Measures for the Administration of Health Licensing Decree No. 38 of the Ministry of Health of the People's Republic of China

Measures for the Administration of Health Licensing Decree No. 38 of the Ministry of Health of the People's Republic of China

《菠菜导航网》已于2004年7月23日经卫生部部务会议讨论通过，现予以发布，自发布之日起施行。

部长

November 17, 2004

Measures for the administration of health administrative licensing

Chapter general provisions

条 为规范卫生行政部门实施卫生行政许可，根据《十大菠菜靠谱老平台》(以下简称《十大菠菜靠谱老平台》)和有关卫生法律法规的规定，制定本办法。

第二条 卫生行政许可是卫生行政部门根据公民、法人或者其他组织的申请，按照卫生法律、法规、规章和卫生标准、规范进行审查，准予其从事与卫生管理有关的特定活动的行为。

Article 3 The implementation of the health administrative license shall follow the principles of openness, fairness, justice and convenience to the people, improve work efficiency and provide quality services。

Article 4 The health administrative license implemented by the health administrative departments at all levels shall have the following legal basis:

(1) laws and administrative regulations;

(2) Decisions of The State Council;

(3) local regulations;

(4) People's Regulations of provinces, autonomous regions and municipalities directly under the Central Government。

Health administrative departments at all levels may not set up health administrative license items on their own, and may not implement health administrative license without statutory basis。

Article 5 The administrative department for public health shall, in implementing the administrative license for public health, strictly abide by the authority and procedures prescribed by laws, rules and regulations。

The health administrative license provided by the laws, regulations and rules shall be implemented by the health administrative organ at a higher level，The health administrative organ at a lower level shall not carry it out;The health administrative license provided by the laws, regulations and rules shall be implemented by the health administrative organ at a lower level，The health administrative organ at a higher level shall not implement it，However, it is necessary to strengthen supervision over the implementation of the health administrative license by the health administrative organs at lower levels。法律、法规、规章未明确规定实施卫生行政许可的卫生行政部门级别的，或者授权省级卫生行政部门对此作出规定的，省级卫生行政部门应当作出具体规定。

第六条 卫生行政部门实施的卫生行政许可需要内设的多个机构办理的，应当确定一个机构统一受理卫生行政许可申请和发放行政许可决定。

第七条 公民、法人或者其他组织对卫生行政部门实施卫生行政许可享有陈述权、申辩权和依法要求听证的权利；有权依法申请行政复议或者提起行政诉讼；其合法权益因卫生行政部门违法实施卫生行政许可受到损害的，The right to claim compensation according to law。

Article 8 Any unit or individual shall have the right to report the act of illegally implementing the health administrative license, and the health administrative department shall verify and handle it in a timely manner。

Chapter II Application and acceptance

第九条 公民、法人或者其他组织申请卫生行政许可，应当按照法律、法规、规章规定的程序和要求向卫生行政部门提出申请。The form of the application shall be provided by the administrative department of health。The applicant may entrust an agent to file an application for health administrative license, and the agent shall provide a certificate of entrustment when handling the application for health administrative license。

Article 10 The health administrative department shall publicize the following contents related to the handling of health administrative licensing matters:

(1) matters, basis, conditions, procedures, time limit and quantity of the health administrative license;

(2) A list of all materials to be submitted;

(3) a model copy of the application form;

(4) the operation process, correspondence address, contact telephone number and supervision telephone number for handling the health administrative license。

有条件的卫生行政部门应当在相关网站上公布前款所列事项，方便申请人提出卫生行政许可，提高办事效率。

The administrative department of public health shall, at the request of the applicant, explain and explain the contents of the publicity。

第十一条 申请人申请卫生行政许可，应当如实向卫生行政部门提交有关材料，并对其申请材料的真实性负责，承担相应的法律责任。The administrative department for public health shall not require the applicant to submit technical data and other materials unrelated to the matters for which the administrative license for public health is applied。

第十二条 卫生行政部门接收卫生行政许可申请时，应当对申请事项是否需要许可、申请材料是否齐全等进行核对，并根据下列情况分别作出处理：

(1) If the application does not need to obtain the health administrative license according to law, the applicant shall be informed immediately that it is not accepted;

（二）申请事项依法不属于卫生行政部门职权范围的，应当即时作出不予受理的决定，并告知申请人向有关行政机关申请；

（三）申请材料存在可以当场更正的错误，应当允许申请人当场更正，但申请材料中涉及技术性的实质内容除外。The applicant shall confirm the correction in writing;

