Accepted review of administrative license points cosmetics
First, the cosmetics executive received permission to review general requirements
(A) the first license application for special use cosmetics administrative claims data submitted by the original 1, four copies, with original copies should be clear and consistent.
(B) for the record, continuation, change, replacement of documents relating to submit original claims data 1.
(C) In addition to inspection reports, notary documents, official documents and third-party documents, the information submitted by the applicant by the original page with official seal or Jifeng Zhang.
(D) the use of A4 size paper to print, use the clear distinguishing mark, according to the provisions of the order, and bound into books.
(E) the use of Chinese legal units of measurement.
(Vi) to declare the content should be complete, clear, complete the same project should be consistent.
(7) All foreign language (foreign address, website, registered trademarks, patents, names, SPF, PFA, or PA, UVA, UVB and other foreign languages must be excluded) should be translated into standard Chinese and foreign language translation attached to the corresponding data before.
(H) Termination of declaration declared again, but also reporting and again declare the termination reason; not return again after the administrative licensing should not be submitted to the administrative licensing (change / extension) a copy of the written decision, and explain again declared reason.
(I) the replacement of cosmetics administrative permit this document (the record evidence) and not within the prescribed time limit continuation applications, cosmetics executive should receive a replacement permit this document (for the record certificate) within 15 days after the filing of a continuation application, but the reissue application should permit this document in the cosmetics executive (for the record certificate) before the expiration of four months.
(X) product formulations should be submitted text and electronic versions.
(K) with the text version of the electronic version of the complete content should be consistent.
(Xii) production and sales documents, the quality management system or proof of good manufacturing practice, manufacturers in different countries belong to the same group of companies that, processing agreements and other documents may also states that more than one product. These products, such as the same time declare a product to the original documents, copies of other products available, and to declare in writing where the original product name; these products, if not simultaneously declare a product to the original documents, and other products to be used after a copy of a notarized and to declare in writing where the original product name.
Second, the special use cosmetics made review of administrative license acceptance points
(A) made special use cosmetics review of the administrative licensing items of information received
1, made special use cosmetics administrative license shall submit the following information:
(1) special use cosmetics made administrative license application form;
(2) Product name name basis;
(3) product quality and safety control requirements;
(4) product design packaging (including product labels, product brochures);
(5) by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information;
(6) product safety may exist in the material of the security risk assessment information;
(7) The provincial food and drug administration issued an audit opinion on the production of sanitary conditions;
(8) Application of Hair, body, breast products, the effect of composition and its use should be submitted based on the scientific literature;
(9) may contribute to the administrative licensing and other information;
(10) the provincial food and drug administration sealed and unsealed samples one does not.
2, special use cosmetics made continuation of the administrative license shall submit the following information:
(1) cosmetics administrative license renewal application form;
(2) original documents of approval of administrative licensing cosmetics;
(3) product named basis (first report has been submitted and no change, except the product name);
(4) Product formulation;
(5) Product quality and safety control requirements;
(6) commercially available product packaging (including product labels, product instructions); If not listed, you can submit product design packaging (including product labels, product brochures);
(7) the applicant where the provincial food and drug administration issued on production, market, monitor submissions or product not listed on the audit opinion;
(8) may contribute to the administrative licensing and other information;
(9) unopened commercially available products 1.
3, special use cosmetics made changes to the administrative licensing shall submit the following information:
(1) cosmetic changes to the administrative licensing application form;
(2) original documents of approval of administrative licensing cosmetics;
(3) According to the application to change the content, shall be separately submitted the following information:
Product name change application shall be submitted to:
① Change the name of Chinese products, should be reasons to change the application form and submit the proposed name change of the Chinese name of the product based on the proposed changes to product design and packaging (including product labels, product brochures);
② Change application of sunscreen products SPF, PFA or PA values, should be submitted to the appropriate SPF, PFA or PA inspection reports to be designed to change the product packaging (including product labels, product instructions).
