FDA Circular No. __________________
 
 
 
TO:
 
ALL
HEATED
TOBACCO
PRODUCT
MANUFACTURERS,
 
 
 
 
 
TRADERS, AND IMPORTERS
 
 
SUBJECT:
 
BATCH
DECLARATION
OF
HEATED
TOBACCO
PRODUCT
 
 
 
 
 
 
REFILLS AND CARTRIDGES
 
 
I.
BACKGROUND
 
 
In
2005,
the
Philippines
ratified
the
World
Health
Organization
(WHO)
 
 
 
 
 
 
 
 
 
 
Framework
Convention
on
Tobacco
Control
(FCTC),
implementing
the
comprehensive,
 
 
 
 
 
 
 
 
 
effective,
and
practical
tobacco
control
measures
enshrined
in
the
legally
binding
 
 
 
 
 
 
 
 
 
 
 
international
treaty.
As
a
State
Party
to
the
treaty,
the
Philippines
is
compelled
to
develop
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
and
implement
laws
and
strategies
to
combat
illicit
trade
in
tobacco
products
in
 
 
 
 
 
 
 
 
 
 
 
 
 
accordance
with
the
terms
of
Article
15
of
the
WHO
FCTC.
Furthermore,
the
Philippines
 
 
 
 
 
 
 
 
 
 
 
 
 
 
is
obliged
to
establish
an
effective
national
tracking
and
tracing
system
for
all
tobacco
 
 
 
 
 
 
 
 
 
 
 
 
 
 
products
that
are
manufactured
in
or
imported
into
the
country,
with
the
use
of
unique
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
identification
markings
to
allow
the
monitoring
of
movement
of
such
products,
thereby
 
 
 
 
 
 
 
 
 
 
 
 
securing the supply chain and assisting in the investigation of illegal trade.
 
 
 
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
batch
declaration
certificate
for
heated
tobacco
product
(HTP)
 
 
 
 
 
 
 
 
 
 
 
refills/cartridges
manufactured
or
imported
by
establishments
with
valid
FDA-issued
 
 
 
 
 
 
 
 
 
electronic
licenses
to
operate
(e-LTOs)
and
product
marketing
authorizations
using
the
 
 
 
 
 
 
 
 
 
 
 
FDA e-Portal System.
 
 
II.
OBJECTIVES
 
 
This
Circular
is
being
issued
to
provide
the
guidelines
on
the
submission
of
 
 
 
 
 
 
 
 
 
 
 
 
 
applications
for
batch
declaration
of
HTP
refills/cartridges
with
the
appropriate
FDA
 
 
 
 
 
 
 
 
 
 
 
product authorization certificate.
 
 
III.
SCOPE
 
 
This
Circular
shall
apply
to
all
manufacturers,
traders,
and
importers
of
HTP
 
 
 
 
 
 
 
 
 
 
 
 
refills/cartridges.
 
  
 
 
IV.
GENERAL GUIDELINES
 
 
1.
Only
HTP
refills/cartridges
with
valid
FDA
product
authorization
certificate
 
 
 
 
 
 
 
 
 
may apply for batch declaration.
 
 
 
2.
All
batches
of
HTP
refills/cartridges
shall
be
declared
with
the
FDA
prior
to
 
 
 
 
 
 
 
 
 
 
 
 
 
importation, release, distribution, or sale.
 
 
3.
Imported
products
of
the
same
batch/lot
number
but
of
different
shipment
shall
 
 
 
 
 
 
 
 
 
 
 
 
be applied separately.
 
 
4.
Submission
of
application
shall
be
done
using
the
FDA
e-Portal
system
 
 
 
 
 
 
 
 
 
 
 
(
​
https://eportal2.fda.gov.ph
​
).
 
 
 
5.
Documents
uploaded
to
the
system
must
conform
to
the
following
 
 
 
 
 
 
 
 
 
 
specifications:
 
 
5.1.
Documents
must
be
in
PDF
format,
while
images
must
be
in
.png
 
 
 
 
 
 
 
 
 
 
 
 
 
format.
Files
should
be
free
from
bugs
and
viruses
that
may
pose
risk
in
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FDA system.
 
