How to Get an FDA Certificate of Product Registration (CPR)

Metro Manila Head Office

Address: 12F Sagittarius Building,
111, H.V. Dela Costa Street Salcedo Village, Makati City 1227
Tel: +63 (02) 8540-9623
Email: info@araraa.com

After acquiring the license to operate your business, the next step for you to be able to sell your products in the Philippines legally is securing a Food and Drug Administration (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.

The FDA Certificate of Product Registration (CPR) is a requirement if you plan to sell any of the following items in the Philippines:

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

Do I need to get a Certificate of Product Registration for cosmetic products?

CPR is not a requirement for cosmetic products. However, cosmetic products need to undergo a product notification.

What happens if I have no Certificate of Product Registration for my products?

According to Philippine laws, failure to secure 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.

Getting a Certificate of Product Registration (CPR) is a vital requirement for non-existent businesses or businesses without an FDA LTO (License to Operate) aiming to penetrate the Philippine market with regulated products. Triple i Consulting offers CPR Housing, providing a strategic edge as it allows the FDA registration process to commence in parallel with business registration. This streamlined approach expedites the product’s entry into the market compared to the conventional registration process, empowering businesses to capitalize on opportunities and flourish in the dynamic Philippine market. With the assistance of CPR Housing services, companies can navigate the regulatory landscape effortlessly and with assurance, enabling them to efficiently and lawfully establish their presence in the Philippines with imported products.

Read More About CPR Housing Here

• Accomplished and duly notarized application forms;
• Actual representative product sample of food supplement (for initial applications);
• Copy of valid contract between manufacturer and trader/distributor/seller/exporter/importer;
• Copies of valid LTOs for manufacturer/trader/distributor/seller/exporter/importer;
• Unit dose and batch formulation (in metric system);
• Technical specifications on all raw materials;
• Certificate of Analysis on raw materials and finished product from the manufacturer;
• Technical specifications of finished product;
• Copy of the original Product Registration in the manufacturing country (for foreign manufactured products).

What are the procedures for processing my FDA Certificate of Product Registration?

• 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 e-mail 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

The registration process for selling an item in the Philippines can be tedious and time-consuming. It’s always best to seek assistance from professionals. Triple i Consulting is an ISO-Certified company dedicated to helping clients get their products certified and approved by the Food and Drug Administration (FDA) in the Philippines in as little time as possible.

If you’d like help getting this done, you can Contact Us Here, fill out the form below, call us at +63 (02) 8540-9623, or email us at info@araraa.com to book an initial consultation with one of our FDA experts.