Republic of the Philippines

Department of Health
Food and Drug Administration

FDA Circular 2016-004

May 02, 2016

Procedure on the use of the New LTO Application

Form for License to Operate (LTO) thru the Food
and Drug Administration (FDA) Electronic Portal
(e-portal)

REY BARTOLO TABAY, RPh.

Executive Secretary, PPhA - CCI
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ALL ESTABLISHMENTS REGULATED
BY THE FOOD AND DRUG
ADMINISTRATION SEEKING
LICENSE TO OPERATE (LTO)

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> Replaces the current Integrated Application Form (IAF) – FDA
Circular No. 2014-003.

> Applicant companies are required to provide true, correct, updated

and complete information pertaining to their type of application.

> Documentary requirements as contained in AO No. 2016-0003,

“Guidelines on the Unified Licensing Requirements and Procedures of
the Food and Drug Administration”, should follow the prescribed
specifications:

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WHAT ARE THE SPECIFICATIONS?

1. All documents for uploading must be in Portable Document

Format (PDF/.pdf), free from bugs, viruses and the like that
may jeopardize the system of the FDA;
2. Before uploading, all documents must be scanned and
complied with 100-150 dots-per-inch (dpi);
3. Filename of documents for uploading should be less than
40 characters in length and should not contain the following
characters \ ? / : * “ > <

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NOTE:

> Accessing the e-portal to file an LTO application requires the

use of an authorized User Account to be provided via email by the
Public Assistance, Information and Receiving (PAIR) Unit upon
request.

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HOW TO REQUEST FOR AN E-PORTAL USER ACCOUNT?

STEP 1: Accomplish an authorization letter addressed to the director

general of the Food and Drug Administration.

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HOW TO REQUEST FOR AN E-PORTAL USER ACCOUNT?

STEP 2:

Once signed and

notarized,
scan the document and
save in .pdf file format.

*SAMPLE

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HOW TO REQUEST FOR AN E-PORTAL USER ACCOUNT?

STEP 3: Send an email to FDA with the following format:

Recipient: pair@fda.gov.ph
Subject: Request for eLTO User Account
Body:
a. E-mail Address (preferably company e-mail address)
b. Name of the Authorized Company Representative
(preferably permanently employed and not merely a consultant)
c. Position in the Company
d. Contact Number
e. Company Name

*NOTE: Attach the scanned authorization letter (.pdf format). Review

all the details and once final, click the send button.

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FDA E-PORTAL USER
ACCOUNT

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HOW TO USE THE
E-PORTAL?

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 1: LOG ON TO http://www.fda.gov.ph -> GO TO EPORTAL

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 2: LOG IN

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 3: HOME PAGE

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 4: DECLARATION AND UNDERTAKING

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 4: DECLARATION AND UNDERTAKING

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 5: FILL UP & PROVIDE THE DATA NEEDED

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 6: UPLOAD THE TECHNICAL & DOCUMENTARY

REQUIREMENTS

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 6: UPLOAD THE TECHNICAL & DOCUMENTARY

REQUIREMENTS

USUAL REQUIREMENTS:
1. PROOF OF BUSINESS REGISTRATION
(EITHER MAYOR’S PERMIT OR DTI PERMIT BUT NOT THE BIR CERTIFICATE
2. RISK MANAGEMENT PLAN (RMP)
3. VALID PRC ID (BACK TO BACK) OF PERSON IN-CHARGE
4. LICENSING SEMINAR CERTIFICATE ON A034
(IF NOT APPLICABLE, YOU MAY SUBMIT A PROMISSORY LETTER)

ADDITIONAL/COMPLIANCE REQUIREMENTS:
1. RESIGNATION LETTER FROM PREVIOUS EMPLOYER
(DULY SIGNED BY THE MANAGER AND RECEIVED BY THE FDA REGIONAL OFFICE)
2. BRGY. CLEARANCE

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 7: DOWNLOAD YOUR ORDER OF PAYMENT

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 7: DOWNLOAD YOUR ORDER OF PAYMENT

ACCOUNT CODE

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 8: PAY AT ANY LBP BRANCHES NATIONWIDE

> LAND BANK OF THE PHILIPPINES (LBP)

> ON COLL PAYMENT

FORMAT:
NAME
NAMEOF
OFESTABLISHMENT
ESTABLISHMENT
ACCOUNT CODE

AMOUNT 

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 8: PAY AT ANY LBP BRANCHES NATIONWIDE

MERCHANT/AGENCY DEPOSIT ACCOUNT NUMBER:

FDA COSMETIC CLEARING ACCOUNT: 0392-2220-06

FORMAT:
NAME
NAMEOF
OFESTABLISHMENT
ESTABLISHMENT
ACCOUNT CODE

AMOUNT 

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 8: PAY AT ANY LBP BRANCHES NATIONWIDE

MERCHANT/AGENCY DEPOSIT ACCOUNT NUMBER:

FDA DRUGS CLEARING ACCOUNT: 0392-2220-14

FORMAT:
NAME
NAMEOF
OFESTABLISHMENT
ESTABLISHMENT
ACCOUNT CODE

AMOUNT 

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 8: PAY AT ANY LBP BRANCHES NATIONWIDE

MERCHANT/AGENCY DEPOSIT ACCOUNT NUMBER:

FDA FOOD CLEARING ACCOUNT: 0392-2220-22

FORMAT:
NAME
NAMEOF
OFESTABLISHMENT
ESTABLISHMENT
ACCOUNT CODE

AMOUNT 

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HOW TO USE THE E-PORTAL USER ACCOUNT?

STEP 8: PAY AT ANY LBP BRANCHES NATIONWIDE

MERCHANT/AGENCY DEPOSIT ACCOUNT NUMBER:

FDA DEVICES CLEARING ACCOUNT: 0392-2220-30

FORMAT:
NAME
NAMEOF
OFESTABLISHMENT
ESTABLISHMENT
ACCOUNT CODE

AMOUNT 

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HOW TO USE THE E-PORTAL USER ACCOUNT?

IMPORTANT POINTS TO TAKE NOTE:

1. REGULARLY CHECK THE STATUS OF YOUR E-PORTAL

APPLICATION.
2. REGULARLY CHECK YOUR EMAIL FOR UPDATES.
3. CHECK THE “SPAM FOLDER” IN YOUR EMAIL.
4. PROCESSING TAKES ABOUT 4-6 MONTHS.
5. IN CASES OF COMPLIANCE, YOU ARE ONLY GIVEN 3 DAYS
TO COMPLY WITH THE DEFICIENCES IN YOUR
APPLICATION. OTHERWISE, THE CENTRAL DIRECTOR
WILL UTOMATICALLY DENY/DISAPPROVE YOUR
APPLICATION.
6. ALWAYS MAKE SURE THAT YOU HAVE CORREECTLY
ENTERED ALL THE INFORMATION/DATA IN YOUR
APPLICATION BEFORE CLICKING THE “NEXT” OR
“SUBMIT” BUTTON.
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Thank you!

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