Product Registration Services in the Philippines for Local and Foreign Enterprises

Local and foreign enterprises seeking to manufacture, import, export, distribute, market, or advertise products in the Philippines are required to register with the Food and Drug Administration (FDA).

Our FDA consultants are closely involved in the product registration, classification, investigational device submissions, and procurement of forms for licensing. We also provide assistance on the renewal of permits/licenses and how to secure compliance with FDA’s specifications on production facilities.

We will assist you in securing and renewing the right licenses/certificates from the FDA, which could be any of the following:

  • License to Operate (LTO)
  • Certificate of Product Registration (CPR)
  • Notification of Cosmetic Product (NCP)

What is the FDA?

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.

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
  • food supplements
  • drugs
  • cosmetics
  • household hazardous
  • pesticides
  • medical devices
  • diagnostics
  • veterinary products

Establishments involved in any of the following are required to register with FDA:

  • manufacture
  • packaging
  • re-packaging
  • trading
  • importation
  • exportation
  • wholesale
  • retail pharmacy (of FDA-regulated products)

Steps on How to Secure a LTO

To successfully register a food or drug product in the Philippines, local and foreign enterprises must secure a License to Operate (LTO) as (1) Importer, Distributor, or Wholesaler if they want to import their products from overseas; or as (2) Manufacturer if they intend to manufacture them 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.


Requirements for Obtaining an LTO

  • Accomplished Application Form
  • Proof of Business Registration
  • Site Master File (for manufacturers of drugs, devices, and cosmetics)
  • Risk Management Plan
  • Proof of payment of fees


Process for Securing an LTO

  • Set up a Philippine business entity or partner with a local distributor
  • Compile necessary documents:
    • Proof of business registration
    • Valid Mayor’s Permit
    • Valid IDs of signatory and representative
  • Request for a company-specific ePortal account
  • Submit the documentary requirements for evaluation
  • Pay filing fees
  • Claim LTO from FDA

Steps on How to Secure a CPR

A CPR is only issued to enterprises and manufacturers that already have a valid LTO. If you have more than one product, you need to register EACH product, specifically their individual variant, flavor, dosage strength, etc. Each product must have its own registration number in the Philippines.


Requirements for Obtaining a CPR

  • Accomplished Application Form
  • Clear and complete loose labels or artworks of all packaging size
  • Pictures of the product in all angles
  • If applicable, justification of label claims (i.e., nutritional facts, Halal logo, nutritional and health claims)
  • Product sample in actual commercial presentation (for food supplements)
  • Proof of payment of fees


Process for Securing a CPR

  • Have a valid LTO based on the company’s activities
  • Revalidate the ePortal account to eRegistration
  • Compile necessary documents:
    • Product Labels (in compliance with FDA’s laws about labeling)
    • Product Analysis (to substantiate claims of vitamins and nutrients based on Philippine RENI; or to prove absence of harmful microorganisms or chemicals)
    • Product Sample
  • Submit the documentary requirements for evaluation
  • Pay filing fees
  • Submit an actual commercial sample
  • Claim CPR from FDA

Applying for an NCP

Similar to applying for a CPR, applying for an NCP requires a valid LTO. However, this is only a requisite for cosmetic products. All other products must be registered with the CPR.


Requirements for Obtaining an NCP

  • Certificate of Manufacturer
  • Certificate of Free Sale or Good Manufacturing Practice Certificate
  • Names, functions, and percentage of each ingredient in the product formulation
  • Clear and complete loose labels or artworks of all packaging size and commercial product packaging
  • Proof of payment of fees


Renewal of Product Licenses/Permits

The validity of the licenses and permits that FDA issues will be in accordance with their product classification and registration.

The duration of product validity per classification are 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