化妆品注册备案管理办法英文版Administrative Measures on Cosmetic Registration and Notification.docx

1、Administrative Measures on Cosmetic Registration and Notification(Decree No. 35 of the State Administration for Market Regulation promulgated on January7, 2021)Chapter I General RulesArticle 1 For the purpose of regulating the registration and notification of cosmetics and ensuring the quality and s

2、afety of cosmetics, these Measures are hereby formulated in accordance with the “Cosmetic Supervision and Administration Regulations55 (CSAR).Article 2 These Measures shall apply to the activities of registration, notification, supervision and administration of cosmetics and new cosmetic ingredients

3、 within the territory of the People's Republic of China.Article 3 The registration of cosmetics and new cosmetic ingredients is the activity where the registration applicant submits an application for registration in accordance with legal procedures and requirements, and then the medical product

4、s administration department reviews the safety and quality controllability of the cosmetics and new cosmetic ingredients applied for registration, and makes a decision on approving the registration or not.The notification of cosmetics and new cosmetic ingredients is the activity where the notificati

5、on applicant submits the documents indicating the safety and quality controllability of cosmetics and new cosmetic ingredients in accordance with legal procedures and requirements, and the medical products administration department files the submitted documents for future reference.Article 4 The sta

6、te implements registration management for special cosmetics and new cosmetic ingredients with higher risk levels, and notification management for general cosmetics and other new cosmetic ingredients respectively.Article 5 The National Medical Products Administration (NMPA) shall be responsible for t

7、he registration and notification management of special cosmetics, imported general cosmetics and new cosmetic ingredients, and guiding and supervising the cosmetic notification-related work undertaken by the medical products administration departments of provinces, autonomous regions, and municipali

8、ties directly under the Central Government. The NMPA may entrust the medical products administration departments of provinces, autonomous regions, and municipalities directly under the Central Government that have the corresponding capabilities to implement notification management of provisions on r

9、egistration of new cosmetic ingredients herein shall apply.Article 39 The Technical Review Institute shall organize technical review in accordance with the technical review requirements within 90 working days from the date of receiving the application documents, and deal with according to the follow

10、ing circumstances:(I) Where the application documents are true and complete and can prove the product safety and quality controllability, the product formula and product executive standards are reasonable and meet the requirements of current laws, administrative regulations, mandatory national stand

11、ards and technical specifications, the Technical Review Institute shall make a technical review conclusion on approval;(II) Where the application documents are untrue or cannot prove the product safety and quality controllability, or the product formula and product executive standards are unreasonab

12、le or do not meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, the Technical Review Institute shall make a technical review conclusion on disapproval;(III) Where the applicant is required to supplement the documents, the Tec

13、hnical Review Institute shall inform he/she of all the contents that need to be supplemented at one time; the applicant shall supplement the documents at one time as required within 90 working days, and the review time limit shall be recalculated after the Technical Review Institute receives the sup

14、plementary documents; if the supplementary documents are not provided within the prescribed time limit, the Technical Review Institute shall make a technical review conclusion on disapproval.Article 40 The NMPA shall review the legality, standardization and completeness of the technical review proce

15、dures and the conclusion within 20 working days from the date of receiving the technical review conclusion, and make a decision on approving the registration or not.The Acceptance Institute shall issue a cosmetic registration hygiene permit or a decision letter of rejecting the registration to the a

16、pplicant within 10 working days after the NMPA makes the administrative approval decision. The cosmetic registration hygiene permit is valid for 5 years.Article 41 If the registration items of a special cosmetic that has been registered are changed, the NMPA shall implement classified management acc

17、ording to the degree of influence of the changed items on the product safety and efficacy:(I) For any change in the items that do not involve safety or efficacy claims, the registration applicant shall inform the NMPA in time;(II) For any change in items that involve safety, as well as substantial c

18、hange in production process, efficacy claims, etc., the registration applicant shall file an application for product registration change to the NMPA;(III) For any change in the product name, formula, etc., which essentially constitutes a new product, the registration applicant shall re-apply for reg

19、istration.Article 42 If a product that has been registered is no longer produced or imported, the registration applicant shall take the initiative to apply for cancellation of the registration hygiene permit.Section IV Renewal of Registration Hygiene permitArticle 43 If the registration hygiene perm

20、it of a special cosmetic expires and requires a renewal, the registration applicant shall apply to renew the registration within 90 to 30 working days before the expiration of the product registration hygiene permit , and promise to meet the requirements of mandatory national standards and technical

