FDA License to Operate (LTO) in the Philippines
The License to Operate is the FDA license your business needs before it can manufacture, import, distribute, or sell any regulated product, and before it can register a single one. We handle the application, the e-Services filing, and the renewals end to end.
Why your business needs an LTO
What it allows, and what it prevents.
It is a legal requirement
Mandatory for any business manufacturing, importing, exporting, distributing, or selling FDA-regulated products.
The gateway to product registration
Required before you can apply for any product authorization, the CPR, CPN, or CMDR. No LTO, no registration.
Mandatory for imports
Customs will not release a shipment of regulated products without a valid LTO behind the importer.
Legal sale and distribution
Required to list and sell through retail, pharmacies, and online marketplaces in the Philippines.
Avoids delays and penalties
Keeps you clear of cease-and-desist orders, customs holds, and administrative sanctions.
Who has to hold an LTO
An LTO is required of any establishment that manufactures, imports, exports, distributes, wholesales, or sells FDA-regulated products: food, drugs, cosmetics, medical devices, and household or urban hazardous substances. It applies regardless of channel, so online-only and home-based sellers need one just as physical stores do.
The FDA also requires a verifiable physical address, including storage facilities where you distribute or import, so a business with no premises will be turned down. The type of LTO then depends on your activity and product category, since a food manufacturer and a cosmetics distributor apply under different categories.
What an LTO application needs
The core documents, plus those that depend on your activity.
Every establishment
- Completed e-application form, with the required declarations and undertakings
- Proof of business registration: DTI, SEC, or CDA
- Barangay and Mayor’s permit
- Proof of fee payment
- Proof of occupancy or ownership of the premises
- Name and PRC ID of the qualified person in charge
Depending on your activity
- Site Master File, for manufacturers of drugs, devices, and cosmetics
- Risk Management Plan, for manufacturers and certain distributors
- Latest audited financial statement or certification of initial capitalization
- Location plan and GPS coordinates, for distributors, importers, and exporters
- Contracts of agreement, for outsourcing or contract manufacturing
The LTO application process
Five stages, all through the FDA e-Services portal.
Step 1 — Application submission
We prepare and file your LTO application through the FDA’s e-Services portal, with the documentation complete and matched to your business activity.
Step 2 — Pre-assessment
The FDA checks the application for completeness and format. We make sure it meets the guidelines so it is not sent back for correction.
Step 3 — Order of payment
The FDA issues an order of payment for the license fees, which we guide you through so they are settled correctly and on time.
Step 4 — Technical evaluation
The FDA reviews the establishment against the rules for your activity and product category, and we handle any queries it raises.
Step 5 — Approval and issuance
On approval the FDA issues your License to Operate, and you can move on to registering your products.
How long an LTO lasts, and renewing it
An LTO’s validity depends on the size of the business. An initial license runs for three years for a small enterprise and up to six years for a medium or large one. Renewals extend it further, by six years for small enterprises and twelve for medium and large.
Renew within the 90 days before the license expires. The FDA reinstated that 90-day window in July 2025, after a temporary 180-day period, and late renewal now carries a surcharge of twice the renewal fee. All applications, new or renewal, go through the FDA’s e-Services portal, and the process usually takes six to eight weeks, so starting well ahead of the expiry date is what keeps you trading without a gap.
Emerhub handles the licensing
Our FDA team prepares the application, files it through the e-Services portal, and manages the FDA through to your license, across food, drug, cosmetic, device, and hazardous-substance establishments. We track the renewal date too, so the license never lapses while you are trading on it.
Not sure which LTO category fits your business, or whether you need one at all? Talk to our FDA team and we will place it correctly before you file.
License to Operate questions
What businesses applying for an LTO ask most.
Is the LTO the same for all businesses?
No. The type of LTO depends on your activity and product category, so a food manufacturer applies under a different category from a cosmetics distributor or a drug importer.
Do I need an LTO to sell regulated products online?
Yes. Online and home-based sellers of FDA-regulated products need an LTO just as physical stores do. The channel does not change the requirement.
Can I apply manually or in person?
No. All LTO applications, whether new, renewal, or a variation, go through the FDA’s e-Services portal. There is no manual or walk-in filing.
Do I need a pharmacist for the application?
For drug establishments, yes. The FDA requires a qualified person in charge, a licensed pharmacist for drugs and suitable technical personnel for other product categories.
Do I need a physical office or warehouse?
Yes. The FDA requires a verifiable physical address, including storage facilities if you distribute or import. A business with no premises will be disapproved, even an online-only one.
How long is an LTO valid?
Three years for a small enterprise and up to six years for a medium or large one. It can then be renewed for a further six or twelve years respectively, filed within the 90 days before expiry.
Talk to our Manila team
Tell us what your business will do — manufacture, import, distribute, or sell — and which FDA category your products fall under. Our Manila team will scope the right LTO, prepare the dossier, file through e-Services, and see it through to issuance.
2 26th St, Taguig
1634 Metro Manila, Philippines