First, the applicant fills in the application form and submits the following related materials to the acceptance window of the US Food and Drug Administration:
1. Application Form for Hygiene License of Cosmetic Production Enterprise.
2. General plan of the production enterprise: the general plan of the factory, the plan of the production workshop, raw material warehouse, inspection room and sample storage room must indicate the use area and orientation of each workshop, the location of doors and windows, light windows and production equipment, and the flow of people.
3. Product catalogue: indicate the product name, category, filing situation and production form.
4. Brief description and sketch of product process (indicate the production equipment used).
5. List of production equipment and inspection equipment related to product production (indicating equipment name, specification, model and purpose).
6. Hygienic inspection report of air and production water in the production workshop (issued by a qualified inspection agency with a reporting period of less than one year).
7, health management, quality management and inspection management measures (provide specific text).
8, health management personnel, quality management personnel and product inspection personnel qualification certificates.
9, cosmetics production practitioners (including preparation, filling, packaging, health management personnel) list, indicating the name, type of work, valid health certificate number, relevant training certificates.
10. A copy of the notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce.
1 1. The original power of attorney of the legal person (except that the agent is the legal representative) and the copy of the identity certificate of the agent (except that the agent is the legal representative, indicate the name of the client, the entrusted matters and the entrusted period).
12, other materials required by the US Food and Drug Administration.
13. Copy of product registration certificate, original or copy of hygiene license, and copy of industrial and commercial business license Description: The copy of the above application materials shall be stamped with the applicant's seal or riding seal page by page, and the stamped seal shall comply with relevant national regulations and have legal effect.
II. The acceptance center accepts the formal examination of the application materials by the US Food and Drug Administration. If the application materials are complete and meet the requirements, a notice of acceptance will be issued on the spot; If the application materials are incomplete or do not meet the statutory requirements, inform the applicant of all the contents that need to be corrected on the spot or within 5 working days; Fails to inform, since the date of receipt of the application materials is accepted.
Three, after the acceptance of the audit, the US Food and Drug Administration will assign personnel to conduct data and on-site audit according to the requirements of the Regulations on Cosmetic Hygiene Supervision, the Detailed Rules for the Implementation of the Regulations on Cosmetic Hygiene Supervision, and the Administrative Measures for the Issuance of Hygiene Licenses for Cosmetic Production Enterprises.
IV. The examination and approval authority of the US Food and Drug Administration shall make a decision on whether to approve or disapprove the administrative license according to the audit results. If the approval (extension) decision is made and the Hygiene License for Cosmetic Production Enterprises shall be issued, the Hygiene License for Cosmetic Production Enterprises shall be issued to the applicant.
Extended data:
Cosmetic size classification:
The batch number of cosmetics is generally called Wei Zhuangzi, so how many categories can Wei Zhuangzi be divided into? Looking at different types of cosmetics, we can find that the approval numbers of cosmetics are "Wei Zhuang Zhun Zi", "Wei Zhuang Te Zi", "Wei Zhuang Jin Bei Zi" and "Wei Zhuang Te Jin" respectively.
Cosmetic approval: it is a domestic cosmetic (qualified) approved by the cosmetics testing department of the Ministry of Health. (For example, brands such as Bomei and Dream Makeup are all sold in China).
Cosmetic preparation word: imported cosmetics are approved by the cosmetics inspection department of the Ministry of Health (that is, they are allowed to be imported only after passing the inspection) (for example, in Lan Zhi, all the products sold at the counter are imported from South Korea, so the cosmetic preparation word will be marked on the outer box). According to the relevant domestic regulations, all imported cosmetics are cosmetic preparation words.
Before the import of ordinary cosmetics goes on the market, it should apply to the Ministry of Health for filing, and the Ministry of Health will issue a filing certificate after examination and approval. The filing number format of ordinary imported cosmetics is "Wei Zhuang Jin Bei Zi (year of issuance)No. * * * *".
For example, Wei Zhuang Jin Bei Zi (2005)No. 1234 indicates that the product was approved for import by the Ministry of Health in 2005, and the general cosmetic number 1234 is the serial number arranged in the order of examination and approval every year, with one serial number for each product. Weizhuang Jinbeizi (four-digit year)No. xxxx.
Special words for health cosmetics: 9 kinds of cosmetics with the functions of hair growth, hair dyeing, perming, hair loss, beauty, bodybuilding, deodorization, freckle removal and sun protection are imported special cosmetics. An application must be submitted to the Ministry of Health. After approval, the Hygiene License for Imported Cosmetics can be issued. The approval number format is "Wei Zhuang Jin". (year of issue)No. * * * ".
Baidu encyclopedia-Wei Zhuangzi