Domestic and Foreign entities that seek to import, export, distribute, market, advertise or manufacture products in the Philippines must comply and register with the Food and Drug Administration (FDA).
The FDA is responsible for the licensing, monitoring, and regulation of the following products that will go out in the market:
- Food
- Food Supplements
- Drugs
- Cosmetics
- Household/Urban Hazardous Products
- Medical Devices
- In-Vitro Diagnostics
What We Offer
Our experienced FDA consultants are closely involved in product registration, classification, investigational device submissions, and procurement of forms for licensing. We will be able to help you with acquiring the following licenses/certificates from the FDA:
- License to Operate (LTO)
- Certificate of Product Registration (CPR)
- Cosmetic Product Notification (CPN)
Aside from obtaining FDA licenses and certificates, our firm also helps with the renewal of permits/licenses as well as securing compliance with the FDA’s specifications on production facilities.
License To Operate (LTO) Application
Before a foreign entity launches a product in the Philippine Market they should check the FDA requirements for certificate of product. If they want to import their products from overseas, they must secure an LTO as Importer, Distributor or Wholesaler. On the other hand, if they wish to manufacture them locally they would have to secure an LTO as Manufacturer.
After acquiring an LTO, the entity is required to apply for the following depending on the classification of the products they intend to introduce:
- Certificate of Product Registration (CPR) – Drug, Food and Household/Urban Hazardous Product
- Certificate of Medical Device Notification (CMDN) / Certificate of Medical Device Registration (CMDR)
- Cosmetic Product Notification (CPN)
Requirements for LTO Registration
When applying for a License to operate it is necessary to prepare the following documentary requirements:
- 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
Certificate of Product Registration (CPR) Application
Before applying for a CPR, you must ensure that your company has successfully obtained an LTO. If you have multiple products to introduce, it must be registered individually based on their individual variant, flavor, dosage strength, etc. These products will have their own registration number.
Requirements for CPR Application
An entity must ensure to prepare the following documentary pre-requisites when applying for 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
Certificate of Medical Device Notification (CDMN) / Certificate of Medical Device Registration (CDMR)
Registration for all categories of medical devices requires a License to Operate.
Requirements for CMDN/CMDR Application
An entity must ensure to prepare the following documentary pre-requisites when applying for a CPR:
- Accomplished Application Form
- Clear and complete loose labels or artworks
- Pictures of the product in all angles
- Certificate of Analysis
- Proof of payment of fees
Cosmetic Product Notification (CPN) Application
Applying for an CPN is almost similar to CPR as this also requires a valid LTO. All products must be registered with the CPR, while CPN is only applicable to enterprises with cosmetic products.
Requirements for CPN Application
Like the CPR and LTO, applying for NCP also requires for several documentary requirements such as the following:
- 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
Product Licenses/Permits Renewal
You may renew your licenses/permits upon expiration. However take note that validity of the licenses and permits that FDA issues will be depending on the product classification and registration.
Below are the duration of the initial licenses and permits product validity per classification:
License to Operate (LTO)
- Foods Establishment – 2 years
- Cosmetic Establishment – 1 year
- Medical Device Establishment – 2 years
- Drug Establishment – 2 years
Certificate of Product Registration (CPR)
- Foods – 5 years
- Food Supplements – 2 years
- Medical Devices – 1 year
- Drug Products 1 to 2 years
Cosmetic Product Notification (CPN)
- Cosmetic Products – 1 year
Register and Distribute Your Products in the Philippine Market Today
With the Philippine’s huge market for consumers , you can maximize the opportunity for growth in manufacturing, importing, exporting, and advertising your products in the country. However, doing so requires you to register with the FDA in order to secure the safety and claims of your products.
If you want to know more about FDA registration and seeking to market your product in the Philippines, you may reach out to business consulting firms to guide you through the registration process the necessary permits and licenses.
Frequently Asked Questions
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)
- Cosmetic Product Notification (CPN)
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.
Confidently Register Your Products with FDA
With our end-to-end registration services, our expert team of business consultants is dedicated to assist you with FDA registration to make sure you market and distribute your products legally.