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The Food and Drug Administration (FDA) regulates product quality in the Philippines. Regulated products include food, medical and pharmaceutical products, and cosmetics. A company dealing in these products needs an FDA certificate to sell its products in the Philippines
Below is an overview of products and companies that must register with the FDA. We also talk about FDA license-to-operate requirements in the Philippines. In addition, we also talk about what happens if your FDA application gets rejected and how you can avoid this.
Food and Drug Administration (FDA) registration in the Philippines
The Food and Drug Administration (FDA) is an agency under the Department of Health. The FDA is responsible for the licensing, monitoring, and regulation of the following:
- Food and beverages
- Cosmetics
- Drugs and/or pharmaceuticals
- Medical devices
- Vaccines
- Household hazardous products
- Pesticides
The FDA oversees the production, sale, and traffic of the products in the list in the Philippine market. The agency aims to protect public health and safety. As such, the agency also conducts inspections and tests to ensure the safety and quality of the listed products.
Who Must Register With FDA Philippines?
A company and the entrepreneurs in the Philippines needs to register with the FDA if it does any of the following with FDA-regulated products:
- Importing
- Exporting
- Wholesale trading
- Distribution
- Manufacturing
To conduct any of the above business activities with products under the jurisdiction of the FDA, you will need an License To Operate (LTO). Also, you will need a certificate of product registration for each product.
How to Get a License to Operate (LTO) from the FDA in the Philippines
A company can apply for an FDA certificate in the FDA central office or regional field office in their location. The first LTO is valid for two years. Renewed LTOs are valid for five years.
Applicants must submit the following documents to the FDA to get an LTO:
- Petition form. The owner, incorporator, or an authorized representative must submit a notarized petition form.
- Joint Affidavit of Undertaking. The owner of the company and an authorized person must sign an affidavit. They will state their understanding of the FDA’s regulations for LTO. An authorized person is a pharmacist or allied health science professional. They must also present their professional license or board certificate.
- Certificate of Attendance to an FDA-sponsored seminar on licensing of establishments. The business owner or relevant authorized person must attend the seminar. It is also possible to submit a promissory letter to compensate the attendance.
- Proof of business registration.It is, for example, your registration with the Securities and Exchange Commission. It is possible to submit your business permit from your local government unit.
- Proof of occupancy or business address. Applicants must submit documents related to the business location. For example, the contract of lease for a rented space.
- Floor plan and vicinity map. Applicants have to submit documents about the business location itself. The documents include a floor plan with dimensions.
Emerhub can assist in preparing and securing the above documents. Our team will also apply for the LTO on your behalf. Fill out the form below and one of our consultants will get in touch with you.
How to Get an FDA Certificate of Product Registration in the Philippines
After getting your license to operate, you can apply for an FDA certificate of product registration. The FDA certificate is valid for 1-2 years and is subject to renewal upon expiration.
To apply for a certificate of product registration, you will need to prepare the following:
- Application form
- Valid license to operate from the FDA. The application process is described above
- Product labels. Provide copies of the product labels in all packaging sizes. These include product photos in all packaging sizes from different angles. You also need to provide supporting documentation for logos/seals/certification per labeling regulations. (Labeling is, for example, a Halal or Sangkap Pinoy Certificate or information on the product.)
- Product documents. The documents must support any product claims, like documents detailing physicochemical and microbiological specifications. The specification must fall under the ASEAN directive regulations.
- Certificate of analysis. This document contains details about the product. The information must be relevant to compliance with food standards and regulations.
- Product sample. You are obliged to provide an actual representative product sample. Your sample needs to appear as it would commercially and complete with all labels.
Our team at Emerhub can assist in preparing the above documents. We will also facilitate the application for the FDA’s certificate of product registration on your behalf.
Emerhub will get your license to operate and a certificate of product registration with the FDA.
Renewing an FDA Certificate of Product Registration (CPR) in the Philippines
The Certificate of Product Registration (CPR), depending on the nature of the product, expires after one or two years. The certificates are renewable at FDA offices. There are two ways to renew CPR: regular and automatic renewal.
CPR must be renewed one month before the expiration.
Regular Renewal of FDA Certificate of Product Registration
In case of any changes to your product, you will have to apply through regular renewal. The requirements for this are the following:
- Application form
- Proof of payment of fees
- Requirements to support amendments. Much like the initial application for CPR, you must be able to support amendments to your product.
- Product labels. You are required, again, to provide copies of product labels in all packaging sizes. Also, submit supporting documentation to use logos/seals per labeling regulations.
Automatic Renewal of FDA Certificate of Product Registration
The FDA also offers automatic renewal. The certificate needs to be renewed one month before expiry. The only requirements for the automatic renewal are the application form and proof of payment of fees.
However, you are required to meet the following conditions:
- File the renewal application before the expiration of the CPR.
- You have not had any modifications to the product or its labels and packaging.
- There are no conditions stated in the existing or valid CPR. If there is a condition in the CPR, include an acknowledgment letter from the FDA
Emerhub can help you renew your CPR. Our consultants will advise you on which CPR renewal method is appropriate for your product. We can assist you in preparing the requirements and can file the renewal application on your behalf.
Avoiding Penalties During FDA Philippines Registration
Selling a product without the necessary certificate will lead to sanctions. Selling uncertified products will lead to the FDA issuing a fine and terminating the product from the market. The FDA will also issue a public warning against your product.
To get your products back in the market, you need a certificate for the relevant products and pay the fine. Consumers may still be wary of your product after the FDA’s public warning against it.
To avoid these, have a license to operate and make sure your products have the appropriate certificates.
Simplify Your FDA Certification Process
Understanding FDA requirements can be challenging. If you need guidance or support with how to get FDA approval in the Philippines, we are here to help.
