Application of Registration for Imported health food
Product Name in Chinese
Made by State Food and Drug Administration
Product Name | Chi. | ||||
Eng. | |||||
Applicant | Chi. | ||||
Eng. | |||||
imported foodAdd. of Applicant | |||||
Manufacturing Enterprise | Chi. | ||||
Eng. | |||||
Country (Region) | Add. | ||||
Application Organization within Territory | |||||
Add. Of Application Organization within Territory | |||||
Tel. | Zip code | ||||
Fax. | Contact | ||||
Health Function Applied | |||||
Guarantee of Applicant Applicant and domestic application agencies of the products should guarantee: contents and documents attached of the application form are real and legitimate. The data comes from studying and detecting the products. If inaccuracies, applicant and domestic reporting agencies of the products will undertake corresponding legal responsibility and all consequences. Applicant(Signature or seal) Legal Representative(Signature) Date: Domestic Application Institution(Signature or seal) Legal Representative(Signature) Date: | |||||
Attached Documents(Writ “√”in □ before each documents) □ 1. Application from of registration for imported health food □ 2. A copy version of evidence for the applicant of legal registration □ 3. The retrieving materials proofing that common name in Chinese of health food is different from other already approved drugs. □ 4. Guarantee of no infringement to other patent already obtained □ 5. A copy version of registration for trademark □ 6.Research and development (R & D) report □ 7. Product formulation(name and translation version in Chinese of raw materials and accessory) and evidence, source of raw materials and accessory and evidence for using □ 8. Efficacy composition/typical composition of contents and test methods □ 9. Diagram of manufacturing process, particular instruction(original text and Chinese translation) and related research materials □ 10. Standard and instruction for quality(Standard for enterprise, original text and Chinese translation)and standard for quality of raw materials and accessory □ 11.Type, name, quality standards and selecting evidence of package materials directly contacting products □ 12.Testing reports issued by inspection organization □ 13.Lable of product and specification sample □ 14.Documents of evidence that the company is corresponded with local quality management standards, issued by relevant agencies of producing country or region □ 15. If application entrusted, original text of power of attorney notarized and copy version of business license should be attached. Representative office of foreign company based in China to do registration, copy version of “Foreign Enterprise Resident Representative Office Registration Certificate” should be provided. □ 16. Documents of evidence for products manufacture and sold in the country or region more than one year. □ 17. Standards related to the products in producing country, region and international organization □ 18. Packaging, labeling and instruction of products coming into the market in producing country and region, and Chinese version □ 19.Other materials may useful for products reviewed □ 20.2 sample unopened of the minimum sales package | |||||
Others need explaining | |||||
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