Traceability in the global supply
chain
Masterclass GDP
Séverine Dewerpe, Healthcare Manager, GS1 Belgilux
March 5th, 2015
Agenda
• Why global standards?
• Developments on traceability across the world
• Global regulatory developments
• Benefits of traceability in the vaccines supply chain
• Q&A
© GS1 Belgium & Luxembourg 2015
Why global standards?
© GS1 Belgium & Luxembourg 2015
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Why global standards?
Lack of standards in daily life is inefficient and
annoying …
© GS1 Belgium & Luxembourg 2015
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Why global standards?
… in healthcare it is
dangerous and inefficient !
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Multiple bar codes on one
package – which one to scan?
Different types of bar codes –
inconsistency; incompatibility
No bar code – need to bar code;
re-package; re-label
© GS1 Belgium & Luxembourg 2015
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The
Need
for Global
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instand
The
Global
standards
in
Healthcare
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© 2013 GS1
© 2013 GS1
© 2013 GS1
© GS1 Belgium & Luxembourg 2015
© 2013 GS1
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Reduce complexity
Speak one language
© GS1 Belgium & Luxembourg 2015
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GS1
An international standard organisation
Not-for-profit
111 Member Organisations
Over one million user companies
(from SME to global companies)
Member driven
150 countries served; 20 different domains
2,500 people helping us
Over 6 billion transactions a day
© GS1 Belgium & Luxembourg 2015
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GS1 Healthcare
A voluntary, global Healthcare User Group
To lead the healthcare sector to the successful development and
implementation of global standards by bringing together experts in
healthcare to enhance patient safety and supply chain efficiencies.
© GS1 Belgium & Luxembourg 2015
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GS1 Healthcare Global User Group
© GS1 Belgium & Luxembourg 2015
GS1 Healthcare around the World
Manufacturers
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3M
Abbott Laboratories/Abbvie
Actavis Pharma, Inc
Actelion Pharmaceuticals Ltd
Alcon Labs
AMAG Pharmaceuticals, Inc
Amgen
Astra Zeneca
B. Braun
Baxter
Bayer
Becton Dickenson
Cook Medical
Covidien
Edwards Lifescience
Eli Lilly and Company
F. Hoffmann-La Roche Ltd
Fresenius
GE Healthcare
Genzyme
Gilead
GlaxoSmithKline
Johnson & Johnson
Medtronic
Merck & Co.
Novartis
Pall Medical
Pfizer
Purdue Pharma
Smiths Medical
Takeda
Teleflex
TEVA
Zimmer
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1WorldSync, Inc.
Advanco
Axway
Blue Sphere Health Ltd.
Dirk Rodgers Consulting, LLC
Excellis Health
GHX
Solution provider
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Marsh Consulting Ltd.
OCS Checkweighers GmbH
Oracle
Seidenader
Tracelink
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AmerisourceBergen (US)
Cardinal Health (US)
CH Aulnay sous Bois (France)
Comparatio Health (Germany)
DHL Exel Supply Chain (UK)
Erasmus MC Rotterdam (NL)
Filip Vtori (Macedonia)
Hong Kong Hospital Authority
HUG Geneva (Switzerland)
King FAISAL Specialist Hospital & Research
Center (Saudi Arabia)
McKesson
Novation (US)
Premier (US)
St. James Hospital (Ireland)
UMC Groningen (NL)
UNI.H.A (representing 17 French university
hospitals)
UPS
Wiener Krankenanstaltenverbund (Austria)
Distributors/Healthcare
providers/GPOs/T&L
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Non-voting members
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AHRMM
Cladimed
EDQM – Council of Europe
FDA USA
Instituto Brasileiro de Ética Concorrencial –
ETCO
Public Health Agency of Canada
US DoD
Members global user group
Manufacturers
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3M
Bayer
Becton Dickinson
Boehringer Ingelheim
Coloplast
Draeger Medical
Genzyme
Hospira
Kimberly-Clark
Novo Nordisk
Pierre Fabre
Purdue Pharma
Sanofi Aventis
Smith and Nephew
St. Jude Medical
Stryker
Terumo
Teva Pharmaceuticals
UCB
Upsher-Smith
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Aexxdis
Alliance Unichem (Netherlands)
Amerinet
AmerisourceBergen
Brocacef (Netherlands)
CH2
Depolabo
Galexis
GAMMA Wholesale
Geodis
McMahon
Mediq (Netherlands)
Owens & Minor
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AMC Amsterdam (Netherlands)
Antonius Ziekenhuis Nieuwegein
(Netherlands)
Ascension Health (US)
Bernhoven Ziekenhuis Uden
(Netherlands)
Capital District Health (Canada)
CH René Dubos Pontoise (France)
Distributors/Wholesalers
Healthcare providers/Retailers