A production company name, address change (including self-change or merger and acquisition) shall be submitted to:
① local industrial and commercial administration department issued the original documents or notarized copies of manufacturer health permit;
② to adjust within the group of domestic enterprises, the industrial and commercial administration should submit the relevant documents issued by the department;
③ involving Taiwan, Hong Kong-invested enterprises or foreign-invested enterprises, can submit a notarized "PRC foreign investment enterprise approval certificate" or "Taiwan, Hong Kong People's Republic of overseas investment enterprise approval certificate," a copy;
④ involve changing the production site, the proposed changes should be submitted to the production company's hygiene products (microbial, chemical health) inspection report and the proposed changes to the production enterprises at the provincial level food and drug administration issued an audit opinion on the production of sanitary conditions.
Manufacturers to change the actual application should be submitted:
① commission involved the relationship between production and processing, production and processing agreement submitted to commission;
② manufacturers belong to the same group of companies, manufacturing enterprises are submitted to the same group of documents issued by the company and the enterprise group product quality assurance documentation;
③ the proposed change of the actual original manufacturer packaging products; proposed changes to the actual production of production of hygiene products (microbial, chemical health) inspection reports;
④ Change the actual manufacturer to be the provincial food and drug administration issued an audit opinion on the production of sanitary conditions.
Change the special use cosmetics categories, each category shall submit the appropriate information required.
Apply for other changes, should detail the reasons and submit the relevant documents.
4, made special use permit this document cosmetic replacement, should submit the following information:
(1) cosmetics administrative permit approval document (record certificate) replacement application form;
(2) the administrative license application for replacement of damaged documents of approval, approval documents shall be submitted to the administrative licensing original cosmetics;
(3) the administrative license apply for a replacement of lost documents of approval shall be submitted to the provincial level above (including provincial) newspaper published in the original statement of loss, loss reissue application should be lost in a statement published after the date of 20 timely.
(B) special purpose-made cosmetics the specific requirements of the administrative review of license accepted
1, one by one and submission of information;
2, the application form should be explanatory notes in accordance with the requirements of the application form fill out the application form;
3, product quality and safety control requirements should include the products meet the "Hygienic Standard for Cosmetics" requirements of the commitment;
4, because of their size too small (such as lipstick, lip balm, etc.) and no description of the contents of the product manual or printed on the container of the product, the product should be packaged in the dossier submitted to the relevant part of the instructions;
5, the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information:
(1) permits inspection agency issued the inspection report should include the following information:
① test application form;
② notice of acceptance testing;
③ Product description;
④ health and safety inspection reports (microbiological, chemical hygiene, toxicology);
⑤ If the following information should be submitted to:
a) human safety inspection report (skin patch, human trial);
b) SPF SPF, PFA or PA inspection reports;
c) Other new projects test report (such as cosmetics in the asbestos testing reports, etc.).
(2) outside the laboratory issued SPF (SPF, PFA or PA) inspection report, it shall submit the following information:
① report issued by the laboratory has been accredited laboratory, shall be submitted to qualification certificate;
② lab report has not been issued by accredited laboratories, the laboratory should be submitted strictly follow the "Good Clinical Practice" (Good Clinical Practice, GCP) or "good laboratory practice" (Good Laboratory Practice, GLP) proof ;
③ other qualified laboratory data help to explain.
Where for the first time outside the inspection reports submitted, shall submit the original or information issued by a laboratory report where the country (region) Industry Association, China to make (consulate), notary approved copy of the confirmation (with translation ), the State Food and Drug Administration approved, again, simply submit a copy of the declaration.
Outside the original laboratory report should be submitted, sampling products meet the requirements, submit at least one of the original product, other products may submit a copy of the declaration and description of where the original product name.
Use outside the laboratory test report issued by, the laboratory should be submitted simultaneously issued by the relevant inspection reports and test samples corresponding to the relationship between documents.
6, the provincial food and drug administration issued an audit opinion on the production of health conditions:
(1) cosmetics hygiene assessment of the application form;
(2) cosmetics sanitation audit form;
(3) product formulation;
(4) production process description and diagram;
(5) production equipment list;
(6) copies of health permits manufacturers.
