ANNEX D
 
GLOSSARY
 
 
 
1.
Advertising
shall
refer
to
the
conceptualizing,
presenting,
making
available
and
 
 
 
 
 
 
 
 
 
 
communication
to
the
public,
through
any
form
of
media
platforms,
any
fact,
 
 
 
 
 
 
 
 
 
 
 
 
data,
or
information
about
the
attributes,
features,
quality
or
availability
of
 
 
 
 
 
 
 
 
 
 
 
consumer products, services, or credit.
 
 
 
2.
Authorization
means
a
permission
embodied
in
a
document
granted
by
the
FDA
 
 
 
 
 
 
 
 
 
 
 
 
to
a
natural
or
juridical
person
who
has
submitted
an
application
to
implement
the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
manufacture,
importation,
exportation,
sale,
offer
for
sale,
distribution,
and/or,
 
 
 
 
 
 
 
 
 
where
appropriate,
the
use,
testing,
promotion,
advertising,
or
sponsorship
of
 
 
 
 
 
 
 
 
 
 
health
products.
The
authorization
can
take
the
form
of
a
permit,
a
license,
a
 
 
 
 
 
 
 
 
 
 
 
 
 
 
certificate
of
registration,
of
accreditation,
of
compliance,
or
of
exemption,
or
any
 
 
 
 
 
 
 
 
 
 
 
 
similar document.
 
 
3.
Batch
Declaration
refers
to
the
declaration
by
a
marketing
authorization
holder
 
 
 
 
 
 
 
 
 
 
 
informing
the
FDA
of
a
specific
batch
of
FDA-registered
vapor
products/HTPs
 
 
 
 
 
 
 
 
 
 
 
refills
or
cartridges
manufactured
or
imported
in
the
Philippines,
prior
to
release
 
 
 
 
 
 
 
 
 
 
 
 
for sale, offer for sale, or distribution of such particular batch into the market.
 
 
4.
FDA
Electronic
Registration
Number
(FERN)
​
shall
refer
to
the
product
 
 
 
 
 
 
 
 
 
 
authorization
issued
by
the
FDA
to
FDA-licensed
companies,
firms
or
non-profit
 
 
 
 
 
 
 
 
 
 
 
organizations to market heated tobacco products and vapor products.
 
 
 
5.
Industry
​
refers
to
manufacturers,
traders,
distributors
(importer,
exporter,
 
 
 
 
 
 
 
 
wholesaler), and retailers of vapor products and/or heated tobacco products
​
.
 
 
6.
Ingredient
means
any
substance
or
additive
that
is
used
for
the
 
 
 
 
 
 
 
 
 
 
 
production/manufacture of the finished product.
 
 
 
7.
Marketing
Authorization
Holder
(MAH)
​
refers
to
a
company,
firm
or
 
 
 
 
 
 
 
 
 
 
non-profit organization that has been granted an authorization by the FDA.
 
 
8.
Nicotine
Shots
refer
to
nicotine
in
liquid
or
any
other
form/substances
that
is
 
 
 
 
 
 
 
 
 
 
 
 
 
added
to
or
mixed
with
vapor
product
refills
or
cartridges
that
has
the
effect
of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
increasing the dosage or nicotine concentration in a refill or cartridge.
  
 
9.
Package
shall
refer
to
packs,
boxes,
cartons,
or
containers
of
any
kind
used
on
 
 
 
 
 
 
 
 
 
 
 
 
 
 
vapor products, which is offered for sale to consumers.
 
 
 
10.
Post-Marketing
Surveillance
(PMS)
​
refers
to
activities
involved
in
safety,
 
 
 
 
 
 
 
 
 
efficacy,
and
quality
monitoring
of
health
products.
This
shall
also
include,
 
 
 
 
 
 
 
 
 
 
 
among
others,
adverse
events
reporting,
product
safety
update
reporting,
 
 
 
 
 
 
 
 
 
collection and testing of health products in the market.
 
 
11.
Primary
Packaging
refers
to
any
material,
including
printed
material,
employed
 
 
 
 
 
 
 
 
 
 
in
the
packaging
of
the
product,
excluding
any
outer
packaging
used
for
 
 
 
 
 
 
 
 
 
 
 
 
transportation
or
shipment,
that
is
​
in
direct
contact
with
the
Vapor
Product
and
 
 
 
 
 
 
 
 
 
 
 
 
 
Heated Tobacco product refill solutions.
 