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CHI Robert Ballanger (France)
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CHRU Strasbourg (France)
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CHU de Québec (Canada)
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CHU DIJON (France)
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Deventer Ziekenhuis (Netherlands)
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Erasmus Medical Center (Netherlands)
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HealthShare NSW Health
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HUG Geneva (Switzerland)
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London Drugs (UK)
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Maxima Medisch Centrum (Netherlands)
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Mayo Clinic (US)
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Sisters of Mercy (US)
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Sobeys Pharmacy (UK)
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UHBS (Switzerland)
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UHCS Augusta VA (US)
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UMC Nijmegen (Netherlands)
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UMC Utrecht (Netherlands)
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VU medical center (Netherlands)
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Walgreens (US)
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Walmart (US)
Associations
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AHA (US)
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CHeS (US)
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CNOP (France)
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EFPIA (Europe)
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Eucomed (Europe)
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FENIN (Spain)
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GIRP (Europe)
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HDMA (US)
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International Hospital Federation
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JFMDA (Japan)
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LEEM (France)
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NACDS (US)
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Patient Safety Foundation (US)
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SNITEM (France)
Others
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GCS UNI H A (France)
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NEHTA (Australia)
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RESA IDF (France)
Local participation
… And many more …
© GS1 Belgium & Luxembourg 2015
GS1 in Healthcare: global system of
standards to ensure visibility
© GS1 Belgium & Luxembourg 2015
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GS1 Identification Keys
• Unique
• Non-significant
Item identifier =
GTIN
Global Trade Item Number
Logistics unit
identifier =
• International
• Secure
• Foundational
SSCC
Serial Shipping Container Code
Location identifier =
GLN
Global Location Number
And more …
© GS1 Belgium & Luxembourg 2015
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Capturing the identification key … and
beyond
Some data carriers can carry more detailed
information about that specific unit
Item identifier
Expiry date
Batch number
Serial number
(21)123
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Scanning & AIs in action...
01108576740020171714112010NYFUL0121192837713A1B2C3D4E5F6G
?
ERP Entries
01108576740020171714112010NYFUL01 21192837 713A1B2C3D4E5F6
A1B2C3D4E5F6
1085767400201720 Nov 2014 NYFUL01
192837
GTIN:
EXPIRATION:
BATCH/LOT:
0901234567001
21.Mai 201
NHRN:
SERIAL:
12345
0901234567001
123456
© GS1 Belgium & Luxembourg 2015
DataMatrix on pharmaceuticals
Ukraine: Pharma regulatory requirement
(2013)
Belgium:
Pilot project unit dose marking
Canada:
Vaccines
Austria:
Cytostatics
Serbia: Pilot
France:
AFSSAPS
regulation (2011)
Turkey: Regulatory requirement
(2010)
US:Traceability
Regulation (2017) Spain: Pilot
South Korea: Pharma regulatory requirement
(2012)
Switzerland: SmartLog Pilot
Colombia: Pilot of INVIMA on
traceability
Brazil: Traceability pilot successfully
completed – ANVISA regulation
Algeria: Pharma
regulatory requirement
(2014)
Saudi Arabia: Pharma
regulatory requirement (2015)
Jordan: Pharma regulatory
requirement (2015)
Argentina: Traceability regulation
country requires DataMatrix
India: Regulatory
requirement for
drug exports 2013
country using DataMatrix in pilots and/or developing requirement for DataMatrix
© GS1 Belgium & Luxembourg 2015
© Copyright GS1 AISBL, 2012. All Rights Reserved.