 
5.2.
Documents
must
be
scanned
and
saved
in
PDF
file
format
at
100-150
 
 
 
 
 
 
 
 
 
 
 
 
dots-per-inch (dpi).
 
 
 
5.3.
Filenames
of
documents
must
contain
less
than
40
characters.
 
 
 
 
 
 
 
 
 
Filenames must not contain the following characters \ ? / : * “ > < |.”
 
 
6.
Incomplete and/or incorrect submissions shall immediately be disapproved.
 
 
7.
The
Regional
Field
Offices
shall
have
the
authority
to
collect
samples
of
 
 
 
 
 
 
 
 
 
 
 
 
particular batches of the HTP refills/cartridges which need further assessment.
 
 
V.
SPECIFIC GUIDELINES
 
 
1.
 
​
Procedural Guidelines the application of batch declaration.
 
 
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
the
option
 
 
 
 
 
 
 
 
 
 
 
below to proceed to the application form:
 1.1.2.1.
Batch
Declaration
–
Heated
Tobacco
Products
(Initial
 
 
 
 
 
 
 
Form)
 
1.1.3.
Click
on
the
dropdown
icon
and
select
the
correct
FDA
product
 
 
 
 
 
 
 
 
 
 
 
authorization certificate number for batch declaration.
 
 
1.1.4.
The
batch
declaration
application
form
is
divided
into
several
 
 
 
 
 
 
 
 
 
parts as provided below:
 
1.1.4.1.
Declaration of Undertaking
 
1.1.4.2.
Company and Product Information (pre-filled)
 
1.1.4.3.
Particulars of the Product Batch
 
1.1.4.3.1.
HTP Refill and Cartridge
 
 
1.1.4.3.1.1.
 
Batch/Lot Number
 
1.1.4.3.1.2.
 
Date of Manufacture
 
1.1.4.3.1.3.
Date
of
Importation
(for
imported
 
 
 
 
 
products)
 
1.1.4.3.1.4.      Batch Size (Quantity)
 
1.1.4.3.1.5.
Expiration Date
 
1.1.4.4.
1.1.4.3.1.6.
 
Target
Market
(For
Local
Distribution
or
 
 
 
 
 
 
for Exportation) Documentary Requirements
 
1.1.4.4.1.
Certificate
of
Analysis
of
the
Finished
Product
 
 
 
 
 
 
 
reflecting the batch/lot number.
 
 
1.1.4.4.2.
Picture
of
the
actual
product,
clearly
showing
the
 
 
 
 
 
 
 
 
commercial label and BIR tax stamp.
 
1.1.4.4.3.
For imported products:
 
1.1.4.4.3.1.
Clear
copy
of
the
commercial
invoice
and/or
 
 
 
 
 
 
 
packaging
list
reflecting
the
batch/lot
 
 
 
 
 
number
and
expiry
date,
or
any
proof
of
the
 
 
 
 
 
 
 
 
 
actual
volume
of
importation
(Note
that
the
 
 
 
 
 
 
 
actual
volume
of
importation
must
 
 
 
 
 
correspond
to
the
actual
volume
stated
in
the
 
 
 
 
 
 
 
 
application form.)
 
1.1.4.4.3.2.
Airway
bill/bill
of
lading
for
the
particular
 
 
 
 
 
 
 
shipment
 
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
Batch
 
 
 
 
 
 
 
 
 
 
 
 
Declaration
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
for
batch
declaration
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 AND PAYMENT
 
 
An
amount
of
​
One
Thousand
Pesos
(P1,000.00)
+
1%
Legal
Research
Fee
​
per
 
 
 
 
 
 
 
 
 
 
 
 
 
application
payable
through
any
payment
options
made
available
by
the
FDA
shall
be
 
 
 
 
 
 
 
 
 
 
 
 
 
required prior to the processing of the application for a batch declaration.
 
 
 
VIII.
EFFECTIVITY
 
 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.
 
 
 
 
 
 