WHAT INFORMATION MUST BE SUBMITTED IN COSMETIC FACILITY REGISTRATION AND COSMETIC PRODUCT LISTING UNDER MOCRA ACT?

According to FDA’s August 2023 draft guidance, following information will be required in Cosmetic Facility Registration:

1. Owner and/or operator of the facility
2. Facility Name, Address, Email & Telephone Number
3. US Agent (for non-US facilities) Name, Email & Telephone Number
4. FEI number or Facility Registration Number, if previously assigned
5. Brand names under which cosmetic products are sold
6. Product category
7. Responsible person for each cosmetic product
8. Type of submission (initial, amended, biennial renewal, or abbreviated biennial renewal)

The Cosmetic Product Listing shall contain:

1. Facility Registration Number of manufacturer
2. Name of Product
3. Responsible person Name & Telephone Number
4. Product Category
5. Ingredient List
6. Product listing number, if any, previously assigned by the FDA.
7. Type of submission (initial, update, abbreviated renewal)

The above information may change once FDA releases final guidance on MoCRA. Please visit our website for most updated information.

Liberty Management Group Ltd. provides assistance with MoCRA submissions.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us