条　行政机关应当将政府信息公开工作经费纳入本机关的年度预算，保障政府信息公开工作的正常进行。

　　第五章　附　则

　　第三十九条　法律、法规授权的具有管理公共事务职能的组织公开政府信息的活动，适用本办法。

　　第四十条　教育、医疗卫生、计划生育、供水、供电、供气、供热、环保、公共交通、邮政、通信、金融以及殡葬等与人民群众利益密切相关的公共企事业单位，在提供社会公共服务过程中制作、获取的信息的公开，参照本办法执行。

　　第四十一条　本办法自2010年7月1日起施行。

State Food and Drug Administration，State Administration for Industry and Commerceof the People’s Republic of China


Provisions for Drug Advertisement Examination



(SFDA Decree No. 27)

The Provisions for Drug Advertisement Examination, adopted by the State Food and Drug Administration and the State Administration for Industry and Commerce of the People’s Republic of China, is now issued in the decree sequence number of the State Food and Drug Administration. The Provisions shall go into effect as of the date of May 1, 2007.



Shao Mingli
Commissioner
State Food and Drug Administration

Zhou Bohua
Minister
State Administration for Industry and Commerceof the People’s Republic of China

March 13, 2007





Provisions for Drug Advertisement Examination


Article 1 The Provisions are formulated for the purposes of strengthening regulation on drug advertisements and ensuring the authenticity and legality of drug advertisements in accordance with the Advertisement Law of the People’s Republic of China (hereinafter referred to as Advertisement Law), the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for the Implementation of Drug Administration Law of the People's Republic of China (hereinafter referred to as Regulations for the Implementation of Drug Administration Law) and other regulations related to supervision on advertisements and drugs.

Article 2 A drug advertisement refers to any advertisement published through various media or forms containing drug name, indications (functions) or other relevant contents, and shall be examined and approved in accordance with the Provisions.

Where only the names of non-prescription drugs (including adopted names and trade names) are publicized or only the names of prescription drugs (including adopted names and trade names) are publicized in professional medical or pharmaceutical journals, the examination is not required.

Article 3 The drug advertisement applied for examination shall be approved provided that it conforms to the following laws, regulations and related provisions:
(1) Advertisement Law;
(2) Drug Administration Law;
(3) Regulations for Implementation of Drug Administration Law;
(4) Criteria for Examining and Publishing Drug Advertisement;
(5) Other provisions of the State on advertisement regulation.

Article 4 The drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government are the drug advertisement examination authorities responsible for examining drug advertisements within their administrative regions. The administrative departments for industry and commerce at or above the county level are supervision and control authorities for drug advertisements.

Article 5 The State Food and Drug Administration shall guide and supervise the examination conducted by drug advertisement examination authorities and punish, in accordance with law, the examination authorities that have violated the Provisions.

Article 6 An applicant for a drug advertisement approval number must be an eligible drug manufacturer or distributor. Where the applicant is a drug distributor, the consent of the drug manufacturer is required.

An applicant may entrust an agent with the application for a drug advertisement approval number.

Article 7 An application for a drug advertisement approval number shall be submitted to the drug advertisement examination authority in the place where the drug manufacturer is located.

An application for an import drug advertisement approval number shall be submitted to the drug advertisement examination authority in the place where the agent of the import drug is located.

Article 8 Where a drug manufacturer or distributor applies for a drug advertisement approval number, it shall submit an Application Form for Drug Advertisement (Appendix 1) with sample manuscript (sample film or sample record) of which the content is consistent with that to be published attached, and an electronic document of drug advertisement application. It shall also submit the following proof documents that are authentic, legal and valid:
(1) Copy of the Business License of the applicant;
(2) Copy of the Drug Manufacturing Certificate or the Drug Supply Certificate of the applicant;
(3) Where the applicant is a drug distributor, the original document proving that the drug manufacturer authorizes the drug distributor to be the applicant shall be submitted;
(4) Where an agent submits an application for a drug advertisement approval number on behalf of the applicant, an original authorization letter given by the applicant to the agent, a copy of business license of the agent and other documents proving the subject’s qualifications shall be submitted;
(5) Copies of the drug approval document (including Import Drug License or Pharmaceutical Product License), copy of approved insert sheet, and label and insert sheet used in practice;
(6) For non-prescription drug advertisement, a copy of registration certificate of non-prescription drug examination or copies of relevant certificates is required;
(7) Where an applicant applies for an import drug advertisement approval number, copies of qualification certificates of the agent of the import drug shall be submitted;
(8) Where the trade name, registered trademark and patent of the drug are involved in an advertisement, copies of the valid certificates and other relevant documents proving the authenticity of the advertisement shall be submitted.

The copy of any approval document prescribed in this Article shall be sealed by the document holder.

Article 9 An advertisement application by an enterprise for a drug shall not be accepted by the drug advertisement examination authorities under any of the following circumstances:
(1) Any of the circumstances under which the application shall be rejected as prescribed in Article 20, Article 22 and Article 23 of the Provisions;
(2) An administrative procedure to withdraw a drug advertisement approval number is in process.

