FDA CIRCULAR  
No. ___________  
  
TO           :   ALL MANUFACTURERS/ EXPORTERS/ IMPORTERS/ DISTRIBUTORS/ 
TRADERS/ RETAILERS OF VAPOR PRODUCTS AND HEATED 
TOBACCO PRODUCTS (HTPs).  
  
SUBJECT : PROCEDURE ON THE APPLICATION FOR LICENSE TO OPERATE 
(LTO) THROUGH THE FOOD AND DRUG ADMINISTRATION (FDA) 
ELECTRONIC PORTAL (E -PORTAL) SYSTEM  
  
  
I.               BACKGROUND  
  
         Pursuant to Republic Act No. 9711, otherwise known as the “FDA Act of 2009”, 
Section 144  of Republic Act No. 11467, Section II of  Executive Order No. 106 and 
consistent with the provision of Republic Act No. 11032, otherwise known as the “Ease 
of Doing Business and Efficient Government Service Delivery Act of 2018” on the 
development of electronic versions of licenses, clearances, p ermits, certifications, or 
authorizations promoting transparency and reducing red tape in business and non -business 
transactions in government, the FDA hereby implements this Circular for the issuance of 
an electronic license to operate (e -LTO) to all esta blishments engaged in the manufacture, 
distribution, importation, exportation, sale including, offering for sale, advertising, and 
transfer of vapor products and heated tobacco products (HTPs).  
  
II.            OBJECTIVE   
  
         This Circular is being  issued to provide the procedural guidelines and documentary 
requirements for e -LTO applications using the FDA E -Portal System.  
  
  
III.          SCOPE AND COVERAGE  
  
This Circular shall cover all establishments seeking to manufacture, distribute, 
import, export, sell, and/or advertise vapor products, heated tobacco products (HTPs), and 
similar products in the Philippines.   
 
 
 
 IV.      GENERAL GUIDELINES  
  
1.     Manufacturers, traders, distributors (importer, exporter, wholesaler), and  retailers of vapor 
products, HTPs, and/or similar products, hereafter referred to as applicants, shall apply for 
an e-LTO through the FDA E -Portal system.  
  
2.    Electronic LTO applications shall be based on the type of activity and product sold by the 
applicant as provided in the table below:  
 
Manufacturer  Vapor Products  LTO as Manufacturer of Vapor 
Products  
Heated Tobacco Products  LTO as Manufacturer of Heated 
Tobacco Products  
Trader  Vapor Products  LTO as Trader of Vapor Products  
Heated Tobacco Products  LTO as Trader of Heated Tobacco 
Products  
Importer  Vapor Products  LTO as Importer of Vapor Products  
Heated Tobacco Products  LTO as Importer of Heated 
Tobacco Products  
Wholesaler  Vapor Products and/or 
Heated Tobacco Products  LTO as Wholesaler/Exporter of 
Vapor Products and/or Heated 
Tobacco Products  
 
Exporter  Vapor Products and/or 
Heated Tobacco Products  LTO as Wholesaler/Exporter of 
Vapor Products and/or Heated 
Tobacco Products  
 
Retailer  Vapor Products and/or 
Heated Tobacco Products  LTO as Retailer of Vapor Products 
and/or Heated Tobacco Products  
 
 
3.     Applicants must first secure a user account following the procedure outlined under Section 
IV, Item 1 of this issuance to access the FDA e -portal system.  
  
4.     Security and integrity of user accounts shall be the responsibility of the owner. Applicants 
must ensure only authorized personnel have access to their user accounts.  
  
5.     Applicants shall use their user accounts, in accordance with existing laws, FDA rules and 
regulations. FDA reserves the right to suspend and cancel user accounts found to be in 
violation of laws, FDA rules and regulations.  
  6.     Applicants shall ensure that the information and documents uploaded to the system and 
submitted to FDA a re true, correct, updated, and complete.  
  