7, to declare the product of the following circumstances, in addition to the above requirements to submit information, should also submit the following information separately:
(1) declaration of products produced by processing of the commission shall submit the following information:
① commissioning party and the commission signed by the commissioning party processing agreement;
② foreign manufacturers commissioned the production of domestic-made products in China should also declare the administrative licensing unit responsible for the record, submitted to the administrative licensing unit of power of attorney in China reporting responsibilities.
(2) the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies, should be submitted to the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies and business groups supporting documents issued by the company's product quality assurance documents .
8, a number of actual manufacturers producing the same product can also make a declaration, one of the actual manufacturer of these products should be provided all the information submitted, in addition, shall submit the following information:
(1) The commission involved the relationship between production and processing, production and processing agreement submitted to commission;
(2) producers of the same group of companies, manufacturing enterprises are submitted to the same group of companies and enterprise groups supporting documents issued by the product quality assurance documentation;
(3) product design packaging (including product labels, product brochures);
(4) other actual manufacturer of hygiene products (microbial, chemical health) inspection reports;
(5) other actual producers provincial food and drug administration issued an audit opinion on the production of sanitary conditions.
9, the following types of samples should be packaged to declare the following provisions:
(1) a sample package of more than two (including two) separate small package or can be separated samples (such as eye shadow, powder, blush, etc.), and to declare the name of a product, the product should be submitted separately and test recipes report; non-independent samples of the packaging or can not be separated, should submit a test report should be submitted separately each part of the product formulation;
(2) sample is not split packs, and to declare a product name, its physical state, composition of different raw materials, product formulations should be submitted separately, inspection reports;
(3) two or two or more must be used in conjunction with the product, a product should be declared. According to many formulations are mixed with the actual situation, to submit inspection reports or mixed formulations were submitted to their inspection reports.
10, No. multicolor series sunscreen cosmetics, when the same basic formula, and apply the sunscreen samples (SPF, PFA or PA) test, it can also make a declaration as a product. Each product dossier should be accompanied by a list of products, basic recipes and a list of colorants and sampling the product list.
Third, the import of special purpose cosmetics review of administrative license acceptance points
(A) special purpose imported cosmetics review of the administrative licensing items of information received
1, the first special use cosmetics import license administration shall include the following information:
(1) special use cosmetics imports administrative license application form;
(2) based on the product name Chinese name;
(3) product formulation;
(4) production process description and diagram;
(5) Product quality and safety control requirements;
(6) products of the original packaging (including product labels, product instructions); to be designed specifically for the Chinese market, packaging, product design and packaging to be submitted at the same time (including product labels, product brochures);
(7) by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information;
(8) products may be a security risk assessment material safety data;
(9) Application of Hair, body, breast products, the effect of composition and its use should be submitted based on the scientific literature;
(10) has been filed with the administrative licensing unit in China, power of attorney a copy of their reporting responsibilities and reporting responsibilities of the administrative licensing unit in China business license and official seal;
(11) cosmetic raw materials and raw materials in line with a high risk of BSE infected material requirements of the Restriction of the undertaking;
(12) products in the producing country (region) or country of origin (region) production and sales documents;
(13) may contribute to the administrative licensing and other information;
(14) permit inspection agency did not break the seal of the commercial seal-like sample 1.
2, imported cosmetics, special use permit continuation of the executive, should include the following information:
(1) cosmetics administrative license renewal application form;
(2) original documents of approval of administrative licensing cosmetics;
(3) The Chinese name of the product name basis (first report has been submitted and no change, except the product name);
(4) Product formulation;
(5) Product quality and safety control requirements;
(6) commercially available product packaging (including product labels, product brochures);
(7) has filed administrative licensing unit in China, power of attorney a copy of their reporting responsibilities, and reporting responsibilities of the administrative licensing unit in China business license and official seal;
(8) may contribute to the administrative licensing and other information;
(9) unopened commercially available products 1.
