进口化妆品申报资料及要求-英文版(2011年新版)

1、Application dossiers for administrative licensing of imported cosmetic required by SFDAPART 1: : Imported cosmetics classificationThe imported cosmetics are divided into two major categories by SFDA: imported cosmetic for particular purpose, and imported cosmetic for nonparticular purpose. The detai

2、led description about the classification is set forth in Appendix 3.PART 2: : Administrative licensing of imported cosmetic forparticular purposeAdministrative licensing of imported cosmetic for particular purpose for the first time, the application dossiers should be provided as follows,(1) Applica

3、tion 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 schematics about the manufacturing processes,(5) Requirements in quality control to ensure the safety of the p

4、roduct,(6) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(7) The certificate of analysis an

5、d relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory,(8) Safety evaluation date on materials that maybe exist in the finished products which have the safety risk.(9) Appli

6、cation for products used in nurturing hair, bodybuilding and breast, the effective constituent and the reference literatures containing the scientific proofs should be provide,(10) The letter of authority for the applicant in China (copy), which has been recorded by SFDA, and the business licence of

7、 the applicant 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 using high risk materials from bovine spongiform encephalopathy (BSE) disease are

8、as,(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 unopened sample product from the market which is sealed by the inspec

9、tion agency with license should be provided simultaneously. The detailed description about the application dossiers are set forth in Appendix 1.PART 3: EE: Administrative licensing of imported cosmetic fornon-particular purposeAdministrative licensing of imported cosmetic for non-particular purpose

10、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 reason for name of the imported products in Chinese,(3) Product formula,(4) Requirements in quality control to ensure th

11、e safety of the product,(5) Original packaging of the product (including the direction and the lable). In case of the product with a proprietary packaging for marketing in China, the intended packaging design (including the direction and the lable) should be provided simultaneously.(6) The certifica

12、te of analysis and relevant dossiers issued by the inspection agency which must be recognized and accepted by SFDA,(7) Safety evaluation date on materials 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 bee

13、n 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 source of the raw material in production should meet the requirements of the restrictions or prohibitions in using high risk materials from bovi

14、ne spongiform encephalopathy (BSE) disease areas,(10) 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.(14) unopened sample prod

15、uct 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 Appendix 2.PART 4: R: The process flow diagram of administrativelicensing of imported cosmeticThe copy of the letter o

16、f authority and business licence are recorded by SFDA Application CenterFill out a form from SFDA administrative licensing system on lineFormal examination by SFDAApplication Center, 5wdReviewed by CHFE, 60wdApproved by SFDA, 20wd(In case of disapprove, the application dossiers are able to be recove

17、red by paper application within 6 months )PART 5: E: ChargeThere is no charge in administrative licensing of imported cosmetic bySFDAAppendix 1The detailed description about the application dossiers foradministrative licensing of imported cosmetic for particularpurpose1. The dossiers should be provi

18、ded 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 manufacturing enterprises, or the authorized agency fo

19、r the administrative licensing in China. Indications should be written 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 person of the authorized agency for the administrativ

20、e 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 copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the req

21、uirements in Article 24 of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic ” (short for The Requirements Of The Dossiers), the original of the power of attorney and the notarized copy should be provided while the application, and a written explanation of the pr

22、oducts name in theoriginal of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the certificate of authorization from the applicant in China.3. The product formula should contain the confirmation of the formula issued by the inspec

23、tion 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 the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the produc

24、ts meet the requirements in "Hygienic Standard for Cosmetics".5. In case of no product directions or 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 rele

25、vant dossiers issued by the inspection agency which must be recognized and accepted by SFDA, or the certificate of analysis on SPF, PFA or PA value issued by abroad laboratory should meet the requirements as follows,1) Application form for inspection;2) Notification of acceptance for inspection;3) D

26、irection of the product;4) Health & Safety testing report (microorganism, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of existing: Human safety testing report (skin patch test , human trials); SPF、 PFA or PA value reports; Additional reports (such as

27、Asbestos inspection report).(2) The application dossiers containing SPF, PFA or PA value reports issued by abroad 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 certifica

28、te should be provided; 2) In case of no authentication certificate, GCP certificate or GLP certificate should be provided; 3) Additional dossiers which are conducive for qualifying.In case of that the reports issued by abroad laboratory are provided for the first time, the original report, or the co