Building blocks for traceability
Unique Identification
- Products
Data Capture
- Barcodes
- Logistics units
- EPC/RFID
- Location & Legal entities
Traceability
Traceability
Data Communication
Links Management
- Share data
- Physical flow
- Retrieve data
- Information flow
© GS1 Belgium & Luxembourg 2015
Key Drivers for traceability
Regulations emerge worldwide
Supply Chain costs increase
Electronic Health Records
Medication errors
Counterfeiting
Brand Protection
BUT
•Traceability is complex, multi-sectorial and cross border, but it is not
always recognized as such
•Traceability is becoming a necessity, but one that is addressed by an
endless number of isolated solutions
•GS1 Standards can help…
© GS1 Belgium & Luxembourg 2015
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Physical Event Data - Recall
• What
what physical objects were involved (e.g. sGTIN in a GS1 Carrier)
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e.g. (01)10222222333334(21)12344(10)A1345B
• When
when the event took place (timestamp)
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e.g. 110922 (22nd September 2011)
• Where
where the event took place (e.g. GLN)
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e.g. 1234567890128 (Goods In, General Hospital)
• Why
what business process step was being carried out
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(e.g. receiving, shipping…)
The 4 W’s
© GS1 Belgium & Luxembourg 2015
Global standards enable …
Compliance with regulations,
effective and efficient implementation of traceability systems in
Healthcare
Such as:
Track & Trace, Authentication, UDI
= Visibility
*Visibility = What, When, Where & Why
© GS1 Belgium & Luxembourg 2015
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EU Commission proposal
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The composition, format and carrier of the unique identifier will be fully
harmonised across the EU. The unique identifier will be placed in a 2D
barcode and contain the manufacturer code, a serialisation number, a
national reimbursement number (if present), the batch number and
the expiry date.
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Medicine authenticity will be guaranteed by an end-to-end verification
system supplemented by risk-based verifications by wholesale
distributors. Medicines will be systematically verified before being
dispensed to patients. Medicines at higher risk of falsification (returns or
medicines not being distributed directly by manufacturers) will be
additionally checked at wholesaler level.
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The repository containing the unique identifiers will be set up and managed
by stakeholders. National competent authorities will be able to access and
supervise the database.
© GS1 Belgium & Luxembourg 2015
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The move
towards
harmonisation
and GS1
standards in
Europe
© GS1 Belgium & Luxembourg 2015
© Copyright GS1 AISBL, 2012. All Rights
Pharma – Different emerging models…
Source ESM presentations
Driver: To address
counterfeiting (falsified
medicines), prevent them
reaching the patient
EFPIA /GIRP/PGEU/ EAEPC
European Stakeholder
Model (ESM)
• A pan-European end-to-end system enabling medicines to be verified at point of
dispensing
• Developed by the stakeholders who will use it on a day-to-day basis
• Run on a non-profit basis; costs to be borne by Manufacturing Authorisation
Holders
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• Pilot in Germany - SecurPharm
© GS1 Belgium & Luxembourg 2015
Pharma – Different emerging models…
Driver: To address counterfeiting (falsified medicines), prevent
them reaching the patient
European Directorate for the Quality of Medicines & HealthCare (EDQM)
eTACT
- Part of the Council of Europe; EDQM members 37 European
countries, bigger than EU
- Traceability from manufacture to
the patient, ultimately give also
patients access to authenticate
product
- MoU with Ukraine
© GS1 Belgium & Luxembourg 2015
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US Federal Drug Quality
and Security Act (DQSA)
…as part of U.S> Drug Quality and Security Act H.R. 3204
• Preempts all state laws – including California
• New programme on securing the identity of parties in the
supply chain, specially new license program for wholesalers
• Migration path: First phase lot bases, serialisation (SNI)
after four years (2017), full track & trace after 10 years
(2023)
• Instead of “pedigree” now “transaction” – until 2017 either
paper or electronic:
1. Transaction Information (TI)
2. Transaction History (TH)
3. Transaction Statement (TS)
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Major deadlines/requirements
2015
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For each change of ownership all three transaction information (TI, TH and TS) need
to be provided
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Request for info by FDA needs to be fulfilled in 48 hours
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Authorized trading partners
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Lot-based information flow
2017
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Serialisation added on package and case
