The Food and Drug Administration (FDA)
Link for RA:
Adoption of the Association of Southeast Asian Nation (ASEAN) Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents
Who can register :
- 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
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.
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.
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
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