21、 specifications. The registration applicant shall be responsible for the authenticity and legality of the submitted documents and promises made.If any registration applicant fails to apply for renewing the registration within the time limit, its application for renewal of registration will no longer

22、 be accepted.Article 44 The Acceptance Institute shall conduct a formal review of the application documents within 5 working days after receiving the application for renewal of registration, accept the application if it meets the requirements, and issue a new registration hygiene permit to the appli

23、cant within 10 working days from the date of acceptance. The validity period of the new registration hygiene permit shall be recalculated from the day after the expiration date of the original registration hygiene permit.Article 45 The medical products administration departments shall supervise the

24、application documents and promises of the special cosmetic that has been renewed for registration. If after supervision and inspection or technical review, it finds that there is a circumstance that does not comply with the mandatory national standards and technical specifications, the registration

25、hygiene permit of the special cosmetic shall be withdrew according to the law.Chapter IV Supervision and AdministrationArticle 46 The medical products administration departments shall supervise and inspect the registration and notification related activities of registration applicants and notificati

26、on applicants in accordance with the provisions of laws and regulations. If necessary, it may conduct an extended inspection of the units involved in the registration and notification activities. The relevant units and individuals shall cooperate, and shall not refuse the inspection or conceal relev

27、ant information.Article 47 During the technical review process of registration, the Technical Review Institute may inform the review and verification institution to carry out on-site verification as needed. Domestic on-site verification shall be completed within 45 working days, and overseas on-site

28、 verification shall be implemented in accordance with relevant overseas provisions on verification. The time used for on-site verification shall not be included in the time limit of technical review.Registration applicants shall cooperate with the on-site verification, and if sampling and testing ar

29、e required, they shall provide samples as required.Article 48 After obtaining the registration hygiene permit of special cosmetics, the registration applicants shall upload the picture of the marketed product labels to the information service platform for public inquiry before the products are put o

30、n the market.Article 49 The cosmetic registration hygiene permit shall not be transferred. If the entity qualification of the original registration applicant is cancelled due to statutory reasons such as business merger or division, and the registration applicant is changed to a newly established en

31、terprise or any other organization, it shall be subject to the application for registration change as prescribed herein.The changed registration applicant shall comply with the provisions on registration applicants herein, and shall be responsible for the quality and safety of the marketed products.

32、Article 50 According to the development of scientific research, if the perception of the safety of cosmetics and cosmetic ingredients changes, or if there is evidence showing that a cosmetic or cosmetic ingredient may be defective, the medical products administration departments undertaking registra

33、tion or notification administration may order the registration applicant or notification applicant of the cosmetic or new cosmetic ingredient to carry out safety re-assessment, or directly organize the relevant ingredient enterprise and cosmetic enterprise to carry out safety re-assessment.If the re

34、sult of the re-assessment shows that the safety of the cosmetic or cosmetic ingredient cannot be guaranteed, the original registration department shall withdraw the registration hygiene permit or the original notification department shall cancel the notification. The NMPA shall include the cosmetic

35、ingredient into the catalog of ingredients prohibited in cosmetic production and announce to the public.Article 51 According to the development of scientific research, cosmetic safety risk monitoring and evaluation, etc., if a cosmetic ingredient is found to have any safety risk which can be elimina

36、ted by setting the use scope and conditions of the ingredient, the restricted use scope and conditions of the ingredient shall be clarified in the IECIC.Article 52 If the medical products administration departments undertaking registration or notification administration are unable to get in touch wi

37、th the registration applicant, notification applicant or domestic responsible person through the registration or notification information, it may list such person as the key supervision target and announce through the information service platform.Article 53 The medical products administration depart

38、ments shall implement risk classification and hierarchical management based on the quality management system operation, post-notification supervision, post-market supervision and inspection, etc. of the notification applicant, domestic responsible person and cosmetic production enterprise.Article 54

39、 The medical products administration departments, technical review, on-site verification, testing institutions and their staff shall strictly abide by relevant laws, regulations, rules and NMPA provisions to ensure that the related work is scientific, objective and fair.Article 55 Without the consen

40、t of the registration applicant or notification applicant, the medical products administration departments, professional technical institutions and their staff, and those participating in the review shall not disclose the trade secrets, undisclosed information or confidential business information su

41、bmitted by the registration applicant or notification applicant, except for those subject to other provisions or involving national security or major social public interests.Chapter V Legal LiabilityArticle 56 If any cosmetic or new cosmetic ingredient registration applicant fails to apply for chang

