FDA Certificate of Product Registration (CPR)

After acquiring the License to Operate (LTO) from the Food and Drug Administration (FDA) for your business, the next step for you to be able to sell your products in the Philippines legally is securing a FDA Certificate of Product Registration (CPR). The CPR is a requirement not just for every product but for each specific category, variant, dosage, and flavor of the product you plan to sell. Having various categories and variants of products means preparing to process not just one but multiple CPRs for each product variant.

1. Food products (beverages, water, canned goods, etc.)
2. Food Supplements 
3. Medicines, Over-The-Counter Drugs, and other Pharmaceutical products
4. Medical Devices
5. Children’s Articles and Toys
6. Heated Tobacco Products
7. Household Urban Hazardous Products (cleaning items, disinfectants, pesticides, etc.)
8. Vapor Products

CPR is not a requirement for cosmetic products. However, if you’d like to sell cosmetic products, you need to undergo the process of obtaining a Certificate of Product Notification (CPN).

According to Philippine laws, failure to secure a CPR for your products is illegal. The FDA issues public health warnings against the purchase and consumption of unregistered products. They will issue a product recall for your products, taking them off the market. Additionally, all concerned establishments will receive a warning from the FDA not to sell, distribute, or advertise the product until a CPR is issued. Otherwise, regulatory sanctions shall be strictly pursued.

According to Philippine laws, failure to secure a CPR for your products is illegal. The FDA issues public health warnings against the purchase and consumption of unregistered products. They will issue a product recall for your products, taking them off the market. Additionally, all concerned establishments will receive a warning from the FDA not to sell, distribute, or advertise the product until a CPR is issued. Otherwise, regulatory sanctions shall be strictly pursued.

• Submit an application for product registration through FDA Électronic Portal for pre-assessment;
• If the application passes the pre-assessment, FDA will issue an Order of Payment.
• Pay the corresponding registration. Once the FDA cashier posts the payment, the next step will be the evaluation.
• If the application is approved, FDA will send an email stating how and where to download the Certificate of Product Registration.
• Obtain endorsement for Certificate of Registration after evaluation of Product Services Division.

• Make sure to file for a renewal application within 90 days of the CPR’s expiration date.
• Check if any condition is stated at the back of the issued Certificate of Product Registration. Those with stated conditions must comply with the requirement and show proof of compliance by attaching a scanned copy of the acknowledgment letter from the FDA signifying that the condition is met. 
• Ensure that there is no change or variation on the product or its packaging label.
• Pay the prescribed renewal fee upon the filing of the application

Triple i Consulting is your trusted partner in navigating the Philippines FDA CPR process. Our team of experienced experts is dedicated to assisting you in acquiring essential regulatory certifications such as a License to Operate (LTO), Certificate of Product Notification (CPN), Certificate of Medical Device Registration (CMDR), Certificate of Medical Device Notification (CMDN), and Clinical Trials (CT). As pioneers in offering business registration services and the first ISO 9001:2008 certified company in the Philippines, Triple i Consulting is a leading consultancy firm specializing in FDA applications.

Save yourself the hassle and let us handle these complex tasks for you. To schedule an initial consultation with one of our knowledgeable FDA experts, contact us now through one of the following channels:

• Contact Us Here
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• Call Us at +63 (02) 8540-9623
• Email us at: info@tripleiconsulting.com