進(jìn)口化妝品申報(bào)資料及要求 英文版(XXXX年新版)

1、Application dossiers for administrative licensing ofimported cosmetic required by SFDAPART ONE: Imported cosmetics classificationTheimported cosmetics are divided into two majorcategories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for non- particular purpose. The detail

2、ed description about the classificationis set forth in Appendix 3.PART TWO: Administrative licensing of imported cosmetic for particular purpose Administrative licensing of imported cosmetic for particular purpose for the first time, the application dossiers should be provided as follows, (1) Applic

3、ation form of administrative licensing of imported cosmetic for particular purpose, (2) The reason for name of the imported products in Chinese, (3) Product formula, (4) Briefly description and schematicsabout the manufacturing processes, (5) Requirements in quality control to ensure the safety of t

4、he product, (6) Original packaging of the product(including the HYPERLINK app:ds:direction direction and the lable). In case of the product withaproprietary packaging for HYPERLINK app:ds:marketing marketingin China, the intended packagingdesign (including the HYPERLINK app:ds:direction direction an

5、d the lable) should be provided simultaneously.(7) The certificate of analysisand relevant dossiersissued by the inspection agencywhich must be recognized and accepted by SFDA, or the certificate of analysison SPF, PFA or PA valueissued byabroad laboratory,(8) Safety evaluation date on materials tha

6、t maybe exist in the finished products which have the safety risk.(9) Application for products used in nurturing hair, bodybuilding and breast, the effective constituent and the reference literatures containing the scientific proofsshould be provide,(10) The letter of authority for the applicant in

7、China(copy), which has been recorded by SFDA, and the business licence of the applicant in China(copy with official seal),(11)The letter of commitmentthat the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high

8、risk materials frombovine spongiform encephalopathy (BSE) disease areas,(12) The certificate of manufacturing and marketing from the country (region) which the products are manufactured or the country(region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 u

9、nopened sample product from the market which is sealed by the inspection agencywith license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 1.PART THREE: Administrative licensing of imported cosmetic fornon-particular purposeAdmini

10、strative licensing of imported cosmetic fornon-particular purpose for the first time, the application dossiers should be provided as follows, (1) Application form of administrative licensing of imported cosmetic fornon-particular purpose,(2) The reason for name of the imported products in Chinese,(3

11、) Product formula,(4) Requirements in quality control to ensure the safety of the product,(5) Original packaging of the product (including the HYPERLINK app:ds:direction direction and the lable). In case of the product withaproprietary packaging for HYPERLINK app:ds:marketing marketing in China, the

12、 intended packaging design (including the HYPERLINK app:ds:direction direction and the lable) should be provided simultaneously.(6) The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA,(7) Safety evaluation date on materials

13、that maybe exist in the finished products which have the safety risk,(8) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of the applicant in China (copy with official seal),(9)The letter of commitment that the raw material and the

14、source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials frombovine spongiform encephalopathy (BSE) disease areas,(10) The certificate of manufacturing and marketing from the country (region) which the products are manufac

15、tured or the country (region) of origin,(13) Additional dossiers which are conducive for the administrative licensing.1 unopened sample product from the market which is sealed by the inspection agency with licenseshould be provided simultaneously. The detailed description about the application dossi

16、ers are set forth in Appendix 2.The copy of the letter of authority and business licence are recorded by SFDA Application CenterPART FOUR: The process HYPERLINK app:ds:flow flow HYPERLINK app:ds:diagram diagram of administrative licensing of imported coThe copy of the letter of authority and busines

17、s licence are recorded by SFDA Application CenterFill out a formFill out a form from SFDA administrative licensing system on lineFormal examinationFormal examination by SFDA Application Center, 5wdReviewed by CHFE, 60wdReviewed by CHFE, 60wd（In case of （In case of disapprove, the application dossier

18、s are able to be recovered by paper application within 6 months）ApprovApproved by SFDA, 20wdPART FIVE: ChargeThere is no charge in administrative licensing of imported cosmetic by SFDAAppendix 1The detailed description about the application dossiers foradministrative licensing of imported cosmetic f

