Process:
I project name: filing of imported cosmetics for non-special purposes
Two. License content: the first import record of non-special purpose cosmetics.
3. The legal basis for setting and implementing the license: Regulations on Cosmetic Hygiene Supervision, Detailed Rules for the Implementation of the Regulations on Cosmetic Hygiene Supervision, Procedures for Hygienic Administrative Licensing of Health-related Products, Provisions on Accepting Applications for Cosmetic Administrative Licensing, and Points for Examining the Acceptance of Cosmetic Administrative Licensing.
4. Charge: No charge.
Verb (abbreviation of verb) quantity limit: There is no quantity limit in this license.
List of materials submitted by the intransitive verb applicant:
InformationNo. (1) Application Form for Administrative License of Imported Cosmetics for Non-Special Use.
Data number (II) Naming basis of Chinese names of products.
Data number (3) Product formula.
DataNo. (4) Product quality and safety control requirements.
Data number (5) Original packaging of the product (including product label and product description); If the package is designed for China market, the product design package (including product label and product description) shall be submitted at the same time.
DataNo. (6) Inspection report and relevant data issued by the licensing inspection institution recognized by China Food and Drug Administration; ?
DataNo. (7) Relevant safety assessment data of substances with possible safety risks in the product.
DataNo. (8) A copy of the power of attorney for reporting the domestic administrative licensing responsibility unit and a copy of the business license for reporting the domestic administrative licensing responsibility unit, and affix the official seal.
DataNo. (9) Commitment letter that the raw materials and sources of cosmetics meet the requirements of prohibiting and restricting the use of high-risk substances in mad cow disease epidemic areas.
DataNo. (10) documents certifying the production and sales of the product in the country (region) of production or the country (region) of origin; DataNo. (11) Other materials that are helpful for administrative licensing.
DataNo. (12) Brief description and sketch of the production process.
DataNo. (XIII) Text version and electronic version of product technical requirements.
Also attached are 1 market samples that have not been sealed by the licensing inspection agency.
Seven. Requirements for application materials:
(1) General requirements of application materials:
1. Submit 1 original application materials.
2. Except for inspection reports, notarized documents, official documents and third-party documents, the original application materials shall be stamped with the official seal or riding seal by the applicant page by page; The original application materials for imported cosmetics (new raw materials) should also be stamped with the official seal or riding seal of China administrative licensing responsibility unit page by page.
3. Print on A4 paper, use obvious distinguishing marks, arrange them in the specified order, and bind them into volumes.
4. Use Chinese legal units of measurement.
5, the declaration content should be complete and clear, the same project should be consistent.
6. All foreign languages (except overseas addresses, websites, registered trademarks, patent names, SPF, PFA or PA, UVA, UVB, etc.). If a foreign language is necessary, it shall be translated into standardized Chinese and attached to the corresponding foreign language materials.
7, after the termination of the declaration, it should also explain the reasons for the termination of the declaration and re declaration; If the applicant refuses the administrative license and declares again, it shall submit a copy of the decision on refusing the administrative license (change/extension), and explain the reasons for declaring again, and shall also submit a written explanation on whether the reasons for refusing the administrative license involve product safety.
8, the product formula should be submitted to the text version and electronic version.
9. The contents of the written version and the electronic version should be consistent.
10, production and sales documents, quality management system or good production practices documents, certificates that production enterprises from different countries belong to the same group company, and entrustment processing agreements can list multiple products at the same time. If these products are declared at the same time, one product uses the original, and other products can use copies, and the name of the declared product where the original is located shall be stated in writing; If these products are not declared at the same time, one product shall use the original, and the other products shall use notarized copies, and the name of the declared product where the original is located shall be stated in writing.
1 1. The electronic version of product technical requirements shall be filled in the online declaration system of cosmetics administrative license of China Food and Drug Administration.
(two) the specific requirements of the application materials:
1, and submit the information item by item.
2. Fill in the application form according to the requirements of the application form.
The letter of guarantee for the Application for Administrative License shall be signed by the legal representative of the imported cosmetics production enterprise or the imported cosmetics new raw material production enterprise or the signatory of its authorized production enterprise or the signatory of its authorized reporting responsibility unit in China; If there is no official seal, it shall be indicated at the signature of the guarantee production enterprise.
The undertaking of the Application for Administrative License shall be signed by the legal representative or its authorized signatory of the unit responsible for reporting administrative license in China, and stamped with the official seal of the unit responsible for reporting administrative license in China.
When signing the power of attorney, the notarized certificate of the power of attorney and its Chinese translation shall be provided, and the Chinese translation shall be notarized in accordance with the original contents. According to the requirements of Article 24 of the Information Requirements, every time an application for administrative license is submitted, the original or notarized copy of the power of attorney shall be submitted at the same time, and the name of the declared product at the place where the original power of attorney is signed shall be stated in writing. The power of attorney of the responsible unit of administrative license declaration in China should not include authorization and signature.