3, special use cosmetics imports of administrative licensing changes should include the following information:
(1) cosmetic changes to the administrative licensing application form;
(2) original documents of approval of administrative licensing cosmetics;
(3) has filed administrative licensing unit in China reporting responsibilities and powers of attorney a copy of business license and official seal;
(4) According to submit an application to change the contents of the following information:
Product name change application shall be submitted to:
① Change the name of Chinese products, should be reasons to change the application form and submit the proposed name change of the Chinese name of the product based on the proposed changes to product design and packaging (including product labels, product instructions); not change the name of foreign imports;
② Change application of sunscreen products SPF, PFA or PA, it shall submit the appropriate SPF, PFA or PA inspection reports, and submit proposed changes to the design of packaging products (including product labels, product instructions).
A production company name, address change (including self-change or merger and acquisition) shall be submitted to:
① Production Government departments or agencies issued the relevant certificates; for inter-firm acquisitions, mergers and the proposed legal changes to name of manufacturer, and may also be submitted to both merger and acquisition contract signed copies of documents to be translated into standard Chinese, the Chinese Chinese translation should be notarized notary public;
② involve changing the production site, the proposed changes should be submitted to the production company's hygiene products (microbial, chemical health) inspection reports.
Chinese name change application manufacturer (foreign name change), should be submitted:
① Chinese manufacturer to change the name of reason;
② packaging design of proposed changes (including product labels, product instructions).
Application for administrative license unit change in China's reporting responsibilities, should be submitted:
① proposed changes to the administrative licensing unit in China, power of attorney a copy of their reporting responsibilities;
② responsibility of the administrative licensing unit in China reporting the name or address change, should be submitted to the local industry and commerce administration department of the change issued by the original documents or notarized copies;
③ revocation issued by the original manufacturers in China and reporting responsibilities of administrative licensing unit of description and by notary public.
Manufacturers to change the actual application should be submitted:
① commission involved the relationship between production and processing, production and processing agreement to submit commission was entrusted to the production quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
② manufacturers belong to the same group of companies, manufacturing enterprises are submitted to the same group of documents issued by the company and the enterprise group product quality assurance documentation;
③ the proposed change of the actual original manufacturer packaging products;
④ Change the actual production to be production of hygiene products (micro-organisms, chemical health) inspection reports;
⑤ the actual production of products used in the production of raw materials and raw materials in line with the high risk of BSE infected material requirements of the Restriction Undertaking.
Change the special use cosmetics categories, each category shall submit the appropriate information required.
Apply for other changes, should detail the reasons and submit the relevant documents.
4, special use cosmetics import replacement administrative permit approval document should include the following information:
(1) cosmetics administrative permit approval document (record certificate) replacement application form;
(2) the administrative license application for replacement of damaged documents of approval, approval documents shall be submitted to the administrative licensing original cosmetics;
(3) the administrative license apply for a replacement of lost documents of approval shall be submitted to the provincial level above (including provincial) newspaper published in the original statement of loss, loss reissue application should be lost in a statement published after the date of the timely submission of 20;
(4) has filed administrative licensing unit in China, power of attorney a copy of their reporting responsibilities and reporting responsibilities of the administrative licensing unit in China business license and official seal.
(B) special use cosmetics imports accept review of the specific requirements of the administrative licensing
1, one by one and submission of information;
2, the application form should be explanatory notes in accordance with the requirements of the application form fill out the application form;
3, the product formula should include the license for the import inspection agency confirmation of product formulations, the samples confirm the date of the acceptance test should be the same date;
4, product quality and safety control requirements should be included in the implementation of country of origin of product quality and safety control requirements (foreign language version and the Chinese translation) and the product meets the "Hygienic Standard for Cosmetics" requirements of the commitment;
5, because of their size too small (such as lipstick, lip balm, etc.) and no description of the contents of the product manual or printed on the container of the product, the product should be packaged in the dossier submitted to the relevant part of the instructions;
6, by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related materials should meet the following requirements:
(1) permits inspection agency issued the inspection report should include the following information:
① test application form;
② notice of acceptance testing;
③ Product description;
④ health and safety inspection reports (microbiological, chemical hygiene, toxicology);
⑤ If the following information shall be submitted to:
a) human safety inspection report (skin patch, human trial);
b) SPF SPF, PFA or PA inspection reports;
c) Other new projects test report (such as cosmetics in the asbestos testing reports, etc.).
