If you plan to manufacture, distribute, or sell regulated products in the Philippines, securing a License to Operate (LTO) from the Food and Drug Administration (FDA) is a legal requirement. To stay compliant and avoid costly penalties, these businesses must understand the new important updates to the LTO application and renewal process. Read more to discover what the FDA LTO is, who needs it, what’s new in 2025, and how to apply successfully.
What is the FDA License to Operate
The FDA License to Operate (LTO) is an official certificate issued by the Philippine Food and Drug Administration. It authorizes a business to legally manufacture, import, distribute, sell, or market products that fall under the FDA’s jurisdiction, including:
- Food and beverages
- Cosmetics
- Drugs and pharmaceuticals
- Medical devices
- Household/Urban Hazardous Substances (HUHS)
- Health-related products (e.g., disinfectants, e-cigarettes)
Operating without a valid LTO can result in penalties, product recalls, and closure orders.
Who Needs the FDA License to Operate
Businesses and individuals involved in the following activities typically require an LTO:
- Manufacturers and traders of FDA-regulated goods
- Importers, exporters, and distributors
- Retailers (in some cases, such as online pharmacies)
- Establishments handling HUHS, such as cleaning agents or pesticides
- Companies selling medical devices or e-cigarettes
Note: Certain businesses may need additional FDA permits, such as Certificates of Product Registration (CPR) or Lot Release Certificates.
Key 2025 Updates: New Renewal and Submission Policies
New policies from the Administrative Order No.2024-0015, passed in November 2024, have taken effect this year. These include:
- End of the 180-Day Early Renewal Policy: Previously, establishments could renew their LTOs up to 180 days before the expiration date under a temporary advisory. As of July 8, 2025, the FDA has officially lifted this provision (Advisory No. 2025-0095-A).
- Renewal Window Reverted to 90 Days Before Expiration: The FDA has reinstated the rule that renewal applications must be submitted no earlier than 90 calendar days before your license expires. Submissions beyond this window will not be accepted.
- Surcharges for Late Renewal: Failing to renew your LTO on time now comes with a surcharge equal to twice the renewal fee. This reinforces the importance of tracking expiration dates and filing on time.
- All Applications Must Go Through the e‑Services Portal: As of June 2, 2025, all licensing applications for Household/Urban Hazardous Substances (HUHS), including initial, renewal, and amendments, must be submitted exclusively through the FDA e-Services Portal. This aligns with their goal to streamline processes and improve traceability, but businesses must ensure their documents are complete, accurate, and properly digitized.
Requirements for Applying for an FDA LTO
Before you apply, prepare the following documents:
- Application Form – Among other information, the applicant shall provide the following information:
- Location Plan
- Global Positioning System (GPS) coordinates
- Name of the Qualified Person
- Proof of Business Name Registration – Any one of the following shall be submitted as proof of business name registration (in PDF):
- For a single proprietorship, the Certificate of Business Registration is issued by the Department of Trade and Industry (DTI)
- For corporations, partnerships, and other Juridical persons, the Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation
- For Cooperative, the Certificate of Registration issued by the Cooperative Authority and the Articles of Cooperation
- For a Government-Owned or Controlled Corporation, the law creating the establishment, if with original charter, or its Certificate of Registration issued by the Securities and Exchange Commission (SEC), and Articles of Incorporation, if without original charter
- Business Permit – When the business or establishment address differs from the business name registration address, the applicant shall submit a copy of the Business Permit (e.g., Mayor’s Permit).
- Proof of Income – such as the latest audited Financial Statement with Balance Sheet (in PDF) shall be submitted. This is to verify the capitalization of the establishment in relation to their corresponding application fees.
The following documents shall be presented to the FDA inspector for examination or review, when required:
- Risk Management Plan (RMP), which shall be required for medium and large food manufacturers, traders, and distributors (importer, exporter, and/or wholesaler)
- b) Site Master File (SMF), which shall be required for applicants applying for LTO as manufacturers of large and medium-sized food manufacturers (CFRR)
Food Business Operators shall ensure that food satisfies the requirements of food law and that control systems are in place to prevent, eliminate, or reduce risks to consumers (IRR of RA 10611 “The Food Safety Act of 2013”)
These are the initial application requirements primarily for food enterprises, and you may be asked to provide additional documentation depending on your business, industry, and the products you sell.
Step-by-Step Guide to Applying for an LTO
- Register an Account on the FDA e-Services Portal 2.0: Go to https://eservices.fda.gov.ph/ and create an account using your official business email. This will serve as your access point for all FDA-related applications and renewals.
- Fill out the LTO Application Form: Select the correct application type and enter your business and product details. Make sure all information matches your supporting documents.
- Upload All Required Documents: Prepare and upload clear, complete documents in accepted file formats (PDF, JPG, PNG). Missing or unclear files may delay your application.
- Pay the Necessary Fees: Settle the assessed fees through FDA-accredited payment channels. Don’t forget to upload the official proof of payment.
- Submit the Application Online: Review your entries and attached files before clicking “Submit.” Once your application is sent, you’ll receive an email confirmation.
- Wait for FDA Evaluation and Inspection: The FDA will review your application and may schedule a site inspection. Prepare your premises and documents for verification, if required.
- Receive Your LTO: If approved, your digital LTO will be issued through the portal and emailed to you. Print and display it at your business location as proof of compliance.
Triple i Consulting provides professional assistance in gathering documentary requirements and navigating the application process. We’ll ensure your application is complete, accurate, and on time.
New LTO Renewal Process
Effective July 8, 2025, follow these updated steps when renewing your FDA License to Operate (LTO):
Renewal Requirements and Steps
- Check your LTO’s expiration date.
- You can only renew within 90 calendar days before it expires.
- Prepare required documents. Renewal requirements include:
- Accomplished e-Application Form with Declaration of Undertaking
- Payment of Fees
- Log in to the FDA e-Services Portal.
- Complete the renewal form.
- Update any changed business information.
- Upload documents and pay the renewal fee.
- Keep a copy of your payment receipt for verification.
- Submit your application.
- Double-check for completeness to avoid delays.
- Wait for evaluation and approval.
- You may be contacted for inspection if needed.
Final Thoughts
The FDA’s updated LTO process for 2025 reflects a stronger push for digitalization, timely compliance, and regulatory efficiency. Affected businesses must adapt to these changes by monitoring renewal dates, preparing accurate documentation, and learning to navigate the e-Services platform.
Are You Applying for or Renewing an FDA License to Operate?
Applying for or renewing an FDA License to Operate (LTO) in the Philippines can be a time-consuming and detailed process. With strict documentation requirements, deadlines, and platform changes, it’s easy to make a mistake or miss a step, leading to penalties or delays in your operations.
That’s where Triple i Consulting comes in. Our team of experienced lawyers and accountants provides comprehensive support for your business, so you don’t have to stress over the paperwork.
Contact us today to schedule an initial consultation with one of our experts:
- Fill out the form below
- Call us at: +63 (02) 8540-9623
- Send an email to: info@tripleiconsulting.com
