进口化妆品申报资料及要求英文版

1、进口化妆品申报资料及要求英文版（XXXX年新版）Applicati on dossiers for adm ini strative lice nsing of imported cosmetic required by SFDAPART ONE: Imported cosmetics classificati onThe imported cosmetics are divided into two major categories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for non

2、- particular purpose. The detailed descripti on about the classification is set forth in Appendix 3.PART TWO: Admi nistrative lice nsing of imported cosmetic for particular purposeAdmi nistrative lice nsing of imported cosmetic for particular purpose for the first time, the application dossiers shou

3、ld be provided as follows,(1) Applicati on form of admi nistrative lice nsing of imported cosmetic for particular purpose,(2) The reas on for n ame of the imported products in Chin ese,(3) Product formula,(4) Briefly descripti on and schematics about the manu facturi ng processes,(5) Requirements in

4、 quality control to ensure the safety of the product,(6) Original packagi ng of the product (in clud ing the direct ion and the lable). I n case of the product with a proprietary packag ing for market ing in China, the inten ded packag ing desig n (in clud ing the directi on and the lable) should be

5、 provided simulta neously.(7) The certificate of an alysis and releva nt dossiers issued by the in specti on age ncy which must be recog ni zed and accepted by SFDA, or the certificate of an alysis on SPF, PFA or PA value issued by abroad laboratory,(8) Safety evaluati on date on materials that mayb

6、e exist in the fini shed products which have the safety risk.(9) Applicati on for products used in nu rturi ng hair, bodybuild ing and breast, the effective con stitue nt and the refere nee literatures containing the scientific proofs should be provide,(10) The letter of authority for the applicant

7、in China (copy), which has bee n recorded by SFDA, and the bus in ess lice nee of the applica nt in China (copy with official seal),(11) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in

8、 using high risk materials from bovinespon giform en cephalopathy (BSE) disease areas,(12) The certificate of manu facturi ng and marketi ng from the country (regi on) which the products are manu factured or the country (regi on) of origin,(13) Additi onal dossiers which are con ducive for the adm i

9、ni strative lice nsing.1 un ope ned sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appe ndix 1.PART THREE: Admi nistrative lice nsing of imported cosmetic

10、 for non-particular purposeAdmi nistrative lice nsing of imported cosmetic for non-particular purpose for the first time, the application dossiers should be provided as follows,(1) Application form of administrative licensing of imported cosmetic for non-particular purpose,(2) The reas on for n ame

11、of the imported products in Chin ese,(3) Product formula,(4) Requireme nts in quality con trol to en sure the safety of the product,(5) Origi nal packag ing of the product (in clud ing the directi on and the lable). In case of the product with a proprietary packaging for marketing in China, the inte

12、n ded packag ing desig n (in cludi ng the direct ion and the lable) should be provided simulta neously.(6) The certificate of an alysis and releva nt dossiers issued by the in specti on age ncy which must be recog ni zed and accepted by SFDA,(7) Safety evaluati on date on materials that maybe exist

13、in the fini shed products which have the safety risk,(8) The letter of authority for the applicant in China (copy), which has bee n recorded by SFDA, and the bus in ess lice nee of the applica nt inChina (copy with official seal),(9) The letter of commitment that the raw material and the source of t

14、he raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovine spon giform en cephalopathy (BSE) disease areas,(10) The certificate of manufacturing and marketing from the country (regi on) which the products are manu factured

15、or the country (regi on) of origin,(13) Additi onal dossiers which are con ducive for the adm ini strative lice nsing.1 un ope ned sample product from the market which is sealed by the inspection agency with license should be provided simultaneously. The detailed description about the application do

16、ssiers are set forth in Appe ndix 2.PART FOUR: The process flow diagram of admi nistrativelice nsing of imported cosmeticThe copy of the letter of authority and bus in ess lice nee are recorded by SFDA Applicati on Cen terFill out a form from SFDA admi nistrativelice nsingsystem on lineFormal exam i

17、n ati on by SFDAApplicati on Cen ter, 5wdReviewed by CHFE, 60wdApproved by SFDA, 20wdPART FIVE: Charge(In case ofdisapprove, theapplicati onpdossiers are able tocosmetic by SFDAThere is no charge in administrative licensing of imbe recovered bypaper applicati on within 6 mon ths)Appe ndix 1The detai

18、led descripti on about the applicatio n dossiers foradmi nistrative lice nsing of imported cosmetic for particularpurpose1. The dossiers should be provided follow ing the list,2. Fill out the application form under the instruction of the form notices,Application form for administrative licensing sho

19、uld be filled out by the manu facturi ng en terprises of imported cosmetic, or the authorizer of the manu facturi ng en terprises, or the authorized age ncy for the administrative licensing in China. Indications should be written in the seal place of the letter of assura nee from manu facturi ng en

