IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ Session 2: Supply Chain Integrity On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. Serialization and Traceability
GS1 Standards: A Manufacturer’s Perspective
Mike Rose
Johnson & Johnson Health Care Systems Inc.
Vice President, Supply Chain Visibility

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Topics
• Protecting patients and consumers
• What is serialization and track & trace?
• Importance of GS1 standards
• Public-Private Partnerships

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Helping Patients and Consumers Receive
Genuine Products
 People
 Policy
 Process
 Information
 Technology
 Enforcement
Requires a
multi-layered approach

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Detecting Counterfeit Products
The Role of Serialization and Bar Codes
 Provides an additional identification
feature to more accurately identify a
package
 Must use the GS1® Standards
 Enables authentication of the package
 However, does not ensure the contents
are genuine
 Must use with additional processes,
security features and measures

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Serialization and Track & Trace
Manufacturer Implications
• Developing public-private partnerships, e.g.,
APEC, ESM, PDSA
• Responding to different regulatory
requirements
• Building new, agile, cost effective capabilities
for serialization and traceability
• Standardizing identifiers for all products (i.e.,
GS1 standards)
• Modifying existing processes, procedures and
IT systems while conforming to GMPs and
GDPs
• Maintaining operational efficiency in
manufacturing as well as distribution
• Integrating with external manufacturers,
customers and regulatory systems

6. © 2014 GS1
Pharma – World (including Europe)
coding & serialisation requirements
2010 2011 2012 2013 2014 2015 2016 2017
Regulated requirement
Tender requirement
Important development
Emerging Regulatory req.
…2018
Libya: serialisation – timeline to be defined
South Africa: traceability – timeline to be defined
Turkey 2010
Track & Trace
Serbia 2010
Traceability regulation
Cyprus 2010
Product Code
USA 2010
FDA SNI guidance
Denmark 2011
Product Code
France 2011
Batch Variable
Europe 2011
European Legislation
India 2011
Serialisation
for export – 3rd level
Argentina 2011
1st product group
Canada 2012
Vx Batch Variable
India 2012
Identification for
tender
requirements
Korea 2012
Batch Variable
Specified drugs
Argentina 2012
Serialisation 2nd
product group
Japan 2012
Revised MHLW
Barcode Guidelines
Korea 2013
Batch Variable
Ethical drugs
India Jan. 2013
Serialisation for
export - 2nd level
Nigeria 2013
MAS all
anti-malarial /
MAS all
antibiotics
Chile 2013
Identification
& traceability
Argentina 2013
Serialisation 3rd
product group
Europe Q4 2014
Delegated acts
finalised
Denmark 2014
AMGROS: DataMatrix
or bar code
England/NHS
2014
GTIN, GLN
and product
data
Mexico 2014
Draft Regulation
on traceability
Singapore 2014
Barcoding on
injectable
Korea
2015
Serialisation
Phase 1
China 2015
Serialisation
Phase III (all
products)
Taiwan
2015/2016
Draft Regulation
Barcode req. -
Saudi Arabia 2015
DataMatrix
Japan 2015
Barcoding
primary level
USA 2015
DSCSA -
Product Tracing
Requirements
(lot/batch/exp)
Brazil 2016
ANVISA Track &
Trace regulation
(all pharmaceuticals)
Saudi Arabia 2017
Serialisation
Ukraine 2016
Serialisation
(manf. & wholesal.)
Jordan 2017
Serialisation
USA 2017
DSCSA - Serialised
product identifiers
Europe 2017
Compliance to FMD
USA 2023
DSCSA - Pkg (item-level)
traceability
Brazil 2015
ANVISA Track & Trace
regulation (3 batches of
product)
China 2013
Serialisation
Phase II
China 2012
Serialisation
Phase I
Algeria: serialisation – timeline to be defined
Philippines
30 June
2015 - GTIN
© Copyright GS1 AISBL, 2012-2014. All Rights Reserved.
Kenya 2014
KEMSA
Barcoding
Ukraine 2017
Serialisation
(retailers)
India 2015
Serialisation for export
Mono-carton
Korea Oct,2014
Serialisation plan
Korea
2015
Serialisation
Phase 2 (end)
Korea 2016
Aggregation
(optional)
Slovenia 2017
DataMatrix
Cannot be distributed without consent from GS1 AISBL

