Requirements for FDA Registration in the Philippines

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The Philippine Food and Drug Administration (FDA) is the national health product regulatory agency created by Republic Act (RA3720), as amended by Executive Order No. 175 and RA 9711. It was created under the Department of Health to license, monitor, and regulate the flow of food, drugs, cosmetics, medical devices, and household hazardous waste in the Philippines.

Read This :   Business Registration

Business entities must secure both a License To Operate (LTO) and a Certificate of Product Registration (CPR) from the FDA Philippines before it can engage in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertisement and/or sponsorship of the following products in the Philippines:

1. Drugs;
2. Pharmaceuticals;
3. Medical devices;
4. Cosmetics;
5. Processed Food;
6. Toys;
7. Child care articles;
8. Veterinary products; and
9. Household/urban pesticides.

The following are the requirements for application of a License to Operate (LTO):

For Initial Application

• Accomplished Application Form with Declaration and Undertaking
• Proof of Business Name Registration
• Site Master File (for manufacturers of drugs, devices and cosmetics)
• Risk Management Plan
• Payment of the appropriate filing fee

For Renewal Application

• Accomplished Application Form with Declaration and Undertaking
• Payment of the appropriate filing fee

Meanwhile, the following are the requirements for securing the Certificate of Product Registration (CPR):

For Initial Application

• Integrated Application Form
• Proof of payment of fees
• Clear and complete loose labels or artworks
• Pictures of the product
• For food supplement, a sample in actual commercial presentation
• As applicable, justification of label claims (i.e. nutritional facts, Halal logo, nutritional and health claims)

For Renewal Application

• Integrated Application Form
• Proof of payment of fees
• Requirements in support of amendments in the renewal application (not applicable for automatic renewal)
• Clear and complete loose labels or artworks

Note that the above-listed requirements are a general list and may vary depending on the type of activity and/or product sought to be registered with the FDA.

For more information, contact Yap, Kung, Ching & Associates Law at info@ykclaw.ph.