(4) The application materials are not complete or do not conform to the statutory form，The notice of correction of application materials shall be issued on the spot or within 5 days，Inform the applicant of all the required corrections at one time，Failure to notify within the time limit，The application shall be accepted from the date of receipt of the application materials;The supplementary application materials still do not meet the relevant requirements，The administrative department for public health may require further correction;

（五）申请材料齐全、符合法定形式，或者申请人按照要求提交全部补正申请材料的，卫生行政部门应当受理其卫生行政许可申请。

第十三条 卫生行政部门受理或者不予受理卫生行政许可申请的，应当出具加盖卫生行政部门专用印章和注明日期的文书。

第十四条 卫生行政许可申请受理后至卫生行政许可决定作出前，申请人书面要求撤回卫生行政许可申请的，可以撤回；撤回卫生行政许可申请的，卫生行政部门终止办理，并通知申请人。

Chapter III Review and decision

Article 15 After accepting the application, the administrative department for public health shall examine the application materials submitted by the applicant in a timely manner。The administrative department of public health shall, in accordance with the provisions of laws, rules and regulations, determine the way of examining application materials。

Article 16 The administrative department for public health shall examine the application materials，应当在受理申请之日起20日内作出卫生行政许可决定； 20日内不能作出卫生行政许可决定的，Approved by the head of the department of public health at the corresponding level，It can be extended by 10 days，The applicant shall be informed in writing of the reasons for the extension。Where laws or regulations provide otherwise for the period of administrative license for health, such provisions shall prevail。

第十七条 卫生行政部门依法需要对申请人进行现场审查的，应当及时指派两名以上工作人员进行现场审查，并根据现场审查结论在规定期限内作出卫生行政许可决定。

第十八条 卫生行政部门依法需要对申请行政许可事项进行检验、检测、检疫的，应当自受理申请之日起5日内指派两名以上工作人员按照技术标准、技术规范进行检验、检测、检疫，并书面告知检验、检测、检疫所需期限。If it is necessary to extend the period of inspection, testing or quarantine, the applicant shall be notified separately in writing。The time required for inspection, testing and quarantine shall not be counted within the period of the health administrative license。

第十九条 卫生行政部门依法需要根据鉴定、专家评审结论作出卫生行政许可决定的，应当书面告知申请人组织专家评审的所需期限。The health administrative department shall make a decision on whether to approve the health administrative license according to the expert evaluation conclusions。If it is necessary to extend the expert review period, the applicant shall be notified separately in writing。The time required for appraisal and expert review shall not be counted within the period of the health administrative license。

第二十条 卫生行政部门依法需要根据考试、考核结果作出卫生行政许可决定的，申请人在考试、考核合格成绩确定后，根据其考试、考核结果向卫生行政部门提出申请，卫生行政部门应当在规定期限内作出卫生行政许可决定。卫生行政部门根据考试成绩和其他法定条件作出卫生行政许可决定的，应当事先公布资格考试的报名条件、报考办法、考试科目以及考试大纲。However, no compulsory pre-examination training for qualification examinations shall be organized, and no teaching materials or other auxiliary materials shall be designated。

第二十一条 卫生行政部门依法需要根据检验、检测、检疫结果作出卫生行政许可决定的，检验、检测、检疫工作由依法认定的具有法定资格的技术服务机构承担。申请人依法可自主选择具备法定资格的检验、检测、检疫机构，卫生行政部门不得为申请人指定检验、检测、检疫机构。

第二十二条 依法应当逐级审批的卫生行政许可，下级卫生行政部门应当在法定期限内按规定程序和要求出具初审意见，并将初步审查意见和全部申报材料报送上级卫生行政部门审批。Where laws and regulations provide otherwise, such provisions shall prevail。In accordance with the statutory requirements, the higher administrative department of health shall not require the applicant to provide repeated application materials。

第二十三条 卫生行政部门作出不予卫生行政许可的书面决定的，应当说明理由，告知申请人享有依法申请行政复议或者提起行政诉讼的权利，并加盖卫生行政部门印章。

第二十四条 申请人的申请符合法定条件、标准的，卫生行政部门应当依法作出准予卫生行政许可的书面决定。Where it is necessary to issue a health administrative license according to law, a health administrative license affixed with the seal of the health administrative department shall be issued to the applicant。卫生行政许可证件应当按照规定载明证件名称、发证机关名称、持证人名称、行政许可事项名称、有效期、编号等内容，并加盖卫生行政部门印章，标明发证日期。

第二十五条 卫生行政部门作出的卫生行政许可决定，除涉及秘密、商业秘密或者个人隐私的外，应当予以公开，公众有权查阅。

第二十六条 卫生行政部门应当建立健全卫生行政许可档案管理制度，妥善保存有关申报材料和技术评价资料。

第二十七条 申请人依法取得的卫生行政许可，其适用范围没有地域限制的，在全国范围内有效，各级卫生行政部门不得采取备案、登记、注册等方式重复或者变相重复实施卫生行政许可。

