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GS1 Standards Implementation Guide Healthcare Deployment Guide for coding standards, tagging and EDI for efficient deliveries and patient safety Release 1.0, Draft, June 2015

GS1 Standards Implementation Guide Healthcare · 2016. 2. 8. · The GS1 system includes a set of standards and directives, used internationally, mainly relating to the identification

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Page 1: GS1 Standards Implementation Guide Healthcare · 2016. 2. 8. · The GS1 system includes a set of standards and directives, used internationally, mainly relating to the identification

GS1 Standards Implementation Guide

Healthcare

Deployment Guide for coding standards, tagging and EDI for

efficient deliveries and patient safety

Release 1.0, Draft, June 2015

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Document Summary

Document Item Current Value

Document Name GS1 Standards Implementation Guide Healthcare

Document Date June 2015

Document Version 1.0

Document Issue

Document Status Draft

Document Description Deployment Guide for coding standards, tagging and EDI for efficient deliveries and patient safety

Contributors

Name Organisation

Change Log

Release Date of Change Changed By Summary of Change

1.0 23 June 2015 Ferran Domènech First edition of the document

1.1 27 July 2015 Ferran Domènech First edition of the document, revised after the GT meeting of 14 July 2015

Disclaimer

GS1®, under its IP Policy, seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in

the Work Group that developed this GS1 Standards Implementation Guide Healthcare to agree to grant GS1 members a royalty-free licence or a RAND licence to Necessary Claims, as that term is defined in the GS1 IP Policy. Furthermore, attention is drawn to the possibility that an implementation of one or more features of this Specification may be the subject of a patent or other intellectual property right that does not involve a Necessary Claim. Any such patent or other intellectual property right is not subject to the licensing obligations of GS1. Moreover, the agreement to grant licences provided under the GS1 IP Policy does not include IP rights and any claims of third parties who were not participants in the Work Group.

Accordingly, GS1 recommends that any organisation developing an implementation designed to be in conformance with this Specification should determine whether there are any patents that may encompass a specific implementation that the organisation is developing in compliance with the Specification and whether a licence under a patent or other intellectual property right is needed. Such a determination of a need for licensing should be made in view of the details of the specific system designed by the organisation in consultation with their own patent counsel.

THIS DOCUMENT IS PROVIDED “AS IS” WITH NO WARRANTIES WHATSOEVER, INCLUDING ANY WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, FITNESS FOR PARTICULAR PURPOSE, OR ANY WARRANTY OTHERWISE ARISING

FROM THIS SPECIFICATION. GS1 disclaims all liability for any damages arising from use or misuse of this Standard, whether special, indirect, consequential, or compensatory damages, and including liability for infringement of any intellectual property rights, relating to use of information in or reliance upon this document.

GS1 retains the right to make changes to this document at any time, without notice. GS1 makes no warranty for the use of this document and assumes no responsibility for any errors which may appear in the document, nor does it make a commitment to update the information contained herein.

GS1 and the GS1 logo are registered trademarks of GS1 Spain.

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Contents

1 Introduction ................................................................................................. 4

2 Efficient delivery process .............................................................................. 4

3 GS1 standard codes ...................................................................................... 5

3.1 Definition of the Product Hierarchy .................................................................................... 5

3.2 GTIN-13 ......................................................................................................................... 6

3.3 GTIN-13/SF .................................................................................................................... 6

3.4 GTIN-14 ......................................................................................................................... 7

Example of Catalogue coding with GTIN-13 ............................................................................ 9

3.4.1 Example of Catalogue coding with GTIN-14 ................................................................ 9

3.5 Changes to GTIN code ..................................................................................................... 9

3.6 Logistic Unit codes: SSCC .............................................................................................. 10

4 GS1 standard labelling requirements .......................................................... 11

4.1 Labelling requirements for trade units in the logistic environment ....................................... 11

4.1.1 Standard full pallet (defined in the catalogue): ......................................................... 11

4.1.2 Mono Item Part Pallet (not defined in the catalogue): ................................................ 12

4.1.3 Mixed Pallet (not defined in the catalogue) ............................................................... 13

4.1.4 Full box (defined in the catalogue) .......................................................................... 14

4.1.5 Part box (not defined in the catalogue) .................................................................... 15

4.1.6 Mixed Box (not defined in the catalogue) ................................................................. 16

4.2 Labelling requirements for Healthcare Products ................................................................. 16

4.2.1 Active Implantable Medical Device .......................................................................... 16

4.2.2 Self-test diagnostic products and in vitro diagnostic medical devices ........................... 17

4.2.3 Other healthcare products ...................................................................................... 17

4.3 Labelling Requirements for Medicines .............................................................................. 17

4.3.1 Medicines for Hospital Pharmacy ............................................................................. 18

4.3.2 Medicines for Retail Pharmacy ................................................................................ 18

4.3.3 Medicines for both Retail and Hospital Pharmacy ....................................................... 19

4.4 Recommendations on Human Readable information ........................................................... 19

5 The electronic packing slip for dispatches (DESADV) .................................. 20

5.1 Logistics DESADV (with SSCC) ........................................................................................ 20

5.1.1 Example Hierarchical Description of a Dispatch with CPS ........................................... 21

5.1.2 Mapping the Logistics DESADV message (with SSCC) ................................................ 24

5.1.3 Example Logistics DESADV message (with SSCC) ..................................................... 33

A.1 Glossary ...................................................................................................................... 35

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1 Introduction

For several years we have been working with the healthcare sector on various actions intended to lead to significant improvements to efficiency in the sector's supply chain. We now need to continue our in-depth study of the automation of logistical processes, using a common language for all agents in the chain.

The use of best practices, such as adopting the standard GS1 coding and symbol system and the EDI DESADV message, is necessary for progress in this area. The GS1 system includes a set of

standards and directives, used internationally, mainly relating to the identification of trade items (consumer units, groups of consumer units, boxes and/or pallets) and enables the transmission of

data through barcodes and EDI. As well as enabling the automation of processes, this standard working method makes it possible to maintain traceability throughout the supply chain.

