Cosmetics

Provisions on the Internal Organizations and Staffing of the Main Responsibilities of the State Food and Drug Administration (GBF [2008] No. 100): “The responsibility of the Ministry of Health for the sanitary supervision and management of cosmetics shall be transferred to the State Food and Drug Administration.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) Basis for naming the product name, original and copy, paper version: 1 original and 4 copies;

(3) Product quality and safety control requirements, original and copy, paper version: 1 original and 4 copies;

(4) Product design package (including product label and product manual), original and copy, paper version: 1 original and 4 copies;

(5) The original and copy of the inspection report and relevant data issued by the competent inspection institution published by the registration and filing inspection information management system of the State Drug Administration, the paper version: 1 original and 4 copies;

(6) The original and copy of the relevant safety assessment materials that may contain safety risk substances in the product. The paper version: 1 original and 4 copies;

(7) Product technical requirements, original and copy, paper version: 1 original and 4 copies; Electronic version: 1 copy;

(8) For the application of hair care, bodybuilding and milk beauty products, the scientific literature, original and copy of the functional ingredients and the basis for their use shall be submitted. Paper version: 1 original and 4 copies;

(9) Other materials that may be helpful to the administrative license, the original and copies, paper version: 1 original and 4 copies;

(10) One sealed and unsealed sample from the provincial food and drug administration, the original;

(11) Product formula, original and copy, paper version: 1 original and 4 copies; Electronic version: 1 copy;

(12) Production process sketch, original and copy, paper version: 1 original and 4 copies;

(13) Production license copy, original and copy, paper version: 1 original and 5 copies.

Provisions on the Internal Organizations and Staffing of the Main Responsibilities of the State Food and Drug Administration (GBF [2008] No. 100): “The responsibility of the Ministry of Health for the sanitary supervision and management of cosmetics shall be transferred to the State Food and Drug Administration.”

Announcement on Issues Concerning the Examination and Approval of the Implementation of the Commitment System for the Extension of Administrative Licensing of Cosmetics for Special Purposes (No. 45 in 2019): For cosmetics for special purposes that apply for extension upon the expiry of the approval certificate (hereinafter referred to as the approval document), the State Drug Administration will approve the application for extension of the approval document and organize technical review afterwards, if the applicant has checked himself and promised to meet the requirements of laws, regulations and standards, And strengthen supervision and inspection in combination with daily supervision.

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) Approval document of cosmetic administrative license (filing certificate), original;

(3) The basis for naming the Chinese name of the product (unless the first application has been submitted and the product name has not changed), the original;

(4) Product formula, original;

(5) Product quality and safety control requirements, original;

(6) Packaging of products sold in the market (including product labels and product manuals). If domestic products are not listed, the original of product design packaging (including product labels and product manuals) can be submitted;

(7) For domestic products, the original of the written opinion on product production, marketing, supervision or review opinion on product unlisted issued by the provincial food and drug administration where the applicant is located shall be submitted;

(8) In case of agent declaration, the copy of the power of attorney of the unit responsible for applying for administrative permission in China that has been filed, and the copy of the business license of the unit responsible for applying for administrative permission in China, affixed with the official seal, and the original copy shall be submitted;

(9) Other materials that may be helpful to the administrative license, original;

(10) One unopened commercial product, original;

(11) Self inspection commitment report, paper version: 1 original, electronic version: 1;

(12) Product sales package and label (including instructions), paper version: 1 original, electronic version: 1;

(13) Production (import) sales certification materials, paper version: 1 original, electronic version: 1;

(14) Other contents that need to be explained (other contents that are helpful for review), paper version: 1 original, electronic version: 1.

Provisions on the Internal Organizations and Staffing of the Main Responsibilities of the State Food and Drug Administration (GBF [2008] No. 100): “The responsibility of the Ministry of Health for the sanitary supervision and management of cosmetics shall be transferred to the State Food and Drug Administration.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) The original of the cosmetic administrative license approval (filing certificate), paper version: 1 original;

(3) For declaration by proxy, a copy of the power of attorney of the unit responsible for applying for administrative permission in China that has been filed and a copy of the business license shall be submitted and affixed with the official seal. The paper version: 1 original;

(4) The corresponding materials shall be submitted according to the content of the change application. The paper version: 1 original.