7.     In the application forms, fields marked with red asterisks (*) are required to be filled -in. Mark 
required fields with N/A, if not applicable.  
  
8.        Documents uploaded to the system must conform to th e following specifications:  
8.1.         Documents/ files/ information uploaded must be free from bugs, viruses, and the like 
that may compromise the FDA system.  
8.2.        Documents must be scanned and saved in PDF file format at 100 -150 dots -per-inch 
(dpi).  
8.3.    Document file names shall be less than 40 characters in length, and shall not contain 
the following characters: \ ? / : * “ > < | .”  
  
9.  Incomplete and incorrect submissions shall immediately be disapproved.  
  
IV.           SPECIFIC GUIDELINES  
  
1.     Issuance of User Account to Access the FDA e -Portal system.  
  
        To file a user account request, follow the procedures outlined below:  
  
1.1            Accomplish the Authorization Letter for the e -LTO User Account application 
(please refer to Annex B).  
1.2            Follow the link below: bit.ly/ePortal2  (please refer to Annex A).  
1.3            Provide all the required information in the user’s registration form.  
1.4            Attach the signed and notarized Authori zation (please refer to Annex B) in pdf 
file format, to the registration form.  
1.5            The User Account credentials will be sent to the email address provided in the 
registration form. The User Account credentials is valid for one (1) year.  
1.6            Issuance of the User Account is within three (3) working days upon receipt of 
the complete and compliant request.  
  
2.   Procedural Guidelines on the Submission of Initial Application for LTO.  
  
2.1            Submission of LTO Application  
 
Submi ssion of application shall be done using the FDA e -Portal, accessible 
through  https://eportal2.fda.gov.ph . To file an application, follow the 
procedure outline below. Please refer to Annex C for the detailed procedural 
guidelines.   2.1.1            Log-in by entering the issued username and password.  
2.1.2         In the home tab, under the navigation pane, select New Application 
and click e -License to Operate (Initial Application) to proceed to the 
LTO application form.  
2.1.3         The LTO application form is divided into several parts as provided by 
the applications wizards. These include:  
  
2.1.3.1          Declaration of Undertaking  
2.1.3.2          General Information  
2.1.3.3          Establishment Information  
2.1.3.4          Establishment Addresses  
2.1.3.5          Product Line (for Manufacturer)  
2.1.3.6          List of Personnel  
2.1.3.7          Upload Documents (Please refer to Annex D)  
  
2.1.4            Accomplish the application form as provided in parts.  
  
2.1.5    An application summary will appear to review the provided information 
and the attached documentary requirements.  
  
2.1.6            An assessment slip will be generated at the end of the step.  
2.1.6.1     The computer -generated assessment slip will be viewed 
through a flash window.  
2.1.6.1          Print and download the file as reference for payment.  
2.1.6.2       To continue with the application, click ‘Next’ to delegate 
the applicat ion to payment posting. The application will 
then move to the Processed folder in the navigation pane.  
2.1.6.3    The status of the application may be checked in the Processed 
folder as indicated by the Task column.  
 2.1.7            To complete the applicat ion submission, the applicant must delegate 
the application to the FDA Cashier/Accounting.  
  
2.2          Payment of Application  
  
All LTO Application may be paid through any payment options made available 
by the FDA.   
  
 
 2.3          Results of Application  
  
The result of the application may either be approved (issuance of LTO) or 
disapproved. The result of the application shall be downloaded from the On -
Process folder of the applicant.  
  
2.3.1       Open the case number of the application and a flash window reflecting 
the output document will appear.  
  
2.3.2       Download and print the document and click ‘Next’ to end the task.  
  
V.            PROCESSING TIME  
  
Applications will be processed preferably within twenty (20) working  days. This 
timeline begins at the time the payment transaction reference number or the official receipt 
number has been verified by the FDA Accounting/Cashier, and ends at the time the result 
of the application has been forwarded to the On -Process folder of the applicant.  
                          
