中新网9月18日电 据国家食药监局网站消息，国家食品药品监督管理局保化司发函说明，就《保健食品清理换证工作方案(征求意见稿)》公开征求意见。意见稿要求，对卫生部和国家局已批准注册未设立有效期的保健食品进行全面清理，设立有效期，统一保健食品批准文号格式，规范保健食品功能声称，提高产品质量安全控制水平。

Beijing on September 18, according to the national food, the administration's web site message,State food and drug supervision and administration department of the 3rd May change that,it[Health food cleaning renewal work plan(draft)]Public to solicit their opinions.The draft requirement,To the ministry of health and GuoGuJu has approved the validity of registration not set up the health food thorough cleaning,The validity of the established,Unified health food approval number format,Standard health food function says,To improve product quality and safety control level.

　　意见稿具体内容如下：

The draft specific content as follows:

　　

保健食品清理换证工作方案(征求意见稿) Health food cleaning renewal work plan(draft)

　　为贯彻落实《食品安全法》及其实施条例对保健食品实行严格监管的要求，做好保健食品综合治理，进一步规范保健食品注册管理，根据《保健食品注册管理办法(试行)》、国家食品药品监督管理局(下称国家局)决定开展保健食品清理换证工作，制定本方案。

In order to thoroughly implement the[Food safety]And its implementing regulations for health food to the strict supervision requirements,Do health food comprehensive treatment,Further standardize health food registration management,According to[For health food registration(trial)]/State food and drug administration(Hereinafter referred to as GuoGuJu)Decided to carry out health food cleaning renewal work,Formulate the scheme.

　　一、指导思想

a/Guiding ideology

　　严格保健食品监管，规范保健食品注册管理，净化保健食品市场，提升保健食品监管水平，保障人民群众保健食品食用安全。

Strict health food supervision,Standard health food registration management,Purification health food market,Improve health food supervision level,Protecting the people's health food safe to eat.

　　二、工作目标

two/Work target

　　对卫生部和国家局已批准注册未设立有效期的保健食品进行全面清理，设立有效期，统一保健食品批准文号格式，规范保健食品功能声称，提高产品质量安全控制水平。

To the ministry of health and GuoGuJu has approved the validity of registration not set up the health food thorough cleaning,The validity of the established,Unified health food approval number format,Standard health food function says,To improve product quality and safety control level.

　　三、工作步骤

three/Work steps

　　保健食品清理换证分阶段实施。2000年12月31日之前取得保健食品批准证书的，申请人应当在2014年6月30日前提出申请；2001年1月1日至2005年6月30日取得批准证书的，申请人应当在2014年7月1日至2015年7月1日前提出申请。

Health food cleaning replacement stages.On December 31, 2000 prior to the approval certificate of the health food,The applicant shall until 30 June 2014 to apply for;On January 1, 2001 to June 30, 2005 obtained the certificate of approval,The applicant shall in July 1, 2014 to July 1, 2015 apply.

　　(一)国产保健食品

(a)Domestic health food

　　1.申请人应当填写《国产保健食品换证申请表》，将换证申报资料原件1份、复印件8份报送所在地省(市、区)食品药品监督管理部门(下称省级局)。申请人为多家的，应当联合推荐一家单位作为申报单位，申报资料应报送推荐单位所在地省级局。

1. The applicant shall fill in[Domestic health care food renewal application form],Will certificate-change material 1 original/A copy of the seat eight provinces(city/area)The food and drug supervision and administration department(Hereinafter referred to as the provincial bureau).The applicant for the home,Recommend a unit shall be joint declaration as a unit,Declaration material shall be submitted to the provincial bureau recommended unit seat.

　　2.省级局应当在收到申报资料后的5日内对申报资料的规范性、完整性进行审查，符合要求的，予以受理。省级局在受理之后的45日内组织生产(试制)现场核查，提出审查意见，与申报资料一并报送国家局。

2. Provincial bureau shall, when receiving a declaration within 5 days after the data to declare the normative data/Examine the integrity,To meet the requirements of,Give accept.Provincial bureau accepts after 45 days after the production organization(development)Field verification,Review opinions put forward,With declare material submitted to the GuoGuJu.

　　3.国家局收到申报资料后，组织集中审查。符合要求的，予以换证，同时收缴原保健食品批准证书。不符合要求的，不予换证。

3. GuoGuJu received after filing materials,Organization focused review.To meet the requirements of,The renewal shall be,At the same time take over the original approval certificate of health food.Do not conform to the requirements,Will not be renewal.

　　4.申请人对不予换证的决定有异议的，可以按照相关规定书面说明理由，并在10日内向国家局提出复审。

4. The applicant does not accept the decision objectionable,Can be in accordance with the relevant provisions written explain the reason,And, within 10 days, put forward to GuoGuJu review.