This document gives detailed information on the requirements of pharmaceutical and healthcare distribution, which will enable synergies in the delivery process, regarding:

■ GS1 standard coding throughout the product hierarchy.

■ GS1-128 standard labelling of logistic groups

■ Optimum use of the EDI DESADV message

2 Efficient delivery process

The process to follow for optimum reception is given below.

The supplier has to send some batches of goods to the recipient's warehouse.

To do this, they prepare the boxes and pallets and each one is coded with the Serial Shipping Container Code (SSCC).

The prepared and labelled goods are loaded into the lorry and dispatched to the recipient's

warehouse.

At the same time, the supplier sends an EDI DESADV message to the recipient of the goods, which contains:

■ SSCC of the pallets

■ Content of the pallets: GTIN + SSCC of the boxes

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■ Date and traceability information

This information can be used to prepare the reception of the goods. This means that preparatory work can be done in the warehouse or that the company's management systems can be prepared to receive the goods with an inspection/check and by simply reading the logistics unit serial codes on

the pallets.

3 GS1 standard codes

The entire GS1 standard is based on the following identification principle:

The unique and unambiguous identification of the different trade units of the product hierarchy will enable us to reference any product or group of products in a label or in commercial and transport documents (orders, delivery notes and/or invoices).

3.1 Definition of the Product Hierarchy

The trade unit means any item where there is a need to register previously defined information, and

which can be valued, ordered or invoiced at any point in the supply chain. These trade units may be a product, a group of products, a single dose, etc. The definition of all the formats available to a customer and the relationship between them is called the product hierarchy.

Within the product hierarchy it is very important to define the different levels or formats which may be found, to make it easier to understand the identification needs of each one.

Definition of the product hierarchy for healthcare products

Term Description Example:

Unit of consumption of patient use

This refers to the unit of the item individually considered in patient use

First grouping Level

Package containing one or several units of consumption, packaged for national distribution sales. Minimum fixed packaged amount, non-variable.

Second grouping

Level

Package containing one or several first grouping level units for sale or national distribution

Logistics Box

Exclusive packaging from the Logistics field containing several units of consumption or unit of consumption groupings.

Pallet Exclusive packaging from the Logistics field containing various logistics boxes.

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Definition of the product hierarchy for medicines

Term Description Example:

Unit of consumption

to patient

This refers to the unit of the item individually considered in patient use

Primary Packaging

First level of packaging of a product. This may refer to the unit of sale in the Pharmacy Office, or if the unit contains more than one dose, it may refer to a lower level.

Primary Packaging

Secondary Packaging

Secondary Packaging

Grouping Level higher than the primary packaging Material, containing one or more units of it.

Logistics Box

Exclusive packaging from the Logistics field containing several units of consumption or unit of

consumption groupings.

Pallet

Exclusive packaging from the Logistics field containing various logistics boxes.

In this sector there are 3 main types of code for uniquely identifying the various trade units:

3.2 GTIN-13

All base units must be identified with a GTIN-13 code, structured as follows:

3.3 GTIN-13/SF

For all units sold in pharmacies, pharmaceutical products, goods and supplies covered by Spanish Social Security (ASSS - Asistencia Sanitaria de la Seguridad Social), there is an exclusive solution for the Spanish market which can provide the National Code of the medicine in the GTIN-13 format. This is structured as follows:

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3.4 GTIN-14

For all units which are designed exclusively for the transport and storage of products in a logistical environment. It is generated including a digit (from 1 to 8) at the start of the code:

Important: A GTIN-14 cannot be created based on a GTIN-13/SF. In this case, the logistic

group must be coded with a GTIN-13.

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Options for assigning codes to different medical trade units

HIERARCHICAL UNIT

GTIN-13 GTIN-13/SF GTIN-14

PRESCRIP

TIO

N Consumer unit for

patients

Sales unit in Retail Pharmacy

Box

Pallet

OVER-T

HE-

CO

UN

TER

Consumer unit for patients

Minimum sales unit in Retail Pharmacy

Box

Pallet

Important: The owner of the product brand is responsible for assigning codes, regardless of

the location and identity of the manufacturer.

Options for assigning codes to different healthcare product trade units

HIERARCHICAL UNIT

GTIN-13 GTIN-13/SF GTIN-14

PRESCRIP

TIO

N Consumer unit for

patients / implant

Sales unit in Retail Pharmacy

Box

Pallet

OVER-T

HE-

CO

UN

TER

Consumer unit for patients / implant

Minimum sales unit in Retail Pharmacy

Box

Pallet

Important: It should be mentioned that the first and second level of the healthcare product

group, if they can be dispensed as such in a pharmacy, can only be coded with a GTIN-13 code different to that of the sales unit (or GTIN-13/SF in the case of a prescription medicine),

and in this case, they will match the minimum sales or dispensing unit.

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Example of Catalogue coding with GTIN-13

Hierarchical unit GTIN code

Consumer unit for patients 8456789123 00 3

Sales unit in Retail Pharmacy 8456789123 01 0

Box 0 8456789123 02 7

Pallet 0 8456789123 03 4

3.4.1 Example of Catalogue coding with GTIN-14

Hierarchical unit GTIN code

Consumer unit for patients 3 8456789123 01 1

Sales unit in Retail Pharmacy 8456789123 01 0

Box 1 8456789123 01 7

Pallet 2 8456789123 01 4

3.5 Changes to GTIN code

A change in one of the following characteristics of any sales unit must be accompanied by a change in the unit's GTIN code:

□ Product name, brand or description.

□ Formulation.

□ Dosage.

□ Net content (weight, volume or any other dimension which affects its commercial use)

□ Packaging configuration

□ Change in the packaging language (adding another language to the packaging does not require changing the GTIN).

□ Form or function.

