PROFICIENCY - ONE-STOP MoCRA SOLUTION
Following the discontinuation of the Voluntary Cosmetic Registration Program (VCRP) in March 2023, the Modernization of Cosmetics Regulation Act (MoCRA) mandates the registration of cosmetic product facilities and product listings. Key requirements include:
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Facility Registration: Manufacturers and processors must register with the FDA, update information within 60 days of changes, and renew registration every two years.
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Product Listing: A "Responsible Person" must list each marketed cosmetic product with the FDA, including ingredients, and update this information annually.
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Responsible Person Definition: This refers to the manufacturer, packer, or distributor whose name appears on the cosmetic product label.
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Adverse Event Reporting: Responsible Persons must report serious adverse events related to cosmetic products to the FDA within 15 business days, including a copy of the product label, and provide additional information within one year of the initial report.
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Safety Substantiation: Manufacturers must ensure product safety without specific testing requirements from the law or FDA regulations.
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Good Manufacturing Practice (GMP): Facilities must adhere to GMP requirements for cosmetic product manufacturing.​
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Services Offered by Provision Consulting Group
Facility Registration
Adverse Event Report
Package Label, Ingredient Review
Online Webpage Review
Responsible Person
cGMP Implementation
Product Listing
Safety Data Substantiation
Our Establishments
We have been in the FDA regulated industry for the past 11 years, serving variety of clients from diverse sectors all around the globe. In midst of AI thriving trend, we still strongly believe that direct involvement of our experienced consultants are what makes our clients' success in the U.S. market.