20、terprises in case of 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 sig ning in the power of attor ney, a

21、no tarized copy and Chin ese copy should be provided, the con siste nt of the Chin ese copy with the original one should be notarized simultaneously. According to the requireme nts in Article 24 of The Requireme nts Of The Applicati on Dossiers For Admi nistrative Lice nsing Of Cosmetic” (short for

22、TheRequireme nts Of The Dossiers), the orig inal of the power of attor ney and the no tarized copy should be provided while the applicati on, and a writte n expla nati on of the product'n ame in the origi nal of the power ofattorney. The content of the sig nature in the power of attorney should

23、not be contained by the content of the certificate of authorizati on from the applica nt in China.3. The product formula should contain the confirmation of the formula issued by the in specti on age ncy with lice nse, and the date of the confirmation should be consistent with the application date.4.

24、 Requireme nts in quality con trol should contain the requireme nts con ducted by the orig inal manu facturer (foreig n Ian guage and the Chin ese copy), and a letter of commitme nt declari ng the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product

25、direct ions or directi ons prin ted on the containers (such as lipstick and lip rouges at compact size), the releva ntexpla nati on should be made in the Packag ing Part.6. The certificate of an alysis and releva nt dossiers issued by thein specti on age ncy which must be recog ni zed and accepted b

26、y SFDA, or the certificate of an alysis on SPF, PFA or PA value issued by abroad laboratory should meet the requireme nts as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) Directi on of the product;4) Health & Safety testing report (microorganism, sani

27、tary chemistry and toxicology);5) The dossiers as follows should be provided in case of existi ng: Human safety testing report (skin patch test , human trials); SPF、PFA or PA value reports; Additional reports (such as Asbestos inspection report).(2) The applicati on dossiers containing SPF, PFA or P

28、A value reports issued by abroad laboratory, the additi onal dossiers as follows should be provided simulta neously: 1) In case of that the laboratory has bee n recog ni zed and accepted by SFDA, the authe nticati on certificate should be provided; 2) In case of no authentication certificate, GCP ce

29、rtificate or GLP certificate should be provided; 3) Additional dossiers which are con ducive for qualify ing.In case of that the reports issued by abroad laboratory are provided for the first time, the origi nal report, or the copy which is no tarized by the local embassy or releva nt associati ons

30、from the country (regi on) of manu facturer. The copy of the report would be allowed in the re-applicati on after hav ing bee n recog ni zed and accepted by SFDA.The orig inal report issued by abroad laboratory should be provided. The orig inal report of at least one product should be provided in ca

31、se of series products, the copy ones of other products are allowed, and the product n ame in the origi nal report should be poin ted.The certificate of the relati on ship betwee n the in spect ing sample and the report issued by the releva nt laboratory should be provided, while the report of abroad

32、 laboratory is provided in the application dossiers.In case of that the relati on ship betwee n the in spect ing sample and the report has been clearly stated in the report (such as the product name has bee n no ted in the report, and the n ame of the sample is con siste nt with the product n ame),

33、the certificate of above is n eedless.7. The certificate of manu facturi ng and marketi ng from the country (regi on) which the products are manu factured or the country (regi on) of orig in should meet the requireme nts as follows,(1) The certificate should be issued by the regulatory authorities o

34、r releva nt associati ons. 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 the regulatory authorities.(2) The certificate should contain the n ame of product, n ame of manu facturer, n ame of the regula

35、tory authority which issues the certificate, and the official seal or the sig nature of legal pers on (or authorizer) should be on the certificate.(3) The n ame of product and manu facturer should be con siste nt withthe applicati on dossiers. In case of con tract manu facturi ng or other ways and t

36、hat the n ame of manu facturer in certificate isn'c on siste nt with application dossiers, a written explanation from the applicant should be provided. The certificate of manu facturi ng and market ing for the imported part of the product which containing various forms should be provided.(4) The

37、 certificate of manu facturi ng and marketi ng should be tran slated into Chin ese in case of being foreig n Ian guages. And the Chin ese copy should be no tarized by no tary public in China.8. The product bel ongs to the follow ing situati ons, additi onal dossiers as follows should be provided sim

38、ulta neously:(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about con tract manu facturi ng betwee n the con sig nor and the con sig nee,2) For imported products, the certificate of QMS or GMP from thecon sig nee, or the approved certificate of cosmetic man

39、u facturi ng from the country (regi on) of manu facturer,3) The approved certificate of cosmetic manu facturi ng from the country (regi on) of manu facturer should meet the requireme nts as follows, The certificate should be issued by regulatory authority or third parties, The copy of the certificat

