Notice on Implementing the Management of Record-keeping of Imported Non-special Use Cosmetics Nationwide (Notice No.88, 2018)

Notice on Implementing the Management of Record-keeping of Imported Non-special Use Cosmetics Nationwide (Notice No.88, 2018)

Published on 9^th Nov, 2018

In order to implement the requirements of Notice of State Council on Promoting the Reform of Separation of Operation Permits and Business Licenses in the whole country ((State Letter (2018) No. 35)), the relevant matters concerning the implement of record-keeping management of imported non-special use cosmetics are hereby announced as follows:

Article 1: Since 10^th Nov, 2018, current approval system and record-keeping management in the pilot free trade zones is changed into national unified record-keeping system for the first import of non-special use cosmetics. The Nation Medical Product Administration (NMPA) will no longer accept the application for administrative licensing of imported non-special use cosmetics.

CIRS summary and comments: The approval system is cancelled for the first import of non-special use cosmetics since 10^th Nov, 2018. The procedures and requirements of new record-keeping system are similar as pilot policy in free trade zones.

Article 2: Before import of cosmetics, the foreign cosmetic manufacturers should appoint the domestic responsible person to log on to the section of “Online Service”of NMPA website (www.nmpa.gov.cn), and to fulfill the record-keeping procedures via the online platform of “record-keeping management system for imported non-special use cosmetics”. The imported non-special use cosmetics can be imported once getting the electronic record-keeping certificate. The recorded products shall be numbered according to the rule of国妆网备进字(abbreviation of province in which the domestic responsible person is located)+four-digit year number+ six-digit sequential number.

CIRS summary and comments: Here are the comparison between the traditional registration and new record-keeping:

1)Pre-market registration with NMPA is changed into pre-market record-keeping with local MPAs.

2)With the new record-keeping system, once receiving the electronic certificate, the import activity can be conducted. Nevertheless, the hard copy of approval license is required to import through traditional registration.

3)Previously, the registration number starts as 国妆备进字J and follows as four-digit year number+ four-digit sequential number. New filing number starts as 国妆网备进字(abbreviation of province in which the domestic responsible person is located) and follows by four-digit year number+ six-digit sequential number.

Article 3: Domestic responsible person registered within the scope of provincial (municipal) administrative areas of Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan, Shaanxi, where the record-keeping management of imported non-special use cosmetics has been implemented in pilot free trade zones, shall make record-keeping at provincial MPAs after filling in and uploading the electronic materials to the record-keeping system. The relevant provincial MPAs shall promptly draw up the guidelines of record-keeping within the administrative area and open to the public. Otherwise, the domestic responsible person registered within the scope of other provincial (municipal) administrative areas, shall fulfill the record-keeping with NMPA.

CIRS summary and comments: Both the NMPA and provincial MPAs handle the record-keeping management of imported non-special use cosmetics depending on the place of registration of domestic responsible person. If registered within the scope of provincial (municipal) administrative areas of Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan, Shaanxi, these local MPAs will handle the record-keeping word directly. Beyond the scope of above provinces (municipalities), NMPA is responsible for the record-keeping work of remaining 21 provinces (municipalities) such as Beijing, Jiangsu, Shandong, Hainan. The procedures and relevant requirements of new filing system are as different as traditional approval system. There are 3 main differences: 1) domestic responsible person will be in charge of both the product record-keeping and product safety in China market. Previously, a foreign applicant has only one China responsible agent for registration. Now it is allowed to have various domestic responsible persons as long as the scope of authorization does not overlap. 2) There is a separate online filing system for imported non-special use cosmetics. Full dossiers need to be uploaded to the new record-keeping system. The assessors will perform the technical review through the online system. No need to submit the sealed sample which will be kept by the domestic responsible person for post-market surveillance. 3) Under the new record-keeping system, once passing the format review, the electronic certificate will be issued for print to import. Technical review shall be performed within 3 months of record-keeping. In principle, new policy will save the whole time of getting the record-keeping certificate so that the new products can come into the market as early as possible.

Article 4: In case the recorded products will be imported at a port other than the administrative areas of province (municipality) where the domestic responsible person is located, it can be imported through supplementing the info of import port and consignee to the filing system.

