FDA CIRCULAR
 
No. ___________
 
 
 
 
TO               :
 
ALL
MANUFACTURERS/
TRADERS/
IMPORTERS
OF
 
 
 
 
 
VAPOR PRODUCTS
 
 
 
 
SUBJECT   :
 
APPLICATION
PROCEDURE
FOR
PRODUCT
 
 
 
 
MARKETING
AUTHORIZATIONS
THROUGH
THE
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
product
marketing
authorization
to
all
vapor
 
 
 
 
 
 
 
 
 
 
 
 
 
products
by
establishments
with
a
valid
FDA-issued
electronic
license
to
operate
(e-LTO)
using
 
 
 
 
 
 
 
 
 
 
 
 
 
the FDA E-Portal System.
 
 
II.
OBJECTIVE
 
 
The
objective
of
this
Circular
is
to
provide
the
procedural
guidelines
and
documentary
 
 
 
 
 
 
 
 
 
 
 
 
 
requirements
for
the
FDA
product
marketing
authorization
application
through
the
FDA
 
 
 
 
 
 
 
 
 
 
 
E-Portal System.
 
 
III.
SCOPE AND COVERAGE
 
 
This
Circular
shall
cover
all
manufacturers,
traders,
and
importers
of
vapor
products
 
 
 
 
 
 
 
 
 
 
 
 
applying
for
product
marketing
authorizations
under
the
Center
for
Cosmetics
Regulation
and
 
 
 
 
 
 
 
 
 
 
 
 
Research.
 
IV.
​
          
​
GENERAL GUIDELINES
 
1.
Only
those
establishments
with
​
valid
e-LTO
as
manufacturer,
trader
or
importer
 
 
 
 
 
 
 
 
 
 
 
can apply for product marketing authorizations.
 
 2.
Vapor
product
refills,
and
cartridges
containing
nicotine
concentrations
above
20
 
 
 
 
 
 
 
 
 
 
mg/mL
but
not
more
than
65
mg/mL
(>20mg/mL-65mg/mL)
in
its
formulation,
 
 
 
 
 
 
 
 
 
 
 
and does not bear health claims, shall be applied for FERN Category 1 (FERN 1).
 
 
3.
Vapor
product
refills,
and
cartridges
with
nicotine
content
not
exceeding
20
 
 
 
 
 
 
 
 
 
 
 
mg/mL
and
does
not
bear
health
claims,
shall
be
applied
for
FERN
Category
2
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(FERN 2).
 
 
4.
Vapor
product
electronic
delivery
devices,
shall
be
issued
a
FERN
Category
3
 
 
 
 
 
 
 
 
 
 
 
 
(FERN
3)
authorization
upon
compliance
to
set
requirements
including
the
 
 
 
 
 
 
 
 
 
 
certificate of conformity issued by the Department of Trade and Industry (DTI).
 
 
5.
No
vapor
products
shall
be
distributed
or
sold
in
the
Philippines
without
the
 
 
 
 
 
 
 
 
 
 
 
 
 
appropriate product marketing authorizations from the FDA.
 
 
6.
Applicants
are
required
to
provide
true,
correct,
updated,
and
complete
 
 
 
 
 
 
 
 
 
 
information pertaining to their type of application.
 
 
7.
Submission
of
application
shall
be
done
using
the
FDA
e-Portal
system,
 
 
 
 
 
 
 
 
 
 
 
accessible through
​
 
​
https://eportal2.fda.gov.ph
​
.
 
 
8.
Documentary
requirements
to
be
uploaded
to
the
system
must
conform
with
the
 
 
 
 
 
 
 
 
 
 
 
 
following specifications:
 
 
8.1.
Documents
must
be
in
PDF
file
format
and
.png
(for
images),
free
from
 
 
 
 
 
 
 
 
 
 
 
 
 
bugs, viruses, and the like that may jeopardize the system of the FDA.
 
 
8.2.
Documents
must
be
saved
in
searchable
PDF
file
format
at
100-150
 
 
 
 
 
 
 
 
 
 
 
dots-per-inch (dpi).
 
 
 
8.3.
Document
filenames
of
documents
shall
be
less
than
40
characters
in
 
 
 
 
 
 
 
 
 
 
 
length, and shall not contain the following characters: \ ? / : * “ > < |.”
 
