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  • 1.  Regarding MoCRA

    Posted 18-Oct-2023 08:12
    Hi all,
    Does anyone known when MoCRA will be effective and we can update our establishment in the CDeR. I know that they say December 29 but nothing is out there yet.

    Winston Costa Pereira

    Sent from my iPhone


  • 2.  RE: Regarding MoCRA

    Posted 19-Oct-2023 04:27

    Hi Winston,

    FDA was seeking comments till 18th October on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). As per the draft guidance on Facility registration and product listing, the electronic portal would be available in October 2023. FDA has recently also published the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures for Cosmetic Facility registration and product listing. FDA also intends to make the Cosmetics Direct electronic submission portal available in the future at https://direct.fda.gov/. 

    Hope this information is useful.

    Thanks & Regards

    Anjali Mukherji



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    Anjali Mukherji
    Gurgaon
    India
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    Original Message


  • 3.  RE: Regarding MoCRA

    Posted 19-Oct-2023 08:51

    Hi Winston.

    Simply put, the system is not up and running as yet.  In fact, I have not even heard from any of my colleagues in the cosmetics world whether or not the beta-testing of the system has even begun at this point.  So as Anjali noted the only guidance we have on timing is that it will become available in October.  I am not entirely sure I would see that happening at this time simply because we are already to 10/19 and the comment period for the forms and the related online guidance document was just completed yesterday.

    Additionally, I am not sure exactly how FDA expected industry or anyone else to provide comments on the screenshot guidance document that they provided because it was extremely poor resolution so I can tell you I had difficulty figuring out what half of the screenshots themselves actually said on them.

    Technically MoCRA is effective already and the registration and product listing is mandatory to be in place and completed by December 29, 2023 for all products in distribution as of December 2022.  After that you get 120 days either from December 29, 2023 (for anything placed on market between December 2022 and December 29, 2023) or from the date of market entry for products initially launched on the market after December 29, 2023 to update your registration and keep the product listing accurate.



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    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
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    Original Message


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