coding rules for medicines requiring verification for the ... · version: 1.01 date of issue:...

Version 101 Date of issue 2013-12-03

Coding of packaging using Data Matrix Code with the product numbers PPN or NTIN

Automatic identification of retail packs in the pharmaceutical supply chain

Coding rules for medicines requiring verification for the German market

Coding rules securPharm

to protect against counterfeiting of medicinal products

Seite 2All contents copyright copy securPharm eV | English V 101

Table of Contents1 Foreword and Introduction 4

2 Scope 5

3 Abbreviated technical information concerning verification - in brief 6

31 Serial number rules 632 Data transfer to the PU Database System 6

4 Coding agreements 6

41 General 642 Pharmacy Product Number (PPN) - Use in Germany 743 National Trade Item Number (NTIN) - Use in Germany 744 Codes and Data on retail packs 7

5 Data content and requirements 8

51 Data Identifiers and Structures 852 Data elements and the corresponding Data Identifiers 9

6 Marking with code and clear text 11

61 Symbology 1162 Matrix size 1163 Code size and quiet zone 1264 Positioning of the Data Matrix Code 1265 Emblem PPN-Code 1266 Clear Text information 1267 Print quality 13

7 Interoperability on the basis of XML-Standards 14


Appendix A Overview and reference of the Data Identifiers 15

Appendix B Code Emblem 16

Appendix C Interoperability based on XML-descriptors 17

C1 General 17C2 Data Format Identifier (DFI) 17C3 XML-Node for Data 18C4 Implementation 18C5 Examples 19

Appendix D Quality and control of the code content (informative) 20

D1 Data Matrix Code as dot code 20D2 Qualification and validation measures 20D3 Checking codes for data content and print quality 20D4 Printing variants 21D5 Quality control statistics 21D6 Testing equipment 22D7 Colours and materials 23D8 Quality criteria in accordance with ISOIEC 15415 and ISOIEC 16022 23

Appendix E Layout ndash Best Practice (informative) 24

Appendix F Bubble-Jet ndash BestPractice (informative) 25

Appendix G Data Matrix Code ndash Symbology description (informative) 25

G1 Module sizes 25G2 Matrix size 26G3 Fixed pattern 26G4 Data area 27G5 Pad characters 27G6 Error correction 27

Appendix H Glossary 28

Appendix I Bibliography 31

I1 Standards 31I2 Reference to specifications 31

Appendix J Document Maintenance Summary 31

Appendix K Imprint 32

All contents copyright copy securPharm eV | English V 101 Seite 4

1 Foreword and Introduction

The EU directive 201162EU of 8 June 2011 amending

the directive 200183EG (European Union regulation

relating to medicinal products for human use) inclu-

des ia additional measures to enhance the protection

against falsified medicines Further to the requirements

relating to the production and sale of medicines phar-

maceutical active ingredients excipients etc that all

medicines prescribed or otherwise in which there is

a potential risk of fraud should have a security feature

which allows wholesalers pharmacists and other invol-

ved parties to verify the authenticity of the medicinal

product and to identify individual packages (Verifica-

tion ndash Article 54 lit (o) Dir 200183 EC) Details are to

be set out by the European Commission in delegated

acts In the next phase the Union member states have

to implement these regulations in their respective phar-

maceutical law

In this context the stakeholders listed below develo-

ped the Project ldquosecurPharmrdquo a concept for the opera-

tional implementation of the verification rules and espe-

cially to carry out a Pilot field test

bull ABDA - Bundesvereinigung Deut-

scher Apothekerverbaumlnde (German Fe-

deral Association of Pharmacists)

bull Bundesverband der Arzneimittel-

Hersteller eV (BAH) (German Medi-

cines Manufacturers Association)

bull Bundesverband der Pharmazeuti-

schen Industrie eV (BPI) (German

Pharmaceutical Industry Association)

bull Bundesverband des Pharmazeutischen

Groszlighandels ndash PHAGRO - eV (Associ-

ation of Pharmaceutical Wholesalers)

bull Pro Generika eV (Association of Ge-

neric Medical Manufacturers)

bull Verband Forschender Arzneimittelhersteller

eV (vfa) (Association of Research-Based Phar-

maceutical Companies)

The very generally expressed EU requirement

for a ldquosafety featurerdquo has to be translated into a

practical solution

Figure 1 Verification concept


The stakeholders decided on an authenticity veri-

fication system using a randomized serial number

for every single package encoded in an ISOIEC

16022 Data Matrix Code data carrier

At the dispensation point the pack serial number will

be verified against the manufacturerlsquos data (End-to-End

verification) refer to Figure 1

Precondition for verification is marking of each

package with a globally unique product number

and its associated serial number This requires an

extension of PZN8 to either PPN or NTIN

In order to automate the verification process

the data must be applied to the packaging in a

standard machine readable form

The Data Matrix Code (DMC) contains either the Phar-

macy-Product-Number (PPN) (refer to Chapter 42) or

the National Trade Item Number (NTIN) (refer to Chap-

ter 43) both of which incorporate the German reimbur-

sement number (PZN8) Further the DMC provides the

safety feature required in the human medicine law of

a randomized serial number relating to each individual

pack Together the product and serial numbers can be

verified against the original data of the pharmaceutical

companies

Use of a standard emblem to identify the DMC requiring

verification is expedient In the pilot phase the DMC

can either use the emblem PPNldquo or eg for technical

reasons until further notice this may be omitted The

DMC must also contains the batch number and expiry

date

To ensure readability and correct interpretation

of the data on medicinal packs for all proces-

ses adherence to the rules set out in this spe-

cification are mandatory for all involved parties

Further information about securPharm can be found at

wwwsecurpharmde

2 Scope

This specification describes the data container on me-

dicinal product packages which holds the necessary

data elements for automatic identification It contains

a detailed description of the encoding and associated

marking of medicinal product packages the data struc-

tures and the form of the data elements as well as the

coding with code size and print quality

Note The rules set out in this specification may

deviate in parts from the current GS1 specifica-

tions however in such cases the rules set out in

this specification take precedence The approp-

riate positions in this document and paragraphs

are marked

Further information relating to code positioning printing

systems scanning technology and the interoperability

with other data structure systems is provided in the ap-

propriate appendices

Transport logistic and the associated external pa-

ckaging are outside the scope of this specification The

underlying ISO coding standards for the securPharm

project allow the operator to integrate the Data and

System of the Pharmacy-Product-Number or National

Trade Item Number into higher-level standard logistic

and aggregation systems (ISO 15394)


3 Abbreviated technical informa-tion concerning verification - in brief

31 Serial number rules

The serial number used for verification is a random

number created by the pharmaceutical entrepreneur

(PU) This random serial number must in combinati-

on with the PZN-based product number be unique for

the life cycle of the product Serial numbers should

be generated by a non deterministic randomisa-

tion method This hinders counterfeiters to guess or

replicate serial numbers

Multi-Country-Packs with several national product

numbers should for verification purposes only be as-

signed one serial number which will then identify the

various product numbers

The technical data specification for the serial numbers

are to be found in Chapter 524

It is the responsibility of the PU to comply with these

rules and to provide serial numbers (together with pro-

duct numbers) in its internal database system as well

as the data transfer to the future PU database system

32 Data transfer to the PU Database System

For the verification process the PU transfers the pa-

ckaging data to the PU Database System These

contain as the following key data elements

bull Product Number (either as PPN or NTIN)

bull Serial number

bull Batch IdentifierNumber

bull Expiry Date

Required product master data will by use of the relevant

PZN be directly transferred from the information servi-

ces of the IFA to the PU Database System

4 Coding agreements

41 General

In addition to the requirements from the Fifth Book Ger-

man Social Security Code (SGB V) the stakeholders in

the German pharmaceutical market agreed to add the

following data elements to the machine-readable iden-

tification of medicinal product packages

bull Product Number

bull Batch Number

bull Expiry Date

bull Serial number (optional)