 
12.
Product
Claims
​
shall
refer
to
health
or
therapeutic
claims
of
a
product,
which
 
 
 
 
 
 
 
 
 
 
 
 
 
indicates
beneficial
effects
to
promote
good
health
by
enhancing/improving
body
 
 
 
 
 
 
 
 
 
 
function,
improving
a
function,
enhancing
or
preserving
health
and/or
reducing
 
 
 
 
 
 
 
 
 
 
the risk of health-related conditions of diseases.
 
 
13.
Product
Marketing
Authorization
​
shall
refer
to
FDA-issued
product
 
 
 
 
 
 
 
 
certification such as FERN and Batch Declaration.
 
 
 
14.
Promotion
shall
refer
to
an
event
or
activity
organized
by
or
on
behalf
of
an
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
vapor
product
manufacturer,
distributors
(importer,
exporter,
wholesaler),
seller
 
 
 
 
 
 
 
 
or
retailer
with
the
aim
of
promoting
vapor
products,
which
event
or
activity
 
 
 
 
 
 
 
 
 
 
 
 
 
would
not
occur
but
for
the
support
given
to
it
by
or
on
behalf
of
the
vapor
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
product
manufacturer,
distributor
(importer,
exporter,
wholesaler),
seller
or
 
 
 
 
 
 
 
 
retailer.
It
may
also
refer
to
the
display
of
vapor
products
or
the
manufacturer’s
 
 
 
 
 
 
 
 
 
 
 
 
 
 
name,
trademark,
logo,
and
the
like
on
non-vapor
products.
This
includes
the
 
 
 
 
 
 
 
 
 
 
 
 
paid
use
of
vapor
products
bearing
the
brand
names,
trademarks,
logos,
and
the
 
 
 
 
 
 
 
 
 
 
 
 
 
like in movies, television, and other forms of entertainment.
 
 
 
15.
Refills
and
Cartridges
are
articles,
which
may
or
may
not
contain
nicotine,
 
 
 
 
 
 
 
 
 
 
 
 
designed
to
be
used
in
conjunction
with
vapor
product
or
HTP
electronic
delivery
 
 
 
 
 
 
 
 
 
 
 
 
 
devices for inhalation.;
 
 
16.
Secondary
packaging
refers
to
any
material,
including
printed
material,
 
 
 
 
 
 
 
 
 
employed
in
the
packaging
of
the
product,
excluding
any
outer
packaging
used
 
 
 
 
 
 
 
 
 
 
 
 
for
transportation
or
shipment,
that
is
​
not
in
direct
contact
with
the
Vapor
 
 
 
 
 
 
 
 
 
 
 
 
 Product
and
Heated
Tobacco
Product
refill
solutions
(e.g.
product
inserts,
tags,
 
 
 
 
 
 
 
 
 
 
 
etc.).
 
 
 
17.
Sponsorship
shall
refer
to
any
public
or
private
contribution
from
vapor
product
 
 
 
 
 
 
 
 
 
 
 
 
industry
in
relation
to
an
event,
team
or
activity
made
with
the
aim
of
promoting
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a
brand
of
vapor
products,
which
event,
team
or
activity
would
still
exist
or
occur
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
with
or
without
contribution.
This
shall
also
include
corporate
social
 
 
 
 
 
 
 
 
 
 
responsibility (CSR) activities by the vapor product industry.
 
 
 
18.
Vapor
Products
​
shall
mean
electronic
nicotine
and
non-nicotine
delivery
 
 
 
 
 
 
 
 
 
systems
(ENDS/ENNDS),
which
are
a
combination
of
(i)
a
liquid
solution
or
gel,
 
 
 
 
 
 
 
 
 
 
 
 
 
that
transforms
into
an
aerosol
without
combustion
through
the
employment
of
a
 
 
 
 
 
 
 
 
 
 
 
 
mechanical
or
electronic
heating
element,
battery
or
circuit
that
can
be
used
to
 
 
 
 
 
 
 
 
 
 
 
 
 
heat
such
solution
or
gel
and
includes
but
not
limited
to
(ii)
a
cartridge,
(iii)
a
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
tank,
and
(iv)
the
device
without
the
cartridge
or
tank.
It
is
commonly
known
as
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
nicotine
salt/salt
nicotine,
and
conventional
‘freebase’
or
classic
nicotine,
and
 
 
 
 
 
 
 
 
 
 
other similar products.