19、or particular purpose1. The dossiers should be provided following the list,2. Fill out the application form under the instruction of the form notices,Application form for administrative licensing should be filled out by the manufacturing enterprises of imported cosmetic, or the authorizer of the man

20、ufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should bewritten in the seal place of the letter of assurance from manufacturing enterprises in case of no official seals.Letter of commitment in application form should be signed by the legal per

21、son of the authorized agency for the administrative licensing in China,or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, anotarized copyand Chinese copy should be provided, the consistent of the Chinese copy with the original one should be

22、 notarizedsimultaneously. According to the requirements in Article 24 of “The RequirementsOf The Application Dossiers ForAdministrative LicensingOf Cosmetic”(short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the applica

23、tion, and a written explanation of the products name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the HYPERLINK app:ds:authorization%EF%BC%9Bcertificate%20of%20authorization certificate of authorization from

24、 the applicant in China.3.The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the application date.4.Requirements in quality control should contain the requirements conducted by th

25、e original manufacturer (foreign language and the Chinese copy), and a HYPERLINK app:ds:letter letter HYPERLINK app:ds:of of HYPERLINK app:ds:commitment commitment declaring the products meet the requirements in Hygienic Standard for Cosmetics.5.In case of no product HYPERLINK app:ds:direction direc

26、tions or HYPERLINK app:ds:direction directions printed on the containers(such as lipstick and lip rouges at compact size), the relevant explanation should be made in the Packaging Part.6. The certificate of analysis and relevant dossiers issued by the inspection agency which must be recognized and a

27、ccepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued byabroad laboratory should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Direction of the product;4) Health & Safety testing report (microorganism, san

28、itary chemistry and toxicology);5) The dossiers as follows should be provided in case ofexisting:Human safety testing report (skin patch test , human trials);SPF、PFA or PA value reports;Additional reports (such as Asbestos inspection report).(2) The application dossiers containing SPF, PFA or PA val

29、uereports issued byabroad laboratory, the additional dossiers as follows should be provided simultaneously: 1) In case of that the laboratory has been recognized and accepted by SFDA, the authentication certificateshould be provided; 2) In case of no authentication certificate, GCP certificate or GL

30、P certificate should be provided; 3) Additional dossiers which are conducive forqualifying.In case of that the reports issued byabroad laboratory are provided for the first time, the original report, or the copy which is notarized by the local embassy or relevant associations from the country (regio

31、n) of manufacturer.The copy of the report would be allowed in the re-application afterhaving been recognized and accepted by SFDA.The original report issued by abroad laboratory should be provided. The original report of at least one product should be provided in case of series products, the copy on

32、es of other products are allowed, and the product name in the original report should be pointed.The certificate of the relationship between the inspecting sample and the report issued by the relevant laboratory should be provided, while the report of abroad laboratory is provided in the application

33、dossiers.In case of that the relationship betweenthe inspecting sample and the report has been clearly stated in the report (such as the product name has been noted in the report, and the name of the sample is consistent with the product name), the certificate of above is needless.7.The certificate

34、of manufacturing and marketing from the country (region) which the products are manufactured or the country (region) of origin should meet the requirements as follows, (1) The certificate should be issued by the regulatory authorities or relevant associations.The copy of the certificate is allowed i

35、n case of without the original l one. The copy of the certificate should be notarized by local embassy or the regulatory authorities. (2) The certificate should contain the name of product, name of manufacturer, name of the regulatory authority which issues the certificate, and the official seal or

36、the signature of legal person (or authorizer) should be on the certificate. (3) The name of product and manufacturer should be consistent with the application dossiers. In case of contractmanufacturing or other ways and that the name of manufacturer in certificate isnt consistent with application do

37、ssiers, a written explanation from the applicant should be provided. The certificate of manufacturing and marketing for the imported part of the product which containing various forms should be provided. (4) The certificate of manufacturing and marketing should be translated into Chinese in case of

38、being foreign languages. And the Chinese copy should be notarized by notary public in China.8. The product belongs to the following situations, additional dossiers as follows should be provided simultaneously:(1) In case of contractmanufacturing, additional dossiers are as follows,1) The protocol ab

39、out contractmanufacturing between the consignor and the consignee,2) For imported products, thecertificate of QMS or GMP from the consignee, or the approvedcertificate of cosmetic manufacturing from the country (region) of manufacturer,3)The approvedcertificate of cosmetic manufacturing from the cou