3. The product formula shall include the confirmation certificate of the imported product formula by the licensing inspection institution, and the confirmation date shall be consistent with the acceptance date of the inspection sample.
4. The product quality and safety control requirements should include the product quality and safety control requirements implemented by the country of origin (foreign language version and Chinese version) and the commitment that the product meets the requirements of cosmetic hygiene standards.
5. If there is no product manual or because of its small size (such as lipstick, lipstick, etc.), the instructions are printed on the product container. ), relevant instructions should be submitted in the product packaging part of the application materials.
6. The inspection report and relevant materials issued by the licensing inspection institution recognized by China Food and Drug Administration shall meet the following requirements:
(1) The inspection report issued by the licensing inspection institution shall include the following information:
1) inspection application form.
2) Check the acceptance notice.
3) Instructions for use of the product.
4) Health and safety inspection report (microbiology, hygiene chemistry, toxicology).
5) The following information shall be submitted:
①
Human safety inspection report (such as human test).
②
Test report of other new projects (such as asbestos test report in cosmetics, etc.). ).
(2) Where an application for changing the name, address and Chinese name of a manufacturer is made in the inspection report of cosmetic administrative license, the relevant licensing inspection agency shall issue a corresponding supplementary inspection report and explain the reasons.
7. Documents proving that products are produced and sold in the country (region) of production or the country (region) of origin shall meet the following requirements:
(1) Certificate issued by the competent department or trade association of the country (region) of production or country (region) of origin of the product. If the original certificate cannot be submitted, a copy can be submitted, which will be confirmed by the issuing agency or the embassy (consulate) of China.
(2) The name of the product, the name of the manufacturer, the name of the organization that issued the document, the seal of the organization or the signature of the legal representative (or its authorized person) and the date of issuance of the document shall be indicated.
(3) The declared product name and manufacturer name shall be completely consistent with the declared contents; In the case of entrusted processing or other production methods, if the production enterprise specified in the certification document is inconsistent with the declared content, the applicant shall issue a certification document to explain it; Multi-dose products that must be used together can only submit the production and sales documents of the imported part of the product.
(4) If the production and sales documents are in foreign languages, they shall be translated into standardized Chinese, and the Chinese translation shall be notarized by a Chinese notary office.
8. If the declared product belongs to the following circumstances, in addition to the above provisions, the following materials shall be submitted separately:
(1) The following materials shall be submitted if the products are declared as commissioned processing and production:
1)
The entrusted processing agreement signed by the entrusting party and the entrusted party.
2)
For imported products, the quality management system of the entrusted production enterprise or the certificate of good production practices or the certificate of cosmetics production qualification that meets the requirements of the laws and regulations of the country (region) where the production enterprise is located shall be submitted.
3)
For imported products commissioned by domestic production enterprises to be produced by overseas enterprises, the power of attorney, production and sales documents and the original packaging of the products for the responsible unit of administrative license in China may not be submitted, but the product packaging design shall be submitted.
4)
The quality management system of the entrusted production enterprise or the certification documents of good production practices or the certification documents of cosmetics production qualification that meet the requirements of the laws and regulations of the country (region) where the production enterprise is located shall meet the following requirements:
①
Issued or recognized by a certification body or a third party. If the original cannot be submitted, a copy can be submitted, which needs to be notarized by the Chinese notary office or confirmed by the embassy (consulate) in China.
②
The name and address of the designated production enterprise shall be completely consistent with the declaration.
(2) If the actual production enterprise and the cosmetics production enterprise (the applicant) belong to the same group company, the certification documents that the actual production enterprise and the cosmetics production enterprise (the applicant) belong to the same group company and the product quality assurance documents issued by the enterprise group company shall be submitted.
9. A number of actual production enterprises can declare the same product at the same time. In addition to submitting all the information according to the above provisions, the products produced by an actual production enterprise shall also submit the following information:
(1) If the relationship between entrusted production and processing is involved, an agreement on entrusted production and processing shall be submitted. For imported products, certificates of quality management system or good production practices of the entrusted production enterprise or certificates of cosmetics production qualification that meet the requirements of laws and regulations of the country (region) where the production enterprise is located shall also be submitted.
(2) If the production enterprises belong to the same group company, the certification documents that the production enterprises belong to the same group company and the product quality assurance documents issued by the enterprise group shall be submitted.
(three) the original packaging of products produced by other actual production enterprises.
(4) Hygienic (microorganism, hygienic chemistry) inspection reports of products of other actual production enterprises.
(5) A letter of commitment that the raw materials and sources of cosmetics used by other actual production enterprises meet the requirements of prohibiting and restricting the use of high-risk substances in mad cow disease epidemic areas.