□ Inclusion of certificates (such as CE)

□ In groups, the number of units contained and their subdivision into intermediate groups.

If you have questions about a particular case which does not appear above, contact AECOC by telephone: 93 252 39 00 or email: [email protected].

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3.6 Logistic Unit codes: SSCC

A logistic unit is an item of any composition established for transport and/or storage which needs to be managed through the supply chain.

The code used for logistic units is known as the SSCC (Serial Shipping Container Code). This code is the key element in an efficient delivery environment.

Trade Unit

Logistic Unit

The SSCC is a serial number assigned to the dispatch unit (pallet, box, package, etc.), an as such

can differentiate two identical packages, for example.

Important: The SSCC code must only be assigned by the company which has put together

the logistic unit and is valid for one year from issue.

The SSCC is structured as follows:

D: Extension digit, from 0 to 9.

P1 P2: GS1 prefix (84 if the company is a member of GS1 Spain).

Ci: Together with P1 and P2 it forms the company prefix issued by GS1 to a member company.

Ii: Serial number of the package

C: Check digit.

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4 GS1 standard labelling requirements

This section precisely defines the content of the GS1-128 label according to the package to be identified.

4.1 Labelling requirements for trade units in the logistic environment

4.1.1 Standard full pallet (defined in the catalogue):

A full pallet is a grouping unit as defined in the catalogue of products and groupings, and identified with its own GTIN code.

Label Content AI Data format

GTIN pallet (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Lot (10) Letters and numbers, up to 20 characters

SSCC (00) 18 digit number

Example 1. Full Pallet label

Important: for products where the expiration date does not need to be specified, the day

field should be filled in with two zeros, “00”. This field will be interpreted as the last day of the indicated month, including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

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4.1.2 Mono Item Part Pallet (not defined in the catalogue):

A part pallet is a grouping unit not defined in the catalogue of products and groupings, and therefore not identified with its own GTIN code.

Label Content AI Data format

GTIN Box content (02) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Number of boxes contained (37) Numbers, up to 8 characters

SSCC (00) 18 digit number

Lot (10) Letters and numbers, up to 20 characters

Example 2. Mono Item Part Pallet Label

Important: for products where the expiration date does not need to be specified, the day

field should be filled in with two zeros, “00”. This field will be interpreted as the last day if the

indicated month, including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

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4.1.3 Mixed Pallet (not defined in the catalogue)

Mixed pallets are those containing different products or boxes with different formats, which do not have unique GTIN codes due to their mixed nature.

Label Content AI Data format

SSCC (00) 18 digit number

Important: The GTIN information on the contained products and groupings, and the

traceability data, will be transmitted to the recipient of the goods via the DESADV message (see 5.1 Logistic DESADV)

Example 3. Mixed Pallet label

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4.1.4 Full box (defined in the catalogue)

A full box is a grouping containing a defined number of consumer units, which has therefore been assigned a GTIN code in the catalogue.

Label Content AI Data format

GTIN of the Box (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Lot (10) Letters and numbers, up to 20 characters

SSCC (00) 18 digit number

Example 4. Full Box label

Important: for products where the expiration date does not need to be specified, the day field

should be filled in with two zeros, “00”. This field will be interpreted as the last day if the indicated month,

including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

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4.1.5 Part box (not defined in the catalogue)

A part box is a grouping containing a certain number of consumer units, which is below the minimum stipulated for a full box in the catalogue. Therefore, it is not assigned a GTIN code.

Label Content AI Data format

GTIN of the unit contained (02) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Number of units contained (37) Numbers, up to 8 characters

SSCC (00) 18 digit number

Lot (10) Letters and numbers, up to 20 characters

Example 5. Part Box label

Important: for products where the expiration date does not need to be specified, the day field

should be filled in with two zeros, “00”. This field will be interpreted as the last day if the indicated month, including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

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4.1.6 Mixed Box (not defined in the catalogue)

A mixed box is a grouping containing different items, which has therefore not been assigned a GTIN code in the catalogue.

Label Content AI Data format

SSCC (00) 18 digit number

Example 6. Mixed Box label

Important: The GTIN information on the contained products and the traceability data will be

transmitted to the recipient of the goods via the DESADV message (see 5.1 Logistic DESADV)

4.2 Labelling requirements for Healthcare Products

4.2.1 Active Implantable Medical Device

Consumer unit for patients / implant

For the implant unit, we will use a GS1-128 symbol, which contains:

Label Content AI Data format

GTIN of the implant unit (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Serial number (if applicable) (21) Letters and numbers, up to 20 characters

Lot (10) Letters and numbers, up to 20 characters

Important: If there is not enough space to print a GS1-128, the marking chosen will be a

GS1-Datamatrix.

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4.2.2 Self-test diagnostic products and in vitro diagnostic medical devices

For this type of product the consumer unit is defined as the unit considered individually at the time of use.

Hierarchical unit Symbol Contents

Consumer unit EAN-13 GTIN of the consumer unit

First grouping level GS1-128

(01) GTIN of the first grouping level

(17) Best Before Date – YYMMDD

(10) Lot Number

4.2.3 Other healthcare products

These healthcare products are those governed by Royal Decree 1591/2009, of 16 October. The classification in annex IX of the Royal Decree differentiates the products by classes.

Each of these classes will have specific identification requirements:

Healthcare Product Classification Symbol on Consumer Unit

Class III and IIb GS1-128

Class I sterile and IIa EAN-13

Class I non-sterile EAN-13

In the case of Class III and IIb healthcare products, the content of the GS1-128 must be:

Label Content AI Data format

GTIN of the implant unit (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Lot (10) Letters and numbers, up to 20 characters

Series (if applicable) (21) Letters and numbers, up to 20 characters

Important: If there is not enough space to print a GS1-128, the marking chosen will be a

GS1-Datamatrix.