第二十八条 同一公民、法人或者其他组织在同一地点的生产经营场所需要多项卫生行政许可，属于同一卫生行政部门实施行政许可的，卫生行政部门可以只发放一个卫生行政许可证件，其多个许可项目应当分别予以注明。

Chapter IV Hearing

第二十九条 法律、法规、规章规定实施卫生行政许可应当听证的事项，或者卫生行政部门认为需要听证的涉及重大公共利益的卫生行政许可事项，卫生行政部门应当在作出卫生行政许可决定前向社会公告，并举行听证。The hearing announcement shall specify the matters of the hearing, the time and place of the hearing, the requirements of the participants and the time and method of filing the application。

第三十条 卫生行政许可直接涉及申请人与他人之间重大利益关系，卫生行政部门应当在作出卫生行政许可决定前发出卫生行政许可听证告知书，告知申请人、利害关系人有要求听证的权利。

第三十一条 申请人、利害关系人要求听证的，应当自收到卫生行政部门卫生行政许可听证告知书后五日内提交申请听证的书面材料。Those who do not submit within the time limit shall be deemed to have waived the right to a hearing。

第三十二条 卫生行政部门应当在接到申请人、利害关系人申请听证的书面材料二十日内组织听证，并在举行听证的七日前，发出卫生行政许可听证通知书，将听证的事项、时间、地点通知申请人、利害关系人。

Article 33 Where an applicant or an interested party withdraws an application for a hearing before the hearing is held, permission shall be granted and the application shall be recorded。

第三十四条 申请人、利害关系人可以亲自参加听证，也可以委托代理人参加听证，代理人应当提供委托代理证明。

35th according to the provisions of the need for a hearing, by the health administrative department of the specific implementation of the administrative license agency responsible for organizing。The hearing shall be presided over by the legal institution of the administrative department of public health。The applicant and the interested party shall not bear the expenses of the hearing organized by the administrative department of health。

Article 36 Where the applicant and the interested party believe that the presiding officer of the hearing has a direct interest in the health administrative license, they have the right to apply for withdrawal。

Article 37 A hearing may be postponed under any of the following circumstances:

(1) The applicant or an interested party fails to show up for a justifiable reason;

(b) the applicant, the interested party proposed the withdrawal application reasons are established, need to re-determine the moderator;

(3) Other circumstances requiring extension。

第三十八条 举行听证时，卫生行政许可审查人提出许可审查意见，申请人、利害关系人进行陈述、申辩和质证。

39th hearing shall make a record, the record of the hearing shall contain the following matters:

(1) matters subject to public health administrative license;

(2) the name, age and identity of the participants in the hearing;

(3) the names of the presiding officer, the hearing officer and the clerk;

(4) the time, place and manner of holding the hearing;

(5) Opinions on the examination of the health administrative license issued by the examination person;

(6) The contents of the statement, defense and cross-examination of the applicant and the interested party。

The hearing host shall submit the hearing record to the applicant and interested parties on the spot after the hearing, and sign or seal it。If the applicant or the interested party refuses to sign, the presiding officer of the hearing shall explain the situation in the hearing record。

Article 40 After the conclusion of the hearing, the presiding officer of the hearing shall put forward written opinions according to the hearing。

Article 41 The time required for a hearing shall not be counted within the period of the health administrative license。

Chapter V Change and continuation

第四十二条 被许可人在卫生行政许可有效期满前要求变更卫生行政许可事项的，应当向作出卫生行政许可决定的卫生行政部门提出申请，并按照要求提供有关材料。The administrative department of public health shall examine the application for alteration made by the licensee in accordance with relevant provisions。对符合法定条件和要求的，卫生行政部门应当依法予以变更，并换发行政许可证件或者在原许可证件上予以注明；对不符合法定条件和要求的，卫生行政部门应当作出不予变更行政许可的书面决定，并说明理由。

Article 43 If it is not a case that can be changed according to laws, regulations and rules, it shall apply for a new health administrative license in accordance with the provisions。

第四十四条 被许可人依法需要延续卫生行政许可有效期的，应当在该卫生行政许可有效期届满30日前向作出卫生行政许可决定的卫生行政部门提出申请，并按照要求提供有关材料。However, where laws, regulations and rules provide otherwise, such provisions shall prevail。

