US FDA Voluntary Cosmetic Registration Form_Qpro Regulatory Services

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U.S. FDA Cosmetic registration is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US. There are two parts in FDA Voluntary Cosmetic Registration Program. Voluntary Cosmetic Establishments Registration and Cosmetic Product Ingredient Statements (CPIS) Filing. The State of California has imposed additional requirements for cosmetic products intended for use in California. Qpro Regulatory Services are always happy to assist you. Complete the following questionnaire which is self explanatory. Please feel free to contact us if you have any queries. U.S. FDA Voluntary Cosmetic Registration Program is Post-market reporting system. A company can participate in Voluntary Cosmetic Registration Program only if their products are in commercial distribution in USA. Whether your company products are in commercial distribution in USA? Yes No If Yes, please provide Products names that are in commercial distribution in USA. Product Names: _______________________________________________________________ California Safe Cosmetics Program reporting is required if the products are sold in California and the product ingredients contain any level (concentration) of a chemical known or suspected to cause cancer or reproductive harm. Whether your cosmetic products are sold in California? Yes No Do your products contain an ingredient known or suspected by an authoritative scientific body cited in the California Safe Cosmetics Act of 2005 (the Act) to cause cancer or reproductive harm? Yes No If Yes, please provide Products names that are in commercial distribution in USA. Ingredients or Chemical Names:___________________________________________________ Comments (If any): ___________________________________________________________________ By: ________________________________________________ Date: _ _ - _ _ - 201_ Signature FDA VOLUNTARY COSMETIC REGISTRATION PROGRAM CALIFORNIA SAFE COSMETICS PROGRAM (CSCP) [email protected] www.usfdacosmetics.net 1

Transcript of US FDA Voluntary Cosmetic Registration Form_Qpro Regulatory Services

Page 1: US FDA Voluntary Cosmetic Registration Form_Qpro Regulatory Services

U.S. FDA Cosmetic registration is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US. There are two parts in FDA Voluntary Cosmetic Registration Program. Voluntary Cosmetic Establishments Registration and Cosmetic Product Ingredient Statements (CPIS) Filing. The State of California has imposed additional requirements for cosmetic products intended for use in California. Qpro Regulatory Services are always happy to assist you. Complete the following questionnaire which is self explanatory. Please feel free to contact us if you have any queries.

U.S. FDA Voluntary Cosmetic Registration Program is Post-market reporting system. A company can participate in Voluntary Cosmetic Registration Program only if their products are in commercial distribution in USA. Whether your company products are in commercial distribution in USA? Yes No If Yes, please provide Products names that are in commercial distribution in USA. Product Names: _______________________________________________________________

California Safe Cosmetics Program reporting is required if the products are sold in California and the product ingredients contain any level (concentration) of a chemical known or suspected to cause cancer or reproductive harm. Whether your cosmetic products are sold in California? Yes No Do your products contain an ingredient known or suspected by an authoritative scientific body cited in the California Safe Cosmetics Act of 2005 (the Act) to cause cancer or reproductive harm? Yes No If Yes, please provide Products names that are in commercial distribution in USA. Ingredients or Chemical Names:___________________________________________________

Comments (If any): ___________________________________________________________________

By: ________________________________________________ Date: _ _ - _ _ - 201_

Signature

FDA VOLUNTARY COSMETIC REGISTRATION PROGRAM

CALIFORNIA SAFE COSMETICS PROGRAM (CSCP)

[email protected] www.usfdacosmetics.net 1

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Voluntary Cosmetic Establishments Registration Form

∗ Type entries in CAPITAL LETTERS. ∗ If you have more than one location, each location should register separately. ∗ Complete a separate Form for each Establishment Location. ∗ Use standard abbreviations whenever necessary. Omit all punctuation. ∗ If you need Cosmetic Product Ingredient Statements (CPIS) Filing Form, California Safe

Cosmetics Program (CSCP) Form or any other forms, please download from our website or contact us.

Original Amendment Cancellation

FDA registration number (for Amendment / Cancellation): ________________________________

Establishment Name: ______________________________________________________________ (Please include Business Entity eg. Ltd., Inc., etc, if any)

Business Type: Manufacturer Packer Both Others: ______________________

Name of Parent Company (if any): ___________________________________________________ (Please include Business Entity eg. Ltd., Inc., etc, if any)

Street Address: _________________________________________________________________

City: ____________________ State/Province: _____________________ ZIP/Pincode: ________

Country: ______________________________ Website: _________________________________

Contact Name: ______________________/______________________/______________________ First Name Middle Name Last Name

Designation: ____________________________ Email: __________________________________

Telephone: _____________________________ Fax: ___________________________________

TYPE OF SUBMISSION

COMPANY INFORMATION

CONTACT INFORMATION

INSTRUCTIONS

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Sl. No Other Business Trading Names (Doing Business As) Type of Action

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PayPal Transaction Number (ID): ___________________________________________________ Date of Payment: _ _ - _ _ - 201__

{Please contact us for Payment related queries or any other information. We are always happy to assist you.} Comments (If any): ___________________________________________________________________

DOING BUSINESS AS

PAYMENT INFORMATION

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Page 4: US FDA Voluntary Cosmetic Registration Form_Qpro Regulatory Services

Qpro Regulatory Services and the undersigned party have today entered into an agreement regarding the provision of consultancy services on the terms and conditions laid out in this Agreement.

∗ In rendering consulting services under this Agreement, Qpro Regulatory Services shall conform

to standards of work and business ethics. However, Qpro Regulatory Services shall bear no liability or otherwise be responsible for complete assurance and delays in the provision of Services.

∗ The Client agrees to provide accurate and sufficient information, adequate technical assistance and documentation, required for Qpro Regulatory Services to be able to perform the Services. The Client shall promptly provide further information Qpro Regulatory Services reasonably deems relevant to perform the task.

∗ The Client is solely responsible for the scientific accuracy, material facts and completeness of information provided to Qpro Regulatory Services.

∗ The Client shall pay to Qpro Regulatory Services fees at the rate specified in the Purchase Order.

∗ The Parties agree to make all reasonable efforts, in good faith, to resolve any dispute arising from implementation of this agreement through informal discussions and the development of mutual satisfactory options.

∗ Qpro Regulatory Services liability in whatever kind or nature cannot exceed the fee for performing the task.

∗ This Agreement shall terminate automatically upon completion by Qpro Regulatory Services of the Services required by this Agreement or 30 calendar days from the effective date of this agreement.

∗ Qpro Regulatory Services is a Private business entity and is not affiliated with U.S. FDA.

By: _______________________________ Company Name: ________________________________ Signature _______________________________________________________________________________ Authorized Person Name _______________________________________________________________________________ Designation Date: _ _ - _ _ - 201_ ___________________________________________________________

AGREEMENT

[email protected] www.usfdacosmetics.net 4