Cosmetics license management approach
Chapter I General Provisions
The first permit to regulate the cosmetic work to protect consumers' health and safety, according to the "PRC Administrative Licensing Law" (hereinafter referred to as the Administrative Licensing Law), "Cosmetics Health Supervision" and the relevant laws and regulations, development of this approach.
The second application for special use in the PRC license cosmetics, cosmetics, new materials licenses and non-special use cosmetics for the record, applies to this approach.
Article according to the State Food and Drug Administration is responsible for licensing special purpose cosmetics, cosmetics, new materials licenses and imports of non-special use cosmetics review. To simplify the import of non-special use cosmetics licensing procedures for imported non-special use cosmetics to implement record management.
Provinces, autonomous regions and municipalities Food and Drug Administration (hereinafter referred to as the provincial food and drug supervision and management departments) shall be responsible for domestic non-special use cosmetics for the record.
Article IV permits shall follow the implementation of cosmetic science, openness, fairness, justice and principle of convenience.
Article applicant shall, in accordance with relevant state laws and regulations, standard specifications, permit application of cosmetics, the disclosure of information as to its permission to declare the safety of cosmetics and its claims of efficacy responsible for and bear the corresponding legal responsibility.
Article 6 All units and individuals for violation of the act, right to the State Food and Drug Administration or the provincial food and drug supervision and management departments to report, the State Food and Drug Administration or the provincial food and drug supervision and administration department shall verify, treatment, and keep the secret.
Article 7 The State Food and Drug Administration and the provincial food and drug regulatory departments shall establish and improve the cosmetic license information management system, timely disclosure has been made or canceled cosmetic license information.
Article applicant State Food and Drug Administration and the provincial food and drug administration departments have implemented cosmetics permission statement the right of defense and the right to request a hearing according to law; the right to apply for administrative reconsideration or institute administrative proceedings; their legitimate rights and interests damage, shall be entitled to claim compensation.
Chapter II Application and Acceptance
Article IX-made cosmetics license applicant must be legally registered in China's cosmetics manufacturers. China-made cosmetics, new materials license applicants should be a new cosmetic raw material manufacturer or cosmetics manufacturers.
Imported cosmetics license applicants should be foreign cosmetics manufacturers. New raw materials imported cosmetics license applicant must be outside the new cosmetic raw material manufacturer or cosmetics manufacturers. The applicant should be entrusted to the same a legally registered in China, and an independent legal entity unit, reporting responsibilities as a unit in China, responsible for the agency to declare the matter. The applicant can change the declaration of the responsible units in China.
Article apply for special use cosmetics, cosmetics, new materials permit, the applicant should give the State Food and Drug Administration to apply, and in accordance with relevant provisions of the filing data.
State Food and Drug Administration received application materials and to trial samples, should be declared within five days of the review of data in the form to make a decision whether to accept or correction.
Imported non-special use cosmetics should be listed before by the applicant in accordance with relevant provisions of the State Food and Drug Administration to submit record information, filing procedures.
State Food and Drug Administration received record information shall be filed within five days of data in the form of review, to make the decision whether to accept or correction.
Article XI apply for domestic non-special use cosmetics for the record, the applicant shall within two months after listing, by the applicant in accordance with relevant provisions of the administrative area where the provincial food and drug supervision and management departments to submit for the record information, filing procedures.
Provincial food and drug administration received record information, the information is complete and the required form, shall be filed on the spot; there can be corrected on the spot reporting data errors should be corrected to allow the applicant on the spot, the spot should be to correct the record after . Filing incomplete or non-compliant forms and can not be corrected on the spot, not for the record, and the reasons.
Article XII of declarations, filing incomplete or non-compliant form, is responsible for receiving applications for leave to cosmetics, food and drug regulatory departments shall inform the need for a one-time correction in its entirety.
Chapter III Examination and Decision
Article XIII apply for special permission to use cosmetics, the State Food and Drug Administration accepted, it shall promptly organize the safety of the product technical review, within 90 days. After the completion of the technical review within 20 days to make a decision whether to grant permission; can not make a decision within 20 days may be extended 10 days, and the reasons for extension shall inform the applicant in writing.
Meet the requirements, granted permission, and in the decision issued within 10 days from the date of permit approval document; not meet the requirements, no license, and a written explanation.
