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Philippines Cosmetic Product Registration

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Philippines Cosmetic Product Registration

COSMETIC REGISTRATION IN PHILIPPINES

Regulatory Authority

The Food and Drug Administration (FDA)

Link for Regulatory Authority

https://www.fda.gov.ph/

Local Regulation

Adoption of the Association of Southeast Asian Nation (ASEAN) Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents.

Who can Register?

  • Owner
  • Incorporator
  • Authorized representative

Data to be Communicated

  • Completed Application Forms, Declarations, and Agreements
  • Proof of Business Name Registration
  • Site Master File (for manufacturers of drugs, devices and cosmetics)
  • Risk Management Plan
  • Payment

Process to Register Cosmetic Product

  • Filing: Upon submitting all requirements, including payment of required fees, an application for a License to Operate (LTO), whether initial, renewal, or variation, and other authorizations, is filed.
  • Evaluation: All LTO applications will be evaluated based on the authenticity of the submitted papers and their conformity with applicable requirements. The application will be rejected if the applicant fabricated, misrepresented material facts or documents, or withheld any material data or information. The applicant may be examined in such circumstances, accusations brought against him, and penalties imposed. If there is a need for clarification on the application, the applicant will be notified, either in writing or by e-mail.
  • Inspection: Manufacturers will be required to conduct a pre-opening inspection. The FDA may visit all covered facilities as part of its post-marketing surveillance efforts. Before a cosmetic product is put on the market, the company or person in charge of it must notify the FDA. The FDA E-Portal, which may be accessed through the FDA official website https://ww2.fda.gov.ph, will be used to submit the notification application

Timeframe and Fees

Validity: 1-3 years

Notification

Before a product can be released to the market, the FDA must be notified using the procedures outlined in the Cosmetic E-Notification v.2.0 User Manual for Applicants. 

The notification should include the following details:

  1. Brand Name / Product Name / Product Variants: Provide the complete name of the product in the sequence of brand name, line name (if applicable), product name, and shade name/number if applicable (e.g., BRAND ABC PRODUCT XYZ EYSHADOW SHADE 1). If there are multiple shades, each shade name/number must be declared.
  2. Product Types: Specify the category of the cosmetic product for which the notification is being submitted.
  3. Particulars of the Product: Select the validity period of the notification, which may be 1, 2, or 3 years, at the discretion of the applicant.
  4. Intended Use: Describe the function or purpose of the product, excluding directions for use (e.g., moisturizing the face, hands, etc.).
  5. Product Presentations: Indicate whether the notification is for (1) a single product, (2) a range of variants with similar composition but differing in colors, flavors, etc., (3) palette(s) within a single product type, or (4) combination products within a single kit.
  6. Local Company Responsible for Placing the Cosmetic Product in the Market: Provide details of the local company responsible for placing the cosmetic products in the market, including a valid LTO number. If the responsible company is a distributor, declare the details of the direct supplier or manufacturer, including Country of Manufacture, Address, etc.
  7. Establishment Information: Specify details of the manufacturer and/or supplier of the notified cosmetic product.
  8. Person Representing the Local Company: Provide the contact information of the company representative who can be reached by the FDA for inquiries or additional document submissions related to the cosmetic product.
  9. Product Ingredient List: List all ingredients in the product using nomenclature from recognized references (e.g., International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services). Botanicals and botanical extracts should be identified by genus and species, with the genus possibly abbreviated. Declare the functions and percentages of ingredients if they are substances with usage restrictions specified in the annexes of the ASEAN Cosmetic Directive.

Additional information:

Manufacturing Requirements: GMP and Ingredient Compliance Manufacturers must ensure that their manufacturing processes and practices, including personnel, premises, equipment, sanitation, and hygiene, comply with the Good Manufacturing Practices (GMP) outlined in the ASEAN guidelines. Please note that a Certificate of GMP Compliance will only be granted upon satisfactory demonstration of compliance and will remain effective for the duration of your current LTO. Subsequently, it must be renewed with each LTO renewal. Additionally, besides adhering to procedures and processes, it is crucial to ensure that ingredients used in cosmetic products comply with ASEAN cosmetic regulations. The annexes of the ASEAN Cosmetic Directive outline prohibitions and regulations for cosmetic product ingredients.

Cosmetic labelling in the Philippines should contain the following information:

  • Product content in weight/volume
  • Brand, product name and function
  • Batch number.
  • Manufacturing/expiration date of the product in clear terms (month/year)
  • Country of Manufacture
  • Instructions/Directions for use
  • List of all ingredients
  • Special precautions

Name and address of company or person who placed the product on the market.