Article 45 After receiving the application for renewal, the administrative department of health shall make a decision on acceptance or rejection in accordance with the relevant provisions of these measures。受理延续申请的，应当在该卫生行政许可有效期届满前作出是否准予延续的决定；逾期未作决定的，视为准予延续。Where the administrative department of public health makes a decision not to accept the application for extension or not to grant the extension, it shall inform the reasons in writing。

被许可人未按照规定申请延续和卫生行政部门不受理延续申请或者不准予延续的，卫生行政许可有效期届满后，原许可无效，由作出卫生行政许可决定的卫生行政部门注销并公布。

Article 46 The administrative license for health obtained according to law shall not be transferred, except for those that may be transferred according to legal conditions and procedures as provided by laws and regulations。

Chapter VI Supervision and inspection

第四十七条 卫生行政部门应当建立健全行政许可管理制度，对卫生行政许可行为和被许可人从事卫生行政许可事项的活动实施全面监督。

第四十八条 上级卫生行政部门应当加强对下级卫生行政部门实施的卫生行政许可的监督检查，发现下级卫生行政部门实施卫生行政许可违反规定的，应当责令下级卫生行政部门纠正或者直接予以纠正。

Article 49 Where the administrative department for public health finds that its staff members have implemented the administrative license for public health in violation of the provisions, it shall immediately make corrections。

卫生行政部门发现其他地方卫生行政部门违反规定实施卫生行政许可的，应当立即报告共同上级卫生行政部门。接到报告的卫生行政部门应当及时进行核实，对情况属实的，应当责令有关卫生行政部门立即纠正；必要时，上级卫生行政部门可以直接予以纠正。

第五十条 卫生行政部门应当加强对被许可人从事卫生行政许可事项活动情况的监督检查，并按照规定记录监督检查情况和处理结果，监督检查记录应当按照要求归档。

第五十一条 卫生行政部门依法对被许可人生产、经营、服务的场所和生产经营的产品以及使用的用品用具等进行实地检查、抽样检验、检测时，应当严格遵守卫生行政执法程序和有关规定。

第五十二条 卫生行政部门实施监督检查，不得妨碍被许可人正常生产经营和服务活动，不得索取或者收受被许可人的财物，不得谋取其它利益。The administrative department of health shall be responsible for the confidentiality of the relevant technical data and trade secrets provided by the licensee。

Article 53 The administrative department for public health shall promptly investigate and punish those who engage in activities of matters subject to public health administrative license in violation of the law。对涉及本辖区外的违法行为，应当通报有关卫生行政部门进行协查；接到通报的卫生行政部门应当及时组织协查；必要时，可以报告上级卫生行政部门组织协查；对于重大案件，由卫生部组织协查。The administrative department for public health shall inform the administrative department for public health of the facts of the illegal cases investigated and investigated and the result of handling them。

第五十四条 卫生行政部门应当设立举报、投诉电话，任何单位和个人发现违法从事卫生行政许可事项的活动，有权向卫生行政部门举报，卫生行政部门应当及时核实、处理。

Article 55 The administrative department for public health, when arranging the working funds, shall give priority to ensuring the funds required for the implementation of the administrative license for public health。

When implementing the administrative license for public health, the administrative department for public health shall not charge any fees, except as provided by laws and administrative regulations。

Article 56 After obtaining the health administrative license, the licensee shall engage in the corresponding activities in strict accordance with the conditions and requirements of the license。

卫生行政部门发现被许可人从事卫生行政许可事项的活动，不符合其申请许可时的条件和要求的，应当责令改正；逾期不改正的，应当依法收回或者吊销卫生行政许可。第五十七条有下列情况之一的，作出卫生行政许可决定的卫生行政部门或者上级卫生行政部门，可以撤销卫生行政许可：

（一）卫生行政部门工作人员滥用职权，玩忽职守，对不符合法定条件的申请人作出准予卫生行政许可决定的；

(2) exceeding statutory powers to make a decision on granting health administrative license;

(3) making a decision on granting health administrative license in violation of legal procedures;

(4) granting an administrative license for health to an applicant who is not qualified to apply or does not meet the statutory conditions;

(5) Other circumstances in which the decision on health administrative license can be revoked according to law。

Where the licensee obtains the health administrative license by cheating, bribery or other improper means, it shall be revoked。

If the revocation of the health administrative license may cause heavy losses to public interests, it shall not be revoked。If the health administrative license is revoked in accordance with the provisions of this article and the legitimate rights and interests of the licensee are damaged, the health administrative department shall make compensation according to law。Article 58 Under any of the following circumstances, the administrative department for public health shall handle the formalities for cancellation of the relevant administrative license for public health in accordance with law:

(1) the period of reexamination of the health administrative license has expired or the period of validity has not been renewed;