The symbology used is Data Matrix Code according to

ISOIEC 16022 (refer to Chapter 61) The syntax is spe-

cified in ISOIEC 15434 (refer to Chapter 5) The data

structure standard is ISOIEC 15418

In this way the machine readability of the data ele-

ments is assured and the technical prerequisite for the

implementation of the EU directive for protection against

counterfeit medicines and also the anticipated additio-

nal requirements for verification of medicinal product

packages

The identification of medicinal products using the Phar-

mazentralnummer (PZN) in Code 39 form is establis-

hed in the the Fifth Book German Social Security Code

(SGB V)

Many processes eg reimbursement system and medi-

cinal product identification are dependent on the PZN

as the product number

However to provide verification in terms of the EU

directive it is necessary to use a unique pan-European

product number


To fulfil this requirement the Pharmacy-Product-Num-

ber (PPN) and the National Trade Item Number (NTIN)

have been created both of which are generated from

the extended PZN (PZN8) The pharmaceutical com-

panies can decide which of the two above named

product numbers to use according to the relevant licen-

sing conditions Existing database and software sys-

tems can use an algorithm to generate the PPN or the

NTIN from the PZN and vice versa Databases can thus

continue to work with the PZN The interoperability with

other number systems eg GTIN (GS1 as responsible

IA) or HIBC (EHIBCC as responsible IA) is safeguarded

by the common use of international standards In the

next two paragraphs an abbreviated description is gi-

ven of the properties and generation methods for the

PPN and NTIN

1 Extract from the joint information from securPharm IFA and GS1 from April 2012 ldquoThe use of the GS1-NTIN is for GS1 Complete Customer companies permanently free For com-panies not yet using the GS1 Complete GS1-NTIN is free for the duration of the pilot The use of the IFA-PPN is for the com-panies permanently freerdquo

42 Pharmacy Product Number (PPN) - Use in Germany

The PZN is converted into the globally unique PPN

as illustrated below

Pharmacy-Product-Number (PPN)

11 12345678 42

Product Registration PZN Check-Digits PPN Agency Code for PZN

Figure 2 PPN generation

The PPN consists of three parts which are identified he-

re with the colours red blue and green The 11 (in red)

is a ldquoProduct Registration Agency Coderdquo (PRA-Code or

PRAC) This code is administered and assigned by the

IFA The 11 is reserved for the PZN Following the 11

(in blue) is the national product number this being the

unmodified PZN (PZN8)

The following digits (in green) are the two-digit check

digits calculated over the complete data element (inclu-

ding the 11) With the PZN as shown in the example the

result is the value bdquo42ldquo

Detailed information about the PPN and the generation

of the check digits can be found in the PPN-Code Spe-

cificationldquo httpwwwifa-coding-systemorgdown-

loadsdePPN_Code_Spezifikation_lang_engl_V1_01

pdf plus under httpwwwifa-coding-systemorgen

home

43 National Trade Item Number (NTIN) - Use in Germany

From the PZN the globally unique NTIN is created as

illustrated below httpwwwgs1-germanydegs1-stan-

dards-im-gesundheitswesenc1181

National Trade Item Number (NTIN)

0 4150 12345678 2

GS1-Prefix for PZN PZN Check-Digit NTIN

Figure 3 NTIN generation

The NTIN is made up of three parts marked here in red

blue and green The 4150ldquo is the prefix assigned by

GS1 Germany to the PZN Followed then (in blue) by

the unmodified PZN (PZN8) The last digit (in green)

is the check digit which is calculated over the comple-

te data element Details concerning the NTIN and the

generation of the check digit are available in the GS1lsquos

NTIN guidelines (httpwwwsecurpharmdematerial

Regeln_zur_Codierung_V1_01pdf)

In addition to the above elements a 0ldquo must be used

as a prefix for this application to complete the 14-digit

format


44 Codes and Data on retail packs

Until further notice the PZN-Code will continue to be applied to retail packs in the Code 39 format This ensures reten-

tion of established processes In addition the Data Matrix Code can be applied Depending on the product the PPN-

Code is made up of different elements either the Product Number alone or in combination with other data elements

In the following table the principle variants are described

Code 39 1

Symbology PZN-Code

Data Matrix Code 2

Symbology Data Matrix Code

PZN PPNNTIN SN LOT EXP

Medicinal products requiring verification radic radic radic radic radic

Medicinal products ndash not requiring verification

radic radic optional optional optional

Other common pharmacy products radic radic optional optional optional

Figure 4 Various applications of Coding 1 In accordance with the Fifth Book German Social Security Code (SGB V) the continued use of the PZN in the PZN-Code is

until further notice mandatory 2 The Data Matrix Code is optional for medicinal products which do not require verification and other common pharmacy

products however it is recommended for use where in addition to the PZN other coded data elements are to be displayed

5 Data content and requirements

51 Data Identifiers and Structures

In Chapter 5 the applicable Data Identifier and characte-

ristics of the data elements are defined Used are the Data

Identifiers (DI) or Application Identifier (AI) in accordance

with the international Data Structure Standards ISOIEC

15418 (refers to ANSI MH1082 Data Identifier and Appli-

cation Identifier) In this regard IFA uses the Data Identifier

(DI) and GS1 uses the Application Identifier (AI)

The above-named standards leave the specific charac-

teristics of the data elements free This document which

is binding for all participating parties defines the data ty-

pe data length and character sets (refer to Chapter 52)

Structure and Data Identifier can be used in either of the

two following variants

A Format 06 as per ISOIEC 15434 and

Data Identifier (DI) as per ISOIEC 15418

(ANSI MH1082)

For details refer to the IFA specification

httpwwwifa-coding-systemorgdownloads

dePPN_Code_Spezifikation_lang_engl_

V1_01pdf

B System Identifier ldquoFNC1rdquo and Application

Identifier (AI) as per ISOIEC 15418

For details refer to the GS1 specification

httpwwwgs1-germanydegs1-

standards-im-gesundheitswesenc1181

The applicable Data Identifiers as well as the da-

ta types character sets and the length of the en-

codeable data are summarised in the Appendix A

If Data Identifiers for further data elements are required

then an appropriate application should be submitted to

securPharm eVldquo


Data Identifiers not defined in this specification which

however use the MH1082 syntax should in the appli-

cations give a correct output and lead to defined states

The scanning process and the corresponding data

capture may not be jeopardized The specified Data

Structures may not be corrupted through any such ex-

tensions

52 Data elements and the corresponding Data Identifiers

521 Product number

bull Data Identifier ldquo9Nrdquo

bull Application Identifier (AI) 01ldquo

For product identification either the Pharmacy-Product-

Number (PPN) or the National Trade Item Number

(NTIN) are used All additional data elements in the data

string correspond to the Product Number In each case

the Product Number contains the PZN and can be ext-

racted from the Product Number (refer to Chapters 42

and 43) The expanded 8 digit PZN must be used

Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number

bull Data Identifier ldquo1Trdquo

bull Application Identifier (AI) 10rdquo

The batch number is generated by the phar-

maceutical entrepreneur and forms therefo-

re the relevant data element for the code

To demarcate batch parts special defined cha-

racters can be used (refer to Appendix A)

Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date

bull Data Identifier ldquoDrdquo


The expiry date is generated by the pharmaceutical

entrepreneur and forms therefore the relevant data ele-

ment for the code

The expiry date has the format ldquoYYMMDDrdquo

YY = 2 digit Year (00-99)

MM = 2 digit Month (01-12)

DD = Day

a) Expiry date with day month and year

(DD = 01-31)

b) Expiry date with month and year

(DD = 00)