7. GS1® STANDARDS IN HEALTHCARE
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Pharmaceutical Item Level Product Serialization
Changes the way we handle our products
A unique serial identification number is assigned to each item identifying it with a product number
and associated serial number.
It’s applied at every package level (bottle, case, and pallet).
These unique numbers are uploaded into a database and can provide timely product intelligence
from manufacturing to the patient.
PREZISTA® 600mg serialized label with 2D data matrix

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12 serialized &
aggregated
Prezista
bottles in a case
261 cases to a
pallet. Each case
has the parent serial
number
Pallet is shipped
(truck, boat, or
airplane) to DC
DC where
individual cases
get pulled from
the pallet ,
scanned and
shipped to
Customer
Wholesaler
Customer
receive products,
scans every case
and ships to
pharmacies,
hospitals, etc.
Wholesaler
ships product
to pharmacies,
hospitals, etc.
They scan bar code
with serial number
Rx
Pharmaceutical Supply Chain
Future with Serialization and Traceability
Regulatory mandates are
demanding visibility of products
from point of packaging to
point of dispense.
• These mandates demand improved
supply chain visibility
• Products are identified, serialized,
authenticated, tracked & traced
• What product? Where has it been?
Where is it going? How long has it
been there?
• Using data captured as product
moves through the supply chain,
answers questions as to the
disposition of inventory

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Using GS1 compliant barcodes (UCC-EAN13)
Each product SKU has one relative barcode
(UCC-EAN13)
Download E-code from website client.
Every E-code is unique
However, every carton has their different, unique
E-code though they have the same UCC- EAN13
China Electronic Tracking Code (E-Code)
• E-code code (serial number) according to code 128C standard
• The electronic tracking code doesn’t follow the GS1 standard – that is, E-code is not
GTIN, SSCC, GLN etc.
• The E-code is given by E-code website client managed by 21th century,
 Acquired by Alibaba which was on IPO in US

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Public-Private Partnerships Needed for Success
APEC Business Advisory Council – Regulations,
Standards and Track & Trace
European Stakeholder Model (ESM) – European
Medicine Verification System for EU Falsified Medicines
Directive
Pharmaceutical Distribution Security Alliance (PDSA) –
US Drug Supply Chain Security Act Consortium

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Industry
Consumer
Government
Public-Private-Consumer Partnerships
Enabling Environment
Enforcement & Prosecution
Zero Tolerance
Awareness Campaigns
International Cooperation
Global Standards
Awareness
Verification
Reporting
Monitoring & Reporting
Awareness Programs for
Consumers & Professionals
Implementation
Global Standards
21 countries

13. APEC Business Advisory Council
Global Data Standards: Supply Chain Integrity for
Pharmaceutical Products

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APEC Business Advisory Council (ABAC)
Global Standards: Serialization and Track & Trace Pilot
 Several pharmaceutical manufacturer participants
 Facilitated by University of Tennessee Health Science
Center and Memphis University with involvement from
GS1 Global
 Phase I - Assessed status of need for global healthcare
standards (report drafted…finalize in next 1-2 months)
 Phase II – Developing serialization and track & trace
pilot

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ABAC – Phase II Project Planning
The goal of Phase II is to develop a pilot for the
utilization of an appropriate standard
o GS1 Healthcare Standards
The project objective is to demonstrate visibility across
the pharmaceutical supply chain from manufacturer to
patient

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ABAC – Phase II Project Planning
Phase II Project Roadmap
o Identification of products with GS1 Standards
o Include automatic identification and data capture (AIDC)
technologies and business-to-business electronic messaging
(eCom)
o Identification of pharmaceutical companies (multinational/local) as
voluntary participants in the large-scale pilot project
o Identification of specific products
o Identification of at least two APEC countries and destination cities
within those countries for participation in the project
o Identification of wholesalers/distributors and their respective
drugstores and/or healthcare provider institutions for participation
o Determination of period of execution of the project