10. Samples meeting the following packaging types shall be declared according to the following provisions:
(1) There are two or more independent small packages or separable samples (such as eye shadow, powder cake, blush, etc.). ) in a sample package and declared under a product name, and the product formula and inspection report shall be submitted separately; For samples that are not individually packaged or cannot be separated, inspection reports shall be submitted, and product formulas shall be submitted separately for each part.
(2) If the samples are packaged in an inseparable combination and declared under the product name, and the material state and raw material composition are different, the product formula and inspection report shall be submitted respectively.
(3) When two or more doses of products must be used at the same time, they should be declared as one product. According to the actual situation of whether a variety of dosage forms are mixed, the mixed inspection report or the inspection report of their respective dosage forms shall be submitted respectively.
(4) For two or more imported products declared by the same production enterprise with the same foreign names but different appearances, words indicating the appearance of the products should be added to the foreign names of the application forms and production and sales documents to show the difference, and relevant explanations should be attached.
1 1, multi-color series of non-special cosmetics can be declared as a group of products at the same time when the basic formula is the same and sampling is applied for toxicological inspection. Each product application should be accompanied by a list of series products, a list of basic formulas and colorants and a list of samples.
12. Imported samples commissioned by overseas enterprises for production and processing by domestic enterprises shall be submitted as domestic products.
Eight. Schematic diagram of bidding process:
Nine, licensing procedures:
(1) Acceptance:
The applicant shall apply to the administrative acceptance service center and submit the application materials according to the catalogue listed in Article 6 of this Notice. The staff of the administrative acceptance service center shall formally review the application materials in accordance with the Provisions on the Acceptance of Cosmetic Administrative License Applications and relevant formal review requirements. If the application does not need to obtain an administrative license according to law, it shall immediately inform the applicant that it will not be accepted; If the application matters do not fall within the scope of functions and powers of the administrative organ according to law, it shall immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative organ; If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be corrected on the spot or within 5 days. If the application materials are not informed within the time limit, it shall be accepted as of the date of receipt of the application materials; If the application matters fall within the scope of functions and powers of this administrative organ, the application materials are complete and conform to the statutory form, or the applicant submits all the supplementary materials according to the requirements of this administrative organ, it shall accept the application for administrative license.
(two) the administrative licensing decision:
China Food and Drug Administration shall complete the administrative review within 20 days from the date of receiving the conclusion of the technical review, and make a decision on whether to approve the administrative license according to law; If a decision cannot be made within 20 days, it may be extended by 10, and a Notice of Extension of Administrative License Decision shall be issued to inform the applicant of the reasons for the extension.
(3) Services:
China Food and Drug Administration shall issue and serve relevant administrative license certificates within 10 days from the date of making the decision on administrative license.
X. Time limit for commitment:
(1) Acceptance: The National Administrative Acceptance Service Center shall make a decision on whether to accept or not within 5 days after receiving the application materials.
(2) Administrative licensing decision: China Food and Drug Administration shall make an approval decision within 20 days; If a decision cannot be made within 20 days, it may be extended by 10, and a Notice of Extension of Administrative License Decision shall be issued to inform the applicant of the reasons for the extension.
(3) Delivery: China Food and Drug Administration shall issue and deliver relevant administrative license documents within 10 days from the date of making the decision on drug registration and approval.
XI。 Executing agency:
Implementing organ: China Food and Drug Administration.
Acceptance place: Administrative Acceptance Service Center of China Food and Drug Administration.
Twelve, the validity and extension of the license:
Cosmetic filing certificate is valid for four years.
Where an applicant applies for extending the validity period of the cosmetic filing certificate, it shall apply 4 months before the expiration of the validity period of the cosmetic filing certificate.
Thirteen. Annual inspection or license inspection: none.
Fourteen, accept the consultation and complaint institutions:
Consultation: China Food and Drug Administration.
Complaints: Resident Supervision Bureau and Legal Department of China Food and Drug Administration.
Note: The working period of this notice is calculated on working days, excluding legal holidays.
Applicant: It must be a foreign cosmetics enterprise or production enterprise. The applicant in China is a China company with independent legal personality, and the applicant in China may have nothing to do with the company's business.
The undertaking of the Application for Administrative License shall be signed by the legal representative or its authorized signatory of the unit responsible for reporting administrative license in China, and stamped with the official seal of the unit responsible for reporting administrative license in China.
Process:
I project name: filing of imported cosmetics for non-special purposes
Two. License content: the first import record of non-special purpose cosmetics.
3. The legal basis for setting and implementing the license: Regulations on Cosmetic Hygiene Supervision, Detailed Rules for the Implementation of the Regulations on Cosmetic Hygiene Supervision, Procedures for Hygienic Administrative Licensing of Health-related Products, Provisions on Accepting Applications for Cosmetic Administrative Licensing, and Points for Examining the Acceptance of Cosmetic Administrative Licensing.
