The Food and Drug Administration (FDA) regulates certain products in the Philippines. These include food, medical and pharmaceutical products, and cosmetics. A business dealing with these products needs an FDA certificate of product registration.
Below you will find an overview of products and companies that need to register with the FDA. We will also detail the requirements necessary to get an FDA certificate in the Philippines. In addition to these, we also talk about what will happen if you fail to get an FDA certificate and how to avoid it.
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Food and Drug Administration 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
- Drugs and/or pharmaceuticals
- Medical devices
- Household hazardous products
The FDA oversees the production, sale, and traffic of such products 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 above products.
Who Must Register With FDA Philippines?
A company in the Philippines needs to register with the FDA it does any of the following with FDA-regulated products:
- Wholesale trading
To conduct any of the above business activities with products under the jurisdiction of the FDA, you will need an LTO. In addition to that, you will need a certificate of product registration for each product.
How to Get a License to Operate from the FDA in the Philippines
A company can apply for an FDA certificate with the Center for Food in the FDA central office. Companies may also apply at the respective FDA regional field office in their location. The LTO is, at first, valid for one year. Renewed LTOs will be valid for two 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 saying that they understand the FDA’s regulations for LTO. The authorized person is a pharmacist or allied health science professional. The authorized person 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 attend.
- Proof of business registration. For example, your registration with the Securities and Exchange Commission. You can also 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. In addition to the proof of occupancy, applicants must also submit documents about the business location itself. This includes 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
- Product labels. You must provide copies of the product’s labels in all packaging sizes. You must also include photos of the product in all packaging sizes from different angles. You must also include supporting documentation for logos/seals per labeling regulations. For example, Halal or Sangkap Pinoy.
- Product documents. The documents must support any product claims. You must also include documents detailing physicochemical and microbiological specifications.
- Certificate of analysis. This document must contain important details about the product. The information must be relevant to compliance with food standards and regulations.
- Product sample. You must also provide an actual representative product sample. Your sample must appear as it would commercially and complete with all labels.
In addition to submitting the above, you must also pay the registration fee. 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.
Register products with the FDA in the Philippines.
Emerhub will get your license to operate and certificate of product registration with the FDA.
Renewing an FDA Certificate of Product Registration in the Philippines
The certificate of product registration (CPR) expires after one or two years. Fortunately, the certificates are renewable. There are two ways to renew your product’s CPR, regular renewal and automatic renewal.
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 must, again, provide copies of your product’s labels in all packaging sizes. You must also submit supporting documentation to use logos/seals per labeling regulations. For example, Halal or Sangkap Pinoy.
Automatic Renewal of FDA Certificate of Product Registration
The FDA also offers automatic renewal. The only requirements for the automatic renewal are the application form and proof of payment of fees.
However, you must meet the following conditions:
- You must file the renewal application before the expiration of the CPR.
- You have not made any changes to the product or its labels and packaging.
- There are no conditions stated in the back of the existing/valid CPR. In case there is a condition, you must include an acknowledgment letter from the FDA with your renewal application. The letter must show that the conditions have been met.
Emerhub can help you renew your CPR. Our consultants will advise you on which renewal method is appropriate for your product. We will also assist in preparing the necessary requirements and will file the renewal application on your behalf.
Avoiding Penalties During FDA Philippines Registration
Selling a product without the necessary certificate will lead to sanctions. The FDA will issue a cease and desist order to prevent the sale of the product. They will also impose a fine. The FDA will also issue a public warning against your product.
To get your products back on the market, you will have to get a certificate for the relevant products and you must pay the fine. But keep in mind that consumers may be wary of your product after the FDA issues a public warning against it.
To avoid these, make sure you have a license to operate and that your products have the appropriate certificates. Consult with our experts to find out what you need to avoid sanctions and penalties from the FDA.
Emerhub’s consultants can help you get an LTO for your business and certificates for your products. Fill out the form below to get in touch with us. Our team will be happy to help you with your concerns regarding FDA certificates in the Philippines.