进口普通化妆品申报过程和所需资料

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您咨询的化妆品申报过程如下：

T he registration process of cosmetic that you consulted as follows：

化妆品申报过程和所需资料

Cosmetic registration process and required information

一、项目启动，提供在华申报责任单位授权书（签订协议后我公司提供模板）

Providing authorization to the responsible units in China.（We will provide the template for you after signing agreement.）（SFDA need5workdays for approval）二、样品检测（时间5个月）

sample testing（5months）

1、贵公司只需提供产品配方、说明书和送检样品；生产企业的基本信息。

You only need to provide product formulas,specifications and testing samples;basic information of manufacturer.

2、送样品检验（根据产品规格来定）。

To send samples for testing.

三、准备申报资料（我公司准备，在做检验同时完成）。

Preparing registration documents.（We complete it during the testing period.）（1）化妆品卫生许可申请表（我公司准备）

Cosmetic sanitation license application form（We complete it）

（2）产品命名依据（国外公司准备，但我公司需要审核）

The named basis（Prepared by foreign company，but we need to review it.）

（3）产品配方(100%复配成分表,含有PEG/SLS/SLES/AES等成分的需要原料厂商提供COA证明，里面要求含有二恶烷的含量证明)（国外提供，但我公司需要审核）Product formula（100%compound ingredients list，please provide the COA or specification of PEG/SLS/SLES/AES,which should include the wt%of dioxane）

（Prepared by foreign company，but we need to review it.）

(4)如成分中有植物提取物，需国外厂商提供成分中植物提取物是否有农药

残留的证明。（国外提供，但我公司需要审核）

If there are plant extract in the ingredients，the foreign company should provide a certificate of whether having pesticide residue or not.Prepared by foreign company，but

we need to review it.）

（5）安全性风险评估资料，根据配方由国外厂商提供（需原料厂商提供每个成分的质量规格证明）Information of security risk assessment,provided by foreign company according to formulas.（Providing quality specification certificate of every ingredient by manufacturer of raw materials）

（6）产品质量安全控制要求（生产企业内控标准）（国外提供，但我公司需要审核）Product quality and safety control requirements(internal control standards of manufacturer)（Prepared by foreign company，but we need to review it.）

（7）药监局认可的检验机构出具的检验报告及相关材料（我公司准备）Testing report issued by inspection department accepted by SFDA and related information.（We complete it）

（8）产品原包装（含产品标签），拟为中国市场设计包装上市的，需同时提供

产品设计包装（含产品标签）（我公司准备）

Product original packaging(including product label),the packaging to be designed for the Chinese market,and is required to provide product packaging design(including the product label)（We complete it）

（9）经公证的自由销售证明（需要国外提供，签合同后我公司可提供样本）

Notarized certificate of Free sale（prepared by foreign company，We will provide the template for you after signing agreement.）

（10）化妆品使用原料及原料来源符合疯牛病疫区高风险物质禁限用要求的承

诺书（我公司准备）

Cosmetics raw materials and raw materials source meet the high risk of BSE infected material Restriction of the undertaking required.（We complete it）

（11）在华责任单位营业执照复印件并加盖其公章（在华单位准备）

The copy of business license with a official seal of responsible unit in China.（The responsible unit in China）

（12）另附许可检验机构封样的样品一件（我公司准备）

Attached a sealedsample of injection department.（We complete it）

（13）如果是委托加工生产形式，需要企业出具被委托生产企业的质量管理体系或良好生产规范的证明文件或符合生产企业所在国（地区）法规要求的化妆品生产资质证明文件。并提供委托加工协议原件。

If the production way is consigned processing，please provide the Quality Management System or Good Manufacture Practice or cosmetic production qualification document in line with manufacturers of the country(region)regulatory of the commissioned manufacturer.And provide the original agreement of consigned processing.

（14）如果是宣称为孕妇、哺乳期妇女、儿童或婴儿使用的产品，应当提供基于安全性考虑的配方设计原则（含配方整体分析报告）、原料的选择原则和要求、生产工艺、质量控制等内容的资料。

If the product is claimed to be used for pregnant，lactating women or children，it should provide the design principle of formula（including the whole analysis report of formula），selection principle of raw material and requirements，manufacturing technique，quality control and so on that based on security.