40、ntry (region) of manufacturer should meet the requirements as follows,The certificate should be issued by regulatory authority or third parties, The copy of the certificate is allowed in case of without the original l one. The copy of the certificate should be notarized by local embassy or notary pu

41、blic. The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actualmanufacture belong to a same company group, the certificate of the relationship and the quality assurancedocuments issued by the company group sho

42、uld be provided.9.In case of the product is manufactured by more than one enterprises, one of the manufacturers should provide the above application dossiers and additional dossiers as follows, (1)In case of contract manufacturing, the protocol about contractmanufacturing should be provided. For imp

43、orted products, the certificate of QMS or GMP from the consigneeor the approvedcertificate of cosmetic manufacturing from the country (region) of manufacturer should be provided. (2) In case of the manufacturers belong to a same company group, the certificate of the relationship and the quality assu

44、rancedocuments issued by the company group should be provided. (3) The original packaging from other actualmanufactures (4) Health & Safety inspection report (microorganism, sanitary chemistry) from other actualmanufactures (5)The letter of commitment that the raw material and the source of the raw

45、material in production should meet the requirements of the restrictions or prohibitions in using high risk materials frombovine spongiform encephalopathy (BSE) disease areas from other actualmanufactures.10.In case of the product containing the forms of packaging as follows, the applications should

46、be made as the following regulations, (1) One sample packaging contains more than two (including two) individually packaging, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product name, the certificates of analysis and formulasof each se

47、parated products should be provided. Sample without individually packaging and separated samples, formulasof each parts and onecertificate of analysis should be provided. (2) The Samplewith a collective packaging which could not be split, the application is made with one product name, and the sample

48、 has variedraw materials & states of matter, the certificates of analysis and formulasfor each product should be provided respectively. (3) In case of the product which contain more than two(including two) formulations, and must be used as a mixture, the application should be made for one product. A

49、ccording to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture or each formulation should be provided.(4)In case of that the application of imported products are made by the same manufacturing enterprises, which contain

50、more than two (including two) original packaging with the same foreign language name but different appearances, the description of the appearances should be added tothe foreign languagenamecolumn of the certificate of manufacturing & marketing and application form, while attached withrelevant explan

51、ation.11.In case of that the sunscreen cosmetics with multiple series have a same basic formula, and make sampling inspection for testing SPF, PFA, PA value, the application is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of ea

52、ch product in this series, basic formula, colorants list and sampling inspection list.12.In case of that the imported products which are manufactured by the enterprise abroadwith a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 2The detailed descr

53、iption about the application dossiers foradministrative licensing of imported cosmetic fornon-particular purpose1. The dossiers should be provided following the list,2. Fill out the application form under the instruction of the form notices,Application form for administrative licensing should be fil

54、led out by the manufacturing enterprises of imported cosmetic, or the authorizer of the manufacturing enterprises, or the authorized agency for the administrative licensing in China. Indications should be written in the seal place of the letter of assurance from manufacturing enterprises in case of

55、no official seals. Letter of commitment in application form should be signed by the legal person of the authorized agency for the administrative licensing in China,or the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copyand Chine

56、se copy should be provided, the consistent of the Chinese copy with the original one should be notarizedsimultaneously. According to the requirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative LicensingOf Cosmetic”(short for The Requirements Of The Dossiers), t

57、he original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the products name in the original of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the HYPERLINK

58、 app:ds:authorization%EF%BC%9Bcertificate%20of%20authorization certificate of authorization from the applicant in China.3.The product formula should contain the confirmation of the formula issued by the inspection agency with license, and the date of the confirmation should be consistent with the ap

59、plication date.4.Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a HYPERLINK app:ds:letter letter HYPERLINK app:ds:of of HYPERLINK app:ds:commitment commitment declaring the products meet the requirem

60、ents in Hygienic Standard for Cosmetics.5.In case of no product HYPERLINK app:ds:direction directions or HYPERLINK app:ds:direction directions printed on the containers (such as lipstick and lip rouges at compact size), the relevant explanation should be made in the packaging part.6. The certificate