Exercise 2b

• Cosmetic products are notified to the FDA instead of being registered
• The notification process is used to inform the FDA that the product will be used by consumers
• The E-Notification Process is widely used due to the pandemic
• The application procedure for electronic cosmetic product notification consists of 4 main parts: Submission, Payment, Download Result, Revalidation
• Submission process for electronic cosmetic product notification:

  • Access the FDA e-Portal at https://www.fda.gov.ph
  • Login using the provided CCRR user account credentials given by the Center for Cosmetics Regulation and Research (CCRR)
  • Select 'New case' in the HOME tab to proceed to the notification form
• Submission process for electronic cosmetic product notification (cont.):

  • The user may select their preferred process from the list displayed to proceed with the application
  • The 'Inbox' tab displays current tasks delegated to the user for further action
  • Other folders like DRAFT, PARTICIPATED, UNASSIGNED, and PAUSED provide additional information
• Submission process for electronic cosmetic product notification (cont.):

  • Fill in the notification form provided in parts by the application wizard
  • Complete the fields as thoroughly as possible, marking required fields with a red asterisk (*)
  • An assessment slip will be generated at the end of the step for download
• Guidelines in filling the notification form:

  • Declaration: Select responses using drop-down lists and click Continue
  • Particulars of the product: Add variants/packaging sizes/packaging types, GTIN, select Product Type and Presentation, and click Next to proceed
  • Local company responsible for placing the product in the market: Provide valid LTO number, activity of the company, and additional details as required
• Guidelines in filling the notification form (cont.):

  • Details of the person representing the company: Name and designation will automatically reflect the current user
  • Product ingredient list: Declare full ingredient list, function, and percentage of restricted ingredients in the formulation
• Information to be declared in the product notification includes:

  • Brand Name: Complete name of the product in sequence (Brand name, Line name, Product name, Shade name/number if applicable)
  • Product Name, Variants, and Types
  • Intended Use: Refers to the function or use of the product
  • Product Presentations: Single product or range of variants
  • Combination Products in a Single Kit
  • Local Company Responsible for Placing the Cosmetic Product in the Market
  • Establishment Information of the Manufacturer and/or Supplier
  • Person Representing the Local Company
  • Product Ingredient List: All ingredients specified using standard references, with functions and percentages declared if necessary
• All ingredients in the product must be specified using nomenclature from standard references like the International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services
• Botanicals and extracts of botanicals should be identified by genus and species, with the genus possibly abbreviated
• Functions and percentages of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive
• Result of Application:

  • A cosmetic e-notification application may be acknowledged or disapproved
  • Acknowledged applications may be revalidated for a new validity date based on the submission date of the revalidation application
• Revalidation Process:

  • Acknowledged cosmetic notifications may be revalidated for a new validity date
  • The same application process applies for revalidation, with no modifications allowed from the previous application
  • If changes are made, a new notification application is required
  • Applicants can choose to cancel the application if desired
• Payment Process:

  • Download the generated assessment form and print copies as needed, noting the reference number for payment options
  • Clients can pay through bank facilities made available by FDA
• Summary of Steps:

  • Access the FDA e-portal and log in
  • Select New case in the Home tab to proceed to the notification form
  • Complete the notification form sections: Declaration, Particulars of the product, Local company, Details of the person representing the company, Product ingredient list
  • Receive the Assessment Form with the Reference Number
  • Receive the Acknowledged Cosmetic Notification Form