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1 Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010

4. International Requirements

Overview

2 2010 – rev. 00Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010

GS1 is a leading global not-for-profit organisation dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors

Formed in 2005 out of the EAN International and the UCC organizations)

The GS1 system of standards is the most widely used supply chain standards system in the world

GS1's products and solutions are used across a wide range of industry sectors


A pedigree is a document that contains prescription drug information and chain of custody as it moves through the supply chainAn ePedigree is an electronic record of drug information and drug chain of custody that is authenticated and updated electronically as drugs move through the supply chainTrading partners - exchange ePedigrees and have the ability to update them working with common standards (GS1 – which provides standards for manufacturers, distributors, wholesalers and retailers for ePedigree informationePedigree - records with complete and accurate information about each transaction during transfer of ownershiplot number, dosage and expiration date of the drugs, company details (name, address, and license number)


National or Company Owned Database


Serialization is the process of identifying an object with aunique serial number that can be exchanged universally

In the pharmaceutical industry is applied to each item, case,and pallet of a drug to track the flow of product within thesupply chains of manufacturers, distributors and wholesalers

Pharmaceutical companies that implemented ePedigreesolutions are now looking at implementing serialization using2D barcode and RFID technology to transfer productinformation between trading partners towards gainingcompliance


European Union


EFPIA European Federation of Pharmaceutical Industries

The initiatives for serialization globally have passed the early stages of implementation in many countriesAs Countries adopt their own standards for serialization, pharmaceutical companies will have to take these standards into consideration when they do business internationally. As a strategy initiative, it is critical for the pharmaceutical companies to understand different legislations and standards in each countryIn May 2007, the European Federation of Pharmaceutical Industries and Associations (EFPIA) issued a guidance document entitled "Packaging Standard for Counterfeit Resistant Packaging and its Implementation into International Supply Chains in Europe".


EFPIA ProposalEfpia Position Paper – Identification and Coding of Pharmaceutical Products in

Europe


The EFPIA Concept in Europe


Safe & Secure Supply Chain

Authentication (e) - Pedigree

ID Verify PhysicalVerify

TrackProactive

TrackRetrospective

ProductSecurity

TransactionSecurity

Europe US


EFPIA Proposal

Information:GTIN (Global Trace Identification Number)Expiry dateBatch numberRandom serial Number (alphanumeric, 20 characters long)

Syntax: GS1 standard identification systemData Carrier: Data Matrix ECC200Traceability Solution: Authentication at point of dispense. Implementation Due Date: Not mandatory yet. EFPIA is promoting

this system by engaging with current European initiatives to put across a common Industry standard and lobbying with European bodies.


BrazilOn January 14 2009, in an effort 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, odontologicaland 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.


Brazil

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.


Brazil – Resolucion n° 59 – November, 2009

Chain = Production, Import, Distribution, Transportation, storage, Dispensation

… Capture Tech. – storage & Data Electronic Transmission

… 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

.. 2D Data Matrix is defined as Data capture technology

… it must Contain Unique Medicine Identifier (UMI) corresponding to each unit commercialized



Producer UMI:Registration Nr. (ANVISA)

Lot Number

Manufacturer Date

Validity Term

CNPJ of the Company receiving the Medicine

Transaction Date



Distributor Database Requirements:

UMICPNJ of the SenderCPNJ of the ReceiverTransaction date



Retailer Database Requirements:

UMICPNJ of the SenderTransaction date


Brazilian RequirementsRegistration number

Lot Number

Manifacture Date

Validity Term

CNPJ (Receiver)

Transaction Date

EFPIA StandardsManufacturer 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.


COUNTRY IMPLEMENTATION DEADLINE

Australia Current (2007)

Belgium Current Brazil 1/14/2012

Canada Current (2008)

Chile 2010

China Current France 12/31/2010

Germany 2009

COUNTRY IMPLEMENTATION DEADLINE

Greece Current (2005)

Ireland Current

Italy Current

Japan 2009

Korea 2013

New Zealand 2009

Turkey 07/01/2009

Serialization Implementation dates for various countries (As of March 2009)

27 Universidad de Belgrano – Medicine Traceability Overview – 18 Majo, 2010

5. Data Matrix


Data Matrix is a very efficient, two-dimensional very high density (2D) “CODE” simbology that uses a small area of square modules with a unique perimeter pattern, which helps the barcode scanner determine cell locations and decode the symbol

Characters, numbers, text and actual bytes of data may be encoded, including Unicode characters and photos


A Data Matrix code is a two-dimensional matrix barcode consisting of black and white "cells" or modules arranged in either a square or rectangular pattern. The information to be encoded can be text or raw data. Usual data size is from a few bytes up to 2 kilobytes. The length of the encoded data depends on the symbol dimension used.Error correction codes are added to increase symbol strength: even if they are partially damaged, they can still be read. A Data Matrix symbol can store up to 2,335 alphanumeric characters.Data Matrix symbols are rectangular in shape and usually square, they are made of cells: little elements that represent bits. Depending on the situation a "light" module is a 0 and a "dark" module is a 1, or vice versa. Every Data Matrix is composed of two solid adjacent borders in an "L" shape (called the "finder pattern") and two other borders consisting of alternating dark and light "cells" or modules (called the "timing pattern"). Within these borders are rows and columns of cells encoding information. The finder pattern is used to locate and orient the symbol while the timing pattern provides a count of the number of rows and columns in the symbol. As more data is encoded in the symbol, the number of cells (rows and columns) will increase. Symbol sizes vary from 8×8 to 144×144.