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ABAC – Phase II Project Planning
Identification of success indicators including:
o Effectiveness of receipt process and forwarding of information to a
traceability web platform for
– Manufacturers
– Wholesalers/Distributors
– Pharmacies
– Healthcare providers
o Capabilities to trace medications by supply channel, commercial
and institutional
o Query capabilities for inspection, oversight, and Control process
o Product recall simulation results

18. European Stakeholder Model
European Medicines Verification System

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EU Falsified Medicines Directive
Requires serialization by manufacturers, and verification
at the point of dispense by pharmacists
Tamper evident features must be applied by
manufacturers
Mandates manufacturers to fund the medicines
verification system
Information can be used by competent authorities for
other purposes – e.g., reimbursement,
pharmacoepidemiology studies
In response, EFPIA formed the European Stakeholder Model (ESM)
bringing together all the relevant stakeholders to be proactive in securing the legal
supply chain and to protect patients

20. ESM STAKEHOLDERS HAVE A COMMON
VISION OF MEDICINES VERIFICATION
 Protect patients
 Secure the legal supply chain
 Be proactive as market
partners
 Set up a stakeholder-
governed model that is
 Functioning
 Harmonised
 Cost-effective
 Inter-operable
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21. FUNDAMENTAL PRINCIPLES FOR
MEDICINES VERIFICATION IN THE EU
•Unique identifier with randomised serial number + tamper evident packaging
•Check of pack’s authenticity at point of dispense
SAFETY
FEATURES
•Transactional data belongs to stakeholder that generated it, e.g. pharmacists for
dispensing data
•No access to data of other stakeholders except for verification purposes
DATA
•Systems governed by independent non-profit organisations, established and
managed by relevant stakeholders
•Systems supervised by EU and/or national authorities
•Data accessible for competent authorities for reimbursement,
pharmacovigilance & pharmaco-epidemiology purposes
GOVERNANCE
•Coding system harmonised across Europe based on ISO-standards allowing
integration of existing national codes
•Flexible to implement national solutions within an EU technical framework
•Interoperable between different national systems through European Hub
SYSTEM
DESIGN
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22. COMMON BASIC CONCEPT: UNIQUE IDENTIFIER
 Data-Matrix code, developed to ISO-standards
 Supports GS1 standards
 Key data elements:
 Product code (GTIN/NTIN)
 Randomised unique serial number
 Expiry date
 Batch number
 National health number (where necessary)
Product #: 09876543210982
Batch: A1C2E3G4I5
Expiry: 140531
S/N: 12345AZRQF1234567890 Expected to be required by
Delegated Act
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23. COMMON BASIC CONCEPT:
“POINT OF DISPENSE VERIFICATION”
Expected to be
required by
Delegated Act
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24. European Medicines Verification System
Design for Interoperability and Efficiency
Germany
National
System
Pharmacy
Wholesaler
Pharmaceutical
Manufacturer
Parallel
Distributor
National
System
European
Hub
24
National Blueprint
System
National Blueprint
System
National Blueprint
System
National Blueprint
System
Blueprint template to reduce cost of national
systems and to ensure interoperability

25. GOVERNANCE STRUCTURE ALLOWS FOR
EFFECTIVE MANAGEMENT OF VERIFICATION
SYSTEM
GENERAL PRINCIPLE
System management and governance by not-for-profit
organisation under supervision of relevant competent authority
EU level and national level organisations cooperate on the basis of
service level agreements
NATIONAL LEVEL
National Medicines Verification
Organisations (NMVO), e.g.
in Germany: securPharm e.V.
EU LEVEL
European Medicines
Verification Organisation
(EMVO, to be founded)
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26. EMVO-MEMBERS ARE ALLOCATED TO A
CONSTITUENCY
Membership open to
other stakeholder
associations
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27. Summary

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Summary
• Growing awareness and
support from regulators for
GS1 standards
• Benefits include:
• Improves patient safety
• Helps fight against counterfeit
products
• Improves supply chain integrity
• Accurately identifies product for
evidence-based medicine,
adverse event reporting
• Helps ensure the 5 R’s, e.g.,
right product, right dosage,
right patient, right route, right
time

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7 Billion Reasons to Care
Serialization and Traceability Will Benefit
Patients and Consumers Around the Globe
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