📢NOTICE! Product pre-market notification®istration will be directly influenced if cosmetics efficacy evaluation abstract is not uploaded
This is a notice from cosmetic enterprises WECHAT group. Yes! From 1 January 2022, when applying for the registration of special cosmetics or the notification of general cosmetics, the cosmetics registrant and notifier shall evaluate the cosmetics efficacy claim as required in Specifications for Cosmetics Efficacy Claim Evaluation(hereinafter referred to as the Specifications ) and upload the abstract of product efficacy claim evidence on the website designated by NMPA. (NMPA Announcement on issuing Specifications for Cosmetics Efficacy Claim Evaluation (NO.50 of 2021))
What should be included in the abstract of cosmetics efficacy claim evidence?
According to Article 19 in the Specifications, the contents of cosmetics efficacy claim evidence shall be briefly listed in the abstract, and the following information shall be at least included:
Successful case of the abstract of cosmetics efficacy claim evidence
Moisturizing
Publicity of Efficacy abstract on NMPA website
【Basic information】
【Moisturizing】
Relevant Article of penalties in CSAR
【CSAR】Article 62 Under any of the following circumstances, the Department in charge of drug Supervision and Administration shall order it to make corrections, give a warning, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan; if the circumstances are serious, it shall order it to stop production and business, and impose a fine of not less than 30,000 yuan but not more than 50,000 yuan, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan on the legal representative or the principal responsible person, the leading person directly in charge and other directly responsible persons of the illegal unit: (1) failing to publish the abstract of cosmetics efficacy claim evidence in accordance with the provisions of the regulations.
ZMUni Tips
Besides that the product applying for notification and registration should conduct efficacy evaluation, the registered and notified product also need supplementing the efficacy evaluation abstract on time! For cosmetics that has been registered or notified before 1 May 2021, cosmetics registrants and notifiers shall before 1 May 2023 evaluate the efficacy claim of the cosmetics and upload the the abstract of cosmetics efficacy claim evidence according to the requirements in the Specifications. For cosmetics that have been registered or notified from 1 May 2021 to 31 December 2022, cosmetics registrants and notifiers shall before 1 May 2022 evaluate the efficacy claim of the cosmetics and upload the the abstract of cosmetics efficacy claim evidence according to the requirements in the Specifications.
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ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心
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