Important: for products where the expiration date does not need to be specified, the day

field should be filled in with two zeros, “00”. This field will be interpreted as the last day if the indicated month, including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

Note: According to the US FDA the minimum marking requirements for Class III, II and I

healthcare products include GS1-128 / GS1-DataMatrix symbols with traceability information, and Lot and/or Serial number, depending on the Product class.

4.3 Labelling Requirements for Medicines

With medicines, we must differentiate between primary and secondary packaging:

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Meanwhile we will divide the requirements into segments according to their sub-channels: Hospital

Pharmacy or Retail Pharmacy.

4.3.1 Medicines for Hospital Pharmacy

Primary Packaging

For all medicines exclusively for hospital use, it is recommendable for the primary packaging to bear a GS1-128 symbol, or if there is not enough space, a GS1- DataMatrix.

Symbol Label Content AI Data format

GS1-128 or

GS1-DataMatrix

GTIN on primary packaging (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Lot (10) Letters and numbers, up to 20 characters

Secondary packaging

For all medicines exclusively for hospital use, it is recommendable for the secondary packaging to bear a GS1- DataMatrix symbol.

Symbol Label Content AI Data format

GS1-128 or

GS1-DataMatrix

GTIN on secondary packaging (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Lot (10) Letters and numbers, up to 20 characters

Important: for products where the expiration date does not need to be specified, the day

field should be filled in with two zeros, “00”. This field will be interpreted as the last day of the indicated month, including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

Note: All medicines affected by European Directive 2011/62/EU must include a serial number

in the GS1-Datamatrix, with the AI (21), after it comes into force.

Note: If the secondary packaging contains a single primary packaging, the GTIN of both can

be the same, as long as there is no stated need to differentiate between the two units.

4.3.2 Medicines for Retail Pharmacy

Sales unit in Retail Pharmacy

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Symbol Label Content Data format

EAN-13 GTIN of the sales unit 13 digit number

Note: All medicines affected by European Directive 2011/62/EU must include a serial number

in the GS1-Datamatrix, with the AI (01), (17), (10) and (21), after it comes into force.

4.3.3 Medicines for both Retail and Hospital Pharmacy

Primary Packaging

Symbol Label Content AI Data format

GS1-DataMatrix

GTIN on primary packaging (01) 14 digit number

Expiration date (17) 6 digit number YYMMDD

Lot (10) Letters and numbers, up to 20 characters

Secondary packaging

It is recommended that the secondary packaging, which will be the sales unit in Retail Pharmacy, include two symbols:

Symbol Label Content AI Data format

Symbol 1 EAN-13

GTIN on secondary packaging

your 13 digit number

Symbol 2 GS1-DataMatrix

GTIN on secondary packaging

(01) 14 digit number

Expiration date (17) 6 digit number

YYMMDD

Lot (10) Letters and numbers, up to 20 characters

Important: for products where the expiration date does not need to be specified, the day

field should be filled in with two zeros, “00”. This field will be interpreted as the last day if the indicated month, including the necessary adjustments for leap years (for example, “190200” is “28 February 2019”, and “200200” is “29 February 2020”)

Note: All medicines affected by European Directive 2011/62/EU must include a GS1-

Datamatrix with the content mentioned in the table plus the AI (21) with a serial number, after it comes into force.

4.4 Recommendations on Human Readable information

According to the GS1 standard, we must differentiate between two types of Human Readable information:

■ HRI (Human Readable Interpretation): The information below or next to the symbol,

representing the same characters that are codified in the symbol.

■ Non-HRI Text: Any other information in text form which appears on the label or packaging of the product or grouping.

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Note: It is recommendable for the information in Non-HRI Text to follow the FDA's UDI

regulations on the unique identification of healthcare devices. For this reason, we recommend

the following format: YYYY-MM-DD.

5 The electronic packing slip for dispatches (DESADV)

The electronic packing slip or Dispatch Advice Message, DESADV, is intended to inform the recipient of the requested products that they are ready for dispatch. The message specifies the products

which will arrive at the buyer's premises.

The DESADV message specifies the goods that have been dispatched or loaded to be sent to the recipient.

The message refers to a single dispatch point and a single destination point.

This message provides the recipient of the message with the information needed to prepare an efficient reception of the goods and to plan the restocking of healthcare organisations. The dispatch

notification includes the order number relating to the delivery.

The Dispatch Advice Message may also include additional information on requested products which were not available when the order was completed:

■ Lot numbers

■ Serial numbers

■ Date of manufacture/production, expiration date, etc.

■ SSCC of the packages

5.1 Logistics DESADV (with SSCC)

To ensure efficient deliveries, the Logistics DESADV must be sent, which includes the individual

identification of the packages contained in a dispatch.

The message may include a hierarchical description of the dispatch, beginning with the top level (the dispatch itself) and ending with the lowest level (items).

To optimise the processes of dispatching and receiving goods, especially in groupings with mixed trade units, we recommend identifying them using Serial Shipping Container Code (SSCC) and sending a Logistics DESADV.

In order to provide a correct hierarchical identification, the DESADV message must be used as indicated in the CPS segment. This segment gives advance knowledge of the configuration of the load in a dispatch.

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5.1.1 Example Hierarchical Description of a Dispatch with CPS

Definition of the hierarchy of a dispatch, consisting of 2 pallets, each one containing 3 boxes.

At the level of the DESADV message, the dispatch hierarchy would specify:

CPS+1' First level description: DISPATCH

PAC+2' The dispatch contains two packages (Pallets)

CPS+2+1' Second level description. First pallet

PAC+++201' Pallet ISO 1

PCI+33E' Pallet marked with SSCC

GIN+BJ+384107280000001058' Serial Shipping Container Code (SSCC 1)

CPS+3+2’ Third level description. First Box contained in Pallet SSCC 1

PCI+33E’ Box marked with SSCC

GIN+BJ+384107280000001068' Serial Shipping Container Code (SSCC 3)

LIN+1++38410738001591:EN' GTIN of the Box with SSCC3

PIA+1+8410738001590:EN' GTIN of the unit contained in Box SSCC3

QTY+12:1' Quantity dispatched 1 of units specified in LIN+1

QTY+59:10' 10 consumer units contained in Box

PCI+17’ Items marked with Lot No.