42、ing the registration of special cosmetics or new cosmetic ingredients as prescribed herein, the medical products administration departments that originally issued the hygiene permit shall order he/she to make corrections, give a warning, and impose a fine of RMB 10,000 yuan to 30,000 yuan.If any cos

43、metic or new cosmetic ingredient notification applicant fails to update the notification information on general cosmetics or new cosmetic ingredients in accordance with the provisions, the medical products administration departments undertaking notification administration shall order he/she to make

44、corrections, give a warning, and impose a fine of RMB 5,000 yuan to 30,000 yuan.If any cosmetic or new cosmetic ingredient registration applicant fails to re-register as prescribed herein, he/she shall be punished in accordance with the provisions of Article 59 of CSAR; if any cosmetic or new cosmet

45、ic ingredient notification applicant fails to re-notify as prescribed herein, he/she shall be punished in accordance with the first paragraph provisions of Article 61 of CSAR.Article 57 If any registration applicant or notification applicant of new cosmetic ingredients violates the provisions of Art

46、icle 21 herein, the medical products administration departments of the provinces, autonomous regions, or municipalities directly under the Central Government shall order he/she to make corrections; if he/she refuses to make the corrections, he/she shall be imposed a fine of RMB 5,000 yuan to 30,000

47、yuan.Article 58 If the medical products administration departments undertaking notification administration find that the notification documents of a notified cosmetic or notified new cosmetic ingredient do not meet the requirements, it shall order the notification applicant to make corrections withi

48、n the time limit. Among them, if the notification documents related to the safety of the cosmetic or new cosmetic ingredient do not meet the requirements as well, it may order the notification applicant to suspend sales and use at the same time.For cosmetics and new cosmetic ingredients that have be

49、en notified but the notification information has not yet been announced to the public, and the medical products administration departments undertaking notification administration finds that the notification documents do not meet the requirements, it may order the notification applicant to make corre

50、ctions and announce the notification information to the public after the notification documents have met the requirements.Article 59 If any notification applicant has the following circumstances, the medical products administration departments undertaking notification administration shall cancel his

51、/her notification of cosmetics or new cosmetic ingredients:(I) Where the notification applicant submits false documents when notification;(II) Where notification applicants notified documents do not meet the requirements, or the notification applicant does not make the corrections within the prescri

52、bed time limit as required, or the notification applicant does not suspend the sales and use of cosmetics or new cosmetic ingredients as required;(III) Where the notified new cosmetic ingredients or cosmetics fall beyond the notification scope.Chapter VI Supplementary ProvisionsArticle 60 The time l

53、imit involved in notice of registration acceptance, notification of technical review opinions, issue of registration hygiene permit and release of notification information, registration re-check, submission of use reports for new cosmetic ingredients, etc. shall be subject to the time of submission

54、or issue through the information service platform.Article 61 If the last process of cosmetics that contacts the contents is completed domestically, such cosmetics shall be deemed as domestic products; if it is completed overseas, such cosmetics shall be deemed as imported products; if it is complete

55、d in Taiwan of China, Hong Kong SAR or Macau SAR, such cosmetics shall be managed by reference to imported products.For products subject to cooperative use or products of combined packaging that are subject to application for registration or handling of notification under one product name, if the la

56、st process that contacts the contents of any dose is completed overseas, such products shall be managed as imported products.Article 62 After cosmetics or new ingredients have been registered or notified, they shall be numbered according to the following rules:(I) Numbering rules for notification of

57、 new cosmetic ingredients:国妆原备字+year (four digits)+serial number of new cosmetic ingredients notified this year.(II) Numbering rules for registration of new cosmetic ingredients:国妆原注字+year (four digits)+serial number of new cosmetic ingredients registered this year.(III) Numbering rules for notifica

58、tion of general cosmetics:Domestic products: the abbreviation of province, autonomous region or municipality directly under the Central Government+G 弟女网备字+year (four digits)+serial number of products notified in the administrative area this year;Imported products:国 1 女网备进字(the abbreviation of the pr

59、ovince, autonomous region or municipality directly under the Central Government where the domestic responsible person is located)+year (four digits)+serial number of products notified nationwide this year;Products from Taiwan of China, Hong Kong SAR and Macau SAR:国妆网备制字 (the abbreviation of province, autonomous region or municipality directly under the Central Government where the domestic responsible person is located)+year (fo