Example Expiry date June 2016

DIAI Data

D 160600

17 160600

This example represents the date as required by

German Drug Law

Example Expiry date 17 June 2016

DIAI Data

D 160617

17 160617

This example shows the precise expiry date

Note In the ANSI MH1082 standard ldquoDrdquo is

defined as a general date In the context of PPN ldquoDrdquo is

only to be used for the product expiry date Other dates

like eg production dates must use other Data Identi-

fiers With the production date this would be the DI ldquo16ldquo

or AI ldquo11ldquo

524 Serial number

Data Identifier ldquoSrdquo

The serial number is created by the pharmaceutical

entrepreneur and forms therefore the relevant data

element for the code It is mandatory for the medicinal

product verification process For products where verifi-

cation is not mandated it is optional

Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765

The usable characters are described in Appendix A


6 Marking with code and clear text

61 Symbology

This chapter describes the code guidelines for clear

texts and elements eg the PPN Code Emblem The

data medium or the symbology is Data Matrix in

accordance with ISOIEC 16022 Error correction

adheres to ECC 220 Other error correction methods

(ECC000 to EC140) are not allowed The characteristics

of the Data Matrix Code are described separately (refer

to Appendix G) If a consistent matrix size is required

then padding characters should be used as necessary

(refer to Appendix G5)

62 Matrix size

Usually the matrix size should not exceed 26x26 or 16x48 modules Smaller matrix sizes are allowed provided the

capacity is sufficient for the encoding of the data

Square codes should be used wherever possible If however the packaging design or printing technology requires it a

rectangular code can be used

Square symbols

Matrix size Dimension (mm) Data capacityRows Columns Typical

X = 035

Min

X = 025

Max

X = 0615

Numeric Alphanumeric

22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols

Matrix size Dimension (mm) Data capacity

Rows Columns Typical X = 035

Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72

X = Module size in mm

Symbology details refer to Appendix G


63 Code size and quiet zone

The code module size may vary between 025 and

0615 mm With due attention to the printing system and

printing quality (refer to Chapter 67) the module size

may be freely set within this size range

Module size means the dimensions of a matrix cell (re-

fer to Chapter 62 and Appendix G1) Typical module

sizes are in the range from 033 to 045 mm

The area immediately surrounding the code should be

free of printing This area is called the quiet zone and

should be at least 3 modules wide

64 Positioning of the Data Matrix Code

There are no specific rules concerning the code

positioning The manufacturer may decide the best po-

sitioning based on the packaging layout and the prin-

ting conditions (refer to Appendix E)

For EMA approvals the code should be printed outside

the ldquoBlue Boxrdquo

65 Emblem PPN-Code

The emblem bdquoPPNldquo on the Data Matrix Code in-

dicates to the retailer the Code which is to be

used for the automatic identification of the pro-

duct number and further data Independent of

the embedding sheme of the PZN in the DMC

(refer to Chapter 1) For products requiring ve-

rification this is also an indicator for identifica-

tion and verification of the retail package (refer

to Chapter 1)

Figure 5 Code Emblem

There are several different possible versions for the

graphical representation of the PPN-Emblem (refer to

Appendix B)

It is possible to apply the emblem either during initial

printing or inline The minimum distance must be main-

tained (quiet zone) During a transition phase the emb-

lem may be omitted giving the medicinal manufacturer

more latitude during the conversion process

66 Clear Text information

Product number

The PZN is the key element of the retail packaging

According to the current applicable statutory rules the

PZN must be applied in text form together with Code 39

(refer to PZN Specification httpwwwpzn8dedown-

loadsdeTechnische_Hinweise_zur_PZN_Codierung

pdf)

For this reason the PPN or the NTIN will not be

printed in text form

Batch number and expiry date

The clear text for batch number and expiry date is

governed by statutory regulations

Serial number

Serial numbers are not to be printed as clear

text as the verification process for medicinal

products is to be fully automated using state-

of-the-art identification technology which ma-

kes the data more accessible and less prone to

error than manual data entry


Other optional data elements

Individual rules governing clear text information are

beyond the scope of this specification

67 Print quality

Code content testing (scan test) is fundamentally diffe-

rent from print quality testing

The basic requirement of a useful code is that it can

be read and that the content corresponds to the esta-

blished rules The practical readability depends on the

scanner being used and the environmental conditions

To ensure a general readability of the code a standar-

dized print quality minimum is defined

With digital printing each print is individual and

for this reason each code has to be scanned to

check the contents (refer to Appendix D3)

The current standard for determining print quality is set

out in ISOIEC 15415 A red light of wave length 660 nm

(+10 nm) is used The synthetic aperture is 80 of the

module size as defined in above standard

Alternatively it is possible to determine print quality with

the built-in ISOIEC 15415 compliant testing capabili-

ties of the data collection system being employed

The print quality is graded either numerically from gra-

de 4 (best) to grade 0 (worst) or alphabetically from A

(best quality) to F (worst quality) (refer to table below)

Quality grades ISOIEC 15415

ISOIEC-grades

A N S I level

With repea-ted testing

Meaning

4 A 35 - 40 Very good

3 B 25 - 349 Good

2 C 15 - 249 Satisfactory

1 D 05 - 149 Adequate

0 F Unter 05 Failed

The print quality grade may not be less than

05 grade (adequate) in accordance with ISO

IEC 15415 In order to ensure readability at the

end of the supply chain (and possibly during) a

print quality grade of 15 (satisfactory) or better

should be targeted

The minimum print quality requirement is valid accor-

ding to standard statistical quality control methods

(refer to Appendix D5)

The printing systems must be capable of printing the

defined codes in the minimum print quality Printing

systems can be tested according to the international

ISOIEC 15419

Further details concerning print quality and test equip-

ment are described in the Appendix D


7 Interoperability on the basis of XML-Standards

In Appendix C a standard is described which should

be used based on XML standards and which provides

a neutral description of the Data Identifiers This allows

for the open exchange of data as illustrated in Figure 6

regardless of symbology and data structures

ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip

Figure 6 XML-based data exchange


Appendix A Overview and reference of the Data Identifiers

The following table lists the characteristics of each individual Data Identifier

Data elements XML-Node

DI AI Data type

Data format

Character lenght

Character subset

Pharmacy- Product-Number(PPN)

ltPPNgt 9N AN --- 4-22 0-9 A-ZNo special charactersNo lower case charactersNo diacritics

National Trade Item Num-ber (NTIN)

ltGTINgt 8P 01 N --- 14 0-9

Batch number ltLOTgt 1T 10 AN --- 1-20 0-9 A-ZAllowed specialcharacters -ldquo and _ ldquoNo lower case charactersNo diacritics2)

Expiry date ltEXPgt D 17 Date YYMMDD 6 0-9

Serial number ltSNgt S 21 AN --- 1-20 1) 0-9 A-ZNo special charactersNo lower case charactersNo diacritics2)

1) The character length is based on the guidelines set out in Chapter 3

2) The GS1 guidelines deviate here The requirement defined here is binding

Note concerning ndash ldquoData formatrdquo

Only for the ldquodaterdquo a firm data format is given

Note concerning ndash Special characters used in the batch number

The only special characters (non-alphanumeric) allowed in the batch number are the underscore ldquo_rdquo and the hyphen

ldquo-rdquo All other special characters have different meanings in diverse applications

The use of such characters present a high risk of incorrect translation and must therefore be reques-

ted through securPharm eVldquo Lowercase characters are not allowed because some systems are unable to

distinguish between upper- and lower-case characters Additionally because of the risk of confusion between lower-

and upper-case characters lowercase characters are excluded from use


Appendix B Code Emblem The string ldquoPPNrdquo in the font ldquoOCR-Brdquo has been defined as the PPN-Code Emblem The graphical representation is

to be found the following sketch

dc

fe

a

b

Nominal dimensions

a results from the chosen module and matrix sizes

b for a square code a = b for rectangular ndash depends

on chosen module and matrix sizes

c 04 a

d )

e results from the required quiet zone ) (Quiet zone

refer to Chapter 63)

f results from the font type and dimension c

) The dimensions d and e should be chosen so that

the code is associated with the emblem

Tolerances The tolerances can be freely determined according to the selected printing process

