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
filing
by
a
marketing
authorization
holder
of
a
notice
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the
FDA,
concerning
the
manufactured
or
imported
batch
or
batches
of
HTPs
prior
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
release for sale, offer for sale, or distribution of such particular batch of batches of HTPs.
 
4.
Designated
Vaping
Area
​
shall
refer
to
an
area
where
the
use
of
vapor
products
shall
be
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
allowed
​
.
 
5.
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 specific HTPs classified as HUHS and health-related devices in the Philippines.
 
6.
Health
Claims
​
shall
refer
to
the
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.
 
7.
Heated
Tobacco
Products
(HTPs)
​
refer
to
tobacco
products
that
may
be
consumed
 
 
 
 
 
 
 
 
 
 
 
 
 
through
heating
tobacco,
either
electrically
or
through
other
means
sufficiently
to
release
 
 
 
 
 
 
 
 
 
 
 
 
an
aerosol
that
can
be
inhaled
without
burning
or
any
combustion
of
the
tobacco.
HTPs
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
include
liquid
solutions
and
gels
that
are
part
of
the
product
and
are
heated
to
generate
an
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
aerosol.
 
8.
Industry
​
refers
to
manufacturers,
traders,
distributors
(importer,
exporter,
wholesaler),
and
 
 
 
 
 
 
 
 
 
 
 
retailers of HTPs
​
.
 
9.
Ingredient
means
any
substance
that
is
added
to
the
mixture
and
present
in
the
finished
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
product.
 
 10.
Marketing
Authorization
Holder
(MAH)
​
refers
to
a
company,
firm
or
non-profit
 
 
 
 
 
 
 
 
 
 
 
 
organization that has been granted an authorization by the FDA.
 
11.
Nicotine
Shots
refer
to
nicotine
in
liquid
or
any
other
form/substances
that
is
added
to
or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
mixed
with
an
HTP
refill
or
cartridge
that
has
the
effect
of
increasing
the
dosage
or
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
nicotine concentration in a refill or cartridge.
 
12.
Package
shall
refer
to
packs,
boxes,
cartons,
or
containers
of
any
kind
used
on
HTPs,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
which is offered for sale to consumers.
 
13.
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.
 
14.
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 HTP refills and cartridges.
 
15.
Promotion
shall
refer
to
an
event
or
activity
organized
by
or
on
behalf
of
an
HTP
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
manufacturer,
distributors
(importer,
exporter,
wholesaler),
seller
or
retailer
with
the
aim
 
 
 
 
 
 
 
 
 
 
 
of
promoting
HTP,
which
event
or
activity
would
not
occur
but
for
the
support
given
to
it
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
by
or
on
behalf
of
the
HTP
manufacturer,
distributor
(importer,
exporter,
wholesaler),
 
 
 
 
 
 
 
 
 
 
 
 
seller
or
retailer.
It
may
also
refer
to
the
display
of
HTP
or
the
manufacturer’s
name,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
trademark,
logo,
and
the
like
on
non-HTPs.
This
includes
the
paid
use
of
HTPs
bearing
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the
brand
names,
trademarks,
logos,
and
the
like
in
movies,
television,
and
other
forms
of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
entertainment.
 
16.
Refills
and
Cartridges
are
articles,
which
may
or
may
not
contain
nicotine,
designed
to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
be used in conjunction with HTP electronic delivery devices for inhalation.
 
17.
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
HTP
refills
and
cartridges
(e.g.
product
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
inserts, tags, etc.).
 
 
18.
Sponsorship
shall
refer
to
any
public
or
private
contribution
from
HTP
industry
in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
relation
to
an
event,
team
or
activity
made
with
the
aim
of
promoting
a
brand
of
HTPs,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 HTP industry.
 
 
 
 