GIN+BX+970420NL’ Lot no.

CPS+4+2' Third level description. Second Box contained in Pallet SSCC 1

PCI+33E' Box marked with SSCC

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GIN+BJ+384107280000001075' Serial Shipping Container Code (SSCC 4)

LIN+2++28410738001662:EN' GTIN of the Box with SSCC 4

PIA+1+8410738001668:EN' GTIN of the unit contained in Box SSCC 4

QTY+12:1' Quantity dispatched 1 of units specified in LIN+2

QTY+59:10' 10 consumer units contained in Box

PCI+17’ Items marked with Lot No.

GIN+BX+93TG306’ Lot no.

CPS+5+2' Third level description. Second Box contained in Pallet SSCC 1

PCI+33E' Box marked with SSCC.

GIN+BJ+384107280000001082' Serial Shipping Container Code (SSCC 5)

LIN+3++38410738001730:EN' GTIN of the Box with SSCC 5

PIA+1+8410738001736:EN' GTIN of the unit contained in Box SSCC 5

QTY+12:1' Quantity dispatched 1 of units specified in LIN+3

QTY+59:20' 20 consumer units contained in Box

PCI+17’ Items marked with Lot No.

GIN+BX+A13276L’ Lot no.

CPS+6+1' Second level description. Second pallet

PAC+++201' Pallet type ISO 1

PCI+33E' Pallet marked with SSCC

GIN+BJ+384107280000001099' Serial Shipping Container Code (SSCC 2)

CPS+7+6’ Third level description. First Box contained in Pallet SSCC 2

PCI+33E’ Box marked with SSCC

GIN+BJ+384107280000001105' Serial Shipping Container Code (SSCC 6)

LIN+4++38410738001867:EN' GTIN of the Box with SSCC6

PIA+1+8410738001866:EN' GTIN of the unit contained in Box SSCC6

QTY+12:1' Quantity dispatched 1 of units specified in LIN+1

QTY+59:10' 10 consumer units contained in Box

CPS+8+6' Third level description. Second Box contained in Pallet SSCC 2

PCI+33E' Box marked with SSCC.

GIN+BJ+384107280000001075' Serial Shipping Container Code (SSCC 7)

LIN+5++18410738001665:EN' GTIN of the Box with SSCC 7

PIA+1+8410738001664:EN' GTIN of the unit contained in Box SSCC 7

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QTY+12:1' Quantity dispatched 1 of units specified in LIN+5

QTY+59:20' 20 consumer units contained in Box

CPS+9+6' Third level description. Third Box contained in

Pallet SSCC 2

PCI+33E' Box marked with SSCC.

GIN+BJ+384107280000001075' Serial Shipping Container Code (SSCC 8)

LIN+5++18410738001542:EN' GTIN of the Box with SSCC 8

PIA+1+8410738001545:EN' GTIN of the unit contained in Box SSCC 8

QTY+12:1' Quantity dispatched 1 of units specified in LIN+5

QTY+59:20' 20 consumer units contained in Box

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5.1.2 Mapping the Logistics DESADV message (with SSCC)

Element Description M/R/C Format SEG DE Qualifier

Transaction name Indicates the type of transaction to be made and the version used.

XXX

UNH+ME000001+DESADV:D:96A:UN:EAN005'

Message ME000001 of DESADV D96A, subset EAN005

M an..14 UNH

1

0065

0052

0054

0051

0057

0062

DESADV

D

96A

UN

EAN005

Transaction identification

Reference number of the dispatch advice message assigned by the issuer of the document. DE1225 will also indicate the function of the message: original (9), modification (4), replacement (5) or copy (31).

XXX

BGM+351+115661+9'

This is a dispatch advice with the number 115661. The message is original.

M an..17 BGM

2

1001

1225

1004

351

9

31

Message date Date of creation of the document. The format used to specify the date should also be indicated: format YYYYMMDD (102) and format YYYYMMDDHHMM (203).

XXX

DTM+137:202006251940:203'

Date of creation of the document: 25 June 2020 at 19:40

M an..35 DTM

3

2005

2379

2380

137

102

203

Estimated date/time of delivery

The estimated date when the goods will be delivered. The format used to specify the

date should also be indicated: format YYYYMMDD (102) and format YYYYMMDDHHMM

(203).

XXX

DTM+191:202006260940:203'

Estimated date/time of delivery: 26 June 2020 at 09:40

M an..35 DTM

3

2005

2379

2380

191

102

203

Total net amount Total net amount of the items described in the packing slip.

XXX

MOA+79:264'

Total net amount: 264 monetary units

C n..18 MOA

5

5025

5004 79

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Element Description M/R/C Format SEG DE Qualifier

Total amount with tax

Total amount of the items described in the packing slip, including tax.

XXX

MOA+139:314'

Total amount with tax: 314 monetary units

C n..18 MOA

5

5025

5004 139

Total gross amount

Total gross amount of the items described in the packing slip.

XXX

MOA+98:284'

Total gross amount: 284 monetary units

C n..18 MOA

5

5025

5004 98

Order number Relates the dispatch advice message with the order number.

XXX

RFF+ON:12332'

Reference to order number 12332

M an..17

SG1

RFF

6

1153

1154 ON

Packing slip number

Relates the current dispatch advice message with the hard copy packing slip.

XXX

RFF+DQ:1234567'

Reference to packing slip number 1234567

M an..17

SG1

RFF

6

1153

1154 DQ

Reference date Date of the document referenced in the previous segment. The format used to specify

the date should also be indicated: format YYYYMMDD (102) and format YYYYMMDDHHMM (203).

