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Certificate of Product Registration (CPR)

In the Philippines, all FDA regulated products must secure a certificate of Registration from the agency before they can be manufactured or sold in the country.

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What is Certificate of Product Registration (CPR) in the Philippines?

The FDA Certificate of Product Registration is a confirmation that a regulated product meets safety standards and is approved for sale and use in the Philippines.

It is important to keep in mind that each regulated product must be registered before it can be manufactured or sold. Moreover, anytime changes are made to a product, you must renew the certificate. Products that do not change can be set up for automatic certificate renewal.

Products Requiring FDA CPR in the Philippines

Food Products

Includes items such as beverages, bottled water, canned goods, and infant formula

Food Supplements

Products like vitamins, minerals, and energy boosters, etc.

Medicines and Pharmaceuticals

Over-the-counter drugs and other pharmaceutical products

Household/Urban Hazardous Products

Cleaning supplies, disinfectants, and pesticides, etc.

Veterinary Products

Veterinary drugs, medicated feeds, and antimicrobials for animals

Not sure which category your product falls under?

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Documents Required for CPR Application and Renewal

Depending on whether you are registering your products for the first time or renewing the CPR, your application will have specific required documentation that must be provided to the FDA.

Following are the key documents required for Certificate of Product Registration (CPR) in the Philippines:

Application form
Valid License to Operate (LTO) issued by the FDA
Product labels in all packaging sizes and from every angle
Product Documents
Certificate of analysis (for medium and high risk products)
Quality Management System (QMS) Documentation
Clinical Data (if applicable)
Product samples (if required)

CPR Regular Renewal Application Requirements:

Application form
Proof of payment of fees
Product labels in all packaging sizes and from every angle
Documents supporting any amendments brought to the product

Emerhub’s FDA registration experts will assist you in securing the necessary documents to register your products. For renewals, we will advise you on the most suitable options for your products and file the renewal applications on your behalf.

How to Get the FDA Certificate of Product Registration in the Philippines?

Following is the process to obtain Certificate of Product Registration by the FDA in the Philippines:

Secure License to Operate (LTO)

Before applying for product registration, businesses must first obtain an LTO. LTO is essential for any entity involved in manufacturing, importing, exporting, or distributing regulated products in the Philippines.

CPR Application Submission and Pre-assessment

Prepare your product registration application and required documents for each product variant such as product labels, photos, other supporting documents and product samples.

Detailed Evaluation

Depending on your product category, the relevant department under FDA conducts thorough evaluation of all submitted documents and product samples to ensure compliance with safety and quality standards

Issuance of Certificate of Product Registration (CPR) by FDA

Once approved, FDA will issue the certificate of product registration for all products and their variants. The initial certificate of product registration is valid for two years while the renewed CPR is valid for five years.

Emerhub’s local experts are well versed in FDA regulations and will handle the entire submission and approval process on your behalf.

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