CIRS summary and comments:: For pilot policy in free trade zones, the recorded products have to be only imported through the port where the registration place of domestic responsible person belongs to the scope of free trade zone. Under the new filing system, it is allowed to have various import ports only if the info of new import ports and consignee is recorded to the filing system in advance.

Article 5: According to the relevant requirements of Notice No. 10, 2017-Notice on Work Program of Record-Keeping for Imported Non-Special Use Cosmetics in Pudong New Area published by CFDA, imported cosmetics manufacturers, who apply for the record-keeping of imported non-special use cosmetics, shall authorize the domestic responsible person, register an ID of filing system, submit the record-keeping info, print the record-keeping certificate and perform other related work.

The related matters, such as testing report of imported non-special use cosmetics, domestic cosmetics enterprises outsourcing the production abroad, refer to CFDA Notice No. 72, 2018 -Clearing the Requirements of Testing Reports Used for the Pilot Implementation of Record-Keeping of Imported Non-Special Use Cosmetics in Pudong New Area and Other Related Matters for implementation

CIRS summary and comments: The requirements of CFDA Notice No. 72, 2018 apply to new record-keeping system as well. If the testing for administrative licensing is finished but the application is not submitted to NMPA yet, testing report is valid for record-keeping at local MPA as well. When the original China responsible agent for registration and new domestic responsible person are different, the applicant needs to provide a statement that the product for filing are same as the one for administrative licensing. And an informed consent form in regard to allowing testing report to be used needs to be provided by the original China responsible agent for registration.

Article 6: The administrative licensing application already submitted and accepted by NMPA before 10^th Nov, 2018 can be withdrew before 20^th Nov, 2018. Domestic responsible person can fulfill the record-keeping and carry out the import on the basis of related requirements of this announcement after that. Otherwise, if not withdrawing on time, NMPA will continue to carry out technical review in the light of previous procedures, the hard copy of approval license will be issued when passing the technical review.

CIRS summary and comments: If products have been already submitted and accepted by NMPA before 10^th Nov, the applicant can choose the traditional registration with NMPA or new record-keeping with local MPA before 20^th Nov. Within the valid period of approval license, the registered products can be imported freely in any port of mainland China. On the basis of new requirements of renewal work, all kinds of license renewal will be transferred to local MPAs. The key point of renewal work is to keep all required info consistent with the registered version. Moreover there are some new regulations issued each year which will impact the renewal work. Besides providing the same dossier as registered one, it will take a lot of time for preparation to comply with the current regulatory requirements and for communication with local MPA to check whether the supporting docs are sufficient. In the end, we may lost the time for renewal and then everything needs to start again.

If imported non-special use cosmetics applied for administrative licensing before 10^th Nov, 2018 have not been approved yet, performing the record-keeping in terms of related requirements of this announcement except of unproved products with safety issue.

CIRS summary and comments: For products not passing the NMPA review, there are two kinds of official comments. One is to submit supplement materials, another is not approved. NMPA might continue reviewing supplementary materials. However, new record-keeping will be conducted at local MPA for unapproved products except of unproved products with safety issue.

Article 7: For approval products under the original approval management system, the hard copy of CFDA license is still valid to carry out the import activity within the period of validity. If CFDA license needs to be reissued or corrected before the expiration date, do it based on the original regulations.

CIRS summary and comments: Within the period of validity, if the license needs to be reissued and corrected, NMPA will deal with this work in terms of original provisions.

Nevertheless, if need to import after expiration date, or having the change of items on the original CFDA license before the end of validity period, new record-keeping is required before import in terms of the requirements of this announcement.

CIRS summary and comments: Although the license is valid, new record keeping is needed as long as requesting the change of items on the CFDA license such as the change of actual manufacturer, China responsible agent.

Article 8: Local Medical Product Administrations shall intensify in- and post-market supervision of recorded imported products. Reinforcing the coordination with customs and relevant departments, reporting the info of product quality and safety promptly, investigating and punishing illegal activities in cooperative with relevant departments.

Hereby announce the above

NMPA
7^th Nov, 2018