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

We will assist you in obtaining the right licenses/certificates from the FDA, such as the following:

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

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.

However, you have to take note that the 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
  • Hazardous Household Products
  • Pesticides
  • Medical Devices
  • Diagnostics
  • Veterinary Products

Applying for an LTO

Before foreign companies can introduce their products in the Philippine market, it’s highly recommended that they first check the FDA requirements for certificate of product. They must first 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 thereafter 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

Applying for 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 will 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

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

  • Cosmetic Products- 1-3 years 

Well-situated to serve companies regionally, Incorp Group is the go-to for tailored advice and seamless execution. For more information on the FDA registration and classification of products in the Philippines, get in touch with our team.

FAQs

What are the 3 licenses and certificates that foreigner investors are required to obtain from the FDA in the Philippines?

Foreign investors and enterprises seeking to import, export, distribute, market, advertise or manufacture products in the Philippines are required to obtain a license(s)/certificate(s) from the FDA in the Philippines such as:

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

What are the requirements to obtain the License to Operate (LTO) under the FDA registration in the Philippines?

The requirements for obtaining the LTO under the FDA registration in the Philippines are the following:

  • 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

When is the Certificate of Product Registration (CPR) issued under the FDA registration in the Philippines?

The CPR under the FDA registration is only issued to enterprises and manufacturers that already have a valid LTO in the Philippines.

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Our Philippine FDA consultants will help you enjoy a seamless product registration process