(2) An administrative license for public health that grants a citizen a specific qualification, and the citizen dies or becomes incapacitated;

(3) Legal person or other organization terminated according to law;

(4) the health administrative license is revoked or withdrawn according to law, or the health administrative license certificate is revoked according to law;

(5) matters subject to the health administrative license cannot be implemented due to force majeure;

(6) Other circumstances in which the health administrative license should be cancelled as provided for by laws and regulations。

第五十九条 各级卫生行政部门应当定期对其负责实施的卫生行政许可工作进行评价，听取公民、法人或者其他组织对卫生行政许可工作的意见和建议，并研究制定改进工作的措施。

Chapter VII Legal liability

第六十条 卫生行政部门及其工作人员违反本办法规定，有下列行为之一的，由上级卫生行政部门责令改正；拒不改正或者有其他情节严重的情形的，对直接负责的主管人员和其他直接责任人员依法给予行政处分：

(1) Refusing to accept an application for health administrative license that meets the statutory conditions;

(2) not publicizing the materials that should be publicized according to law at the place where the health administrative license is accepted;

(3) In the process of accepting, reviewing and deciding on the administrative license for health, failing to fulfill the obligation of statutory notification to the applicant and interested parties;

（四）申请人提交的申请材料不齐全、不符合法定形式，能够一次告知而未一次告知申请人必须补正的全部内容的；

(5) failing to explain to the applicant the reasons for refusal of acceptance or refusal of the health administrative license;

(6) failing to hold a hearing when a hearing should be held according to law。

第六十一条 卫生行政部门及其工作人员违反本办法规定，有下列行为之一的，由上级卫生行政部门责令改正，并对直接负责的主管人员和其他直接责任人员依法给予行政处分；涉嫌构成犯罪的，移交司法机关追究刑事责任：

(1) granting an administrative license for health to an applicant who does not meet the statutory conditions or making a decision on granting an administrative license for health beyond the statutory functions and powers;

(2) refusing the health administrative license to the applicant who meets the statutory conditions or not making a decision to grant the health administrative license within the statutory time limit;

(3) Soliciting or accepting property or seeking other benefits;

(4) Other illegal circumstances as provided for by laws and administrative regulations。

第六十二条 卫生行政部门不依法履行监督职责或者监督不力，造成严重后果的，由其上级卫生行政部门责令改正，并对直接负责的主管人员和其他责任人员依法给予行政处分；涉嫌构成犯罪的，移交司法机关追究刑事责任。第六十三条申请人提供虚假材料或者隐瞒真实情况的，卫生行政部门不予受理或者不予许可，并给予警告，申请人在一年内不得再次申请该许可事项。第六十四条被许可人以欺骗、贿赂等不正当手段取得卫生行政许可的，卫生行政部门应当依法给予行政处罚，申请人在三年内不得再次申请该卫生行政许可；涉嫌构成犯罪的，移交司法机关追究刑事责任。第六十五条被许可人有下列行为之一的，卫生行政部门应当依法给予行政处罚；涉嫌构成犯罪的，移交司法机关追究刑事责任：

(1) altering, reselling, renting, lending or illegally transferring the health administrative license by other means;

(2) engaging in activities beyond the scope of the health administrative license;

(3) providing false materials, concealing the true information of activities or refusing to provide true materials in the course of health supervision and inspection;

(4) Changes to items that should be applied for in accordance with law without approval;

(5) Other illegal acts as prescribed by laws, regulations and rules。

第六十六条 公民、法人或者其它组织未经卫生行政许可，擅自从事依法应当取得卫生行政许可的活动的，由卫生行政部门依法采取措施予以制止，并依法给予行政处罚；涉嫌构成犯罪的，移交司法机关追究刑事责任。

Chapter VIII Supplementary Provisions

Article 67 The time limit for the implementation of the health administrative license as provided for in these measures refers to working days, excluding legal holidays。Article 68 The samples of the health administrative licensing documents provided for in these measures are for reference and implementation by all localities。In addition to the samples of documents provided for in these measures, provincial health administrative departments may supplement corresponding documents according to work needs。Article 69 The administrative departments of public health may refer to these Measures for the implementation of non-administrative approval。

Article 70 These Measures shall come into force as of the date of promulgation。

附件：

Sample of Health administrative License Document (omitted)

1. Receipt of administrative license application materials

2. Notice of correction of application materials

Notice of acceptance of application for administrative license

Iv. Decision of administrative license application not accepted

5. Notice of extension of administrative licensing technology review

Notice of extension of administrative license decision

7. Decision of no administrative license

Viii. No change/extension of administrative license decision

9. Decision on revocation of administrative license