XXX

DTM+171:20200625:102'

Date of the referenced document: 25 June 2020

R an..35

SG1

DTM

7

2005

2379

2380

171

102

203

Origin of the message

Operational location (GLN) of the issuer of the document.

XXX

NAD+MS+8456789300084::9'

The issuer of the document is Operational location 8456789300084

M n13

SG2

NAD

8

3035

3055

3039

MS

9

Destination of the message

Operational location (GLN) of the destination of the document.

XXX

NAD+MR+8480000009012::9'

The recipient of the document is Operational location (GLN) 8480000009012

M n13

SG2

NAD

8

3035

3055

3039

MR

9

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Element Description M/R/C Format SEG DE Qualifier

Supplier of the goods

Operational location (GLN) of the supplier of the goods

XXX

NAD+SU+8456789300084::9'

The supplier of the goods is Operational location (GLN) 8456789300084

M n13

SG2

NAD

8

3035

3055

3039

SU

9

Buyer Operational location (GLN) identifying the buyer.

XXX

NAD+BY+8480000009012::9'

The buyer is Operational location (GLN) 8480000009012

M n13

SG2

NAD

8

3035

3055

3039

BY

9

Recipient of the delivery

Operational location (GLN) identifying the recipient of the delivery. This is only necessary when it is different to the message recipient.

XXX

NAD+DP+8480000009012::9'

The recipient of the delivery is Operational location (GLN) 8480000009012

R n13

SG2

NAD

8

3035

3055

3039

DP

9

End user Code identifying the end user of the delivered goods.

XXX

NAD+UC+8422555120002::9'

The end user is identified by Operational location (GLN) 8422555120002

C n13

SG2

NAD

8

3035

3055

3039

UC

9

Identification of the transport provider

Identification of the transport provider. The transport provider's operational location or Fiscal ID (NIF) is noted in DE3127 and its name in DE3128.

The transport mode must also be indicated: maritime transport (10), rail transport (20), road transport (30), air transport (40) or multi-modal transport (60).

XXX

TDT+20++30++8456789000007::9:Transportes Zeta'

The transport is by road and the transport provider is identified by the

operational location 8456789000007 and the name Transportes Zeta

C an..17

SG6

TDT

14

8051

8067

3055

3128

3127

20

10

20

30

40

60

9

Name

Identification number of the dispatch

Identifies the dispatch (first grouping level). For ease of use we recommend sequential numbering.

XXX

CPS+1'

The dispatch is identified by the number 1

M an..12

SG10

CPS

15

7164

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Element Description M/R/C Format SEG DE Qualifier

Identifier of the hierarchical parent

Identifier of the hierarchical level, also indicating the hierarchical level immediately above.

XXX

CPS+2+1'

The grouping within the dispatch is identified by the number 2 (pallet) and the parent level

is grouping number 1 (dispatch)

M an..12

SG10

CPS

15

7166

Number and type of packages in the dispatch

Indicates the number of units in the dispatch and specifies the type of group in DE 7065. For example, a pallet ISO 1 (201), a half pallet ISO 0 (200), a box (BX), a CHEP plastic box (DH), a carton (CT), a shrink-wrap (SW), etc. See the list of EANCOM codes.

XXX

PAC+1++201'

The dispatch contains a pallet ISO 1

M an..8

SG11

PAC

16

7065

7224 EANCOM

Width of the grouping.

Numerical value of the width of the grouping. We recommend using millimetres (MMT) as the unit of measurement.

XXX

MEA+PD+WD+MMT:120'

The width of the grouping is 120 millimetres

C n..18

SG11

MEA

17

6311

6313

6411

6314

PD

WD

EANCOM

Height of the grouping.

Numerical value of the height of the grouping. We recommend using millimetres (MMT) as the unit of measurement.

XXX

MEA+PD+HT+MMT:340'

The height of the grouping is 340 millimetres

C n..18

SG11

MEA

17

6311

6313

6411

6314

PD

HT

EANCOM

Depth of the grouping.

Numerical value of the depth of the grouping. We recommend using millimetres (MMT) as the unit of measurement.

XXX

MEA+PD+DP+MMT:200'

The depth of the grouping is 200 millimetres

C n..18

SG11

MEA

17

6311

6313

6411

6314

PD

DP

EANCOM

Gross weight of the grouping

Gross weight of the grouping including packaging. We recommend using grams (GRM) as the unit of measurement.

XXX

MEA+PD+AAB+GRM:250'

The gross weight of the grouping is 250 grams.

C n..18

SG11

MEA

17

6311

6313

6411

6314

PD

AAB

EANCOM

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Element Description M/R/C Format SEG DE Qualifier

Handling instructions

Specifies the handling instructions for the dispatch, such as:

Foodstuffs (EAT), Pest controlling (PSC), Crushable (CRU), Outsized (BIG), Unstackable (UST), Fragile, Handle with care (HWC), Stacking restricted (STR), etc. If the code is an EANCOM code this should be indicated with a 9 in DE 3055.

XXX

HAN+HWC::9'

The item is fragile and should be handled with care

C an..3

SG12

HAN

19

3055

4079

9

EAT

PSC

CRU

BIG

UST

HWC

STR

Identification of the dispatch

This code indicates that the Serial Shipping Container Code (SSCC) will be identified.

XXX

PCI+33E'

The next segment identifies the SSCC

M an..3

SG13

PCI

20

4233 33E

SSCC code of the grouping

Serial Shipping Container Code (SSCC) uniquely identifying the individual packages being transported.

XXX

GIN+BJ+354123450000000014'

The SSCC code of the grouping is 354123450000000014

M an..3

SG14

GIN

21

7405

7402 BJ

Line sequence number

Line sequence number of the message generated by the application.

XXX

LIN+1++8412345123450:EN'

Line sequence number 1

M n..6

SG15

LIN

22

1082

Identification of the shipped item

GTIN code (EAN) of the shipped unit.