Provisions on the Internal Organizations and Staffing of the Main Responsibilities of the State Food and Drug Administration (GBF [2008] No. 100): “The responsibility of the Ministry of Health for the sanitary supervision and management of cosmetics shall be transferred to the State Food and Drug Administration.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) If the application for reissue is damaged due to the administrative license approval (filing certificate), the original of the cosmetic administrative license approval (filing certificate) shall be submitted. The paper version: 1 original;

(3) If the application for reissue is lost due to the loss of the administrative license approval document (filing certificate), the original of the loss statement published in the newspapers and periodicals at or above the provincial level (including the provincial level) shall be submitted. The application for reissue of the lost statement shall be submitted in a timely manner 20 days after the date of publishing the loss statement;

(4) For declaration by proxy, a copy of the power of attorney of the unit responsible for applying for administrative permission in China, which has been filed, and a copy of the business license of the unit responsible for applying for administrative permission in China, which is affixed with the official seal, shall be submitted. The paper version: 1 original.

Provisions on the Internal Organizations and Staffing of the Main Responsibilities of the State Food and Drug Administration (GBF [2008] No. 100): “The responsibility of the Ministry of Health for the sanitary supervision and management of cosmetics shall be transferred to the State Food and Drug Administration.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) Development report, paper version: 1 original and 4 copies;

(3) Production process description and sketch, paper version: 1 original and 4 copies;

(4) Requirements for quality and safety control of raw materials, including specifications, testing methods, substances with potential safety risks and their control. Paper version: 1 original and 4 copies;

(5) Toxicological safety assessment data, including relevant safety assessment data of substances with potential safety risks in raw materials. Paper version: 1 original and 4 copies;

(6) For declaration by proxy, a copy of the power of attorney of the unit responsible for applying for administrative permission in China and a copy of the business license of the unit responsible for applying for administrative permission in China that has been filed and affixed with the official seal shall be submitted. The paper version: 1 original and 4 copies;

(7) Other materials that may be helpful for administrative licensing, paper version: 1 original and 4 copies;

(8) Submit samples for approval.

Article 10 of the Regulations on the Hygiene Supervision of Cosmetics: “Cosmetics for special purposes refer to those used for hair care, hair dyeing, perm, hair removal, milk beauty, body building, deodorization, spot removal and sun protection.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) Basis for naming the Chinese name of the product, paper version: 1 original and 4 copies;

(3) Product formula, paper version: 1 original and 4 copies; Electronic version: 1 copy;

(4) Production process description and sketch, paper version: 1 original and 4 copies;

(5) Product quality and safety control requirements, paper version: 1 original and 4 copies;

(6) Original packaging of the product (including product label and product manual); If it is planned to design packaging specifically for the Chinese market, the product design packaging (including product label and product manual) shall be submitted at the same time. Paper version: 1 original and 4 copies;

(7) The paper version of the inspection report and relevant data issued by the competent inspection institution published by the registration and filing inspection information management system of the State Drug Administration: 1 original and 4 copies;

(8) The paper version of the relevant safety assessment materials that may contain safety risk substances in the product: 1 original and 4 copies;

(9) For the application of hair care, bodybuilding and milk beauty products, the scientific literature on the functional ingredients and the basis for their use shall be submitted. Paper version: 1 original and 4 copies;

(10) A copy of the power of attorney of the responsible unit applying for administrative permission in China and a copy of the business license of the responsible unit applying for administrative permission in China that has been filed and affixed with the official seal. The paper version: 1 original and 4 copies;

(11) Letter of commitment that the raw materials used for cosmetics and their sources meet the requirements for prohibition and restriction of high-risk substances in the epidemic area of mad cow disease. Paper version: 1 original and 4 copies;

(12) Documentary evidence of the production and sales of the product in the country (region) of production or the country (region) of origin (paper version: 1 original and 4 copies);

(13) Other materials that may be helpful for administrative licensing, paper version: 1 original and 4 copies;

(14) One commercial sample sealed and not unsealed by the license inspection agency, Original (According to the requirements of the Provisions on the Acceptance of Cosmetics Administrative License Application, the imported products shall submit the market packaging when submitting the license application. The market packaging here has two meanings. The market packaging submitted for the first application for the license refers to the packaging for overseas marketing; the market packaging submitted for the import renewal application refers to the packaging for sales in the Chinese market.);

(15) Product technical requirements, paper version: 1 original and 4 copies; Electronic version: 1 copy.

Article 10 of the Regulations on the Hygiene Supervision of Cosmetics: “Cosmetics for special purposes refer to those used for hair care, hair dyeing, perm, hair removal, milk beauty, body building, deodorization, spot removal and sun protection.”

