APPLICATION FOR FDA LICENSE TO OPERATE (LTO) IN THE PHILIPPINES

I. REQUIREMENTS

1. Authorization Letter for eLTO User Account Application

2. Completed Application Form with Declaration and Undertaking (i.e. Declaration
and Undertaking of Responsibilities of the Applicant)

NOTE: The applicant should be a qualified person: if it is a drug establishment, a

pharmacist with PRC ID and Certificate of Attendance in an Appropriate FDA
Seminar, or a Pharmacist Assistant with Certificate of Training.

3. Proof of Business Name Registration (i.e. SEC Registration and Articles of

Incorporation
4. Site Master File (i.e. contains specific instructions about quality management
policies and activities of the production site)
5. Risk Management Plan (i.e. contains details on how to identify, characterize and
prevent risks relating to the product)
6. Proof of Payment (Fees in cash or Manager’s Check payable to Food and Drug
Administration shall be paid to the cashier/Landbank)

WHO MAY APPLY? Residents of the Philippines (Filipino citizens or alien holders of
resident visas) and majority Filipino-owned companies may apply for LTO

II. PROCEDURE

A. FILING

1. Create a eLTO User Account by sending an email to FDA’s Public Assistance

Information and Receiving Unit via pair@fda.gov.ph.
2. Once the applicant has a valid eLTO User Account, he can access the E-portal.
3. Fill up the forms and upload scanned copies, in PDF, of the foregoing
requirements.

B. EVALUATION

1. FDA will check the veracity and completeness of the documents submitted by
the applicant.
2. The applicant will be notified in writing or through email in case there is a
need for clarification.

C. INSPECTION
 1. There will be pre-opening inspection for manufacturers.
2. FDA may also inspect covered establishments at any time.

III. TIMELINE

- User Accounts are usually issued within two (2) days upon FDA’s receipt of
completed request by the applicant.
- The issuance of LTO will take about 30-90 days after posting of payment.
- The validity of the LTO shall be for three (3) years for Initial Issuance and five (5)
years for Renewal.

IV. COSTS

FEES ON GENERAL CERTIFICATION

Certification Fees
1. Re-issuance of an Authorized or PhP2,000.00
License (Lost of Damaged Original) (approx. US$40)
2. Certification/Clearance Php500.00
(approx. US$10)
3. Bureau of Customs Clearance (i.e. Php1,000.00
import permits for sample of products (approx. US$20)
for registration)
4. Certificate of Free Sale Php1,000.00
(approx. US$20)
5. Permit to Carry/Mail (Personal Use) Php100.00/transaction
(approx. US$2)
6. Permit to Carry/Mail (Research and Php500.00/transaction
Development Use) (approx. US$10)
7. Major Variation of LTO (w/inspection) PhP3,000.00
(approx. US$60)

FEES ON DRUG REGULATION AND RESEARCH

Fees in Philippine Peso (PhP)

LICENSE TO OPERATE Initial (3 years) Renewal (5 years)
1. Manufacturer 112,500.00 190,000.00
(Manufacturer, (approx. US$2,250) (approx. US$3,800)
Packer, Repacker)
2. Manufacturer-Trader 45,000.00 60,833.33
 (approx. US$900) (approx. US$1216)
3. Distributor (Exporter, 45,000.00 60,833.33
Importer, Wholesaler) (approx. US$900) (approx. US$1216)
4. Drugstore/Pharmacy/ 6,750.00 10,833.33
Other Similar Outlets (approx. US$135) (approx.. US$216)
5. Contract Research 45,000.00 60,833.33
Organization/Sponsor (approx. US$900) (approx. US$1216)

Fees in Philippine Peso (PhP)

PRODUCT REGISTRATION Initial (3 years) Renewal (5 years)
1. New Chemical Entities 155,000.00
(approx.. US$3,100)
2. Generic Products 76,000.00 53,500.00
(approx.. US$1,520) (approx.. US$1,070)
3. Biologicals and 170,000.00 68,000.00
Vaccines (approx. US$3,400) (approx. US$1,360)
4. Other Drug Product 76,000.00 53,500.00
Classification (approx.. US$1,520) (approx.. US$1,070)

OTHER PERMITS AND CLEARANCES

1. Certificate of Pharmaceutical Product PhP1,500.00

(approx. US$30)
2. Product Classification PhP1,500.00
(approx. US$30)