(2) outside the laboratory issued SPF (SPF, PFA or PA) inspection report, shall submit the following information:
① report issued by the laboratory has been accredited laboratory, shall be submitted to qualification certificate;
② lab report has not been issued by accredited laboratories, the laboratory should be submitted strictly follow the "Good Clinical Practice" (Good Clinical Practice, GCP) or "good laboratory practice" (Good Laboratory Practice, GLP) proof ;
③ other qualified laboratory data help to explain.
Where for the first time outside the inspection reports submitted, shall submit the original or information issued by a laboratory report where the country (region) Industry Association, China to make (consulate), notary approved copy of the confirmation (with translation ), the State Food and Drug Administration approved, again, simply submit a copy of the declaration.
Outside the original laboratory report should be submitted, sampling products meet the requirements, submit at least one of the original product, other products may submit a copy of the declaration and description of where the original product name.
Use outside the laboratory test report issued by, the laboratory should be submitted simultaneously issued by the relevant inspection reports and test samples corresponding to the relationship between documents.
7 products in the producing country (region) or country of origin (region) production and sales documents, shall meet the following requirements:
(1) by the producing country or country of origin (regional) government authorities or industry associations issued. Can not submit original documents, and may submit a copy of a copy shall be issued by the institution or country that (consulate) to confirm;
(2) shall contain the product name, manufacturer name, issued by the file name of the institution and an institution seal or the legal representative (or authorized) signature and document issuance date;
(3) set forth in the product name and manufacturer name should be exactly as declared; such as processed or otherwise produce, the documents set forth in the manufacturers declared to be inconsistent with the time, should be description of the applicant to be issued documents; be used in conjunction with the multi-dose products can be submitted only imports some of the production and sale of documents;
(4) production and sales documents such as a foreign language should be translated into standard Chinese, Chinese translation by Chinese notary public.
8, to declare the product of the following circumstances, in addition to the above requirements to submit information, should also submit the following information separately:
(1) declaration of products produced by processing of the commission shall submit the following information:
① commissioning party and the commission signed by the commissioning party processing agreement;
② imported products should be submitted to be commissioned by producers of quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
③ domestic producers outside the company commissioned the production of imported products in China may submit their reporting responsibilities on the administrative licensing unit of power of attorney, production and sale of original documents and product packaging, product packaging design should be submitted;
④ was commissioned manufacturer's quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents must meet the following requirements:
a) issued by the certification or approval, or third parties. Can not submit the original, may submit a copy of a copy notarized by a notary public or by the Chinese to make our country (consulate) to confirm;
b) set forth in the manufacturer name and address should be exactly as declared.
(2) the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies, should be submitted to the actual manufacturer and cosmetics manufacturer (applicant) belong to the same group of companies and business groups supporting documents issued by the company's product quality assurance documents .
9, a number of actual manufacturers producing the same product can also make a declaration, one of the actual manufacturer of these products should be provided all the information submitted, in addition, shall also submit the following information:
(1) The commission involved the relationship between production and processing, production and processing agreement submitted to commission, commissioned by imported products should also be submitted by the production quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
(2) producers of the same group of companies, manufacturing enterprises are submitted to the same group of companies and enterprise groups supporting documents issued by the product quality assurance documentation;
(3) the actual production of production of other products of the original packaging;
(4) other actual manufacturer of hygiene products (microbial, chemical health) inspection reports;
(5) other actual producers of raw materials and cosmetic raw materials used meet the high risk of BSE infected material requirements of the Restriction of the undertaking.
