Establishment level · Required first
FDA License to Operate (LTO) in the Philippines
The LTO authorises a business establishment to handle regulated health products. It must be obtained before any product registration or notification can be filed — making it the first and most critical step for entering the market with food, drug, cosmetic or medical device products. The LTO covers the establishment, not the individual products.
- New application: 30–40 working days
- Renewal: 2–3 months, including a facility inspection
- Required before any CPR or CPN can be filed
Or call 0917 631 8876 — Mondays to Fridays.
What it is for
What the LTO actually buys you
What sits underneath everything else you file.
It is not optional
The LTO authorises an establishment to handle regulated health products. Manufacturers, importers, distributors and food, drug, cosmetic and medical device establishments all need one.
Everything else waits on it
No Certificate of Product Registration and no Cosmetic Product Notification can be filed until the LTO is active. Until it lands, nothing else moves.
It licenses the establishment, not the product
The licence covers your business. Individual products are registered separately on top of it, each with their own certificate and number.
Importers need one behind them
Importers and distributors handling regulated products need the establishment licence in place. We file the consignee LTO alongside the standard establishment licence.
Letting it lapse is expensive
Operating with an expired LTO can result in establishment closure, product recall and administrative sanctions. Renewal is filed ahead of expiry, never after.
Who it covers
Does your business need one?
Make it, bring it in, ship it out, move it, wholesale it or sell it — if the product is FDA-regulated, the establishment behind it needs a licence. That covers food, drugs, cosmetics, medical devices and household or urban hazardous substances. What decides it is who handles the product, not what the business calls itself.
Establishment types
- Manufacturers
- Importers
- Distributors
- Drug establishments
- Cosmetic establishments
- Medical device establishments
- Food establishments
The sales channel makes no difference
Selling online or working from home does not exempt you. The requirement follows the handling of regulated products, not the shopfront, so online-only and home-based sellers are licensed on the same basis as physical stores.
You need a verifiable physical address
The FDA licenses premises, including the storage used for distribution or importation — which is also why renewals carry a facility inspection. A business with nothing to inspect has nothing to license.
Your category shapes the application
A food manufacturer and a cosmetics distributor apply under different establishment categories. The licence type follows both your activity and your product, so the two applications are not interchangeable.
Requirements
The documents you will be asked for
One pack everybody files, and a second that turns on what your business actually does.
Everyone files these
Six documents, whatever you sell
- 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
These turn on what you do
Expect two or three, not all five
- Site Master FileManufacturers of drugs, devices and cosmetics
- Risk Management PlanManufacturers and certain distributors
- Latest audited financial statement, or certification of initial capitalisation
- Location plan and GPS coordinatesDistributors, importers and exporters
- Contracts of agreementOutsourcing or contract manufacturing
Send us the product and what you do with it, and we will name the exact documents before you chase a single one — ask us first.
Rules worth knowing
- Renewal must be filed before the existing licence expires — not after it.
- Renewals and variations include a facility inspection, which is why they run longer than a new application.
- Operating with an expired LTO can result in establishment closure, product recall and administrative sanctions.
What we file
Working turnarounds, not best cases. Each line is a filing we handle end to end.
| Filing | Code | Turnaround |
|---|---|---|
| FDA LTO — New ApplicationStart here | CM-FDA-001 | 30–40 working days |
| FDA LTO — Renewal | CM-FDA-002 | 2–3 months (incl. facility inspection) |
| FDA LTO — Variation (address / establishment details) | CM-FDA-003 | 2–3 months (incl. facility inspection) |
| FDA LTO — Consignee | CM-FDA-006 | Upon engagement |
| Pharmacist for FDA Compliance (Outsourced) | CM-FDA-008 | 3–5 working days |
Questions we get
Do we need a License to Operate before registering a product?
Yes. The LTO licenses the establishment, not the product, and it has to be in place before any Certificate of Product Registration or Cosmetic Product Notification can be filed. It is the first step for anyone bringing food, drug, cosmetic or medical device products to market.
How long does FDA registration take?
A new LTO application runs 30 to 40 working days. A Certificate of Product Registration takes 20 to 30 working days, and a Cosmetic Product Notification 15 to 20 working days. LTO renewals and variations take 2 to 3 months because they include a facility inspection.
How long do the certificates stay valid?
CPR validity is 2 years for supplements and 5 years for food products. A CPN is valid for 1 year and renews annually. LTO renewal has to be filed before the existing licence expires.
What happens if our LTO lapses?
Operating with an expired LTO can result in establishment closure, product recall and administrative sanctions. This is why renewal is filed ahead of expiry rather than after it.
We sell through a local distributor — who holds the licence?
The establishment that handles the product needs the LTO. For cosmetics in particular, a foreign brand selling through a local distributor has to make sure that distributor holds a valid cosmetic-establishment LTO before any notification is filed.
Do you provide the pharmacist the FDA requires?
Yes. We provide an outsourced pharmacist for FDA compliance, typically arranged within 3 to 5 working days, for establishments that need one to satisfy their licensing conditions.
The other two licences
Where we come in
We prepare and file on your behalf, track the application through the FDA, and come back to you when something is needed rather than leaving you to chase it. Tell us the product and where you are in the process, and we will confirm exactly which filings apply and in what order.
Call or WhatsApp0917 631 8876