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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

59 Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi 2010 – rev. 1.0

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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61 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

ISO/IEC 15961 ISO/IEC 18000ISO/IEC 15962 ISO/IEC 15962

Annexes

62 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

63 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

Hand Held Industrial

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64 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

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)

66 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

Bill of Lading

Material Tracking

Wireless

Batch

Fixed Station

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67 Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi 2010 – rev. 1.0

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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70 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

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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76 Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi 2010 – rev. 1.0

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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79 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

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

81 2010 – rev. 1.0Buenos Aires – ETIF 2010 - International and ANVISA Traceability Requirements – G. Rossi

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.