10, the following package types of samples should be declared according to the following provisions:
(1) a sample package of more than two (including two) separate small package or can be separated samples (such as eye shadow, powder, blush, etc.), and to declare the name of a product, the product should be submitted separately and test recipes report; non-independent samples of the packaging or can not be separated, should submit a test report should be submitted separately each part of the product formulation;
(2) sample is not split packs, and to declare a product name, its physical state, composition of different raw materials, product formulations should be submitted separately, inspection reports;
(3) two or two or more must be used in conjunction with the product, a product should be declared. According to many formulations are mixed with the actual situation, to submit inspection reports or mixed formulations were submitted to their inspection reports.
11, No. multicolor series sunscreen cosmetics, when the same basic formula, and apply the sunscreen samples (SPF, PFA or PA) test, it can also make a declaration as a product. Each product dossier should be accompanied by a list of products, basic recipes and a list of colorants and sampling the product list.
12, domestic production and processing enterprises overseas enterprises entrust the import samples, submit to trial by domestic product samples.
Fourth, imports of non-special use cosmetics review of administrative license acceptance points
(A) imports of non-special use cosmetics review of the administrative licensing items of information received
1, the first non-special use cosmetics import license administration shall include the following information:
(1) imports of non-special use cosmetics administrative license application form;
(2) based on the product name Chinese name;
(3) product formulation;
(4) Product quality and safety control requirements;
(5) product of the original packaging (including product labels, product instructions); to be designed specifically for the Chinese market, packaging, product design and packaging to be submitted at the same time (including product labels, product brochures);
(6) by the State Food and Drug Administration identified the license inspection agency issued the inspection report and related information;
(7) products may be security risks with the safety assessment of material information;
(8) has filed administrative licensing unit in China, power of attorney a copy of their reporting responsibilities and reporting responsibilities of the administrative licensing unit in China business license and official seal;
(9) cosmetics raw materials and raw materials used meet the high risk of BSE infected material requirements of the Restriction of the undertaking;
(10) products in the producing country (region) or country of origin (region) production and sales documents;
(11) may contribute to the administrative licensing and other information;
(12) permit inspection agency did not break the seal of the commercial seal-like sample 1.
2, imported non-special use cosmetics administrative license renewal shall include the following information:
(1) cosmetics administrative license renewal application form;
(2) cosmetics filing the original certificate;
(3) product named basis (first report has been submitted and no change, except the product name);
(4) Product formulation;
(5) Product quality and safety control requirements;
(6) commercially available product packaging (including product labels, product brochures);
(7) has filed administrative licensing unit in China, power of attorney a copy of their reporting responsibilities, and reporting responsibilities of the administrative licensing unit in China business license and official seal;
(8) may contribute to the administrative licensing and other information.
(9) unopened commercially available products 1.
3, imports of non-special use cosmetics to change the administrative license shall include the following information:
(1) cosmetic changes to the administrative licensing application form;
(2) cosmetics filing the original certificate;
(3) has filed administrative licensing unit in China reporting responsibilities and powers of attorney a copy of business license and official seal;
(4) According to submit an application to change the contents of the following information:
Product name change application shall be submitted to:
Change the Chinese name of the product should be reasons to change the application form and submit the proposed name change of the Chinese name of the product based on the proposed changes to product design and packaging (including product labels, product instructions); not change the name of foreign imported products.
A production company name, address change (including self-change or merger and acquisition) shall be submitted to:
① Production Government departments or agencies issued the relevant certificates; for inter-firm acquisitions, mergers and the proposed legal changes to name of manufacturer, and may also be submitted to both merger and acquisition contract signed copies of documents to be translated into standard Chinese, the Chinese Chinese translation should be notarized notary public;
② involve changing the production site, the proposed changes should be submitted to the production company's hygiene products (microbial, chemical health) inspection reports.
Chinese name change application manufacturer (foreign name change), should be submitted:
① Chinese manufacturer to change the name of reason;
② packaging design of proposed changes (including product labels, product instructions).
Application for administrative license unit change in China's reporting responsibilities, should be submitted:
① proposed changes to the administrative licensing unit in China, power of attorney a copy of their reporting responsibilities;
② responsibility of the administrative licensing unit in China reporting the name or address change, should be submitted to the local industry and commerce administration department of the change issued by the original documents or notarized copies;
③ revocation issued by the original manufacturers in China and reporting responsibilities of administrative licensing unit of description and by notary public.
