IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. © Zuellig Pharma.
All Rights Reserved.
BY Fu-Wen Chang / Senior QA Manager
2015-02-06

2. © Zuellig Pharma. All Rights Reserved.
• Pharmaceutical Distribution Model
• Introduction of Zuellig Pharma Inc.
• Practices of Counterfeiting
Product Handling
• Challenges
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3. © Zuellig Pharma. All Rights Reserved.
To understand
• how Zuellig Pharma to prevent the
counterfeited products from entering
into supply chain.
• how to effective handling of
counterfeited products found through
the distribution and warehousing
cycle.
3

4. © Zuellig Pharma. All Rights Reserved. 4
Manufacturer
Road Transport
Air Transit
Road Transport
Dispatch
Customers
Pharmacy
Hospital
Pharmaceutical Distribution Model
Distribution Center
Wholesaler

5. © Zuellig Pharma. All Rights Reserved. 5
Introduction of Zuellig Pharma Inc.
Zuellig Pharma Inc. Taiwan
Distribution Center
• PIC/S GMP certified
• GDP rewarded

6. © Zuellig Pharma. All Rights Reserved. 6
Introduction of Zuellig Pharma Inc.

7. © Zuellig Pharma. All Rights Reserved. 7
Introduction of Zuellig Pharma Inc.
Key Figures Sales Channels
• Established 1988(DC in 2005).
• Annual Sales of around 1.3 bio USD
• 500+ employees
• Single Distribution Center
• 3 offices
• Representing over 30 International
Manufacturers
• Around 51% Market Share of
Multinational Pharmaceutical
products in Taiwan
• Largest promoter in the DS/GP
channels with over 100 sales
representatives
Number of Customers %
Hospital / HP 532 100%
Clinic / GP 7,946 84%
Pharmacy / DS 7,367 85%
TOTAL 15,845 85%
Note: In terms of value, coverage exceeds 96% of Total
Market Value

8. © Zuellig Pharma. All Rights Reserved. 8
Manufacturer
Road Transport
Air Transit
Road Transport
Dispatch
Practices of Counterfeiting Product Handling
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital

9. © Zuellig Pharma. All Rights Reserved. 9
Manufacturer
Road Transport
Air Transit
Road Transport
Practices of Counterfeiting Product Handling
INBOUND: Receiving
•Accept finished goods
only from Principal-
authorized Personnel
and forwarders with
corresponding delivery
documents.
Distribution Center
Wholesaler

10. © Zuellig Pharma. All Rights Reserved. 10
Manufacturer
Road Transport
Air Transit
Road Transport
INBOUND: Receiving
•Goods receipts from
forwarder shall be taken
sampling or QA check by
principal if required.
This checking process
will ensure that the
products received are
genuine.
Distribution Center
Wholesaler
Practices of Counterfeiting Product Handling

11. © Zuellig Pharma. All Rights Reserved. 11
Dispatch
INBOUND: Returned
•Goods returned from
customers must be
checked against the lot
number which can be
traced back to the
legitimate source.
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital
Practices of Counterfeiting Product Handling

12. © Zuellig Pharma. All Rights Reserved. 12
Dispatch
INBOUND: Returned
Counterfeit products can
usually be identified by:
•Poor packaging/paper quality
•Anti-fraud label (if any)
•Color
•Blister layout (if applicable)
•Color of the content (such as
table, capsules, etc)
•Purity of the color of the content
•Labeling & leaflet
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital
Practices of Counterfeiting Product Handling

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STORAGE & REPACAKGE
•Alert principals immediately of
any incident where stocks may
have been lost or stolen.
•Samples, rejected product,
rejected packaging components
shall be disposed of in
accordance with established
procedures so that
unauthorized use or diversion
is not possible.
•Used product containers or
cartons shall be defaced or torn
prior to disposal.
Practices of Counterfeiting Product Handling

14. © Zuellig Pharma. All Rights Reserved. 14
REDRESSING
•Excess Principal-supplied
packaging components,
stickers, and/or promotional
items in the repacking section
shall be controlled, monitored,
recorded and locked. The
details and quantity shall be
coordinated with the Principals
concerned for proper disposal
in accordance with established
procedures.
Practices of Counterfeiting Product Handling

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Dispatch
OUTBOUND
•Deliver stocks only to licensed and authorized customers,
distributors, hospitals and pharmacies.
•Products are secured during whole delivery.
•Delivery route monitoring by GPS.
•DRS ensures all deliveries are tracking.
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital
Practices of Counterfeiting Product Handling

16. © Zuellig Pharma. All Rights Reserved. 16
Manufacturer
Road Transport
Air Transit
Road Transport
Dispatch
Any confirmed or suspected
counterfeited product found
during stock in/out, must be
immediately communicated
to the principal for further
investigation and prompt
action.
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital
Practices of Counterfeiting Product Handling

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Manufacturer
Road Transport
Air Transit
Road Transport
Dispatch
Zuellig Management and the
concerned Principal shall be
notified immediately of
incidents where
counterfeiting or illegal
trading is suspected.
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital
Practices of Counterfeiting Product Handling

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Manufacturer
Road Transport
Air Transit
Road Transport
Dispatch
Any counterfeited products
found in the supply chain
will immediately be
physically segregated and
stored in a dedicated area
away from all other
medicinal products and be
appropriately labelled.
Distribution Center
Wholesaler
Customers
Pharmacy
Hospital
Practices of Counterfeiting Product Handling

19. © Zuellig Pharma. All Rights Reserved. 19
Dispatch
Challenges
Distribution Center
Wholesaler
Secondary Wholesaler
Middlemen
Customers
Pharmacy
Hospital
Customers
GDP
controlled
Not
controlled

20. © Zuellig Pharma. All Rights Reserved. 20