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.
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:
A company in the Philippines involved in any of the following are required to register with the FDA:
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:
CPRs are applicable for all product classifications except cosmetics, as these require an NCP to be officially registered with the FDA.
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.
Among other information, the applicant shall provide the following information
The Certificate of Business Registration issued by the Department of Trade and Industry (DTI).
The Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation.
The Certificate of Registration issued by the Cooperative Authority and Articles of Cooperation.
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.
When the business or establishment address is different from the business name registration address, the applicant shall submit a copy of the Business Permit.
This is to verify the capitalization of the establishment to their corresponding application fees.
This shall be required for medium and large food manufacturers, traders, and distributors (for importer, exporter and/or wholesaler).
This shall be required for applicants applying for LTO as manufacturers of large and medium food manufacturers.
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.
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.
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 [email protected]