The following orientations are in principle possible

In exceptional cases the emblem can be applied to an adjacent surface


Appendix C Interoperability based on XML-descriptors

C1 General

For manufacturers wholesalers pharmacies and

clinics the interoperability of coding is a prerequisi-

te for reading and unequivocal identification of data

elements Integrated interoperability helps to ensure

cost-effective processes for the involved parties The

interoperability is based on the joint use of the IEC

standards 15434 Syntax for High Capacity Media ISO

IEC 15459 Unique identifier as well as System and Data

Identifiers according to ISOIEC ISOIEC 15418

In order to provide manufacturers and users in

the pharmaceutical field an even greater inter-

operability in this Appendix an XML-based

standard is described for interpreting the data

This applies both for data transmission to the prin-

ter as well as for data transmission from the code

reader to the connected systems

The Standard set out in this appendix applies only to

the data contents ie it does not refer to the layout

properties of the code which include the provisions of

the clear text printing and symbology (eg Data Matrix

Code)

During data transmission and in accordance with this

standard the data will be uniformly named using XML

nodes independent of the Data Identifiers used in the

code Following layers are formed in the representation

of the data

Application XML nodes

Data envelope ISOIEC 15434 eg

Format 05 Format 06 etc

Data structure Data Identifier (DI)

or Application Identifier (AI)

Symbology eg Data Matrix Code

C2 Data Format Identifier (DFI)

By the transmission of XML-Standard data elements

the properties for the display of the data in the Data

Matrix Code are assigned to the Data-Format-Identifier

(DFI) and only this is transferred

The DFI tells us which data envelope according to ISO

IEC 15434 which Application Identifier (AI or DI) and

whether a macro according to ISOIEC 16022 is used

The DFI instructions can be found in Table 1

XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418

IFA 06 Macro 06 DI-ASC

GS1 FNC1 AI-GS1

Table 1 Data Format Identifier

The DFI can have the values ldquoIFArdquo or ldquoGS1rdquo and is

transferred in the attribute of the higher level XML node

ltContentgtldquo


C3 XML-Node for Data

The table below shows the XML-Nodes for data and

their mapping to the Data Identifier (DI) und Application

Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

ltPPNgt 9N ---- Product number

ltGTINgt ---- 01 Product number

ltLOTgt 1T 10 Batch number

ltEXPgt D 17 Exipry date

ltSNgt S 21 Serial number

Table 2 XML-Nodes for Data

The complete list of currently defined nodes is shown

in Appendix A On this technical level of the description

there is no difference between NTIN and GTIN On this

basis the comprehensive term GTIN is used

ltContentgt envelops the XML nodes ltDatagt

(refer to Appendix C4 and Appendix C5)

From the XML-Data and the DFIldquo value contained the-

rein the printer derives all necessary information to

create the Data Matrix Code This includes the data ele-

ments the DI or AI the delimiters and the header

C4 Implementation

The XML description can be used both in the da-

ta transfer to the printer driver as well as for the data

output from the code readers (refer to schematic

representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag

MH1082- Daten- bezeichner

Code

Printer Reader

Figure 7 Data transfer based on XML description

The drivers for interpreting the XML description can

be part of the higher-levels systems (MES) or the

printer and reader The use of the unified description

enhances interoperability and helps to reduce errors

Further the uncertainty regarding non-printable control

character in transmission and interpretation is elimina-

ted in the XML description

When reading the code the scanner puts the data

content in the XML structure by using the corres-

ponding XML nodes By default data transmission

from the code reader to the higher systems only the

data is transferred without the ldquoDFIrdquo Output of DFIldquo is

optional for cases when eg the correct use of structures

within the code is to be checked

Generic XML description of data transmissi-

on to the printer and from the code reader

ltContent dfi=ldquovalue_dfildquogt

ltdata _ 1gtvalue _ data _ 1ltdata _ 1gt


ltdata _ ngtvalue _ data _ nltdata _ ngt

ltContentgt

When transferring from the code reader the value of

ldquodfirdquo is optional


C5 Examples

In the following examples the use of the four data elements product number batch number expiry date and serial

number is illustrated

Example 1 Data transfer to printer ndash IFA-Format

Product number PPN Data Identifier DI Data Format Identifier IFA

System

PPN 111234567842 Batch 1A234B5 Expiry Date 31122015 Serial number 1234567890123456

Coding IFAldquo

ltContent dfi=IFAldquogt

ltPPNgt111234567842ltPPNgt

ltLOTgt1A234B5ltLOTgt

ltEXPgt151231ltEXPgt

ltSNgt1234567890123456ltSNgt

ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer

Example 2 Data transfer to printer ndash GS1-Format

Product number GTIN Data Identifier AI Data Format Identifier GS1

Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System

GTIN 04150123456782 Batch 1A234B5 Expiry Date 31122015 Serial number 1234567890123456

Coding ldquoGS1ldquo

ltContent dfi=ldquoGS1ldquogt

ltGTINgt04150123456782ltGTINgt




ltContentgt

Printer

Example 3 Data transfer from scanner ndash IFA-Format


Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt

Example 4 Data transfer from scanner ndash GS1-Format

Product number GTIN Data Identifier DI Data Format Identifier GS1

Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt

If you have any questions or suggestions about this appendix please send them to IFA GmbH


Appendix D Quality and control of the code content (informative)

D1 Data Matrix Code as dot code

In accordance with the minimum requirements for print

quality it is to be noted that codes such as dot codes

where the printing quality is tested in accordance with

ISOIEC TR 29158 (Direct Parts Marking) should not

be used with the PPN Dot codes are not specified for

Data Matrix in the ISOIEC 16022 Scanners can often

not read dot codes or read rates are unacceptably low

The only exception here are dot codes where the indi-

vidual dots (data cells) are so wide and that they touch

each other so that they pass the ISOIEC 15415 test and

are generally readable

D2 Qualification and validation measures

The equipment for applying and testing of codes is

subject to the general qualification requirements

Likewise the ancillary processes have to meet the

general validation requirements

Definition and scope of qualification measures and the

validation process are not part of this specification

D3 Checking codes for data content and print quality

D31 General requirements

The location and extent of testing equipment for scan

ability and print quality will depend on whether the

packaging materials are used pre-printed or inline

During the intake checking of packaging materials

due care should be paid to the extent and nature of the

control of the pre-printed codes or the placeholders for

code labels

The achievable print quality of the code depends on

the substrate material and the printing process and

may therefore be significantly better than the minimum

requirement

D32 Scan testing

During the scan test the built-in acquisition system

tests if

bull the code is present

bull the correct symbology was used and

bull the content complies with the specifications

It also ensures that non-existent non-readable or

incorrect Codes are rejected

D33 Print quality testing

The print quality can generally be tested with two

different methods

1 Using measurements according to ISOIEC 15415

(for details refer to Appendix D61)

2 Using built-acquisition systems (for details refer to

Appendix D62) with the ability to analyze and

determine the print quality according to ISOIEC

15415


D4 Printing variants

D41 Packaging with pre-printed codes

D411 Quality control by the packaging

manufacturer - assured print quality from

the supplier

The codes are applied by the packaging material

supplier He has to ensure that the codes exist are

readable exhibit the correct symbology contain

the defined content and record the serial numbers

Furthermore he shall take the appropriate measu-

res to ensure that the code content and the the print

quality of the printed codes meet the minimum defined

requirements This is checked by the pharmaceutical

entrepreneur as part of supplier qualification

The applied codes are scanned once again during

the medicine packaging process In these cases a

complete check is carried out at the place of use of the

presence readability and use of the correct symbol

and correct content The actual serial number is also

captured during this step

D42 Inline printing of packaging without pre-printed codes

D421 Continuous scanning and spot

checks on print quality

The codes are inline printed on the packaging during

the medicine packaging process As described in

Appendix D32 through the detection system each

code is subjected to scan testing Also the serial

number of each code is recorded When required

additionally a testing device should be used to

carry out offline quality control of the printed code in

accordance with ISOIEC 15415 (for details refer to

Appendix D61)