29、py which is notarized by the local embassy or relevant associations from the country (region) of manufacturer.The copy of the report would be allowed in the re-application after having been recognized and accepted by SFDA.The original report issued by abroad laboratory should be provided. The origin

30、al report of at least one product should be provided in case of series products, the copy ones 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 laborato

31、ry should be provided, while the report of abroad laboratory is provided in the application dossiers.In case of that the relationship between the 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

32、is consistent with the product name), the certificate of above is needless.7. The certificate 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

33、 the regulatory authorities or relevant associations. 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 name of product, name of manufactu

34、rer, name of the regulatory authority which issues the certificate, and the official seal or 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 contract manufacturing or ot

35、her ways and that the name of manufacturer in certificate isnt consistent with applicationdossiers, 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) T

36、he certificate of manufacturing and marketing should be translated into Chinese in case of 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:

37、(1) In case of contract manufacturing, additional dossiers are as follows,1) The protocol about contract manufacturing between the consignor and the consignee,2) For imported products, the certificate of QMS or GMP from the consignee, or the approved certificate of cosmetic manufacturing from the co

38、untry (region) of manufacturer ,3) The approved certificate of cosmetic manufacturing from the country (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 withou

39、t the original l one. The copy of the certificate should be notarized by local embassy or notary public. The name and address of the manufacture should be consistent with the application dossiers.(2) In case of the manufacture (applicant) and the actual manufacture belong to a same company group, th

40、e certificate of the relationship and the quality assurance documents issued by the company group should 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

41、 case of contract manufacturing, the protocol about contract manufacturing should be provided. For imported products, the certificate of QMS or GMP from the consignee or the approved certificate of cosmetic manufacturing from the country (region) of manufacturer should be provided.(2) In case of the

42、 manufacturers belong to a same company group, the certificate of the relationship and the quality assurance documents issued by the company group should be provided.(3) The original packaging from other actual manufactures(4) Health & Safety inspection report (microorganism, sanitary chemistry)

43、 from other actual manufactures(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 materials from bovine spongiform encephalopathy (BSE) disease areas from other actual

44、 manufactures.10. In case of the product containing the forms of packaging as follows, the applications should 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,

45、 etc.), and the application is made with one product name, the certificates of analysis and formulas of each separated products should be provided. Sample without individually packaging and separated samples, formulas of each parts and one certificate of analysis should be provided.(2) The Sample wi

46、th a collective packaging which could not be split, the application is made with one product name, and the sample has varied raw materials & states of matter, the certificates of analysis and formulas for each product should be provided respectively.(3) In case of the product which contain more

47、than two (including two) formulations, and must be used as a mixture, the application should be made for one product. According 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 provide

48、d.(4)In case of that the application of imported products are made by the same manufacturing enterprises, which contain more than two (including two) original packaging with the same foreign language name but different appearances, the description of the appearances should be added to the foreign la

49、nguage name column of the certificate of manufacturing & marketing and application form, while attached with relevant explanation.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 applicati

50、on is allowed to be made as one group of product. The application dossiers for each series should be attached with the name of each 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 ab

51、road with a contract manufacturing from resident enterprise, the products are provide as homemade ones.Appendix 2The detailed description about the application dossiers for administrative licensing of imported cosmetic for non-particular purpose1. The dossiers should be provided following the list,2

52、. 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 manufacturing enterprises, or the authorized agency for the administrative lic

53、ensing in China. Indications should be written 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 person of the authorized agency for the administrative licensing in China, or

54、 the authorizer of the legal person, with official seal on the letter.When signing in the power of attorney, a notarized copy and Chinese copy should be provided, the consistent of the Chinese copy with the original one should be notarized simultaneously. According to the requirements in Article 24

55、of “The Requirements Of The Application Dossiers For Administrative Licensing Of Cosmetic ” (short for The Requirements Of The Dossiers), the 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 theorigin

56、al of the power of attorney. The content of the signature in the power of attorney should not be contained by the content of the 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

57、, and the date of the confirmation should be consistent with the application date.4. Requirements in quality control should contain the requirements conducted by the original manufacturer (foreign language and the Chinese copy), and a letter of commitment declaring the products meet the requirements

58、 in "Hygienic Standard for Cosmetics".5. In case of no product directions or 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

59、the inspection agency which must be recognized and accepted by SFDA 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, sanitary chemistry and toxicology);5) The dossiers as follows should be provided in case of exist