XXX

LIN+1++8412345123450:EN'

The shipped item is identified by the GTIN code (EAN) 8412345123450

M n..14

SG15

LIN

22

7143

7140 EN

Internal buyer code

Internal code of the buyer of the item

XXX

PIA+1+ABC1234:IN'

The buyer's item number: ABC1234 is also provided as

additional identification

C an..35

SG15

PIA

23

4347

7143

7140

1

IN

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Element Description M/R/C Format SEG DE Qualifier

Internal supplier code

Internal code of the supplier of the item

XXX

PIA+1+434339:SA'

The vendor's item number: 434339 is also provided as

additional identification

R an..35

SG15

PIA

23

4347

7143

7140

1

SA

Serial number Serial number of the item defined in the segment LIN

XXX

PIA+1+1234:SN'

The serial number is 1234

C an..35

SG15

PIA

23

4347

7143

7140

1

SN

Coded description of the item

Coded identification of the type of item: Consumer unit

(CU) or Dispatch unit (DU).

XXX

IMD+C++CU::9'

The item is a consumer unit

C an..3

SG15

IMD

24

7077

3055

7009

C

9

CU

DU

Minimum storage temperature

Minimum temperature at which the item should be stored

XXX

MEA+SO+TC+CEL::-4:4'

The minimum storage temperature is -4º Centigrade

C n..18

SG15

MEA

25

6311

6313

6411

6162

SO

TC

CEL

Maximum storage temperature

Maximum temperature at which the item should be stored

XXX

MEA+SO+TC+CEL::-4:4'

The maximum storage temperature is -4º Centigrade

C n..18

SG15

MEA

25

6311

6313

6411

6152

SO

TC

CEL

Quantity dispatched

Total units dispatched of the item defined in the segment LIN

When the item weight is variable the unit of

measurement should be specified. For example: grams (GRM), litres (LTR), etc.

XXX

QTY+12:400'

400 units of the item indicated in the segment LIN have been dispatched

M n..15

SG15

QTY

26

6063

6411

6060

12

GRM

LTR

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Element Description M/R/C Format SEG DE Qualifier

Number of consumer units in the unit ordered

Total consumer units contained in each unit ordered of the item indicated in the segment LIN.

XXX

QTY+59:12'

The number of units contained is 12.

R n..15

SG15

QTY

26

6063

6060 59

Net amount per line

The net amount per line of the item is the result of multiplying the net price by the quantity.

XXX

MOA+203:264'

Net amount per line: 264 monetary units

C n..18

SG15

MOA

27

5025

5004 203

Amount per line with tax

Amount per line with tax Result of multiplying the price with tax by the quantity.

XXX

MOA+388:314'

Amount per line with tax: 314 monetary units

C n..18

SG15

MOA

27

5025

5004 388

Item line number Specifies the item line number within the order.

XXX

RFF+LI:2'

The item line number is 2

R an..17

SG16

RFF

31

1153

1154 LI

Package identification

This code indicates that data relating to the item will be identified. For example, expiration

date, lot number, etc.

XXX

PCI+36E'

The supplier's instructions are shown below

C an..3

SG20

PCI

36

4233 36E

Expiration date Expiration date of the delivered item. Obligatory if the item has one.

For products where the expiration date does not have to be specified, segment DTM, DE 2379, should indicate the qualifier 609 with the 4-digit format: YYMM. This field will be interpreted as the last day of the indicated month, including the necessary adjustments for leap years (for example, “1902” is “28 February 2019”, and “2002” is “29 February 2020”)

XXX

DTM+36:20070625:102'

Expiration date: 25 June 2007

DTM+36:2002:609'

Expiration date: 29 February 2020

C an..35

SG20

DTM

37

2005

2379

2380

36

102

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Element Description M/R/C Format SEG DE Qualifier

Packaging date Packaging date of the delivered item. Obligatory if the item has one.

XXX

DTM+365:20070622:102'

Packaging date: 22 June 2007

C an..35 SG20

DTM

37

2005

2379

2380

365

102

Lot number A distinctive combination of numbers and/or letters identifying a lot or batch, so the complete history of its manufacture can be traced. Obligatory if available.

XXX

GIN+BX+98767'

The lot number is 98767

C an..3

SG21

GIN

39

7405

7402

BX

Quantity difference information

This segment is used to specify the quantity variance and reasons for variance between what was ordered and what is available, as specified in the segment QTY at the line level. For negative values the variable must be expressed as a negative.

XXX

QVR+-20:21+BP'

20 units of the original order are not available

C n..15

SG23

QVR

40

6063

6064

21

Reason for the discrepancy

This field is used to specify the reason for the discrepancy in quantities. The options are: item withdrawn by the wholesaler (AA), item no longer made (AB), item out of stock at the factory (AD), partial delivery which will be followed by a back order (BP), partial delivery considered complete without the back order (CP), item out of stock due to act of god (OS), item out of stock at the wholesaler (OW) and item temporarily unavailable at the wholesaler (TW).

XXX

QVR+-20:21+BP'

There will be a partial delivery followed by a back order

C an..3

SG23

QVR

40

4221 AA

AB

AD

BP

CP

OS

OW

TW

Change reason code

This field specifies the reason for the change. The possible values are: adjustment (AJT), item code unknown (AUE - EANCOM code), out of stock (AV), alternative quantity and unit of measurement (AQ), the order is a substitution for the original order (IS), difference in package (PC), difference in unit of measurement (UM) and the requested quantity is not as agreed (WV). Also, when the code is an EANCOM code this should be indicated with a 9 in DE3055.

XXX

QVR+-20:21++AUE::9'

The code for the requested item is unknown

C an..3

SG23

QVR

40

3055

4295

9

AJT

AUE

AV

AQ

IS

PC

UM

WV

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Element Description M/R/C Format SEG DE Qualifier

Number of segments

Indicates the number of segments in the message. As well as the DE 0062, the message reference number is stated.

