Transcript Animal Health Products Identification

Animal Health Products
Identification Standard
A first step towards traceability
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What is IFAH?
• IFAH is the global representative body of manufacturers
of veterinary medicines, vaccines and other animal
health products in both developed and developing
countries across five continents
• IFAH is an international non-profit organisation
registered under Belgian law and is based in Brussels,
Belgium
• IFAH represents both Animal Health Companies and
Associations. These associations comprise both local
medium-size enterprises (SMEs) and international
companies. They represent most of the global market
for animal health products
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IFAH Mission Statement
• The mission of IFAH is to promote a
predictable, harmonised, science-based and
innovative market place for the provision
of quality animal medicines, vaccines and
other animal health products. These
contribute to a healthy and safe food
supply and to a high standard of health and
welfare for animals and people
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IFAH Goal
• To ensure that the contribution of the
Animal Health Industry to the health and
quality of animal and human life through
the advancement of sound science is
understood by society at large
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IFAH Structure
The Secretariat
GRCT
(Global Regulatory
Core Team)
GAT
(Global Antibiotics
Team)
BOARD
GIMCT
(Global Image
Management Core
Team)
GFCCT
(Global Food Chain
Core Team)
GTCT
(Global Traceability
Core Team)
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IFAH Members
Member Associations
EUROPE
Belgium
PHARMA.BE
Croatia
Vetcro
Denmark
VIF
France
SIMV
Germany
BfT
Greece
HAVEPHARM
Ireland
APHA
Israel
MAI
Italy
AISA
The Netherlands
FIDIN
Portugal
APIFARMA
Slovenia
WAH (SPMA)
Spain
VETERINDUSTRIA
Switzerland
SGCI/SSIC
United Kingdom
NOAH
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IFAH Members
Member Associations
NORTH AMERICA
Canada
United States
CAHI
AHI
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IFAH Members
Member Associations
CENTRAL & SOUTH AMERICA
Argentina
CAPROVE
Brazil
SINDAN
Mexico
INFARVET-CANIFARMA
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IFAH Members
Member Associations
ASIA/PACIFIC
Australia
Indonesia
AVCARE
ASOHI
Japan
JVPA
Korea
KAHPA
New Zealand
AGCARM
AFRICA
South Africa
SAAHA
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OCTOBER, 26th, 2004 THE COMPLETION
OF A CYCLE
• CEESA Manulog and the Traceability Working Group of IFAH have merged
into the IFAH’s Global Traceability Core Team
• The GTCT is composed of experts designated by their respective CEOs
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–
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AHI
R. Phillips
BAYER
H. Malik
BOEHRINGER INGELHEIM D. Mann
CEESA
H. Marion
CEVA
P. Bonassieux/
M. Chaton-Schaffner
– ELANCO
M. Mitchelson
– FORT DODGE
B. Conover/
(S.Verouden)
– INTERVET
R. Janssen
– JANSSEN
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–
–
–
–
–
–
–
B. Van Merris/
(W. Peeters)
MERIAL
JC. Muller (chair)
MONSANTO
T. Helscher
NOVARTIS
R. Billo
PFIZER
R. Hollander
(M. Walchak)
VETOQUINOL
Y. Lambert
VIRBAC
L. Cesar
SCHERING PLOUGH I. Forrester
SIMV
F. Lasvergères
• The GTCT met several times and agreed by consensus the recommendation
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OCTOBER, 26th, 2004 THE COMPLETION
OF A CYCLE
The Board of Directors of IFAH endorsed
the GTCT recommendation for products
identification and for the traceability printed
support as the worldwide standard for
Animal Health Industry.
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AN URGENT NEED IN EU, BUT A
GLOBAL INVESTMENT
• Trend in EU is to require, from a regulatory point of view,
optical readable information containing the batch number,
imposing in-line printing of the said information
– Decree 306 dated 16/05/2001 in Italy, originally in force in Sept.
05 postponed up to end of 2007,
– Decree 263/2003 in France requiring record at every step as of
March 2006 admitted 80% end of 2007, completed end of 2009,
other countries moving to the same direction
– Article 18 of EU regulation 178/2002
– Introduction in Portugal of batch traceability at human pharma first
– In preparation in Belgium
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AN URGENT NEED IN EU, BUT A
GLOBAL INVESTMENT
• Increasing number of multilingual packs
• Products are moving through the borders: produced here,
sold there
• Uniformity of the system and uniqueness of numbering is
essential
• A single system to avoid 25 different ones.
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THE CONSENSUS
RECOMMENDATION
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•
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Use the EAN/UCC worldwide standards
Use GTIN for product identification: uniqueness
Code with EAN Application Identifiers Standard
Support with Datamatrix ECC200 symbology
registered by EAN in July, 2004
• DMECC200 allows for:
– An extended flexibility/possibility to carry additional data
– Very low printing errors
– Error check and correcting system allowing reading even with a high
level of damage (Reed Solomon)
– Limited artwork redesign (can be printed on end flaps)
– Small size
– In-line printing with high speed inkjet, laser and heat transfer
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ENCODATION OF DATA
• The coding standard used is EAN/UCC128
standard using the special character FNC1 as
starter and group separator
• Example of concateneted coding string:
FNC1(02)01234567890128(17)YYMMDD(10)ABC123456FNC1(37)10
This code means a group of 10 units of the product bearing code: 01234567890128, batch number
ABC123456, expiring YYMMDD
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SYMBOLIC REPRESENTATION
• Datamatrix ECC200 symbol as support
• Printed on line
Datamatrix with id, exp date, batch n°, (plus quantity
and serial number for test) on visible side of flap (50 characters)
Real size 7x7mm
Per comparison, an
EAN128
with only id and
batch nb.
(20 characters)
Product id
Expiry date
Batch number
Quantity
(01)3400969846935(17)090504(10)L123456(37)1
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SIZE COMPARISON
Plenty of codes exist. The best fitting on our pharmaceutical
products is Datamatrix. It is the smallest size at the moment
for the same content.
For example:
MicroPDF417
0.66” wide 0.16” high 6.7 mil X-dimension, 3:1 Y:X ratio
(Minimum height configuration)
4 columns x 8 rows
Data Matrix ECC200 0.18” wide 0.18” high 10 mil cell size, 18 X 18 matrix
MicroPDF417 is 4 times larger than Datamatrix ECC200
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Thanking you for your attention
Any question?
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