FDA Registration

Businesses engaged in the manufacture, import, export, distribution, market, or advertisement of products in the Philippines are required to register with the FDA during the set-up phase of the business.

 Food and Drug Administration

The Food and Drug Administration (or FDA, formerly BFAD) is a government agency under the Department of Health responsible for licensing and regulating products for distribution in the Philippines. It regulates certain products in the Philippines.

FDA’s registration requirements and processing timeline will depend on the classification of the products you want to market, which could be any of the following:

• • Food and Beverages, Food Supplements
  • Drugs and/or Pharmaceuticals
  • Cosmetics
  • Household Hazardous
  • Pesticides
  • Medical devices
  • Diagnostics
  • Veterinary Products

A company in the Philippines involved in any of the following are required to register with the FDA:

• • Manufacturing
  • Packaging and/or Re-packaging
  • Trading
  • Importation
  • Exportation
  • Wholesale
  • Distribution
  • Retail Pharmacy (of FDA-regulated products)

To conduct any of the above business activities with products under the jurisdiction of the FDA, a foreign investor or company must first secure a License to Operate (LTO) from the FDA as: (1) Importer, Distributor, or Wholesaler if their products are going to be imported from different countries; or as (2) Manufacturer if their products are going to be manufactured locally.

After obtaining an LTO, they are required to apply for either of the following depending on the classification of their products:

• • Certificate of Product Registration (CPR)
  • Notification of Cosmetic Product (NCP)

CPRs are applicable for all product classifications except cosmetics, as these require an NCP to be officially registered with the FDA.

What is a License to Operate (LTO)?

A License to Operate or LTO is a license which must be secured in order to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of food, drugs, cosmetics, health products, and other medical products and devices.

Requirements for Obtaining an LTO

Among other information, the applicant shall provide the following information:

• • Accomplished Application Form (web-based form)
  • Location Plan
  • Global Positioning System (GPS) coordinates
  • Name of the Qualified Person
  • Proof of Business Registration
    • For single proprietorship: The Certificate of Business Registration issued by the Department of Trade and Industry (DTI)
    • For Corporation, Partnership, and other Juridical Person: The Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation.
    • For Cooperative: The Certificate of Registration issued by the Cooperative Authority and Articles of Cooperation
    • For Government-Owned or Controlled Corporations: The law creates the establishment, if with original charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation, if without original charter.

• • Business Permit. When the business or establishment address is different from the business name registration address, the applicant shall submit a copy of the Business Permit.
  • Proof of Capital or Income. This is to verify the capitalization of the establishment to their corresponding application fees.
  • Risk Management Plan. This shall be required for medium and large food manufacturers, traders, and distributors (for importer, exporter and/or wholesaler).
  • Site Master File. This shall be required for applicants applying for LTO as manufacturers of large and medium food manufacturers.

Additional Requirements, as applicable based on FDA Circular 2021-012 (Food Traders/Distributors):

• • Franchise Agreement. For franchises, a copy of the Franchise agreement is recommended to be submitted. The business name of the establishment reflected in the LTO shall be based on the trade name indicated in the franchise agreement. In addition, this must be consistent with the business name registration.
  • Contract of Agreement. For the appropriate determination of activity to be indicated in the LTO, a copy of the Contract of Agreement is recommended to be submitted. The basis for the LTO activity shall depend on the legally binding contract agreement between the applicant and its client/supplier.

Process for Securing an LTO

[1] Set up a Philippine business entity or partner with a local distributor.

[2] Compile necessary documents.

• Proof of business registration
• Valid Mayor’s Permit
• Valid IDs of signatory and representative

[3] Request for a company-specific e-Portal account. 

[4] Submit the documentary requirements for evaluation.

[5] Pay filing fees.

[6] Claim LTO from FDA. 

 You know what’s best for you. Let Filepino guide you through this process of obtaining an LTO for your business and certificates for your products. Email us at info@filepino.com.