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2D DataMatrix on package, linear or 2D on case
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Transaction information in electronic format
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Information on product ID plus serial number in 24 hours
2023
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Interoperable electronic tracing and exchange of transactions
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Traceability on item level (secondary package level)
Still a lot of open questions – recent request for comments by FDA
until 21st April
© GS1 Belgium & Luxembourg 2015
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WHO VPPAG recommendations for
vaccines
• VPPAG* Recommendations on use of bar codes on
vaccine packaging to be included in the next WHO
Generic Preferred Product Profile (gPPP)
• Project in Tanzania proving the benefits of bar coding
for vaccines will be launched this year
*Vaccine Presentation and Packaging Advisory Group
http://www.who.int/immunization/policy/committees/vppag/en/index2.html
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Proof of principle in Tanzania
• Tracking vaccines from manufacturer to
recipient
• Reduce wastage and spoilage by
improved inventory management and
logistics information
• Tracking down to the district level
• Final objective – link the vaccine to the
child
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Pilot in the US
National Childhood Vaccine Injury Act (NCVIA) requires
documentation of manufacturer and lot number of vaccines
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Project from Sept 2011 to
Aug 2013
Participants:
2 Vaccine Manufacturers
8 vaccines
217 Immunizers
10 Immunization Information
Systems
Products with GTIN, Lot and
expiration date
© GS1 Belgium & Luxembourg 2015
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Results
• Preliminary results confirm a positive effect on vaccine data
accuracy and completeness
• Providers have positive perceptions regarding impact of 2D
barcoding on efficiency and accuracy
• Providers are willing to adopt practices to incorporate 2D barcode
vaccine use but not until the majority of vaccines are 2D
barcoded
• Detailed information at
http://www.cdc.gov/vaccines/programs/iis/2d-vaccine-barcodes/
© GS1 Belgium & Luxembourg 2015
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New McKinsey & Company
Report quantifies supply chain issues in Healthcare
New McKinsey report “Strength in unity: The
promise of global standards in healthcare”
Highlights the cost savings and patient
safety benefits of adopting a single global
supply chain standard in healthcare
Available at:
http://www.gs1.org/healthcare/mckinsey or
http://www.gs1.org/docs/healthcare/McKinsey_Healthcare_
Report_Strength_in_Unity.pdf
Source: http://www.mckinsey.com
© GS1 Belgium & Luxembourg 2015
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New McKinsey & Company
Huge cost savings and patient safety benefits when
adopting a single global standard in healthcare
•“Implementing global standards across the entire healthcare
supply chain could save 22,000-43,000 lives and avert 0.7
million to 1.4 million patient disabilities”
•“Rolling out such standards-based systems globally could prevent
tens of millions of dollars’ worth of counterfeit drugs from
entering the legitimate supply chain”
•[We] “estimate that healthcare cost could be reduced by $40
billion-$100 billion globally” from the implementation of global
standards
•“Adopting a single set of global standards will cost significantly
less than two” (between 10-25% less cost to stakeholders)
SOURCE: McKinsey report, “Strength in unity: The promise of global standards in healthcare”, October 2012
© GS1 Belgium & Luxembourg 2015
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Global standards
The need for global
standards
• Healthcare is local
- Healthcare providers are
local
- Regulations are local
• Healthcare is global
- Healthcare supply chains
often cross borders
Country-by-country
solutions are not sufficient
nor effective
© GS1 Belgium & Luxembourg 2015
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GS1 Belgilux Healthcare Day
Save the date: 9 March, Brussels, Tour & Taxis
Please join us! You will learn…
• How GS1 global standards get
implemented worldwide and help to
improve patient safety and supply
chain efficiency
• About new regulations on traceability
and UDI (Unique Device
Identification) across the world
• Use cases and implementation at
manufacturers, wholesalers and
hospitals
© GS1 Belgium & Luxembourg 2015
Imagine a world …
© GS1 Belgium & Luxembourg 2015
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GS1, One language, one voice
Global GS1 standards will make this a reality
–
get engaged and support the ongoing
efforts!
IMPROVE PATIENT
SAFETY
© GS1 Belgium & Luxembourg 2015
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Contact
Séverine Dewerpe
Healthcare & Barcodes Manager
GS1 Belgium & Luxembourg
E Sdewerpe@gs1belu.org
T +32 2 290 57 73
W www.gs1belu.org
© GS1 Belgium & Luxembourg 2015
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Questions?
© GS1 Belgium & Luxembourg 2015
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