　　(二)进口保健食品

(two)Imported health food

　　1.进口保健食品批准证书持有者应当委托中国境内代理机构进行申报，填写《进口保健食品换证申请表》，将换证申报资料原件1份、复印件8份报送国家局。

1. Imported health food approval certificate holder shall appoint a Chinese domestic agency for declaration,Fill in[Imported health food renewal application form],Will certificate-change material 1 original/A copy of the GuoGuJu 8.

　　2.国家局收到申报资料后，组织集中审查。对符合要求的，予以换证，同时收缴原保健食品批准证书。对不符合要求的，不予换证。

2. GuoGuJu received after filing materials,Organization focused review.To meet the requirements of,The renewal shall be,At the same time take over the original approval certificate of health food.To fail to meet the requirements,Will not be renewal.

　　3.申请人对不予换证的决定有异议的，可以按照相关规定书面说明理由，并在10日内向国家局提出复审。

3. The applicant does not accept the decision objectionable,Can be in accordance with the relevant provisions written explain the reason,And, within 10 days, put forward to GuoGuJu review.

　　(三)在换证审查工作中，申请人应当按照国家局的要求，在规定时间内提交有关补充资料。申请人名称、地址或中国境内代理机构发生改变的，应当首先按照有关规定申请变更备案。

(three)In the review of the work,The applicant shall, in accordance with the requirements of the GuoGuJu,Within the prescribed time submit relevant supplementary material.The applicant name/Address or China agency changed,In accordance with the relevant provisions shall first apply for alteration for the record.

　　四、资料要求

four/Material requirements

　　申请人应当按照保健食品注册相关要求提供以下申报资料：

The applicant shall, in accordance with the health food registration requirements provide the following declaration material:

　　(一)保健食品换证申请表；

(a)Health food renewal application form;

　　(二)保健食品批准证书及其附件的复印件；

(two)The approval certificate of health food and copy of attachment;

　　(三)申请人营业执照或其它机构合法登记证明文件复印件；

(three)The applicant business license or other institutions legal registration certificate copy;

　　(四)申请人对他人已取得的专利不构成侵权的保证书；

(four)The applicant to others already obtained patent not an infringement of the guarantee;

　　(五)商标注册证复印件(无注册商标的不需提供)；

(five)Copy of the trademark registration certificate(No of registered trade mark do not need to provide);

　　(六)产品配方及其用量；

(six)The product formula and its dosage;

　　(七)原料、辅料质量标准；

(seven)Raw materials/Complementary makings quality standard;

　　(八)功效成分/标志性成分、含量及检测方法；

(eight)Efficacy components/landmark composition/Content and test method;

　　(九)产品技术要求；

(nine)Technical requirements for products;

　　(十)生产工艺简图及详细说明；

(ten)Production process diagram and detailed instructions;

　　(十一)按照标准格式修改后的说明书样稿(文字版和电子版)；

(eleven)According to the standard format the revised manual sample(Text version and the version);

　　(十二)国产产品所在地省级保健食品生产监督管理部门出具的产品生产许可证明文件复印件(未生产的，应当按照保健食品注册的相关规定试制三批样品后由省级局现场核查并抽样送检)；

(twelve)Domestic product the local provincial health food production supervision and management departments of production license issued by the proof documents(Not production,Health food registration shall, in accordance with the relevant provisions of the trial-manufacture three batch of samples by provincial bureau after the on-site inspection and sampling inspection);

　　(十三)近五年产品销售情况和消费者的反馈情况的总结；

(13)Nearly five years product sales and consumer feedback summary;

　　(十四)保健食品最小销售包装、标签和说明书实样；五年内未生产的，应当提供最小销售包装、标签和说明书样稿；

(fourteen)Health food minimum sales package/Labels and specifications sample;Five years not production,Should provide a minimum sales package/Labels and specifications sample;

　　(十五)多个申请人联合申报的，应当提交联合申报负责人推荐书；

(15)Many applicants joint declaration,The joint declaration shall be submitted recommendation;

　　(十六)产品申报时功能、安全与现行规定不一致的，应当补充提供符合现行规定的试验报告等相关材料。

(16)Product declaration by function/Safety and the current provisions inconsistent,Should be added to the current regulation test report and other related materials.

　　以上申报资料不能完整提供的，申请人应当在提出申请时书面说明理由。

Above declaration material can't complete the offer,The applicant shall, when filing the application in a written explanation.