Article 10 After receiving an application for drug advertisement approval number, where the dossier is complete and in conformity with statutory requirements, the drug advertisement examination authority shall issue an Acceptance Notice of Drug Advertisement; where the dossier is incomplete or not conforming to the statutory requirements, one notification on all the content to be supplemented or corrected shall be given to the applicant on the spot or within five working days; if the notification to the applicant is not issued within the timeline, the application is deemed as being accepted upon the date when the dossier is received.

Article 11 Within ten working days upon accepting an application, the drug advertisement examination authority shall check the authenticity, legality and validity of the documents submitted by the applicant, and shall examine the advertisement content in accordance with law. For the drug advertisement in conformity with statutory requirements, a drug advertisement approval number shall be issued; for those not in conformity with statutory requirements, the authority shall make a decision of not issuing a drug advertisement approval number and notify the applicant of the decision with reasons in written form and the applicant’s right to apply for administrative reconsideration or to bring an administrative suit by law.

For approved drug advertisement, the drug advertisement examination authority shall report to the State Food and Drug Administration for records and send the approved Application Form for Drug Advertisement to the authority responsible for advertisement supervision and control at the same level for records. Where there is any problem in the drug advertisement reported to the State Food and Drug Administration for records, the State Food and Drug Administration shall instruct the drug advertisement examination authority to correct it.

The drug regulatory departments shall announce the approved drug advertisement timely.

Article 12 Where a drug advertisement is to be published in the province, autonomous region or municipality directly under the Central Government other than the place where the drug manufacturer and the agent of the import drug are located (hereinafter referred to as “non-local drug advertisement”), it shall, before being published, be submitted for records to the drug advertisement examination authority in the place where the advertisement is to be published.

Article 13 The following materials for non-local drug advertisement shall be submitted for record:
(1) Copy of the Application Form for Drug Advertisement;
(2) Copy of the approved drug insert sheet;
(3) For television or audio broadcast advertisement, it is required to submit the audio tape, compact disc or other medium carrier on which the content is consistent with the approved content.

The copy of any document prescribed in this Article shall be sealed by the document holder.

Article 14 For application for putting non-local drug advertisement on record in accordance with Articles 12 and Article 13 of the Provisions, the drug advertisement examination authority shall, within five working days after accepting the application, put such drug advertisement on record, endorse the word “recorded” on the Application Form for Drug Advertisement, affix the seal specific for drug advertisement examination and send the form to the supervision and control authorities for advertisements at the same level for future reference.

Where the drug advertisement examination authority of a place where a drug advertisement is to be put on record finds that the drug advertisement is not conformed with the relevant provisions, it shall fill in the Opinion on the Record of Drug Advertisement Examination (Appendix 2), submit it to the original drug advertisement examination authority for check, and copy it to the State Food and Drug Administration.

Within five working days upon receiving the Opinion on the Record of Drug Advertisement Examination, the original drug advertisement examination authority shall give its opinions to the drug advertisement examination authority of the place where the drug advertisement is to be put on record. Where no consensus is achieved between the original drug advertisement examination authority and the drug advertisement examination authority of the place where a drug advertisement is to be put on record, the case may be submitted to the State Food and Drug Administration that shall make a final judgment.

Article 15 The valid term of a drug advertisement approval number is one year. It shall become invalid upon expiration.

Article 16 The content of an approved drug advertisement is not allowed to be changed when being published. Where any change to the drug advertisement is needed, a new drug advertisement approval number shall be obtained.

Article 17 Where an advertisement applicant publishes a drug advertisement by itself, it shall keep the original Application Form for Drug Advertisement for two years for future check.

Where an advertisement publisher or advertising operator is authorized by the applicant to publish a drug advertisement, it shall check the original Application Form for Drug Advertisement, publish the advertisement in accordance with the approved content and keep a copy of the Applicant Form for Drug Advertisement for two years for future check.

Article 18 Where there is any of the following circumstances for an approved drug advertisement, the original drug advertisement examination authority shall issue a Notice of Drug Advertisement Re-examination (Appendix 3) and conduct the re-examination. The drug advertisement may continue to be published during the re-examination.

(1) The State Food and Drug Administration finds that the content of the drug advertisement approved by the drug advertisement examination authority is not in conformity with the provisions;
(2) A supervision and control authority for advertisement at or above provincial level makes a re-examination proposal;
(3) Other circumstances where a re-examination is required by a drug advertisement examination authority.

After re-examination, where the drug advertisement is not in conformity to the statutory requirements, the Application Form for Drug Advertisement shall be taken back and the original drug advertisement approval number shall become invalid.

Article 19 Drug advertisement examination authorities shall cancel the drug advertisement approval number in any of the following circumstances:
(1) Where a Drug Manufacturing Certificate or the Drug Supply Certificate is revoked;
(2) Where a drug approval document is withdrawn or cancelled;
(3) Where the State Food and Drug Administration or the drug regulatory department of the province, autonomous region or municipality directly under the Central Government instructs to stop the production, sales and use of the drug.

Article 20 For any alteration to the approved content of a drug advertisement for false propaganda, the drug regulatory departments shall instruct to stop the publication of the advertisement immediately, revoke the drug advertisement approval number, and shall not accept any application for advertisement of the drug within one year.

