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,
permits,
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
establishments
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 are 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 the 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 Authorization (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
 
 
Submission
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 C)
 
 
 
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
application
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
application
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
15
days
after
publication
in
a
newspaper
of
general
 
 
 
 
 
 
 
 
 
 
 
 
 
 
circulation and the Office of National Administrative Register of the UP Law Center.