VI.          FEES  
  
Applications shall be charged with the fees pursuant to the schedule of fees stated 
under Annex E of this issuance.  
  
VII.        SEPARABILITY CLAUSE  
  
If any provision in this Circular, or application of such provision to any 
circumstances, is held invalid, the remainder of the provisions in this Circular shall not be 
affected.  
  
VIII.    EFFECTIVITY DATE  
  
This Circular shall take effect immediately.  
  
 
  
                    ROLANDO ENRIQUE D. DOMINGO, MD  
                                          Director General , Food and Drug Administration  
   ANNEX A  
  
                                        Online User’s Registration Form  
  
  
  
The Form can be accessed through the link below:  
bit.ly/ePortal2  
  
 
 
  
  
 
  
 
 
 
 
 
 
 
                                                                   ANNEX B  
  
Template for the Authorization Letter  
   
[COMPANY LETTERHEAD]  
  
(DATE)  
  
The Director General  
Food and Drug Administration  
Civic Drive, Filinvest City  
Alabang, Muntinlupa City  
  
Dear Director General:  
  
In accordance with Republic Act No. 9711 and other related issuances, we 
________________________________________ (Company Name) with business address at 
___________________________________________________________ ____________ hereby 
authorize ________________________ (Name of Company Representative) as the account 
holder of eLTO and shall be responsible for all applications submitted through the e -LTO 
system.  
  
I hereby undertake and warrant that the data and infor mation submitted in connection with this 
application as well as other submissions in the future including variations are true, correct, and 
reflect the total information available.  
  
 
_______________________________________  
(Owner/President/CEO/Authorized Officer)  
  
 Subscribed and sworn to me this ____ day of ______ at _____________________________.  
  
_____________________________  
              Notary Public  
  
Doc No ________  
Page No ________  
Book No _______  
Series of _______  
 ANNEX C  
  
Submission of LTO Application Through the FDA e -Portal V.2  
  
  
1.   Access the FDA e -Portal 
V.2 at  
https://eportal2.fda.gov.ph  
2.  Log-in by entering the 
issued username and 
password.    
  
3.   In the HOME tab, select 
New Application in the 
navigation pane and click 
e-License to Operate 
(Initial Application) to 
proceed to the LTO 
application form.   
  