Announcement on Issues Concerning the Examination and Approval of the Implementation of the Commitment System for the Extension of Administrative Licensing of Cosmetics for Special Purposes (No. 45 in 2019): For cosmetics for special purposes that apply for extension upon the expiry of the approval certificate (hereinafter referred to as the approval document), the State Drug Administration will approve the application for extension of the approval document and organize technical review afterwards, if the applicant has checked himself and promised to meet the requirements of laws, regulations and standards, And strengthen supervision and inspection in combination with daily supervision.

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) The original of the approval document of cosmetic administrative license (filing certificate);

(3) The basis for naming the Chinese name of the product (unless the first application has been submitted and the product name has not changed), the original;

(4) Product formula, original;

(5) Product quality and safety control requirements, original;

(6) Packaging of products sold in the market (including product labels and product manuals). If domestic products are not listed, the original of product design packaging (including product labels and product manuals) can be submitted;

(7) For domestic products, the original of the written opinion on product production, marketing, supervision or review opinion on product unlisted issued by the provincial food and drug administration where the applicant is located shall be submitted;

(8) In case of agent declaration, the copy of the power of attorney of the unit responsible for applying for administrative permission in China that has been filed, and the copy of the business license of the unit responsible for applying for administrative permission in China, affixed with the official seal, and the original copy shall be submitted;

(9) Other materials that may be helpful to the administrative license, original;

(10) One unopened commercial product, original;

(11) Self inspection commitment report, paper version: 1 original; Electronic version: 1 copy;

(12) Product sales package and label (including instructions), paper version: 1 original; Electronic version: 1 copy;

(13) Production (import) sales certification materials, paper version: 1 original; Electronic version: 1 copy;

(14) Other contents that need to be explained (other contents helpful for review), paper version: 1 original; Electronic version: 1 copy.

Article 10 of the Regulations on the Hygiene Supervision of Cosmetics: “Cosmetics for special purposes refer to those used for hair care, hair dyeing, perm, hair removal, milk beauty, body building, deodorization, spot removal and sun protection.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) The original of the cosmetic administrative license approval (filing certificate), paper version: 1 original;

(3) For declaration by proxy, a copy of the power of attorney of the unit responsible for applying for administrative permission in China that has been filed and a copy of the business license shall be submitted and affixed with the official seal. The paper version: 1 original;

(4) The corresponding materials shall be submitted according to the content of the change application. The paper version: 1 original.

Article 10 of the Regulations on the Hygiene Supervision of Cosmetics: “Cosmetics for special purposes refer to those used for hair care, hair dyeing, perm, hair removal, milk beauty, body building, deodorization, spot removal and sun protection.”

The time required for technical review and applicant’s supplementary information and supplementary information review is not included.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) If the application for reissue is damaged due to the administrative license approval (filing certificate), the original of the cosmetic administrative license approval (filing certificate) shall be submitted. The paper version: 1 original;

(3) If the application for reissue is lost due to the loss of the administrative license approval document (filing certificate), the original of the loss statement published in the newspapers and periodicals at or above the provincial level (including the provincial level) shall be submitted. The application for reissue of the lost statement shall be submitted in a timely manner 20 days after the date of publishing the loss statement;

(4) For declaration by proxy, a copy of the power of attorney of the unit responsible for applying for administrative permission in China, which has been filed, and a copy of the business license of the unit responsible for applying for administrative permission in China, which is affixed with the official seal, shall be submitted. The paper version: 1 original.

Step 2: Acceptance

Step 3: Technical review

Step 4: Administrative licensing decision

Step 5: Delivery

(2) The Chinese name of the product is based on;

(3) Product formula;

(4) Product quality and safety control requirements;

(5) Original packaging of the product (including product label and product manual); If it is planned to design packaging specifically for the Chinese market, the product design packaging (including product label and product manual) shall be submitted at the same time;

(6) The inspection report and relevant materials issued by the license inspection agency recognized by the State Food and Drug Administration;

(7) Relevant safety assessment materials that may contain safety risk substances in products;

(8) A copy of the power of attorney of the responsible unit applying for administrative permission in China and a copy of the business license of the responsible unit applying for administrative permission in China that have been filed and affixed with the official seal;

(9) Letter of commitment that the raw materials used for cosmetics and their sources meet the requirements for prohibition and restriction of high-risk substances in the epidemic area of mad cow disease;

(10) Documents certifying the production and sales of products in the country (region) of production or the country (region) of origin;

(11) Other materials that may be helpful for filing;

(12) One commercial sample sealed and not unsealed by the license inspection agency.