License to Operate (LTO) application
Starting a business in food, cosmetics, pharmaceuticals, healthcare or regulated retail? You need an FDA License to Operate before you open. We take you from eligibility review to approval.
Which LTO is this?
This is the FDA License to Operate for businesses that make, import, distribute or sell regulated products, not the Land Transportation Office.
For an importer, wholesaler or distributor, our service fee is PHP8,000 for a new LTO and PHP5,000 for a renewal. The FDA fee is separate: PHP5,000 for drugs, PHP4,000 for food or PHP3,000 for cosmetics.
End-to-end LTO assistance
Pair your LTO with our virtual office, incorporation and permit services for a complete, turnkey setup.
- 1
Eligibility review
We review your business to confirm which LTO you need and which regulator issues it.
- 2
Documents
Company papers, facility layout, standard operating procedures and regulatory forms, prepared to current requirements.
- 3
Filing & follow-up
We submit your application and handle follow-ups and any requests for more information.
- 4
Inspection prep
If a site inspection is needed, we help get your facility, documents and team ready.
- 5
Clear updates
You'll know where your application stands at every step.
LTO questions
Who needs an LTO?
Businesses in food, cosmetics, pharmaceuticals, healthcare and retail of regulated products, before they start operating.
What do I need to apply?
For an importer, wholesaler or distributor: a business permit or barangay clearance, your SEC or DTI registration and the ID of the authorized person.
How long does it take?
Up to 2 to 3 months for a new LTO, a renewal or an amendment.
What comes after the LTO?
Usually product registration. See the full list of FDA product registration fees.
Start your LTO application.
Talk to our team about your business and the license you need.