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You do not need a regulatory professional, this is not mandated within MoCRA. The ultimate legal responsibility lies with the US Responsible Person. They should have sufficient regulatory knowledge to meet the requirements of MoCRA, if they do not they can use the support of Worldover to help meet the requirements of MoCRA.

The deadline for the product listing & facility registration is 29th December 2023. However, the FDA will not be enforcing this element of MoCRA until 1st July 2024 so the industry has an additional 6 months from 29th December 2023 to comply but are advised to list products and/or register their facility as soon as they are able to do so. Legally, the additional 6 months is not an extension, it is 6 months where the FDA will not be enforcing. Other parts of MoCRA which have a deadline of 29th December 2023 will be enforceable from that date. This means cosmetic brands need to ensure they have adequate safety substantiation for their products and are reporting serious adverse events as well as recording all adverse events appropriately.

The FDA does not require a specific way for the information to come in. If the EU report contains the required information to demonstrate adequate substantiation of the safety of the product it is fine. It is your responsibility to make sure you have records to support this. The FDA have not stipulated what the report needs to look like.