D422 Continuous scanning and spot checks

on print quality

The codes are printed on the packaging inline during



individual code is subjected to read checking Also the

serial number of each code is recorded In contrast with

Appendix D421 a testing device will be used to check

the printing quality of each code compliance to ISOIEC

15415 (for details refer to Appendix D62)

D5 Quality control statistics

Testing of the print quality according to ISOIEC

15415 must always be performed in the context of a

standardized sampling procedure using generally

accepted statistical rules Briefly this means if one

code should fall below the acceptable level then

within the production batch more products have to be

checked If the error in the application of standardized

sampling procedure exceeds the acceptable level

appropriate corrective action has to be taken

Sampling procedures in accordance with ISO 2859

and ISO 3951 should be used In these standards a

defined statistical method is described which leads to the

assessment of whether a production batch is

acceptable or not The sampling methodology is

designed to intelligently control the time and effort in

quality inspection costs

The underlying principle of this statistical method is that

a certain level of defects is acceptable

The inline inspection of the print quality according to

ISOIEC 15415 (refer to Appendix D33) is considered

in the context of the sampling procedure as a very

frequent random sampling The statistical method for

intelligent control of the quality testing that can also be

used for inline inspection


D6 Testing equipment

D61 Testing in compliance to ISOIEC 15415

The print quality is measured in compliance to ISOIEC

15415 with measuring devices (verifier) The measu-

ring devices meet the requirements of the international

standard ISOIEC 15426-2 The most important require-

ments of a measuring device are

bull Calibration has to be traceable back to national

standards (eg PTB NIST)

bull The measurement must be performed under

predefined conditions regarding lighting

camera angle and distance (Template ISOIEC 15415

reference design)

bull Ambient light may only change the measurements

within the allowable tolerances of ISOIEC 15426-2

bull A regular calibration of equipment must be carried

out by the user

bull A regular monitoring to check measurement

accuracy must be carried out by the user

bull The requirements of the symbology standard with

respect to the reference decode algorithm must be

maintained so that different decode algorithms do

not lead to different results

The measurement is performed offline Because of

costs random samples tests are normal A 100

testing using this method of measurement is not

justifiable

Reading devices such as commercially available bar-

code scanners may not be subjected to the same

restrictions as measuring devices in regards to reading

distance reading angle lighting angle and ambient

light conditions Scanners must be capable of reading

codes under a wide range of conditions The defined

minimum print quality supports this

There remains a small residual risk that repeated

print quality tests of the same codes produce slightly

different results This applies even if the same codes

are tested with different verifiers

D62 Testing based on ISOIEC 15415

Many acquisition systems for the scan testing (refer to

Appendix D32) have the ability to continually analyze

and test the print quality inline This is a test which is

related to ISOIEC 15415 The method is often used as

an alternative to offline testing (refer to Appendix D33)

These systems use the same criteria for testing the print

quality as defined in the ISOIEC 15415 However there

are constraints on the scanner such as the wavelength

and angle of incidence of the light source or repeated

code testing from various angles which can not be pro-

vided for because of the integration in the packaging

line

The test results are related to ISOIEC 15415 Such

results should be set in correlation to a verifier result

(refer to Appendix D61) within eg the qualifying

process

Data capture systems which test according to the ISO

IEC 15415 method ensure a complete 100 inline

inspection (scan and print quality control) of each code


There remains a small risk as the acquisition system

which is primarily designed for best scanning results

eg adaptive lighting auto-focus and auto-zoom lenses

or optimized decoding algorithms In such conditions

the data acquisition system despite comparison with

the test results from ISOIEC 15415 can sometimes

provide different quality results

D7 Colours and materials

Acceptable colours and substrates The print

substrate must have a uniform diffusely reflecting

surface Surfaces that are highly reflective (metallic

metallic effects) are unsuitable Rough or embossed

surfaces are also not to be used The following co-

lour requirements are based on the assumption that

commercial scanners use red light

Substrate colour white red yellow or orange

(under red light)

Module or code colour black blue or green

(dark under red light)

Negative Data Matrix symbols in which the colours

of the substrate material and the module or matrix are

reversed are allowed

When using inkjet printing on outer packaging it may

be required to provide a corresponding recess in the

surface coating so that the ink adheres and dries

The minimum quality requirement (refer to Chapter 67)

determines the minimum contrast and thus the scope

for coloured codes

D8 Quality criteria in accordance with ISOIEC 15415 and ISOIEC 16022

Listed below are the most important test

parameters from the standard with short

description

bull Decode ndash Reference decode and Code internal

structure

bull Symbol contrast ndash Contrast between the

brightest and the darkest elements in the complete

symbol

bull Modulation (MOD) ndash refers to the reflectance

uniformity of a symbolrsquos light modules to each

other and also the reflectance of the dark modules

to each other

bull Reflectance margin ndash similar to Modulation

except that the code words which were correc-

ted by the Error correction are set here as Grad 0

(= Fail) in the decision matrix

bull Contrast Uniformity ndash MOD values are

determined for all code words The MOD values

are used for determining the modulation and the

reflection area The contrast uniformity is the worst

MOD value (informative)

Errors in Modulation Reflection area and Cont-

rast Uniformity refer to

bull Unused Error Correction (UEC) ndash the larger the

value the less errors had to be corrected

bull Axial Non-Uniformity (AN) ndashcode has been

expanded or compressed in the x or y axes

bull Grid Non-Uniformity (GN) ndash degree of grid

distortion compared to the ideal grid Grid non

uniformity does typically not influence axial non

uniformity

bull Fixed Pattern Damage (FPD) ndash All code parts

which do not contain data or error correction

values are checked for damage This means the L


pattern for code orientation recognition the clock

track for grid reconstruction and the quiet zone

Contrast non-uniformity which is in the data area

graded as modulation is an additional aspect if it

appears in the fixed pattern

bull Print growth ndash informative parameter which

shows if black elements have been printed wider

or smaller than intended

bull Module size ndash The size of a single matrix cell of a

complete code is called Module size The size of

the module will determine the scanner specifica-

tion in regard to depth of field resolution and mini-

mum reading distance

bull Matrix sizes ndash The complete Code is composed

of individual matrix cells (= Module) of a set iden-

tical module size The international standard ISO

IEC 16022 defines the smallest Matrix size as 10x10

Modules and the largest matrix size as 144x144 In

practical applications allowed matrix sizes are li-

mited in order to restrict the relationship of camera

resolution to matrix size and to have enough pixels

per module and thus increase scan reliability

Appendix E Layout ndash Best Practice (informative) These examples show how even on relatively small

areas the available code and plain text may be printed


Appendix F Bubble-Jet ndash BestPractice (informative)

These printer systems often have a cartridge system

with an integrated print head Other similar systems use

print heads which are separated from the ink reservoir

All such printer systems have a specific resolution (eg

300 600 720 dpi) Furthermore the ink drops over-

lap to create a smooth edge The print density can be

affected by the ink type and amount

These variables must be considered in the printer

setting It is advantageous if the printing system

only allows those code size settings that can be printed

without distortion If the recommended size gradation

of the code that is enforced by the printerlsquos resolution

is not observed then printing errors will become worse

as the print resolution is reduced (necessary at higher

speeds)

Appendix G Data Matrix Code ndash Symbology description (informative)