40、e is allowed in case of without the orig in al l one. The copy of the certificate should be no tarized by local embassy or no tary public. The name and address of the manufacture should be consistent with the applicati on dossiers.(2) In case of the manu facture (applica nt) and the actual manu fact

41、ure belong to a same company group, the certificate of the relationship and the quality assura nee docume nts issued by the compa ny group should be provided.9. In case of the product is manu factured by more tha n one en terprises, one of the manu facturers should provide the above applicati on dos

42、siers and additi onal dossiers as follows,(1) I n case of con tract manu facturi ng, the protocol about con tract manu facturi ng should be provided. For imported products, the certificate of QMS or GMP from the con sig nee or the approved certificate of cosmetic manu facturi ng from the country (re

43、gi on) of manu facturer should be provided.(2) In case of the manu facturers bel ong to a same compa ny group, the certificate of the relati on ship and the quality assura nee docume nts issued by the compa ny group should be provided.(3) The origi nal packag ing from other actual manu factures(4) H

44、ealth & Safety in spect ion report (microorga nism, san itary chemistry) from other actual manu factures(5) The letter of commitment that the raw material and the source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk material

45、s from bovinespon giform en cephalopathy (BSE) disease areas from other actual manu factures.10. In case of the product containing the forms of packagi ng as follows, the applicati ons should be made as the follow ing regulati ons,(1) One sample packag ing contains more tha n two (in clud ing two) i

46、n dividually packag ing, or separated samples (such as eye shadow, pressed powder, blush, etc.), and the application is made with one product n ame, the certificates of an alysis and formulas of each separated products should be provided. Sample without in dividually packagi ng and separated samples

47、, formulas of each parts and one certificate of an alysis should be provided.(2) The Sample with a collective packag ing which could not be split,varied raw materials & states of matter, the certificates of an alysis and formulas for each product should be provided respectively.(3) In case of th

48、e product which con tai n more tha n two (in cludi ng two) formulati ons, and must be used as a mixture, the applicati on should be made for one product. Accord ing to whether the product with multiple formulations is used as a mixture or separated ones, the certificates of analysis for the mixture

49、or each formulation should be provided.twoofwith(4) 1 n case of that the applicati on of imported products are made by the same manufacturing enterprises, which contain more than (in clud ing two) orig inal packagi ng with the same foreig n Ian guage n ame but differe nt appeara nces, the descripti

50、on of the appeara nces should be added to the foreign Ianguage name column of the certificate manufacturing & marketing and application form, while attached releva nt expla natio n.11. In case of that the sun scree n cosmetics with multiple series have asame basic formula, and make sampling insp

51、ection for testing SPF, PFA, PA value,the applicatio n is allowed to be made as one group ofproduct. The applicati on dossiers for each series should be attached with the name of each product in this series, basic formula, colorants list and sampli ng in specti on list.12. In case of that the import

52、ed products which are manufactured by the en terprise abroad with a con tract manu facturi ng from reside nt en terprise, the products are provide as homemade on es.Appe ndix 2The detailed descripti on about the applicatio n dossiers foradmi nistrative lice nsing of imported cosmetic for non-particu

53、larpurpose1. The dossiers should be provided follow ing 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 manu facturi ng en terprises of imported cosmetic, or the authorizer of the manu factu

54、ri ng en terprises, or the authorized age ncy for the administrative licensing in China. Indications should be written in the seal place of the letter of assura nee from manu facturi ng en terprises in case of no official seals.Letter of commitment in application form should be signed by the legal p

55、erson of the authorized agency for the administrative licensing in China, or the authorizer of the legal person, with official seal on the letter.When sig ning in the power of attor ney, a no tarized copy and Chin ese copy should be provided, the con siste nt of the Chin ese copy with the original o

56、ne should be notarized simultaneously. According to the requireme nts in Article 24 of The Requireme nts Of The Applicati on Dossiers For Admi nistrative Lice nsing Of Cosmetic” (short for TheRequireme nts Of The Dossiers), the orig inal of the power of attor ney and the no tarized copy should be pr

57、ovided while the applicati on, and a writte n expla nati on of the product'n ame in the origi nal of the power ofattorney. The content of the sig nature in the power of attorney should not be contained by the content of the certificate of authorizati on from the applica nt in China.3. The produc

58、t formula should contain the confirmation of the formula issued by the in specti on age ncy with lice nse, and the date of the confirmation should be consistent with the application date.4. Requireme nts in quality con trol should contain the requireme nts con ducted by the orig inal manu facturer (

59、foreig n Ian guage and the Chin ese copy), and a letter of commitme nt declari ng the products meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product direct ions or directi ons prin ted on the containers (such as lipstick and lip rouges at compact size), the releva ntexpla nati on should be made in the packag ing part.6. T