　　进口保健食品还应该提供以下资料：

Imported health food should also provide the following information:

　　(一)由境外厂商常驻中国代表机构办理再注册事务的，应当提供《外国企业常驻中国代表机构登记证》复印件，境外生产厂商委托境内代理机构负责办理再注册事项的，需提供经过公证的委托书原件以及受委托的代理机构营业执照复印件；

(a)Overseas manufacturers by the resident representative of China institutions to the affairs of the registration,Shall provide[The representative offices of foreign enterprises permanent registration certificate]copy,Overseas manufacturers entrust domestic agencies shall be responsible for registration again,Must provide a notarized power of attorney of the original and the entrusted agency a photocopy of its business license;

　　(二)产品生产国(或地区)有关机构出具的该产品生产企业符合当地相应生产企业质量管理规范以及允许该产品生产销售的证明文件，该证明文件必须经所在国家(地区)公证机关公证和驻所在地中国使领馆确认。

(two)The product producer(Or region)Issued by the relevant authorities of the product production enterprise in accordance with local corresponding production enterprise quality management standard and allow the product sales documents,This document must be approved by the state(area)Notarial organs and is located in the Chinese embassy and consulate there confirmed.

　　五、不予换证的情形

five/Not the case

　　(一)未在规定时间内提出换证申请的；

(a)Not in the specified time the renewal application is put forward;

　　(二)原料、辅料、产品存在食用安全问题的；

(two)Raw materials/accessories/Existing products edible security;

　　(三)配方或原料、辅料不符合现行规定的；

(three)Formula or raw materials/Materials does not conform to the provisions of the present;

　　(四)生产工艺不符合现行规定的；

(four)The production process does not conform to the provisions of the present;

　　(五)保健功能不在现行功能范围内的(功能名称调整的除外)；

(five)Health care function is not within the scope of the current function(Function name except adjustment);

　　(六)其他不符合现行规定的。

(six)Other does not conform to the provisions of the present.

　　六、其他要求

six/Other requirements

　　保健食品清理换证工作政策性强，涉及面广，时间紧，任务重，既关系到人民群众健康安全，又关系到企业利益和保健食品产业发展。各级各部门要高度重视，加强组织领导，组织相关培训，落实好这项工作。

Health food cleaning renewal work policy is strong,Covers a wide range,Time tight,task,Not only is related to people's health and safety,And related to the enterprise benefit and health food industry development.Various departments at all levels should attach great importance to,To strengthen the organization and leadership,Organization related training,Implement the work well.

　　(一)国家局各有关部门要加强指导协调、经费保障和人员培训，完善审评审批数据库和信息查询系统。要委派专人负责清理换证工作咨询，开通咨询电话、电子邮箱、网站专栏等，及时解答相关问题。要根据换证工作进度，及时更新数据库产品批准或注销信息，分期分批上网公告。

(a)GuoGuJu all relevant departments should strengthen the guidance and coordination/Funds safeguard and personnel training,Perfect evaluation for examination and approval database and information query system.To appoint person will be responsible for clearing up the renewal work consultation,Opened consultation telephone/E-mail/Website column, etc,Timely solve related problems.The renewal work according to the schedule,Update database product approval or cancellation of the information,By instalments announced online.

　　(二)各省级局要把工作落实到人，严格按照规定程序、时限、要求等进行资料审查。各省级局之间要加强协调配合。对换证工作中遇到的问题，要及时报告国家局。

(two)The provincial bureau to put the work carries out to the people,In strict accordance with the prescribed procedures/Time limit/Requirements of material review.Between each provincial bureau to strengthen coordination.To the problems encountered in the work,To timely report GuoGuJu.

　　(三)申请人在规定时间内提出产品换证申请并受理的，凭受理通知书，其原批准证书继续有效。已受理产品变更申请和技术转让产品注册申请的，申请人应当在该许可事项办结后30日内提出换证申请。

(three)The applicant within the prescribed time proposed the renewal product application and accepted,By the acceptance notice,The original approval certificate shall continue to be valid.Already accepted product application for change and technology transfer product registration application,The applicant shall in the licensing items completed within 30 days after the application is put forward.

　　(四)申请人在取得新的批准证书后，应当在6个月内严格按照新的批准证书内容组织生产，此前使用原标签、说明书生产的产品允许销售至保质期结束。

(four)The applicant has the approval certificate in new after,Ought to be in 6 months in strict accordance with the new content of the approval certificate of production organization,After using the original label/Manual production products allow sales to the expiry.

　　(五)对不予换证或未在规定时间内提出换证申请的，申请人应当自国家局公告之日起停止产品生产，现有产品允许销售至保质期结束。

(five)Not to the renewal or not in the specified time the renewal application is put forward,The applicant shall GuoGuJu since the date of publication of the stop production,Existing products allow sales to the expiry.

　　(六)自换证通知下发之日起，停止受理无有效期保健食品的技术转让和变更申请(变更备案除外)。

(six)Since the date of the notice issued,Stop accept no valid health food technology transfer and application for change(Change except for the record).