Before you can start selling food items, cosmetics, or drugs in the Philippines, you need to secure first a Certificate of Product Registration (CPR) from the Food and Drug Administration (FDA).
Obtaining a CPR for your product involves knowing if it needs one, having the proper documents and requirements, and applying for it using the FDA’s system. Take note that each product being registered will have its own CPR. This means that each variant, flavor, and dosage will have its own certificate—basically, each item must be registered individually. There is no bulk processing option for FDA CPR application on their website.
Need to know more about how to apply for a Certificate of Product Registration from the FDA? Keep reading.
Click the links below to go directly to that part of this article:
- Products with Required Certificate of Product Registration (FDA CPR)
- Requirements for FDA CPR
- How to Get Certificate of Product Registration from FDA
- Automatic CPR Renewal
- Penalty for Products with no CPR
Products with Required Certificate of Product Registration (FDA CPR)
Which products need a CPR? The following items do:
1) Food Products (canned goods, bottled beverages, infant formulae, etc.)
2) Medicines, Pharmaceuticals, and Over-the-Counter Drugs
3) Medical Devices
4) Food Supplements (vitamins, minerals, energy boosters, etc.)
5) Toys
6) Veterinary Products (pet medications, vitamins, supplements, etc.)
7) Hazardous Household Products and Urban Pesticides (cleaning supplies, disinfectant sprays, etc.)
Do cosmetics need a Certificate of Product Registration?
Cosmetic products do not have a CPR, and instead are required to have a product notification. While the FDA needs to be informed regarding such cosmetics, the procedure outlined here is for obtaining a CPR only.
Requirements for FDA Certificate of Product Registration
If your product is listed above, you are required to process a CPR for your product. The following are the requirements for doing so:
1) A valid LTO or License to Operate which can be obtained from the FDA
2) A clear, scanned, and colored copy of loose labels of all packaging sizes for the products (or equivalent, as defined by FDA), as well as pictures of the product from all angles and in different packaging sizes. This allows easy recognition of a product as the same one being registered.
- For food supplements, include blister packs, Alu-Alu packs, and secondary packaging (i.e. paper box or cardboard box).
3) Other requirements for traders, wholesalers, and distributors of locally manufactured food products / for importers and distributors
4) Documents to support product claims, such as:
- Technical/nutrition health studies or reports
- Market research studies
- Certificate of analysis, quantitative analysis, and computations
- Scientific reports or studies published in peer-reviewed scientific journals
- Supporting certificates to allow the use of “Sangkap Pinoy”, Halal, Organic, Kosher, and other claims in compliance with current labeling requirements
5) Certificate of Analysis stating essential details to determine product compliance to food standards and regulations for the following:
- Medium to high-risk products with standards of identity such as food for infants and young children, foods intended for special medical purposes, bottled water, etc) the certificate of analysis must be uploaded. The list of low, medium, and high risks can be found here on the FDA website.
- Fortified food products covered by R.A. 8176 (iodized salt) and R.A. 8976 (cooking oil, flour, and refined sugar)
6) For food supplements, additional requirements include:
- A stability study of the actual food supplement
- Safety data, such as toxicity tests, must be attached to address safety concerns regarding the product.
7) Actual representative product sample of food supplement (for initial application only, and is not needed during CPR renewal).
Note: This is a list of general requirements; additional requirements and procedures may be required by the FDA depending on the product being registered. Confused? You can ask us about it.
Once you have these requirements, you can opt to register these products online using the FDA e-registration system, which can be found here.
How to Get Certificate of Product Registration from FDA
The following is the basic CPR e-registration procedure (as per FDA Circular 2016-014):
1) Secure your FDA E-registration log-in details.
2) Log in to the FDA website e-portal.
3) For first-time product applications, click on “New Case.”
4) Type the details of needed information of product, such as brand name, product name, food category, list of ingredients, product specifications, and other pertinent information.
5) Upload the required documents. The documents needed vary per product and if the product is for export or not. Please check the FDA website for more details.
Note: Maximum 2MB per attachment in PDF or PNG format, and 25 MB max for all attachments per application
6) Print Order of Payment and pay corresponding fees either in person at the FDA Main Office located in Alabang, through the Bancnet online payment gateway option as per FDA Advisory 2015-021, or whatever FDSA recommends on their site.
7) You can track the application progress through the process map indicated on the FDA website.
Automatic CPR Renewal
To make CPR renewal automatic, the following conditions must be met:
1) The renewal application must be filed before the expiration date of the CPR;
2) The automatic renewal fee must be paid prior to the filing of application; and
3) There should be no condition stated at the back of the issued Certificate of Product Registration.
In case of a condition, compliance with the condition must be met and proven by including a scanned copy of the acknowledgment letter from the FDA indicating that the condition has been met.
Penalty for Products with no CPR
What if you release the product to the market without the proper certification? Not only is this illegal, but once FDA is notified, they will issue a cease and desist order. They will take your products off the market AND require you to pay fines AND process CPRs for your products that were taken off the shelves.
Going against the law can destroy the name of your business as well. The FDA issues public health warnings against products without CPRs, and this means bad publicity for your brand.
All in all, the hassles and penalties brought about by not doing things properly is just not worth the risk.
Does the application for an FDA CPR sound too tedious?
If applying for a CPR sounds like a hassle to do it yourself, then let us help! Our team of experts can help you with the whole FDA process, not just for product registration. If you have any inquiries, you may contact us here.