According to the State Council License separation The decision-making and deployment of the reform and the work requirements of the State Drug Administration for the implementation of the filing management of imported non special purpose cosmetics throughout the country,The policy interpretation of our province on the record management of imported non special purpose cosmetics is as follows

one Policy background

To implement the State Council License separation Decision making and deployment of reform,Accelerate the transformation of government functions,Fully stimulate the vitality of market players,according to Circular of the State Council on promoting License separation Notice of reform Guofa 2018 35number and Announcement on the implementation of the filing administration of imported cosmetics for non special purposes nationwide Announcement of the State Drug Administration2018Year88number hereinafter referred to as Notice Requirements,Guangdong Provincial Drug Administration issued Circular of Guangdong Provincial Drug Administration on carrying out the filing management of imported cosmetics for non special purposes hereinafter referred to as announcement ,Formulated Guide for filing imported non special purpose cosmetics ,Further clarify the specific requirements for Guangdong Province to carry out the filing management of imported non special purpose cosmetics.

two Implementation date and filing scope

since Notice From the date of publication,The domestic responsible person is registered within the administrative region of Guangdong Province,The first import of non special purpose cosmetics shall be uniformly adjusted from the current approval management of the State Drug Administration and the filing management of the pilot implementation of the free trade test zone to the filing management of the provincial drug administration.

three Handling method

An imported cosmetics manufacturer applying for the first import of cosmetics for non special purposes shall, before the product is imported,Entrust the domestic responsible person to log in to the government website of the State Drug Administration www.nmpa.gov.cn Online service column,adopt Filing management system for imported non special purpose cosmetics hereinafter referred to as Filing system Handle account registration Submission of product filing information.After uploading the electronic filing data on the online filing platform,File with the relevant department responsible for filing management.

four Processing window

In order to facilitate enterprises to handle relevant matters,Our province is currently in the Provincial Bureau Huangpu District, Guangzhou Nansha District, Guangzhou Guangdong pilot free trade zone Shenzhen Qianhai Shekou area Zhuhai Hengqin new area has set up5Multiple processing windows,The domestic responsible person shall be in accordance with the administrative region of the place of registration,Go to the office window set up by relevant departments within the corresponding region for filing.

five Supplement the information of import port and consignee

The products that have been filed are planned to be in the province where the domestic responsible person is located area city Imported from ports outside the Administrative Region,Relevant information such as import port and consignee shall be supplemented through the filing system before import.

six Differences between domestic responsible persons and units reporting responsibility in China

Provisions on acceptance of cosmetic administrative license application State Food and Drug Administration 2009 856number The responsible unit for declaration in China specified in the refers to the unit authorized and entrusted by overseas cosmetics production enterprises,Be responsible for matters related to product agency declaration,An independent legal person in China who is responsible for the application materials and bears corresponding legal liabilities.The same overseas cosmetics manufacturer can only authorize one responsible reporting unit in China.

The domestic responsible person refers to the person authorized by the overseas cosmetics production enterprise,Be responsible for the import and operation of products,It is an enterprise legal person registered in Guangdong Province that undertakes the corresponding responsibility for product quality and safety according to law.Overseas cosmetics production enterprises may, according to the needs of their business activities,Authorize multiple domestic responsible persons.However, the scope of authorization shall not be repeated,Multiple domestic responsible persons shall not be authorized for the same product.

seven Domestic responsible personvs Difference of consignee

The domestic responsible person is authorized and entrusted by the import enterprise,Be responsible for the import and operation of products,And undertake corresponding product quality and safety responsibilities according to law The consignee is entrusted by the domestic responsible person,Handle import matters at ports other than the provinces where the domestic responsible person is located,Bear joint and several liabilities in accordance with the entrustment agreement.The domestic responsible person shall go through the filing procedures,Fill in relevant information of consignee The consignee does not need to fill in the information,Cooperate with local regulatory authorities in supervision and inspection.

eight Differences between filing management and license management

The implementation of filing management is on the premise of not reducing the requirements of product safety supervision,Only adjust the way of product supervision and management.Filing management is based on data requirements Inspection and detection Safety risk assessment and other main responsibility requirements to ensure product quality and safety,Consistent with administrative license management requirements.The domestic responsible person shall submit the filing materials according to the requirements of the working procedures, and can carry out relevant business activities with the electronic filing certificate after completing the filing,Problems found in supervision during and after the event,By ordering correction Suspension of imports Off the shelf Recall and other means,Handle according to law.

nine Result query and information disclosure

The data received online is consistent with the paper data received by the office window,And meet the filing requirements,Confirm filing,The filing information system automatically generates filing vouchers The domestic responsible person can print the record information voucher by himself through the record management system of imported non special purpose cosmetics of the State Drug Administration,The product filing information shall be published on the filing service platform of imported non special purpose cosmetics of the State Drug Administration,website www.nmpa.gov.cn Cosmetics query column.

ten Supervision and inspection of filing materials and supervision and management during and after the event

The drug regulatory department shall organize the supervision and inspection of the filed materials after the product is filed,Conduct on-site inspection if necessary.It is found that the filed materials do not meet the requirements,But it does not affect the judgment of product safety,The domestic responsible person shall be required to30Relevant materials shall be supplemented and submitted within days It is found that the product safety cannot be judged according to the existing data,The domestic responsible person shall be informed to supplement and submit relevant materials,And suspend the import and sale of the product until it is confirmed that the filing materials meet the requirements It is found that there are illegal situations or product quality and safety problems,The regulatory authorities will investigate and deal with it according to law,And order the relevant products off the shelf Recall processing.

eleven Connection with the original administrative license and filing pilot

Products accepted or not approved by the State Drug Administration,According to Notice and announcement Filing as required by,Unless it is not approved for reasons related to product safety.

Products with administrative license,Within the validity period of the license, you can continue to handle import with paper approval,It needs to be reissued or corrected during the period,It can be handled according to the original procedure.It still needs to be imported after the expiration of the validity period,Or changed before the end of the validity period,The record shall be handled again.

Products registered in the original free trade zone,No re filing is required.

twelve Subject responsibility of domestic responsible person

Domestic responsible persons shall fulfill their commitments,Establish a quality and safety management system for imported non special purpose cosmetics,Strengthen product traceability and quality management,Take responsibility for product quality and safety,Ensure that the import and operation of cosmetics meet the requirements of laws, regulations and standards.In case of product quality and safety problems,Relevant information shall be actively disclosed to the public and recalled in time.