Manufacturers to change the actual application should be submitted:
① commission involved the relationship between production and processing, production and processing agreement to submit commission was entrusted to the production quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
② manufacturers belong to the same group of companies, manufacturing enterprises are submitted to the same group of documents issued by the company and the enterprise group product quality assurance documentation;
③ the proposed change of the actual original manufacturer packaging products;
④ Change the actual production to be production of hygiene products (micro-organisms, chemical health) inspection reports;
⑤ the actual production of products used in the production of raw materials and raw materials in line with the high risk of BSE infected material requirements of the Restriction Undertaking.
Apply for other changes, should detail the reasons and submit the relevant documents.
4, record imports of non-special use cosmetics replacement certificate shall include the following information:
(1) cosmetics administrative permit approval document (record certificate) replacement application form;
(2) apply for a replacement for the broken record certificate, the certificate shall be submitted to the original cosmetics line for the record;
(3) apply for a replacement for filing the certificate is missing, more than should be submitted to the provincial level (including provincial) newspaper published in the original statement of loss, loss reissue application should be lost in a statement published after the date of the timely submission of 20;
(4) has filed administrative licensing unit in China, power of attorney a copy of their reporting responsibilities and reporting responsibilities of the administrative licensing unit in China business license and official seal.
(B) imports of non-special use cosmetics specific requirements of the administrative review of license accepted
1, one by one and submission of information;
2, the application form should be explanatory notes in accordance with the requirements of the application form fill out the application form;
3, the product formula should include the license for the import inspection agency confirmation of product formulations, the samples confirm the date of the acceptance test should be the same date;
4, product quality and safety control requirements should be included in the implementation of country of origin of product quality and safety control requirements (foreign language version and the Chinese translation) and the product meets the "Hygienic Standard for Cosmetics" requirements of the commitment;
5, because of their size too small (such as lipstick, lip balm, etc.) and no description of the contents of the product manual or printed on the container of the product, the product should be packaged in the dossier submitted to the relevant part of the instructions;
6, by the State Food and Drug Administration identified the license inspection agency issued the inspection report should include:
(1) test the application form;
(2) notice of acceptance tests;
(3) Product description;
(4) Health and Safety Inspection Report (micro-organisms, hygiene chemistry, toxicology);
(5) If the following information should be submitted to:
Other new projects test report (such as cosmetics in the asbestos testing reports, etc.).
7 products in the producing country (region) or country of origin (region) production and sales documents, shall meet the following requirements:
(1) by the producing country or country of origin (regional) government authorities or industry associations issued. Can not submit original documents, and may submit a copy of a copy shall be issued by the institution or country that (consulate) to confirm;
(2) shall contain the product name, manufacturer name, issued by the file name of the institution and an institution seal or the legal representative (or authorized) signature and document issuance date;
(3) set forth in the product name and manufacturer name should be exactly as declared; such as processed or otherwise produce, the documents set forth in the manufacturers declared to be inconsistent with the time, should be description of the applicant to be issued documents; be used in conjunction with the multi-dose products can be submitted only imports some of the production and sale of documents;
(4) production and sales documents such as a foreign language should be translated into standard Chinese, Chinese translation by Chinese notary public.
8, to declare the product of the following circumstances, in addition to the above requirements to submit information, should also submit the following information separately:
(1) declaration of products produced by processing of the commission shall submit the following information:
① commissioning party and the commission signed by the commissioning party processing agreement;
② imported products should be submitted to be commissioned by producers of quality management system or good manufacturing practice certificate or meet the manufacturer country (region) regulatory requirements for cosmetics production qualification documents;
According to many formulations are mixed with the actual situation, to submit inspection reports or mixed formulations were submitted to their inspection reports.
Beijing Tong Rui Union Technology Co., Ltd.
Tel: 0086-10-64284605 0086-10-84366465
Fax: 0086-10-84366465
E-mail: bj500@126.com bj2180@gmail.com