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58 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Key Project Results (ABSTRACT)
KR1 The model EFPIA supports for “Product Verification at the
Point of Dispense” works in practice
90% of pharmacist find the
system easy to use
85% find the system generally
fast
99% transaction completed within
1 sec.
75% users doesn’t feel extra
effort using in daily works
KR2 Effective identification of fake packs as well as expired packs
and recalled products
KR3 system availability and performance allow pharmacists to
work at normal pace and without significant additional effort
KR8 The presence of more than one code on the pack causes
confusion for the user and will jeopardise user acceptance Layout problems
Basic Training required
Semplification required: to use a
single CODE, will avoid false
reading & Reworks
KR9 The necessary data segregation and data security can be
technically ensured
KR10 Pharmacists are highly interested to get expiry date and
batch number in machine readable form
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5. Worldwide Inititives
Technology Overview
60 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Product Identification means a readable graphic/electronic sequence of
character (code) which can be Individually recognize and collected
Human reading is:
Expensive
Imprecise
Time Consuming
Subject to the Human
… Not adequate for industrial use
Refers to the methods of automatically identifying objects, collecting data
about them, and entering that data directly into computer systems -
with/without human involvement
Technologies typically considered as part of AIDC include Barcode, Radio
Frequency Identification (RF-ID), Biometrics, MAG-Stripes, Optical Caratcter
Recognition (OCR), Smart Cards, and voice recognition
AIDC is also commonly referred to as “Automatic Identification,” “Auto-ID,”
and "Automatic Data Capture.
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ISO/IEC 15961 ISO/IEC 18000ISO/IEC 15962 ISO/IEC 15962
Annexes
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63 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Hand Held Industrial
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Features ACTVIVE RFID Passive RFID
Tag Power Source Internal TAGEnergy Transferred
Using RF from reader
Tag Battery YES NO
Availability of Power ContinuousOnly in field form
READER
Required Signal
Strength to TAGLow High
Range More than 50 mt 3 TO 5 Mt, usually less
Multi Tag Reading1000 TAGS recognised
(at high speed)
Few hundreds TAGs
within 3 mt
Data Storage 128 KB R/W 128B R/W
65 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Barcode & “Printed Simbology” RF - ID
Optical Technology
Barcode Label and Barcode Reader
“Passive CODE “ and printed once
Economic Support (Label)
Barcode Rader and 2D Reader are standard product
(even portable)
Barcode reader has standard PC Connection
(Keyboard emulation, Serial, USB)
Multiple reading
Reading Accuracy
Easy to Produce on demand / on line
Print only once
Need Physycal/direct Contact
Less flexible in Time
Radio Frequency TECHNOLOGY
Use a Chip (TAG) and a Reader (Antenna)
Different sequence of data can be recorded
into the chip memory
TAGs could be R/W, Passive or Active
More Expensive Support (Label)
Dedicated Device
Multiple Reading
Reading Accuracy
Integration with other sensors
TAGs could be modified
Doesn’t need Physycal/Direct Contact
More flexible in time (re-use of label/support)
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Bill of Lading
Material Tracking
Wireless
Batch
Fixed Station
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6. Worldwide Initiatives
Track&Trace Solutions
68 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
A Unique Identification Number will trace medicines throught alla the Supply Chain in
REAL TIME
This is the most complex scenario, „cause of requires the active involvment of each
steps/location with a unique centralized Database
Coul be implemented together with e-Pedigree
DB
PharmacyManufacturer Wholesaler A Wholesaler B
Shipment JHKL Shipment JHKL Shipment JHKLShipment JHKL
69 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
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EFPIA system architecture
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74 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Track&Trace system were introduced in the
pharmaceutical and animal health environment to
obviously cover:
Track a single unit of product from the manufacturer to
the pharmacy (or point of dispensing), through the entire
supply chain
Trace a single unit of product backwards, starting from
the end customer to the manufacturer
75 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Traceability since today:
o At batch level
o Linear barcode including product code read automatically with a
barcode reader at pharmacy level (best case/not in all countries)
o Batch number and expiry date written in clear on the secondary and
primary packaging
Traceability Tomorrow:
o At unit of sales level (i.e. at box level)
o Product code, batch number expiry date included in the code in
order to be read automatically and avoid dispensing errors
o Deliver the right product to the patient
o Automatic detection of expired products
o Serialization (1 randomized number per box) would allow to prevent
counterfeits and fight reimbursement fraud
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7. Worldwide Mandatory
Requirements
The Brasilian Resolution
77 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
On January 14 2009, to curb the growing counterfeit market, Brazil
passed a law (Nº 11.903) mandating the drug manufacturers and
distributors to act on the specific serialization and track and trace
requirements of electronic identification and data capture
This three year plan is by far the most aggressive deadline laid out
by the Brazilian government. The following is the pertinent text of the
law
It is created the National System of Medications’ Control, involving
the production, marketing, distribution and medical, odontological
and veterinary prescription, as well as the other types of actions
provided for in the sanitary controls
Every medication produced, distributed or sold within the national
territory will be controlled by means of the National System of
Medications’ Control
78 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
The control is equally applicable to medical, odontological and
veterinary prescriptions
The control will be made by means of an identification system
exclusive for the products, service providers and users, with the
adoption of capture technologies, storage and electronic data
transmission
The products and their distributors will receive specific identification
based on data capture system by electronic means
Other components related to the production, distribution, import,
export, marketing, prescription and use of medications can be
included by the federal sanitary vigilance agency
The proper federal sanitary vigilance agency will implement and
coordinate the National System of Medications’ Control
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Brazil – Resolucion n° 59 – November, 2009
Chain = Production, Import, Distribution, Transportation,
storage, Dispensation
Capture Technology:
o storage & Data Electronic Transmission
o 2D Data Matrix is defined as Data capture technology
“… it must Contain Unique Medicine Identifier (UMI)
corresponding to each unit commercialized”
“… All the transaction shall be registered and be available to
the supervision bodies of the National System of health
Surveillance…”
“… Secondary packaging of all medicines shall contain ID and
safety Methods to make possible the Product traceability from
Manufacturing to Dispensation”
80 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi
Producer UMI: Registration Nr. (ANVISA)
Lot Number
Manufacturer Date
Validity Term
CNPJ of the Company
receiving the Medicine
Transaction Date
Distributor
Database
Requirements: UMI
CPNJ of the Sender
CPNJ of the Receiver
Transaction date
Retailer
Database
Requirements: UMI
CPNJ of the Sender
Transaction date
Authoririty Database
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Brazilian Requirements
Registration number
Lot Number
Manifacture Date
Validity Term
CNPJ (Receiver)
Transaction Date
EFPIA Standards
Manufacturer Product Code (GTIN/EAN 14 or pseduo GTIN
14 digits
UNIQUE Serial Number (randomized)
up to 20 Alpha Numeric Char.
Expiry Date 6 Digits (yymmdd)
Batch Number up to 20 Alpha Numeric Char.