Article 21 Where any illegal advertisement in which the scope of indications (functions) of the drug is expanded without authorization, the therapeutic effectiveness is exaggerated extremely, or which seriously cheats or misleads the customers, is found, the drug regulatory department at or above the provincial level shall take mandatory administrative measures to suspend the sales of the drug within their administrative area and order the enterprise that illegally publishes the drug advertisement to issue a correction notice in relevant local media.

After the enterprise that illegally publishes the drug advertisement issues a correction notice as required, the drug regulatory department at or above the provincial level shall make a decision on lifting the mandatory administrative measures within 15 working days; where it is necessary to test the drug, the drug regulatory departments shall determine whether to lift the mandatory administrative measures within 15 days as from the day when the test report is issued.

Article 22 Where a drug advertisement application providing false materials is found by the drug advertisement examination authority during the examination, no further application of the enterprise in respect of the advertisement of the drug shall be accepted within one year.

Article 23 Where a drug advertisement with an approval number is found by the drug advertisement examination authority to have provided false materials, such drug advertisement approval number shall be revoked and no further application from the enterprise in respect of the advertisement of the drug shall be accepted within three years.

Article 24 Any drug advertisement, of which the approval number is taken back, cancelled or revoked in accordance with Article 18, Article 19, Article 20 and Article 23 of the Provisions, shall be discontinued for publication immediately; non-local drug advertisement examination authorities shall stop filing the record of the advertisement of the enterprise with the drug advertisement approval number.

Where a drug advertisement examination authority takes back, cancels or withdraws a drug advertisement approval number in accordance with Article 18, Article 19, Article 20 and Article 23 of the Provisions, it shall notify the supervision and control authority for advertisements at the same level within five working days from the day when the administrative decision on the matter is made; the supervision and control authority for advertisements shall handle it in accordance with law.

Article 25 Where a non-local drug advertisement is found not put on record in the drug advertisement examination authority of the place where it is published, the authority shall instruct to file its record within a time limit. If the record is not filed within the time limit, the drug advertisement in the above-mentioned place shall be suspended.

Article 26 The drug regulatory department at or above the county level shall monitor and check the publishing of drug advertisement that has been examined and approved. For any illegal drug advertisements, drug regulatory departments at all levels shall fill in the Notice on the Transfer of Illegal Drug Advertisement (Appendix 4) and transfer it to an supervision and control authority for advertisements at the same level together with such materials as samples of illegal drug advertisement; where the content of approved non-local drug advertisement is altered without permission, the drug advertisement examination authority of the place where the advertisement is published shall advise the original drug advertisement examination authority to revoke its approval number in accordance with Article 92 of the Drug Administration Law and Article 20 of the Provisions.

Article 27 Where an illegal drug advertisement is published and the circumstances are serious, the drug regulatory department of province, autonomous region or municipality directly under the Central Government shall announce the matter to the public and timely report it to the State Food and Drug Administration. The State Food and Drug Administration shall summarize and release the collected information periodically.

Where any false or illegal drug advertisement is published and the circumstances are serious, it shall be announced to the public jointly by the State Administration for Industry and Commerce and the State Food and Drug Administration if necessary.

Article 28 For any drug advertisement published without approval, or the contents published inconsistent with the approved ones, the supervision and control authority for advertisements shall impose a punishment in accordance with Article 43 of the Advertisement Law; where it constitutes false advertisement or misleading propaganda, the supervision and control authorities for advertisements shall impose a punishment in accordance with Article 37 of the Advertisement Law and Article 24 of Anti-Unfair Competitions Law.

In the process of investigation of an illegal drug advertisement, where there is a need to affirm any drug technical information, the supervision and control authority for advertisements shall notify the drug regulatory department at or above the provincial level. The drug regulatory department at or above the provincial level shall give the affirmation result to the supervision and control authorities for advertisements within ten working days after receiving the notification.

Article 29 The staff members that examine and supervise drug advertisements shall be trained in such laws and regulations as the Advertisement Law and the Drug Administration Law. Where the staff members in drug advertisement examination department or in supervision and control authority for drug advertisements neglect their duty, abuse their power, or practice favoritism and commit irregularities, they shall be given an administrative sanction in accordance with law. If a crime is constituted, they shall be investigated for their criminal liabilities in accordance with law.

Article 30 A drug advertisement approval number shall be “X Yao Guang Shen (Shi) No. 0000000000", “X Yao Guang Shen (Sheng) No. 0000000000", “X Yao Guang Shen (Wen) No. 0000000000". “X” is the abbreviation for a province, autonomous region or municipality directly under the Central Government. “0000000000” is a number with ten digits, in which the first six represent year and month of the examination, and the last four represent advertisement approval sequence number. “Shi”, “Sheng” or “Wen” represents certain classification code used in advertising media.

Article 31 These Provisions shall come into force as of May 1, 2007. The Provisions for Drug Advertisement Examination issued by the State Administration for Industry and Commerce and the Ministry of Health (Decree of State Administration for Industry and Commerce No. 25) on March 22, 1995 shall be annulled therefrom.