4. Charge: No charge.
Verb (abbreviation of verb) quantity limit: There is no quantity limit in this license.
20 14 how to apply for filing of domestic non-special cosmetics-cosmetics-online service-filing of domestic non-special cosmetics.
Enterprise registration-submission of materials-pending audit-on-site audit
Do imported cosmetics need non-special cosmetics filing certificate? Yes, I know. At present, there are two ways to apply for the Record Certificate of Imported Cosmetics for Non-Special Use: First, the US Food and Drug Administration in China and Beijing applies for the record, and after obtaining the record, you can import the cosmetics you filed at ports all over the country. It takes 65,438+0-2 years to file an application, but at present it takes 4-6 months, but only if you find the right institution. Second, if your enterprise is registered in Pudong New Area, Shanghai, you can apply there directly, and the approval time is 1-3 months. However, products can only be imported through Pudong New Area. I hope the above contents are helpful to you. If you have any questions, please feel free to leave a message for consultation.
What are the applications for the declaration of domestic special-purpose cosmetics? (1) An application form for the hygiene administrative license of domestic cosmetics for special purposes;
(two) the provincial health supervision department (food and drug supervision department) issued by the production hygiene conditions audit opinion;
(three) to apply for hair care, bodybuilding and * * * products, the functional ingredients and the basis for use shall be submitted;
(4) enterprise standards;
(five) the inspection reports and related materials issued by the recognized cosmetics inspection institutions are arranged in the following order:
1, inspection application form;
2, check the acceptance notice;
3. Product description;
4, hygiene (microbial, physical and chemical) inspection report;
5, toxicology safety inspection report;
6, human safety test report.
(6) Where an application is made by an entrusted agent, an agency certificate shall be provided;
(seven) other information that may be helpful to the review.
65438+ 0 originals and 4 copies of the above information. Enclosed please find 1 unopened sample.
Who has imported cosmetics? Do you know how to classify special-purpose cosmetics and non-special-purpose cosmetics? Special-purpose cosmetics refer to a kind of cosmetics used to change the local state of human body, or promote human beauty, or eliminate the unfavorable factors of human beauty. This kind of cosmetics is characterized by semi-permanent decoration (such as perm) or treatment (such as freckle removal). Cosmetics for special use must be approved by the Ministry of Health, and can only be produced and sold after obtaining the approval number.
Cosmetics for special purposes include the following categories:
1. Hair care cosmetics: cosmetics that help hair growth and reduce hair loss and hair breakage;
2. Hair dyeing cosmetics: cosmetics with the function of changing hair color;
3. Perm cosmetics: cosmetics that can change the curvature of hair and keep it relatively stable;
4. Hair removal cosmetics: cosmetics that can reduce and eliminate body hair;
5.* * * cosmetics: cosmetics that help * * * keep fit;
6. Bodybuilding cosmetics: cosmetics that help to keep fit;
7. Deodorizing cosmetics: cosmetics used to eliminate body odor such as underarm odor;
8. Freckle-removing cosmetics: cosmetics used to reduce skin epidermal pigmentation;
9. Sunscreen cosmetics: cosmetics that can absorb ultraviolet rays and reduce the harm of sun exposure to the skin.
How to check the filing of domestic non-special cosmetics In order to strengthen the management of domestic non-special cosmetics, the State Food and Drug Administration of the United States organized and formulated the "Administrative Measures for the Filing of Domestic Non-special Cosmetics", which was recently promulgated and implemented. The Measures clarify the filing management of domestic non-special cosmetics, the requirements for designated inspection institutions, the selection of inspection institutions, the requirements for inspection institutions and inspection work, and the filing requirements for domestic non-special cosmetics that have been put on the market for the first time since 20 1 1.
What are the procedures for filing imported cosmetics for special purposes? Get ready first
Product samples that need to be filed. I want more.
A foreign authorization certificate must be notarized by a foreign notary office.
The sales record of this product abroad this year.
Product composition analysis table, the total should reach 100%.
Label sample, Chinese label
Business license. Want this product sales qualification.
It usually takes 3-6 months to file a case.
After filing, it will be cleared according to general trade import.
Regarding filing, we have a way to submit it once, instead of submitting it many times like other companies.
Is the filing of domestic non-special cosmetics effective? It is not an invalid problem, but a hard condition now. If your brand is not filed, there will be safety supervision, drug supervision or industry and commerce to check the filing of this product. If it is found that it is not filed, you know the consequences!
Do domestic non-special cosmetics have to be filed? The state implements a registration and supervision system for cosmetics, and all products that want to be listed normally need to be registered. Other questions can also be sent privately.