The Data Matrix Code in the current version ECC200

can be either square or rectangular

G1 Module sizes

Module size means the dimension of a matrix cell

of the complete code The module size is freely

scaleable within the dimensions described in

Chapter 52 and determined by the printing and

scanning technology used

Examples of identical codes in different module

sizes


G2 Matrix size

The matrix size is determined by the number of modu-

les ISOIEC 16022 is the minimum size of a matrix of

10x10 square version modules and the maximum size

is 144x144 modules

The rectangular version starts with the matrix size 8x16

and increases to 16x48 modules In Chapter 52 the

PPN matrix sizes are described

Example matrix size 32x32 module


Example matrix size16x48 module


G3 Fixed pattern

The Data Matrix Code comprises of fixed pat-

tern and an area for the code data

The red marked portion of the fixed pattern is called

the finder pattern Lrdquo This pattern allows the scanner to

locate and orientate the code

Here the red marked portion of the fixed pattern is

called the clock track The clock track indicates the

matrix of the code

The red areas of the fixed pattern are only used in code

from a matrix code sizes of 32x32 modules and larger

The above illustrated L- and clock patterns are repeated

in these codes

The red-marked outline of the code is the lowest per-

missible Quiet Zone width The width is a matrix row or

column It is recommended in practice to use the tre-

ble the width


G4 Data area

The red area is for data storage of the data matrix

codes In this area there are the code words for data

and for error correction Symbols up to to a matrix size

of 26x26 modules only have one red data segment

G5 Pad characters

The table shown in Chapter 62 with the two square

26x26 and 32x32 versions of code modules have 44 or

62 codewords for data If eg 48 codewords are to

be used then the capacity of a 26x26 matrix is not

sufficient A 32x32 matrix with 62 codewords must then

be used The difference between the capacity of 62 code

words and the required 48 code words is filled with pad

characters The padding must be performed in a fixed

schema which is defined in the Data Matrix ISOIEC

16022

If the application is always with a fixed matrix size eg

26x26 modules although sometimes 22x22 or 24x24

modules or modules would be sufficient the excess

code capacity should be filled with padding characters

If filled with (scanner) readable data the data

structure is destroyed and the code is unusable

G6 Error correction

The error correction of the data matrix codes is defi-

ned in ISO IEC 16022 The Reed Solomon method is

employed It should be noted that the process of error

correction is based on the code words and not on the

individual matrix cells

In the illustration a codeword consisting of 8 displayed

matrix cells is displayed Each matrix cell is highligh-

ted in the picture with the red checkerboard pattern

If a matrix cell appears light instead of dark then the

codeword is invalid If all matrix cells are the wrong

colour the codeword remains invalid If a partial area of

the code is ruined then the code words from this area

are impacted But it is possible that even the data from

relatively large areas of seemingly faulty (continuous)

areas may be reconstructed by the error correction If

many small matrix sites randomly scattered over the

entire symbol are impacted then many code words

will be impacted and the error correction capability has

reached its limits


Appendix H Glossary

As a matter of principle the terms and definitions of ISO

IEC 19 762 Part 1 and Part 2 apply in this specification

The following are additional terms and abbreviations

used in this document

bull AMG The purpose of the German Medicinal

Products Act (AMG) is to guarantee in the

interest of furnishing both human beings and

animals with a proper supply of medicinal products

safety in respect of the trade in medicinal products

ensuring in particular the quality efficacy and

safety of medicinal products in accordance with

the AMG contained provisions (refer to sect 1 AMG)

bull Application Identifier (AI) By the users of GS1

specified Identifier which exactly define the en-

coded data contents These are worldwide valid

and in multilines of business applicable referring

to ISO 15418 In the German language publishes

by GS1 under Datenbezeichnerldquo

bull BARCODE Optical data carrier consisting of

lines Colloquially two dimensional matrix codes

are sometimes referred to as 2D barcodes This

includes the Data Matrix Code

bull Code 39 A bar code type specified in ISOIEC

16388 The printed space requirements of this

code is high for a relatively low data volume

bull Continous Ink-Jet (CIJ) This is a form of inkjet

printing Usually this printing process generates

dot codes which are explained in the glossary

The printing process creates a constant stream

of ink droplets which is deflected electrostatically

The solvent evaporates rapidly Due to the high sol-

vent content the ink dries and adheres very well

to all non-porous surfaces The resolution is low

bull Data Identifier (DI) From the bdquoASC MH 10 Data

Identifier Maintenance Committeeldquo assigned Data

Identifiers listed in the standard ANSI MH1082

(normative reference ISOIEC 15418) The Data

Identifier always is terminated with an alphabetic

characters These can to provide differentiation

with variants have a one two or three digit prefix

bull Data Matrix Code Two dimensional Matrix code

which comprises of square elements In the version

ECC 200 of ISOIEC 16022 the Code uses an error

correction for missing spots or damaged places

Adjacent code elements of the same colour should

continue into one another without break

bull DFI ndash Data Format Identifier Defines the pa-

rameters according to the ISO standard Additio-

nally sets out the guidelines for the use and form

of the following parts the envelope data according

to ISOIEC 15434 the specific application identi-

fier (AI or DI) which macro is to be used (ISOIEC

16022) and the appropriate syntax Currently the

value for the DFI ldquoIFArdquo or ldquoGS1rdquo are defined

bull Dot code These are two-dimensional codes

which are typically composed of round detached

dots The Data Matrix standard does not specify a

dot code variant In reality there are many dot code

data matrix applications Scanners would be nee-

ded which are capable of reading such forms In

the PPN application as an open system scanners

types are not specified For this reason the Data

Matrix Dotcode variant is not allowed

bull European Medicines Agency (EMA) European

regulatory agency for medicines for use in the

European Union


bull Global Trade Item Number (GTIN) A worldwide

unequivocal article number which is used in many

sectors (FMCG chemistry health service fashion

DIY military sector banks etc) The GTIN (former

EAN) can be encoded in different data carriers

as for example in a bar code by the type EAN-13

Other encoding of the GTIN in GS1-128 Data mat-

rix code and GS1-DataBar is possible The respon-

sible IA is GS1

bull GS1 ndash registered Trademark GS1 is the

abbreviation for Global Standards One which is

registered as IA and administrates the global GS1

number system

bull HIBC ndash Health Industry Bar Code The HIBC is

a compressed structure and is mainly used for the

labelling of medical products The HIBC system

identifier is prefixed with a ldquo+rdquo alphanumeric pro-

duct codes of 2 to 18 digits may be used followed

by the variable product data (refer to wwwhibcde)

bull IFA Informationsstelle fuumlr Arzneispezialitaumlten IFA

GmbH (wwwifaffmde) German Information Center

for Medicinal Products agency responsible for

issuing the PZN and the PRA-Code

bull Issuing Agency Code (IAC) The registration

code assigned to an approved Issuing Agency(IA)

by the Registration Authority for ISOIEC 15459ldquo

An Issuing Agency is able to offer itsrsquo participants a

system for globally unique identification of objects

The NS (Neder- landse Norm) is mandated by the

ISO to act as a Registration Authority

bull Module size Specifies the size of a cell in the

matrix Data Matrix Code

bull National Trade Item Number (NTIN) A glo-

bally unique article number in which the national

article number is embedded through the use of a

GS1-prefix For the PZN the prefix 4150 has been

assigned The GTIN Data Identifier is the AI 01ldquo

bull Optical readable media (ORM) A generic term

for coding that are captured with optical devices

This includes OCR fonts barcodes and 2D-Codes

etc

bull OTC Medicines Over the counter is a term for non-

prescription medicines According to sect 48 AMG me-

dicines are classified as non-prescription if they

do not endanger the health of user when used as

intended even if they are used without medical su-

pervision Non- prescription medicines are grouped

into pharmacy-only and freely-sold medicines

bull Pharmaceutical entrepreneur (PU) is in the

case of medicines which require authorization

or registration the owner (called ldquoPharmazeuti-

scher Unternehmer (PU)rdquo in Germany) PU is also

whoever introduces in his name medicines into the

supply chain (sect4 Abs 18 AMG) This means that if

the medicine is brought into the supply chain by

another party other than the owner then both par-

ties must be specified in the identification eg both

as PU or as Ownerldquo and Distributorldquo This applies

when in addition to the authorisationregistration

owner one or more parties distribute medicines

then the latter should be identified as (further) PUldquo

or as Co-distributorldquo In both legal and the secur-

Pharm project terms all the above named parties

are PU and thus responsible for the compliance of

the appropriate responsibilities where applicable

bull Pharmacy-Product-Number (PPN) A globally

unique article number for products in the area of

health care in which the national article number

is embedded It consists of a two-digit prefix

(Product Registration Agency code) followed by

the national product number (PZN in Germany)