Article 14 When applying cosmetics, new materials licenses, the State Food and Drug Administration accepted, it shall promptly organize the safety of new materials for technical review, within 90 days. After the completion of the technical review within 20 days to make a decision whether to grant permission; can not make a decision within 20 days may be extended 10 days, and the reasons for extension shall inform the applicant in writing.
Meet the requirements may be granted permission, the State Food and Drug Administration granted permission for new materials to the cosmetic form of lists announcement; not meet the requirements, no license, and a written explanation.
Article XV imported non-special use cosmetics application filed with the State Food and Drug Administration accepted, shall be made within 20 days whether to approve the record of decision.
Meet the requirements may be granted for the record, and in the decision issued within 10 days from the date of filing the certificate; not meet the requirements, not the record, and a written explanation.
Article XVI requires additional information, delayed retrial, the applicant should review the comments received from the date of the trial within one year of the State Food and Drug Administration to submit corrected information, overdue, as a declaration of termination.
Article XVII The applicant received State Food and Drug Administration issued a "recommended not to approve" technical review comments of the administrative licensing this book, may within 10 days according to relevant provisions of the State Food and Drug Administration to review agency to make technical defense applications, and a written explanation.
Chapter Review
Article 18 The applicant of the State Food and Drug Administration made no objection to the decision of the license may not permit the receipt of the written decision within 30 days from the date of the State Food and Drug Administration to submit a written application for review and the reasons .
Article 19 The State Food and Drug Administration received an application for review, shall review the matter in accordance with the original application review timelines and requirements, and make a review of the decision. Revocation of the decision not to license, issued to the applicant the appropriate permit this document (the record evidence); to maintain the original decision no longer accept the application for review, the applicant in accordance with relevant laws and regulations, make application for administrative reconsideration or to the people's court administrative proceedings.
Diershitiao review was limited to the original non-licensed content and reporting information.
Chapter change, renewal, replacement, cancellation and error correction
Twenty-one applications for cosmetic changes to permit this document (filing documents) contain content, the applicant shall submit an application to submit relevant information in accordance with relevant regulations.
State Food and Drug Administration, after receiving claims data, should be declared within five days of data in the form of review, to make the decision whether to accept or correction.
Apply cosmetic changes to permit this document set out the contents of the State Food and Drug Administration should be within 60 days after accepting the application for disclosure of information on the technical review. Apply cosmetic changes to the contents of the record contained evidence, the State Food and Drug Administration should be within 20 days after accepting the application for review of claims data.
Meet the requirements, grant changes and decisions made within 10 days from the date of the permit approval document issued after the change (for the record evidence); not meet the requirements, no change, and a written explanation.
Article 22 has been the record of domestic non-special use cosmetics products, the original record content is changed, change the contents of the response to re-record.
Article 23 continues to apply cosmetics Permit Document (record certificate) is valid, it should be in the cosmetics Permit Document (record certificate) before the expiration of four months to apply. Cosmetics for a replacement permit this document (the record evidence) and not within the prescribed time limit extension application should be receiving a replacement cosmetics Permit Document (record certificate) within 15 days after the filing of a continuation application, but the reissue application should be permitted in the cosmetics approval document (record certificate) before the expiration of four months.
Cosmetic application of Article 24 permit renewal, the applicant shall submit an application to submit relevant information in accordance with relevant regulations.
State Food and Drug Administration, after receiving claims data, should be declared within five days of the review of data in the form to make a decision whether to accept or correction.
License renewal application for special use cosmetics, the State Food and Drug Administration should accept the application within 60 days after the review of claims data. For extension of non-special use cosmetics import license, the State Food and Drug Administration should accept the application within 20 days after the review of claims data.
Meet the requirements may be granted extension, and in the decision issued within 10 days from the date of permit approval document (record certificate); not meet the requirements, not to continue, and a written explanation.
Article 25 Permit Document (record certificate) apply for a replacement of lost, should 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.
Article 26 change, renewal and replacement of cosmetics Permit Document (record certificate) Certificate No. unchanged.
Article 27 of the following circumstances, the State Food and Drug Administration should cancel the corresponding cosmetic Permit Document (record certificate):
(A) cosmetic Permit Document (record certificate) holders to apply for cancellation of;
(B) the State Food and Drug Administration safety monitoring results show that there are security risks of cosmetics;
(C) cosmetics Permit Document (record certificate) holders have legally terminated their legal qualifications;
(D) violation of laws and regulations, have withdrawn their cosmetics Permit Document (record certificates);
(E) shall be deleted by the other cases.
