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Drug and Cosmetics Registration

Imported special-use cosmetics application documents

   Source��   outao

List of application documents :
Data number (1) Application form for administrative approval of imported special-use cosmetics;
Data number (2) Rationale for nomenclature of the product’s Chinese name;
Data number (3) Product formulas.
Data number (4) Descriptions and diagrams of the production process.
Data number (5) Product quality and safety control requirements;
Data number (6) Original package (including product labels and product brochures); Package design intended specifically for the Chinese market shall be submitted (including product labels and product brochures);
Data number (7) Testing report issued by CFDA-accredited testing institutions and related dossier;
Data number (8) Safety evaluation data of the product’s potential safety hazards;
Data number (9) For application of products for hair growth, fitness, breast-beautification, the scientific literature for effective ingredients and rationale for use shall be submitted;
Data number (10)Copies of the certificate of entrustment and business licenses of recorded units responsible for Administrative approval in China, the copies shall be stamped with the official seal
Data number (11)Letter of commitment ensuring that the cosmetic materials and sources of materials are in line with the requirements for restriction and prohibition of substances from BSE affected high risk areas;
Data number (12)Documents proving production and sales of the product in the producing country (region) or country (region) of origin;
Data number (13)Additional information that may be useful for administrative approval;
Data number (14)Text version and electronic version of the product technical requirements.
Attached with 1 sample of marketed product sealed by designated test institutions.

Application process diagram :