Product Registration

The Food and Drug Administration (FDA), formerly known as BFAD, is a government agency under the Department of Health responsible for licensing and regulating products for distribution within the Philippines.

The registration criteria and processing timelines imposed by the FDA are contingent upon the product classification, which could include any of the following:

– Food

– Food Supplements

– Drugs

– Cosmetics

– Household Hazardous

– Pesticides

– Medical Devices

– Diagnostics

– Veterinary Products

Entities involved in activities such as manufacturing, packaging, re-packaging, trading, importation, exportation, wholesale, or retail pharmacy of FDA-regulated products are mandated to register with the FDA.

– Completed Application Form

– Proof of Business Registration

– Site Master File (for drug, device, and cosmetic manufacturers)

– Risk Management Plan

– Proof of fee payment

The process to secure an LTO involves establishing a Philippine business entity or collaborating with a local distributor, compiling essential documents, and submitting them for evaluation. The applicant must also pay the required fees and subsequently collect the LTO from the FDA.

A Certificate of Product Registration (CPR) is exclusively issued to enterprises and manufacturers that already possess a valid LTO. Enterprises with multiple products must register each product, including individual variants, flavors, dosage strengths, etc., each with its unique registration number in the Philippines.

Requirements for Obtaining a CPR consist of:

– Completed Application Form

– Clear and complete packaging labels or artwork for all package sizes

– Images of the product from all angles

– Justification for label claims (e.g., nutritional facts, Halal logo, nutritional and health claims) if applicable

– Commercial product presentation sample (for food supplements)

– Proof of fee payment

The process to secure a CPR necessitates a valid LTO based on the company’s activities, revalidation of the ePortal account to eRegistration, compiling the requisite documents, and submitting them for evaluation. The applicant must also pay the stipulated fees and provide an actual commercial sample for the issuance of the CPR by the FDA.

Similar to CPR applications, securing a Notification of Cosmetic Product (NCP) mandates the possession of a valid LTO. However, this requirement is only applicable to cosmetic products. All other product categories require CPR registration.

Requirements for Acquiring an NCP include:

– Certificate of Manufacturer

– Certificate of Free Sale or Good Manufacturing Practice Certificate

– Details of each ingredient in the product formulation, including names, functions, and percentages

– Complete packaging labels or artwork for all package sizes and commercial product packaging

– Proof of fee payment

License/Permit Renewals

The duration of licenses and permits granted by the FDA depends on the product classification and registration. The validity period is as follows:

For LTOs:

– Foods: 5 years

– Cosmetic Products: 2 years

– Medical Devices: 2 years

– Drug Products: 2 years

For CPRs:

– Foods: 5 years

– Medical Devices: 1 year

– Drug Products: 1-2 years

For NCPs:

– Cosmetic Products: 1-3 years

Proper licensing and registration are vital for your company to legally manufacture, import, export, and distribute food and drug products within and outside of the Philippines. With a wealth of business registration and corporate compliance services at our disposal, our team can streamline the product registration process in the Philippines, making it fast and reliable.