and a two digit check digit The national product

number is thus converted into a globally unique

product number to be unique in international

business transactions The responsible IA is IFA

bull Pharmazentralnummer (PZN) German Natio-

nal Number Product number for pharmaceutical

products and pharmacy typical products availa-

ble The issuance of the PZN number is regula-

ted by law and under the responsibility of the IFA

Refer to httpwwwifaffmde service_indexhtml

bull PPN-Code Describes a Data Matrix ECC 200

code according to ISOIEC 16022 and the data

structure and syntax of ISOIEC 15418ANSI

MH1082 and ISOIEC 15434 The leading data


element contains the code of the PPN ldquoPharma-

cy-Product Numberrdquo (PPN) and depending on

the application additional data elements For me-

dicines requiring verification this would be ldquose-

ri- al numberrdquo ldquobatch numberrdquo and ldquoexpiry daterdquo

bull Product Registration Agency (PRA) The

assigning authority for national product numbers

which in con- junction with the PRA-Code can be

converted to PPN

bull Product Registration Agency Code (PRA-

Code) Two digit prefix to the unique identifier of a

PPN Assig- ned to and administered by the IFA

bull Random serial number Non-deterministically

generated serial number

bull RX-Medicines Prescription drugs were often

referred as RX drugs

bull securPharm An Association founded by the con-

federation of pharmaceutical manufacturers phar-

macists and wholesalers in order to develop and

pilot test a concept for the verification of medicines

bull SI ndash System Identifier A System Identifier

consists of a character or a combination and

refers to the code at the beginning of the da-

ta structure used or syntax System Identi-

fiers are standardized according to DIN 66401

bull Verification The process of detecting counterfeits

or duplicates medicines by the printing of unique a

serial number on packages is understood here as

verifica-tion In the field of optical codes the term ve-

rification and quality control for the printing of codes

is used In order to achieve clarity of the terms used

in the present specification verification only in the

context of fraud detection The print quality control is

always referred to as a bar code or matrix code tes-

ting verification (cf English ldquobar code verificationrdquo

within the meaning of the printing quality control)

bull XML Extensible Markup Language (XML)

is a markup language which defines a set of

rules for hierarchical structured data in text form


Appendix I Bibliography

I1 Standards

ISO 22742 Packaging - Linear bar code and two-dimensional symbols for product packaging

ANSI MH1082 Data Identifier and Application Identifier Standard

ISOIEC 15418 Information technology -- Automatic identification and data capture techniques -- GS1 Ap- plication Identifiers and ASC MH10 Data Identifiers and maintenance Referenz to ANSI MH1082

ISOIEC 15415 Information technology -- Automatic identification and data capture techniques -- Bar code print quality test specification -- Two-dimensional symbols

ISOIEC 15434 Information technology -- Automatic identification and data capture techniques -- Syntax for high-capacity ADC media

ISOIEC 15459-2 Information technology -- Unique identifiers -- Part 2 Registration procedures

ISOIEC 15459-3 Information technology -- Unique identifiers -- Part 3 Common rules for unique identifiers

ISOIEC 16022 Information technology -- Automatic identification and data capture techniques -- Data Mat- rix bar code symbology specification

ISOIEC 19762-1 Information technology -- Automa- tic identification and data capture (AIDC) techniques -- Harmonized vocabulary -- Part 1 General terms relating to AIDC

ISOIEC 19762-2 Information technology -- Automa- tic identification and data capture (AIDC) techniques -- Harmonized vocabulary -- Part 2 Optically readable media (ORM)

ISO 2859-1 Sampling procedures for inspection by attributes Part 1 Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection

ISO 3951 Sampling procedures and charts for inspection by variables for per cent nonconforming

ISOIEC 10646 Information technology -- Universal Coded Character Set (UCS)


I2 Reference to specifications

The following listed specifications contain the necessary details of coding In particular to two possible structures in the data matrix code

A specifications of the IFA

See Specification of PPN codeldquo for use in the secur-Pharm project httpwwwifa-coding-systemorgdownloadsdePPN_Code_Spezifikation_lang_engl_V1_01pdf

Part of the IFA Coding system httpwwwifa-coding-systemorgenhome

B specifications of the GS1

1) Identification of Medicines in Germany ndash NTIN Guideline for use in the securPharm pilot project (httpwwwgs1-germanydeservicedateidownloadtx_mwbase [action] =initDownloadamptx_mwbase[uid] =742amptxmw-base [file name] =Kennzeichnung_von_Phar-mazeutika_in_Deutschlandpdf)

2) Marking of Pharmazeutika in Germany ndash NTIN guide for the use in securPharm-Pilot project (httpwwwgs1-germanydegs1-standards-im-gesundheitswesen c1181)

3) General GS1 Spezification (httpwwwgs1-germanyde)

Appendix J Document Maintenance Summary

Version Date Type of Change ChangeV 10 2012-09-30 First release

V 101 2013-12-03 LayoutContent Correction

Chapter 4 51 6 Appendixes A C H


Appendix K Imprint

securPharm eV Hamburger Allee 26 - 28

60486 Frankfurt am Main

Internet httpwwwsecurPharmde

The content has been created with great care If you discover errors or omissions then please let us know

Remark on the preparation of this specification

The Working Group (AG) Codingldquo of the securPharm Project created this specification Apart from the mem-bers of the group AG Coding other professionals provide occasional assistance in the preparation of the above documentation The Working Group comprised of (in alphabetical name order)

bull Klaus Appel Informationsstelle fuumlr Arzneispezialitaumlten (IFA) FrankfurtMain

bull Dr Ehrhard Anhalt Bundesverband der Arzneimittel-Hersteller (BAH) Bonn

bull Tobias Beer Boehringer Ingelheim Pharma GmbH amp Co KG Ingelheim

bull Thomas Bruumlckner Bundesverband der Pharmazeutischen Industrie (BPI) Berlin

bull Dr Stefan Gimmel Stada Arzneimittel AG Bad Vilbel

bull Dr Clemens Haas Fresenius Kabi Deutschland GmbH Oberursel

bull Stefan Lustig Boehringer Ingelheim Pharma GmbH amp Co KG Ingelheim

bull Heinrich Oehlmann Eurodata Council NaumburgThe Hague

bull Helmut Reichert ABDATA Pharma-Daten-Service Eschborn

bull Dr Joachim Reineck Merz Group Services GmbH Reinheim

bull Kay Reinhardt Salutas Pharma GmbH Barleben

bull Paul Rupp (Leader of the working group) Sanofi-Aventis Schwalbach

bull Wilfried Weigelt Mitglied im Normenausschuss NIA-01-31



1Foreword and Introduction

2Scope

3Abbreviated technical information concerning verification - in brief

31Serial number rules

32Data transfer to the PU Database System

4Coding agreements

41General

42Pharmacy Product Number (PPN) - Use in Germany

43National Trade Item Number (NTIN) - Use in Germany

44Codes and Data on retail packs

5Data content and requirements

51Data Identifiers and Structures

52Data elements and the corresponding Data Identifiers

6Marking with code and clear text

61Symbology

62Matrix size

63Code size and quiet zone

64Positioning of the Data Matrix Code

65Emblem PPN-Code

66Clear Text information

67Print quality

7Interoperability on the basis of XML-Standards

Appendix AOverview and reference of the Data Identifiers

Appendix BCode EmblemThe string ldquoPPNrdquo in the font ldquoOCR-Brdquo has been defined as the PPN-Code Emblem The graphical representation is to be found the following sketch

Appendix CInteroperability based on XML-descriptors

C1General

C2Data Format Identifier (DFI)

C3XML-Node for Data

C4Implementation

C5Examples

Appendix DQuality and control of the code content (informative)

