Howready
readyare
areyou
you for
for the
the new e-cigarettes
How
e-cigarettes legislation?
legislation?
Be fully
fully supported
supported for
for the
Be
the forthcoming
forthcoming implementation
implementation of
of Article
Article 20
20
of
the Tobacco Products Directive 2014/40/EU on 20th May 2016
of the Tobacco Products Directive 2014/40/EU on 20th May 2016
Do you have the have all the necessary information to hand to submit your e-liquid product
Do
you have
theHealth
haveAuthority?
all the necessary information to hand to submit your e-liquid
notification
to the
product notification to the Health Authority?
Do you know what information you need to include in your product notification filing?
Do you know what information you need to include in your product notification filing?
Do you know what information you might be missing and where to get it from?
Do you know what information you might be missing and where to get it from?
Do you know if your vendors are supplying you with TPD compliant raw materials and packaging
Do
you know if your vendors are supplying you with TPD compliant raw materials and
materials?
packaging
materials?
Do you actually
know who the primary manufacturers of your raw materials are, or are your
suppliers
actually aknow
broker?
Do
you actually
who the primary manufacturers of your raw materials are, or are
your
suppliers
actually
a broker?
Will your labelling be compliant
with the new directive?
Will
yourmanufacturing
labelling be processes
compliant
with the new
directive?
Are your
documented,
robust
and validated?
Are
yourproducts
manufacturing
processes
documented,
robust and validated?
Do your
comply with
the emissions
testing requirements?
Do you
a robust
Qualitywith
Management
Systemtesting
in placerequirements?
with a formal change control system to
Do
yourhave
products
comply
the emissions
record and validate any proposed changes to your raw materials and packaging materials to ensure
Do you have a robust Quality Management System in place with a formal change
ongoing compliance once you have achieved your product notification?
control system to record and validate any proposed changes to your raw materials
The consequences
could
be a batch
recall
and
revocation
of your
your
andpackaging
materialsoftonon-compliance
ensure ongoing
compliance
once
you
have
achieved
productnotification.
notification?
Do you
have a formalof
recall
procedure in place?
Have
confirmed
thatand
it works?
• The
consequences
non-compliance
could
beyou
a batch
recall
revocation of
your
notifiquestions
cation. to find the answers to and time is ticking away, so let Diamond Pharma
There are
so many
Services
take
the a
strain
andrecall
reduce
your stressinby
supporting
you confi
with their
during
• Do
youuphave
formal
procedure
place?
Have you
rmedexpertise
that it works?
these challenging next few months and beyond
There are so many questions to find the answers to and time is ticking away, so let
Diamond Pharma Services take up the strain and reduce your stress by supporting you
with their expertise during these challenging next few months and beyond.
Diamond Pharma Services can provide you with the following support:
Diamond Pharma Services can provide you with the following support:
Generation of product Notifications
Setting up manufacturing processes
Submission
of Notifications
Health
Authorities
Generation
of product to
Notifi
cations
Provision
of RPup manufacturing processes
Setting
Updates/amendments
tocations
Notifications
Submission of Notifi
to Health Authorities Manufacturing
Provisionsite
of audits
RP
Generation
of product labelsto Notifications
Updates/amendments
QualityManufacturing
Manual generation
site audits
Generation
of product
leaflets
Generation
of product
labels
Generation
of Quality
Quality
ManualManagement
generation Systems
Vapo-vigilance
PVproduct
for e-liquids
Generation–of
leaflets
Product
development
process Systems
Generation
of Quality
Vapo-vigilance
– PV Lena
for e-liquids
Product
development process
To request support,
please contact
Demetre T: +44 (0) 7876 664543
E: [email protected]
To request support, please contact Lena Demetre
T: +44 (0) 7876 664543 E: [email protected]