L shape locator pattern

Clock pattern off on sequence

Clock pattern off on pattern

This cell is always white for ECC200

One cell quiet zone surrounds the matrix

Cell size is important- 0.015 inches/0.33mm seems to give best read rates-and is GS-1 recommended


The symbol is square and can range from 0.001 inch per side upto 14 inches per side. As an example of density, 500 numericonly characters can be encoded in a 1-inch square using a 24-pin dot matrix printer. The sample shown above encodes 20ASCII characters

Data Matrix is being used to encode product and serial numberinformation on electrical rating plates; to mark of surgicalinstruments in Japan; to identify lenses, circuit boards, and otheritems during manufacturing

Data Matrix symbols require a 2-D scanner; they cannot be readusing an ordinary linear barcode scanner. A number of scannersare on the market using both laser and CCD cameratechnologies.

Data Matrix symbols can be printed using most professional-grade thermal transfer label printers on the market


Compared to other barcode types, Data Matrix is approximately 30times smaller than a Code 39 barcode representing the same data.

The 2D Data Matrix is barcode also the recommended choice whensending barcodes over faxed documents, because the symbol canwithstand many poor resolution and scanning issues.

The required Reed-Solomon error correction built into Data Matrix ECC200 is able to reconstruct and verify the data scanned for improved accuracy.

In a study at The Center for Automatic Identification at Ohio University, the statistical probability of a misread error with Data Matrix is 1 in 10.5 million scans, compared to a misread error probability of 1 in 1.7 million with the Code 39 barcode.


The encoding and decoding process of Data Matrix is very complex

Several methods have been used for error correction in the past

All current implementations have been standardized on the ECC200 error correction method, which is approved by ANSI/AIM BC11 and the ISO/IEC 16022 specification

ID Automation 2D Data Matrix barcode products all support ECC200 by default and are based on the ANSI/AIM BC11 and the ISO/IEC 16022 specifications.

The Reed-Solomon error correction algorithms of ECC200 allow the recognition of barcodes that are up to 60% damaged


Capacity is a function of data type1556 Bytes

2335 ASCII Characters

3116 Numeric Digits

2D Data Matrix codes capture the largest amount of data in by far the smallest footprint

50 characters fit in 6 mm x 6 mm square


It is a EAN.UCC (GS 1) standard since July 2004It is using international syntax EAN.UCC (GS1) 128

It is the smallest symbol for a given quantity of information

It is robust : the Reed Solomon error correction system allow readability v/s code damage (information redundancy)

Data matrix can be printed with technologies currently used in Pharmacy

It is cost competitive (0.1 to 0.3 cents of €)

Data Matrix has been used successfully by IFAH for coding all animal health products worldwide


Linear and 2D Barcode Simbology Evaluation Chart

Code 39 without check digit: Code 128 Auto:

Aztec: Data Matrix ECC200 with ASCII encoding mode:

PDF417 in Text encoding mode: QR-Code with Error Correction L


a 20% contrast between black & white is sufficient to read a 2D data Matrix

To Encode information using 2D Data Matrix 6 set of Character are available, from the smallest smallest, only numbers and space to the extended which includes all alphanumerics & special Char.

Error Correction could use 6 different algorithms: as more correction capacity has been applied, as more redundant is the information, and even the SIZE of the encoded symbol; Reed-Solomon is the recommended correction algorithm

The print ELEMENTS, even if the code it is a Matrix Code could be either squared pixel or raounded

The CODE could be printed via dot printers, ink jet, thermal (direct and Transfer), laser etc.

Ink jet could be used to direct mark product surface


There are many Printing Technologies which are different for performances, accuracy, readability, supported material/films

Continuous Inkjet (CIJ)Piezo Drop on Demand inkjet (DOD)Thermal Drop on DemandScribing LaserThermal Transfer Over printer (TTO)Print & Apply


Because of the required Reed Solomon error correction built in to ECC200 Data Matrix, it is very dependable and can even be read in with a scanner when part of the symbol has been destroyedWith Data Matrix, the worst case chance of a misread is 1 error in 10.5 million scans In a Code 39 barcode, the worst case chance of a misread is 1 error in 1.7 million*

Barcode Type Worst Case Accuracy Best Case Accuracy

Data Matrix 1 error in 10.5 million 1 error in 612.9 million

PDF417 1 error in 10.5 million 1 error in 612.4 million

Code 128 1 error in 2.8 million 1 error in 37 million

Code 39 1 error in 1.7 million 1 error in 4.5 million

UPC 1 error in 394 thousand 1 error in 800 thousand

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