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Product Registration

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.

What We Offer 

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

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

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/urban hazardous
  • medical devices
  • in-vitro diagnostics

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)

A Step-by-Step Process on How to Secure an 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)
  • Certificate of Medical Device Notification (CDMN) / Certificate of Medical Device Registration (CMDR)
  • Cosmetic Product Notification (CPN)

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:
  • Request for a company-specific ePortal account
  • Submit the documentary requirements for evaluation
  • Pay filing fees
  • Claim LTO from FDA

A Step-by-Step Guide 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 CPN

Similar to applying for a CPR, applying for a CPN 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 a CPN

  • 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 initial 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 License to operate (LTO) 

  • Food Establishment – 2 years
  • Cosmetic Establishment – 1 year
  • Medical Device Establishment – 2 years
  • Drug Establishment – 2 years

For Certificate of Product Registration (CPR)

  • Foods – 5 years
  • Food Supplements – 2 years
  • Medical Devices – 1 year
  • Drug Products – 1-2 years

For Cosmetic Product Notification (CPN)

  • Cosmetic Products – 1 year

Obtain an FDA License for Your Food and Drug Products in the Philippines

It is imperative to secure proper licensing and registration to allow your company to legally manufacture, import, export, and distribute food and drug products within and outside of the Philippines.  With a large pool of business registration and corporate compliance services, our team can help you achieve a fast and reliable product registration process in the Philippines.

Product Registration Services in the Philippines FAQs

What kind of companies are required to register with FDA?

Any enterprise engaged food and drug production in the Philippines must register with FDA, including those involved in the following activities:

  1. Manufacturing
  2. Packaging
  3. Re-packaging
  4. Trading
  5. Importation
  6. Exportation
  7. Wholesale
  8. Retail Pharmacy (of FDA-regulated products)

What will I need to obtain for my company to secure FDA Licensing?

If you plan to establish a business in the Philippines engaged in the production of food, cosmetics, and drug production, you must secure any of the following that is applicable to your company: 

  1. License to Operate (LTO)
  2. Certificate of Product Registration (CPR)
  3. Notification of Cosmetic Product (NCP)

How long is the validity for FDA-issued lisences and permits?

  1. For LTOs
    1. Foods – 5 years
    2. Cosmetic Products – 2 years
    3. Medical Devices – 2 years
    4. Drug Products – 2 years
  2. For CPRs
    1. Foods – 5 years
    2. Medical Devices – 1 year
    3. Drug Products – 1 to 2 years
  3. For NCPs
    1. Cosmetic Products – 1 to 3 years

Need to Register Your Product/s with the Philippine FDA?

We will process your application requirements so you can legally manufacture, import, export, market, and/or distribute your product/s in the Philippines.

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