Understanding FDA License to Operate (LTO) and Certificate of Product Registration (CPR)

In the Philippines, any business engaged in the manufacture, importation, distribution, or sale of products regulated by the Food and Drug Administration (FDA) including food, drugs, cosmetics, medical devices, and health-related items must secure specific licenses from the FDA before operating. Two of the most critical authorizations are the License to Operate (LTO) and the Certificate of Product Registration (CPR). These documents ensure that businesses comply with the regulatory standards designed to protect public health and consumer safety.

What is an FDA License to Operate (LTO)?

The FDA License to Operate (LTO) is an official authorization granted to establishments involved in the manufacturing, importation, distribution, wholesale, or retail of FDA-regulated products. The LTO certifies that the company possesses adequate facilities, qualified personnel, and quality systems that meet FDA standards.

Without an LTO, a company is not legally permitted to engage in the sale or distribution of regulated goods. It serves as proof of the business's operational legitimacy under Philippine law.

Key Requirements for LTO Application

• Accomplished FDA e-Portal application form

• SEC/DTI registration and Mayor's/BIR permits

• List of qualified personnel (e.g., pharmacist or quality officer)

• Location plan and facility photos

• Proof of ownership or lease of premises

• Payment of applicable fees

Validity and Renewal

An LTO is typically valid for five (5) years. Renewal must be filed at least three (3) months before expiration to prevent penalties or business interruption.

What is a Certificate of Product Registration (CPR)?

The Certificate of Product Registration (CPR) is issued by the FDA to authorize the sale and distribution of a specific product in the market. It certifies that the product has passed safety, quality, and efficacy evaluations in accordance with FDA standards.

Products Requiring CPR

• Processed food and beverages

• Dietary supplements and vitamins

• Cosmetics and personal care products

• Medical devices and diagnostic kits

• Pharmaceutical drugs and vaccines

• Household hazardous substances

Application Requirements for CPR

• Valid FDA License to Operate (LTO)

• Product formulation and technical data

• Certificate of Analysis or laboratory report

• Packaging and labeling samples

• Payment of fees and supporting documentation

Validity and Renewal

A CPR is valid for five (5) years and must be renewed prior to its expiration to ensure uninterrupted authorization to distribute or sell the product.

Importance of FDA LTO and CPR Compliance

Compliance with FDA regulations not only fulfills legal obligations but also promotes public health and business credibility. Having an FDA LTO and CPR assures consumers, investors, and partners that the products being sold are safe and of high quality.

Non-compliance can result in administrative sanctions, product recalls, suspension of operations, or even criminal liability under Republic Act No. 3720 (Food, Drug, and Cosmetic Act).

Common Issues and Compliance Tips

Businesses commonly encounter challenges such as incomplete documentation, incorrect product classification, or outdated facility requirements. To prevent delays or rejections, companies should:

• Consult with FDA-accredited regulatory experts

• Keep documents and licenses up-to-date

• Monitor FDA circulars and announcements regularly

• Maintain accurate production and distribution records

• File renewals ahead of schedule

How DV Consulting Can Help

DV Consulting Inc. provides full regulatory assistance in securing FDA LTOs and CPRs for Philippine businesses. Our team of compliance specialists ensures that your applications meet all FDA requirements from document preparation to e-portal submission and post-approval compliance.

Through our guidance, you can focus on your business growth while we handle the technical and regulatory aspects of your FDA compliance journey.

Obtaining an FDA License to Operate and Certificate of Product Registration is a critical step for all companies involved in health, food, and consumer products. These certifications uphold consumer safety, legal compliance, and business integrity. With expert guidance from DV Consulting, your company can navigate the process efficiently and confidently.