4.   Accomplish the application 
form as provided in parts by 
the application wizard. Fill -
in the fields as completely 
as possible. Fields marked 
with a red asterisk (*) are 
required to be filled -in. 
Mark required fields with 
N/A, if not applicable.  
·    Declaration - Proceed 
with the application 
by selecting your 
response using the 
drop-down list and 
click ‘Next’.   ·    General Information - 
Select the applicable 
product classification 
and primary activity 
of the applicant 
establishment. Tick 
the secondary activity 
and select the 
declared capital. 
These shall be based 
on the selected 
product classification 
and primary activity. 
To continue to the 
next step, tick the box 
to certify all 
information is true 
and correct, then 
‘Next’.   
·    Establishment 
Information -  
Fill-in the necessary 
information. All provided 
information shall be 
reflected also on the 
submitted Proof of 
Business Name 
Registration. Tick the box 
to certify all information 
is true and correct, then 
‘Next’.   ·    Establishment 
Addresses – Declare 
all the addresses of 
the applicant 
establishment by 
ticking the type of 
address applicable. 
The applicant may 
simultaneously tick 
the plant, office, and 
warehouse if all three 
have the same 
address. Utilize the 
dropdown li st when 
selecting the region, 
province, city and zip 
code. Click Show 
Map Tool and a 
separate window will 
appear showing the 
GPS map of the 
address. Move the 
arrow to the exact 
location of the 
establishment. Click 
‘Submit’. The GPS 
coordinates will be 
automatically updated 
when you move the 
arrow, then click 
‘Submit’. Select the 
desired mailing 
address by clicking 
“Set this address as 
my mailing address” 
and then click ‘Add 
Address’. For 
manufacturers, please 
provide one (1) plant 
address. Submission  
  is lim ited to one (1) 
plant address per 
manufacturer only. 
Tick the box to certify 
all information is true 
and correct, then 
‘Next’.  ·    Product Line (For 
Manufacturer Only) – 
Select the applicable 
product line from the 
dropdown list and 
click ‘Add’. Tick the 
box to certify all 
information is true 
and correct, then 
‘Next’.   
·    List of Personnel – 
Declare the 
Authorized and 
Qualified personnel. 
Select the Type of 
Personnel and provide 
the required 
information. An 
establishment may 
add only one (1) 
Authorized 
Representative and 
one (1) or more 
Qualified Personnel. 
The Authorized 
Representative should 
be the owner of the 
establishment while 
the Qualified 
Personnel must be an 
Allied Health Science 
Professional.  Click 
‘Add’ after every 
submission of 
personnel. Tick the 
box to certify all 
information is true 
and correct, then 
‘Next’.   ·    Upload Documents – 
Upload the required 
document/s in PDF 
format: Proof of 
Business Name 
Registration, Site 
Master File (For 
Manufacturers Only), 
Risk Management 
Plan (if applicable), 
Seminar Certificate, 
and Government -
Issued ID of 
Authorized and 
Qualified Personnel. 
Tick the box to certify 
all information is true 
and correct, then 
‘Next’. Applicants 
may upload 
documents 
simultaneously.   
·    Application Summary 
– It reflects all the 
declared information 
and uploaded 
documents. The 
applicant 
establishment may 
review and recheck 
the information. If 
there are corrections 
to be made, the 
applicant may revisit 
the pages of the 
application form by 
clicking ‘Previous 
Steps’. The applicant 
establishment may  also view the attached 
document by clicking 
its file name.  
·    Order of payment – A 
computer generated 
document will appear 
reflecting the 
appropriate fees and 
charges. The applicant 
establishment should 
save and print a copy 
of the document as 
reference for 
payment. Click ‘Next’ 
to continue and 
delegate the 
application to 
payment verification.  
   5.   The application will 
undergo evaluation, 
checking, quality assurance 
and final recommendation. 
The application may either 
be approved (issuance of 
LTO) or disapproved. The 
result may be downloaded 
through the On -Process 
folder of the applicant 
establishment. Download 
and print the document and 
click ‘Next’ to end the task.   
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 ANNEX D   
Documentary Requirements for the LTO Application  
Manufacturer  Distributor/Trader  Retailer  
Accomplished application 
form for  
Manufacturers  Accomplished application 
form for  
Traders/Distributors  Accomplished application 
form for  
Retailers  
Payment  Payment  Payment  
Proof of Business Name  
Registration  
((DTI/SEC)  Proof of Business Name  
Registration  
(DTI/ SEC)  Proof of Business Name  
Registration  
(DTI/SEC)  
Site Master File  
Risk Management Plan  
   
  
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 ANNEX E  
Fees and Charges for LTO Application  
 
 LICENSE TO OPERATE  Fees (in PhP)*  
Initial  
(1 Year)  Renewal  
(3 Years)  Variation  
(Major – w/ 
inspection)  
Vapor Products (VP) and Heated  Tobacco Products ( HTP) Establishment:  
Retailers (VP + HTP) 5,000.00  15,000.00  2,500.00  
Wholesaler/Exporter (VP + HTP) 10,000.00  30,000.00  5,000.00  
Importer (VP)  12,000.00  36,000.00  6,000.00  
Importer (HTP) 25,000.00  75,000.00  12,500.00  
Traders (VP)  12,000.00  36,000.00  5,000.00  
Traders (HTP) 25,000.00  75,000.00  12,500.00  
Manufacturers (VP)  15,000.00  45,000.00  7,500.00  
Manufacturers (HTP) 40,000.00  120,000.00  20,000.00  
VARIATION (Minor – w/out inspection)   2,000.00 / variation