How MoCRA compliance and AEM software are transforming cosmetics industry reporting
Summary
Bellomo offers expert advice on navigating these regulatory changes and the critical role of effective post-market surveillance in the evolving cosmetics landscape. Companies have 15 days to report to the FDA a serious adverse event, and without a proper intake process and system, it will be difficult to meet the time requirement. JB: Cosmetics have been granted the ability to use electronic contact as a means for receiving adverse events from consumers, which has not been allowed in other industries, such as drugs or dietary supplements. We have been able to create a branded URL or QR code that companies can use on their cosmetic primary and secondary labels that brings consumers to a dedicated web domain with over 40+ fields to collect all necessary information for investigating and reporting an adverse event. This is why collecting information and providing the assessment is crucial in understanding a company’s next steps and potential liability for the products that are receiving adverse event reports.
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