Service Phone:020-87687760
Registration dossier of Dietary Supplement 保健食品注册所需资料
2016-12-16author:利伟保健

保健食品注册所需资料

Documents required for registration of Dietary Supplement


第九条 生产和进口下列产品应当申请保健食品注册:

(一)使用保健食品原料目录以外原料(以下简称目录外原料)的保健食品;

(二)首次进口的保健食品(属于补充维生素、矿物质等营养物质的保健食品除外)。

首次进口的保健食品,是指非同一国家、同一企业、同一配方申请中国境内上市销售的保健食品。

Article 9  Products should apply for health food registration:

1) Its raw materials are not listed on the Health Food Raw Material List;

2) First time imported Health Food (Except vitamins, minerals).

First time imported Health Food is the health food sold in the China market but come from different countries, different companies and use different formulations.

 

第十条 产品声称的保健功能应当已经列入保健食品功能目录。

Article 10  The health function claims of the product should have been included in Health Food Function List. 

 

保健品注册所需材料如下:

Documents required for registration of Dietary Supplement are as below:

 

第十一条 国产保健食品注册申请人应当是在中国境内登记的法人或者其他组织;进口保健食品注册申请人应当是上市保健食品的境外生产厂商。

申请进口保健食品注册的,应当由其常驻中国代表机构或者由其委托中国境内的代理机构办理。
  境外生产厂商,是指产品符合所在国(地区)上市要求的法人或者其他组织。

Article 11  The applicant of domestic health food registration should be legal person or other corporation registered in China; the applicant of imported health food should be a foreign manufacturer of health food, which are sold in that foreign market.

The entity that applies for the registration of imported health food should be its representative office in China or authorized agency in China.

Foreign manufacturer is the legal person or other organization and its product conform to their local legal requirements.

 

第十二条 申请保健食品注册应当提交下列材料:
  (一)保健食品注册申请表,以及申请人对申请材料真实性负责的法律责任承诺书;
Article 12  Apply for health food registration should submit the application materials as below:

1) Application Form and the letter of commitment;

(二)注册申请人主体登记证明文件复印件;
  2) The copy of business license of the applicant;

(三)产品研发报告,包括研发人、研发时间、研制过程、中试规模以上的验证数据,目录外原料及产品安全性、保健功能、质量可控性的论证报告和相关科学依据,以及根据研发结果综合确定的产品技术要求等;

3) Research and Development report of the product, which include researchers, time, research process, validation data of the test above pilot scale, raw materials not listed on the health food raw materials list, verification report and related scientific evidences of product safety, health function, quality controllability, product technical requirements base on research results and other information.

(四)产品配方材料,包括原料和辅料的名称及用量、生产工艺、质量标准,必要时还应当按照规定提供原料使用依据、使用部位的说明、检验合格证明、品种鉴定报告等; 

4) Formula of the product, which include name, dosage, manufacturing technology, quality standard of raw materials and auxiliary materials. Basis of use of raw materials, explanation of the used part, inspection qualify certificate, variety analysis report and other information may be needed when necessary;
  (五)产品生产工艺材料,包括生产工艺流程简图及说明,关键工艺控制点及说明; 

5) Manufacturing process of the product, which include diagram and description of production process, instructions of key process control points;
  (六)安全性和保健功能评价材料,包括目录外原料及产品的安全性、保健功能试验评价材料,人群食用评价材料;功效成分或者标志性成分、卫生学、稳定性、菌种鉴定、菌种毒力等试验报告,以及涉及兴奋剂、违禁药物成分等检测报告; 

6) Product safety and health function evaluation information, which include safety, health function evaluation and population tasty quality evaluation of raw materials not list on the health food raw materials list and the product; test report of functional component, hygiene, stability, species identification and species toxicology; test report refer to stimulant and illegal drugs;
  (七)直接接触保健食品的包装材料种类、名称、相关标准等;

7) Type, name and related standards of the Package materials that directly touch the product;
  (八)产品标签、说明书样稿;产品名称中的通用名与注册的药品名称不重名的检索材料;

8) Sample of Label and instruction book; retrieval materials show that the general name of the product is not in duplicate of registered drugs;
  (九)3个最小销售包装样品;

9) Three sample sales packages;

十)其他与产品注册审评相关的材料。

10) Other related information.

 

第十三条 申请首次进口保健食品注册,除提交本办法第十二条规定的材料外,还应当提交下列材料:
Article 13  For the first time imported health food registration, except all the information mentioned in article 12, supplementary materials have to be submitted as below:

(一)产品生产国(地区)政府主管部门或者法律服务机构出具的注册申请人为上市保健食品境外生产厂商的资质证明文件;
  1) Business License of the applicant issued by its local governmental or legal officials;

(二)产品生产国(地区)政府主管部门或者法律服务机构出具的保健食品上市销售一年以上的证明文件,或者产品境外销售以及人群食用情况的安全性报告;

2) The certificate issued by its local governmental or legal officials to show that the product has been produced and sold at least one year there; Or its oversea sales report and the safety report of population consumption condition;

(三)产品生产国(地区)或者国际组织与保健食品相关的技术法规或者标准;

3) Health Food Technology regulation or standard of its manufacturer country or international organization;
  (四)产品在生产国(地区)上市的包装、标签、说明书实样。
  由境外注册申请人常驻中国代表机构办理注册事务的,应当提交《外国企业常驻中国代表机构登记证》及其复印件;境外注册申请人委托境内的代理机构办理注册事项的,应当提交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。

4) Sample of product package, label, instruction book in its manufacturer country.

If the representative office in China conducts the registration, they have to submit ‘The Foreign Company Resident Representative China office Registration Certificate’ and its copy. If the authorized agency does the registration, they have to submit the verified authorization letter and a copy of their business license.

 

《保健食品注册与备案管理办法》Provisions for the Registration and Filling of Health Food.docx


Next:Provisions for the Registration and Filling of Health Food
Previous:Documents required for Filing of Dietary Suppleme 保健食品备案所需资料