XXX

UNT+23+ME000001'

The message ME000001 has 23 segments

M n..6 UNT

43

0062

0074 Ref. men.

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5.1.3 Example Logistics DESADV message (with SSCC)

The following schema explains the scenario corresponding to the DESADV message described below. This is a dispatch advice message from a Supplier (GLN 8410738000104) sending 2 Pallets to the customer (GLN 8434587000009):

■ Pallet 1 (SSCC: 384107380000000006)

□ 2 Boxes of GTIN 18410738000033 (SSCC1: 384107380000000020 and SSCC2: 384107380000000037)

- GTIN of the contained item: 8410738000036

□ 3 Boxes of GTIN 18410738000040 (SSCC3: 384107380000000044, SSCC4:

384107380000000051 and SSCC5: 384107380000000068)

- GTIN of the contained item: 8410738000043

□ Mixed Box 3 (SSCC6: 384107380000000075)

- 10 items of GTIN 8410738000005

- 15 items of GTIN 8410738000012

■ Pallet 2 (SSCC: 384107380000000013)

□ 3 Boxes of GTIN 18410738000026 (SSCC3: 384107380000000082, SSCC4:

384107380000000099 and SSCC5: 384107380000000105)

- GTIN of the contained item: 8410738000029

Scenario 1. Dispatch relating to the example Logistic DESADV message

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UNH+ME000001+DESADV:D:96A:UN:EAN005' Message header

BGM+351+CM587441+9' Dispatch advice number CM587441

DTM+137:20200401:102' Message date 1 April 2020

DTM+191:20200403:102' Scheduled delivery date 3 April 2020

RFF+ON:12332' Dispatch relating to the order number 12332

DTM+171:20200325:102' Order date 25 March 2020

RFF+DQ:AL1234' Number of the hard copy delivery slip is AL1234 CPS+1' First CPS, indicating the Dispatch; without parent

level. PAC+2++201' Number of packages = 2 pallets ISO 1

CPS+2+1' Second CPS, indicating the first Pallet; Parent = Dispatch

PAC+1++201' Pallet type ISO 1

PCI+33E' Marked with SSCC GIN+BJ+384107380000000006' SSCC of the first Pallet

CPS+3+2' Third CPS, indicating the boxes contained in the first pallet; 6 boxes; Parent = Pallet 1

PAC+6++CT' The Pallet contains 6 boxes

LIN+1++18410738000033:EN' First line. GTIN of the Box

PIA+1+8410738000036:EN’ GTIN of the contained consumer unit

QTY+12:2' Quantity dispatched: 2 Boxes

PCI+17’ Items marked with Lot No.

GIN+BX+93TG306’ Lot no.

PCI+33E' Identified by SSCC

GIN+BJ+384107380000000020: 384107380000000037'

SSCCs of the two Boxes with GTIN 18410738000033

LIN+2++18410738000040:EN' Second line. GTIN of the Box QTY+12:3' Quantity dispatched: 2 Boxes

PCI+33E' Identified by SSCC

GIN+BJ+384107380000000044: 384107380000000068'

SSCCs of the two Boxes with GTIN

18410738000040

CPS+4+2’ Fourth CPS, indicating the Mixed Box; Parent = Pallet 1

PAC+25+PA’ The Mixed Box contains 25 consumer units.

PCI+33E' Marked with SSCC GIN+BJ+384107380000000075’ SSCC of the Mixed Box

LIN+3++8410738000005:EN’ Third line. GTIN of the consumer unit QTY+12:10' Quantity dispatched: 10 consumer units LIN+4++8410738000015:EN’ Fourth line. GTIN of the consumer unit QTY+12:15' Quantity dispatched: 15 consumer units

CPS+5+1' Fifth CPS, indicating the second Pallet; Parent = Dispatch

PAC+1++201' Pallet type ISO 1

PCI+33E' Marked with SSCC GIN+BJ+384107380000000013' SSCC of the first Pallet

CPS+6+5' Sixth CPS, indicating the boxes contained in the second pallet; Parent = Pallet 2

PAC+3++201' The Pallet contains 3 boxes

LIN+5++18410738000026:EN' Fifth line. GTIN of the Box PIA+1+8410738000029:EN’ GTIN of the contained consumer unit

QTY+12:3' Quantity dispatched: 3 Boxes

PCI+33E' Identified by SSCC

GIN+BJ+384107380000000082: 384107380000000105'

SSCCs of the two Boxes with GTIN 18410738000026

UNT+44+ME000001’ Total of 44 segments in the message

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A.1 Glossary

GS1 term Description

DESADV Dispatch Advice. EDI message corresponding to the electronic delivery slip.

EDI Electronic Data Interchange. Standard electronic data interchange (EANCOM®) between commercial agents.

GS1 New nomenclature for the organisations EAN International / UCC.

GS1-128 Standard symbols, part of Code-128, used exclusively to symbolise data structures according to the GS1 standard.

GS1-DataMatrix 2-dimensional symbols consisting of cells in a print frame, according to the specifications of the GS1 identification system.

GTIN Global Trade Identification Number. Unique, universal and unambiguous numbers for identifying

any trade item.

Application Identifier (AI) Numeric prefixes created to give an unequivocal meaning to the standardised data elements found in a GS1 128 or GS1-DataMatrix.

Primary packaging material First level of packaging of a product. This may refer to a sales unit for retail pharmacy, or if it holds more than one dose, it may refer to a lower level.

Secondary packaging material Higher grouping level than the Primary packaging

material, of which it contains one or more units.

Root / Company Code Part of the GS1 identification system, which lets GS1 member companies assign unique identification codes.

SSCC Serial Shipping Container Code. Registration number assigned to the dispatched logistic unit.

Consumer unit Refers to the item unit considered individually in use by or for patients

Order unit Commercial presentation format in which the purchased product is available on the market and is provided by the supplier

Sales unit in Retail Pharmacy Product presentation format dispensed to patients in retail pharmacies.