 
9.
Incomplete and incorrect submissions shall immediately be disapproved.
 
 
 
 
 
 V.           SPECIFIC GUIDELINES
 
1.
Procedural
Guidelines
for
Product
Marketing
Authorization
Application
of
Vapor
 
 
 
 
 
 
 
 
 
Products
 
 
1.1.
Submission of Product Marketing Authorization Application
 
 
1.1.1.
Log-in by entering the issued username and password.
 
 
1.1.2.
On
the
home
tab,
under
the
navigation
pane,
select
among
the
following
 
 
 
 
 
 
 
 
 
 
 
 
options to proceed to the application form:
 
 
1.1.2.1.
FERN 1 - ENDS/ENNDS - E-liquid Registration (Initial Form)
 
1.1.2.2.
FERN 2 - ENDS/ENNDS - E-liquid Registration (Initial Form)
 
1.1.2.3.
FERN 3 - ENDS/ENNDS - Device Registration (Initial Form)
 
 
1.1.3.
The
product
marketing
authorization
application
form
is
divided
into
 
 
 
 
 
 
 
 
 
several parts as provided by the application wizards. These include:
 
 
1.1.3.1.
Declaration of Undertaking
 
1.1.3.2.
Local
Company
Responsible
for
Placing
the
Product
in
the
 
 
 
 
 
 
 
 
 
Market
 
1.1.3.3.
Product Source
 
1.1.3.4.
Particulars of the Product
 
1.1.3.5.
Full
Ingredient
Listing
indicating
the
percentage
and
function
of
 
 
 
 
 
 
 
 
 
each ingredient (for ENDS/ENNDS E-Liquid)
 
1.1.3.6.
Full
Component
Listing
indicating
the
function
of
each
 
 
 
 
 
 
 
 
component (for Electronic Delivery Devices)
 
1.1.3.7.
Documentary Requirements (for uploading)
 
 
1.1.3.7.1.
For FERN 1 Applications:
 
1.1.3.7.1.1.
Product Information File 
​
(see Annex A)
 
1.1.3.7.1.2.
Pre-Application
Documentary
Evaluation
(PADE)
 
 
 
 
Certification
​
(see
guidelines
for
the
issuance
of
 
 
 
 
 
 
 
PADE certification)
 
 
1.1.3.7.2.
For FERN 2 Applications:
 
1.1.3.7.2.1.
Product Information File 
​
(see Annex A)
 
 1.1.3.7.3.
For FERN 3 Applications:
 
1.1.3.7.3.1.
DTI Certification for Vapor Product Devices
 
1.1.3.7.3.2.
Product Information File 
​
(see Annex A)
 
 
1.1.4.
Accomplish the application form as provided in parts.
 
 
1.1.5.
An
application
summary
will
appear
to
review
the
provided
information
 
 
 
 
 
 
 
 
 
 
and the attached documentary requirements.
 
 
1.1.6.
Assessment slip will be generated at the end of the step.
 
 
1.1.6.1.
The
computer-generated
assessment
slip
will
be
viewed
through
a
 
 
 
 
 
 
 
 
 
flash window.
 
1.1.6.2.
Print and download the file as reference for payment.
 
1.1.6.3.
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.
 
1.1.6.4.
The
status
of
the
application
may
be
checked
in
the
Processed
 
 
 
 
 
 
 
 
 
 
 
folder as indicated by the Task column.
 
 
1.1.7.
To
complete
the
application
submission,
the
applicant
must
delegate
the
 
 
 
 
 
 
 
 
 
 
application to the FDA Cashier/Accounting.
 
 
 
1.2.
Payment of Application
 
 
The
application
may
be
paid
through
any
payment
options
made
available
by
the
 
 
 
 
 
 
 
 
 
 
 
 
 
FDA.
 
 
1.3.
Results of Application
 
 
The
result
of
the
application
may
either
be
approved
(issuance
of
product
 
 
 
 
 
 
 
 
 
 
 
 
authorization
certificate)
or
disapproved.
The
result
of
the
application
shall
be
 
 
 
 
 
 
 
 
 
 
 
downloaded from the On-Process folder of the applicant.
 
 
1.3.1.
Open
the
case
number
of
the
application
and
a
flash
window
reflecting
 
 
 
 
 
 
 
 
 
 
 
 
the output document will appear.
 
1.3.2.
Download and print the document and click ‘Next’ to end the task.
 
  
 
VI.
​
          
​
PROCESSING TIME
 
 
Applications
will
be
processed
within
twenty
(20)
working
days.
The
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.
 
 
VII.
 
 
​
FEES
 
Applications
shall
be
charged
with
the
fees
pursuant
to
the
schedule
of
fees
 
 
 
 
 
 
 
 
 
 
 
 
 
stated under 
​
Annex B
​
 of this issuance.
 
 
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..
 
IX.
 
PENALTIES
 
Violation
to
any
provisions
of
this
Circular
shall
be
subject
to
the
 
 
 
 
 
 
 
 
 
 
 
 
penalties/sanctions
provided
under
Book
III,
Article
XI
of
the
Rules
and
Regulations
 
 
 
 
 
 
 
 
 
 
 
 
Implementing
Republic
Act
No.
9711,
The
Food
and
Drug
Administration
Act
of
2009,
 
 
 
 
 
 
 
 
 
 
 
 
 
and other penalties provided by other applicable laws.
 
 
 
X.
​
            
​
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.