D1Data Matrix Code as dot code

D2Qualification and validation measures

D3Checking codes for data content and print quality

D4Printing variants

D5Quality control statistics

D6Testing equipment

D7Colours and materials

D8Quality criteria in accordance withISOIEC 15415 and ISOIEC 16022

Appendix ELayout ndash Best Practice (informative)These examples show how even on relatively small areas the available code and plain text may be printed

Appendix FBubble-Jet ndash BestPractice (informative)

Appendix GData Matrix Code ndashSymbology description (informative)

G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary

Appendix IBibliography

I1Standards

I2Reference to specifications

Appendix J

Appendix KImprint


Table of Contents1 Foreword and Introduction 4

2 Scope 5

3 Abbreviated technical information concerning verification - in brief 6

31 Serial number rules 632 Data transfer to the PU Database System 6

4 Coding agreements 6

41 General 642 Pharmacy Product Number (PPN) - Use in Germany 743 National Trade Item Number (NTIN) - Use in Germany 744 Codes and Data on retail packs 7

5 Data content and requirements 8

51 Data Identifiers and Structures 852 Data elements and the corresponding Data Identifiers 9

6 Marking with code and clear text 11

61 Symbology 1162 Matrix size 1163 Code size and quiet zone 1264 Positioning of the Data Matrix Code 1265 Emblem PPN-Code 1266 Clear Text information 1267 Print quality 13

7 Interoperability on the basis of XML-Standards 14



































maceutical law
























practical solution


























companies






date






wwwsecurpharmde

2 Scope













are marked






































bull Serial number


bull Expiry Date




4 Coding agreements

41 General






bull Product Number

bull Batch Number

bull Expiry Date











packages




(SGB V)






product number

















PPN and NTIN






11 12345678 42



















home






0 4150 12345678 2














format







Code 39 1

Symbology PZN-Code

Data Matrix Code 2



























(ANSI MH1082)




V1_01pdf











securPharm eVldquo








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint



































maceutical law
























practical solution


























companies






date






wwwsecurpharmde

2 Scope













are marked






































bull Serial number


bull Expiry Date




4 Coding agreements

41 General






bull Product Number

bull Batch Number

bull Expiry Date











packages




(SGB V)






product number

















PPN and NTIN






11 12345678 42



















home






0 4150 12345678 2














format







Code 39 1

Symbology PZN-Code

Data Matrix Code 2



























(ANSI MH1082)




V1_01pdf











securPharm eVldquo








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint

























companies






date






wwwsecurpharmde

2 Scope













are marked






































bull Serial number


bull Expiry Date




4 Coding agreements

41 General






bull Product Number

bull Batch Number

bull Expiry Date











packages




(SGB V)






product number

















PPN and NTIN






11 12345678 42



















home






0 4150 12345678 2














format







Code 39 1

Symbology PZN-Code

Data Matrix Code 2



























(ANSI MH1082)




V1_01pdf











securPharm eVldquo








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint



























bull Serial number


bull Expiry Date




4 Coding agreements

41 General






bull Product Number

bull Batch Number

bull Expiry Date











packages




(SGB V)






product number

















PPN and NTIN






11 12345678 42



















home






0 4150 12345678 2














format







Code 39 1

Symbology PZN-Code

Data Matrix Code 2



























(ANSI MH1082)




V1_01pdf











securPharm eVldquo








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint

















PPN and NTIN






11 12345678 42



















home






0 4150 12345678 2














format







Code 39 1

Symbology PZN-Code

Data Matrix Code 2



























(ANSI MH1082)




V1_01pdf











securPharm eVldquo








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint







Code 39 1

Symbology PZN-Code

Data Matrix Code 2



























(ANSI MH1082)




V1_01pdf











securPharm eVldquo








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint








tensions


521 Product number










Example

DIAI Data

9N 110375286414

01 04150037528643

522 Batch number








Example

DIAI Data

1T 12345ABCD

10 12345ABCD

523 Expiry date





ment for the code




DD = Day


(DD = 01-31)


(DD = 00)



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint



DIAI Data

D 160600

17 160600


German Drug Law


DIAI Data

D 160617

17 160617







or AI ldquo11ldquo

524 Serial number







Example

DIAI Data

S 12345ABCDEF98765

21 12345ABCDEF98765




61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint



61 Symbology











62 Matrix size





Square symbols


X = 035

Min

X = 025

Max

X = 0615


22 22 77 55 135 60 43

24 24 84 60 148 72 52

26 26 91 65 160 88 64

32 32 112 80 197 124 91

Rectangular symbols



Min X = 025

Max X = 0615


16 36 56x126 4x90 98x221 64 46

16 48 56x168 4x120 98x295 98 72






















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint




















65 Emblem PPN-Code









to Chapter 1)




Appendix B)







Product number






pdf)






Serial number











67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint





67 Print quality























ISOIEC-grades

A N S I level


Meaning


3 B 25 - 349 Good



0 F Unter 05 Failed






should be targeted







ISOIEC 15419










ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint








ltPPNgt 11012hellip

ltGTINgt 012345

ltSNgt 12334hellip

ltLOTgt 12ABC

ltEXPgt 151231

ltPZNgt 01234567

hellip

hellip

hellip






DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint





DI AI Data type

Data format

Character lenght

Character subset




ltGTINgt 8P 01 N --- 14 0-9


















dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint




dc

fe

a

b

Nominal dimensions




c 04 a

d )











C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint



C1 General





















Code)





of the data
















XML

Data

Format

Identifier

(DFI)

Format-ID

according ISO

IEC 15434

Data-Type

Identifier

according ISO

IEC 16022

Data

Identifier

Application

Identifier

according ISO

IEC 15418


GS1 FNC1 AI-GS1




ltContentgtldquo





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint





Identifier (AI)

Data Identifier

XML-Node

DIdfi=IFAldquo

AI dfi= GS1ldquo

Descrip-tion

















C4 Implementation




representation)

Driver

MES- System

Terminal Printer

Terminal Reader

MES- System A

nwen

der

- A

pp

likat

ions

eben

eS

yste

meb

ene

XML-Tag


Code

Printer Reader






















ltContentgt




C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint


C5 Examples





System


Coding IFAldquo






ltContentgt

Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

Printer



Data Carrier

FNC104150123456782

101A234B5FNC1

17151231

211234567890123456

System








ltContentgt

Printer



Data Carrier

Mac069N111234567842Gs

1T1A234B5Gs

D151231Gs

S1234567890123456

System


Scanner ltContentgt





ltContentgt



Data Carrier

FNC104150123456782

101A234B5FNC1

1717231

211234567890123456

System


Scanner ltContentgt





ltContentgt































code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint






























code labels




requirement

D32 Scan testing


tests if








different methods






15415






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint






the supplier



























Appendix D61)


on print quality















































reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint














reference design)




out by the user










justifiable
























line




process





















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint


















(under red light)











for coloured codes




description


structure



symbol




to each other



















uniformity













































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint










































speeds)




G1 Module sizes







sizes


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint


G2 Matrix size




is 144x144 modules








G3 Fixed pattern








matrix of the code




in these codes




ble the width


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint


G4 Data area





G5 Pad characters










16022







G6 Error correction



















reached its limits


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint


Appendix H Glossary


































































European Union










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint










sible IA is GS1




number system




























etc






















































converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint










converted to PPN

































I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint



I1 Standards





























Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint


Appendix K Imprint























2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint




2Scope




4Coding agreements

41General








61Symbology

62Matrix size



65Emblem PPN-Code


67Print quality





C1General


C3XML-Node for Data

C4Implementation

C5Examples





D4Printing variants


D6Testing equipment






G1Module sizes

G2Matrix size

G3Fixed pattern

G4Data area

G5Pad characters

G6Error correction

Appendix HGlossary


I1Standards


Appendix J

Appendix KImprint

coding rules for medicines requiring verification for the ... · version: 1.01 date of issue:...

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