Article 28 permit this document due to cosmetics (filing documents) printing errors, number errors and other errors (not including the applicant to declare the error), the applicant shall apply the provisions of correction and submit relevant information.
State Food and Drug Administration, after receiving claims data, should be declared within five days of the review of data in the form to make a decision whether to accept or correction.
Permit Document proposed correction of the applicant, the State Food and Drug Administration should accept the application within 30 days after the review of claims data. The applicant proposed correction of the record evidence, the State Food and Drug Administration should accept the application within 20 days after the review of claims data.
Correcting granted to the applicant qualified cosmetic renewal permit this document (the record evidence); not correcting the issue the applicant a notice approving comments.
Chapter Permit Document and record management certificate
Article 29 The special use permit this document cosmetics, imported non-special use cosmetics filing certificate valid for four years.
Article 30 made special use cosmetics approval number for the country style special character makeup + G +4 digit year number + 4-bit sequence number certification.
Special use cosmetics import license number into the special makeup for the country style word + J +4 digit year number + 4-bit sequence number certification.
Record imported non-special use cosmetics makeup the symbol for the country style of preparation into words + J +4 digit year number + 4-bit sequence number certification.
第三十一条 cosmetics Permit Document (record certificate) shall not transfer, alter, lend, sell, rent, non-forged.
Article 32 of the provincial food and drug supervision and management departments should strengthen the filing records and information management products, the domestic non-special use cosmetics record information should be published promptly.
Chapter VII Supervision and inspection
Article 33 The State Food and Drug Administration and the provincial food and drug regulatory departments shall establish and improve the cosmetic license management system, and its licensing practices and the applicant engaged in the activities of the cosmetics licensing matters overall supervision. Found in the department of personnel shall be permitted in violation of regulations should be rectified immediately.
Article 34 The State Food and Drug Administration should strengthen supervision and management of the provincial food and drug supervision and management departments for the record, it was discovered non-compliance should be ordered to correct.
Article 35 of the following circumstances, the State Food and Drug Administration should revoke the license cosmetics:
(A) abuse their powers, neglect their duties, do not meet the statutory requirements of the licensing of cosmetics;
(B) the staff beyond the statutory authority to implement license;
(C) violation of due process to implement the staff permission;
(D) cosmetic license should be revoked according to law in other cases.
Chapter VIII of the liability
Article 36 in the cosmetics licensing process, the State Food and Drug Administration and the provincial food and drug supervision and management department staff in violation of the provisions of the following circumstances, in accordance with "Administrative Licensing Law" the relevant provisions to be addressed:
(A) meets the statutory requirements of the cosmetics permit application as inadmissible or non-filing;
(B) in cosmetic acceptance, the review process, not to inform the applicant to fulfill legal obligations;
(C) the declaration submitted by the applicant cosmetics license information is not complete, the form of non-compliance, can one tell a one-time inform the applicant without the entire contents of the correction;
(D) unauthorized charges or not in accordance with the statutory criteria for project fees;
(E) ask for or accept property or seek other benefits;
(F) shall hold a hearing should be held without a hearing.
Article 37 The applicants did not disclose relevant information or provides false information in an application for leave, the State Food and Drug Administration should not accept its application for license or not license, and give a warning, the applicant shall not re-apply within one year of the license.
Article 38 The applicant fraud, bribery or other improper means to obtain cosmetic permit this document (the record evidence), the State Food and Drug Administration should revoke the permit approval document (record certificate), within three years, the applicant shall declare the license again ; suspected of a crime is constituted, criminal responsibility shall be investigated.
Article 39 The applicant of the following acts, food and drug regulatory departments shall be given administrative punishment according to law; suspected of a crime is constituted, criminal responsibility shall be:
(A) forged, altered, sold, leased, lent or otherwise illegal transfer of permit approval document (record certificates);
(B) to conceal the situation, providing false information or samples;
(Iii) shall apply for unauthorized changes to the matters to change;
(D) laws, regulations and rules and regulations of other offenses.
Chapter IX Supplementary Provisions
Article 40 The duration of this approach to working days, excluding legal holidays.
Article 41 The State Food and Drug Administration responsible for the interpretation.
Article 42 These Measures shall go into effect (date).
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