Identification and Barcoding
of Medicinal Products
for Human Use
1. Objective and Scope
JFDA adopted the following instructions for the purpose of improving Jordan
healthcare supply chain efficiency, inventory management , combat
counterfeiting as well as cost savings by means of capture technology,
electronic storage and transmission of data.
All stakeholders need to work to commonly agreed standards if the benefits
are to be realized fully. Using GS1 Standards and bar code requirements at
various levels of product packaging.
This will also help Jordan Healthcare sector to develop their investment
strategy to be complied with global healthcare new developments and to build
the infrastructure that is adequate with new modern technologies this will lead
to improve Patient safety and reduce costs.
MOH & JFDA are working to build their Databases in order to enable drug
verification and control stock management as well as to control and manage
prices of pharmaceutical products.
© 2011 GS1
Benefits
AIDC systems use globally unique Identifiers encoded within specific
bar code symbols to identify all the items involved in healthcare: the
improvements seen are the result of fewer medication errors and
enhanced record keeping. Using unique identifiers such as GS1 "Keys"
to manage supplies and purchase electronically can cut costs
dramatically as well as improve efficiency. Unique identifiers encoded in
machine readable bar code symbols provide the means to differentiate
all the items involved in the healthcare supply chain. This ability, when
linked with providing an item’s batch number or serial number together
with its expiry date, enables the traceability of all healthcare products
from production to delivery to the patient (point-of-care).
© 2011 GS1
2. Definitions
Healthcare Primary Packaging
The first level of packaging for the product marked with an AIDC data carrier either on the
packaging or on a label affixed to the packaging. For non-sterile packaging, the first level of
packaging can be the packaging in direct contact with the product. For sterile packaging, the first
level of packaging can be any combination of the sterile packaging system, May consist of a single
item or group of items for a single therapy such as a Kit. For packaging configurations that include a
retail consumer trade item, primary packaging is a packaging level below the retail consumer trade
item.
Healthcare Secondary Packaging
Healthcare Secondary Packaging is defined as a level of packaging that may contain one or more
primary packages or a group of primary packages containing a single item. A secondary package can
for example be a box containing one or more tubes, bottles of pills, blister packs or similar products.
Case / Shipper
These are packaging configurations that may be used as either trade items or logistic units. Case /
shippers may contain one or more items in their Primary Packaging and/or Secondary Packaging.
Pallets may contain one or more case / Shippers.
© 2011 GS1
3. Identification of Products (Mandatory)
a) GTINs (Global Trade Item Numbers): The GTIN is the GS1 Identification "Key" used to uniquely identify each
product type/variant. It is a number composed of at most 14 digits used to uniquely identify products on a global
scale. GTIN is allocated by Jordan Numbering Association (GS1 Jordan).
Generation of GTINs:
Please Note: - The company prefix number in this manual is only an example. The supplying company has to use the
company prefix number issued by GS1 Jordan or any other GS1 member organizations in other countries.
GTIN -13:
Data structure and format of GTIN-13
GS1 Company Prefix
N1 N2 N3 N4
N5
> < Item Reference
N6 N7 N8 N9
N10
N11
N12
Check Digit
N13
1) The company prefix number allocated by GS1 Jordan to your company
2) Item reference number (Variable length dependent on length of company prefix number allocated)
3) Check Digit
Example:
Check
GS1 Company Prefix > < Item Reference
Digit
6 2 5 1 2 3 4 5 0 0 0 1
7
In this example, we have
•Used company prefix number “62512345”
•Assigned item reference number “0001”
•Calculated Check Digit “ 7”
© 2011 GS1
Identification of Products (Mandatory)
GTIN -12:
Data structure and format (GTIN – 12):
1) Company prefix number allocated by GS1 Jordan on registration
2) Item reference number (Variable length dependent on length of company prefix number allocated)
3) Check Digit
Check
GS1 Company Prefix > < Item Reference
Digit
N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11
N12
GTIN -8:
The structure of GTIN – 8:
All GTIN 8 product codes are always allocated by GS1 Jordan.
N1
N2
N3
GS1 Item Reference
N4
N5
N6
N7
Check Digit
N8
Example:
GS1 Item Reference
6
© 2011 GS1
2
5
0
0
0
Check Digit
1
2
Identification of Products (Mandatory)
GTIN-14:
Data structure and format (GTIN – 14):
Indicator
Digit
N1
N2
N3
Check
GS1 Company Prefix
> < Item Reference
Digit
N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14
•In this example we have generated GTIN-14 from GTIN-13. GTIN-14 can also be generated from GTIN-13,
GTIN-12 & GTIN-8. Please refer to GS1 General Specifications on the use of indicator digit in healthcare.
1) The company prefix number allocated by GS1 Jordan.
2) Item reference number (Variable length, dependent on length of company prefix number allocated)
3) Check Digit
Example: Using the company prefix “62512345”
Indicator
Digit
0
Company Prefix Code
6
2
5
1
2
3
> <
4
5
Item Reference Check
Digit
0 0 0 1
7
In this example
•Use “0” as Indicator Digit* to generate GTIN-14 from a GTIN-13
•GS1 company prefix number is “62512345”
• Item reference number “ 0001”
•Check Digit. This uses the previous 13 digits as per pre-defined algorithm, to calculate the fourteenth digit
i.e. the check digit. In this example “7”.
© 2011 GS1
Attributes
GS1 Application Identifiers are a finite set of defined identifiers used to connect physical things
and logical things to information or business messages related to them. The definitions for them
reside in a standard called the GS1 General Specifications.
b) Application Identifiers (AIs) - for Additional Information
Following are examples of Application Identifiers (AIs) that are used in the Healthcare,
there are over 100 GS1 AIs in total.
- Application Identifier – AI (10) – Batch/Lot number:
Example: (10) ABC1234
- Application Identifier – AI (17) - Expiration date:
Example: (17) 010113 : 01January 2013
Application Identifier – AI (21) - Serial number:
Example: (21) 11005566SN
- Application Identifier – AI (7004) - Active Potency
- Application Identifier – AI (8008) - Date and Time of Production:
Example: (8008) 130113081520 - 13th January 2013 time 08.15.20
© 2011 GS1
4. Procedures
I.
© 2011 GS1
Healthcare Primary Packaging (Optional )
The first level of packaging with bar code application will be
implemented according to the developments in local and
global market.
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Procedures
II.
Healthcare Secondary Packaging
a) Identify Healthcare Secondary Packaging by GTIN only (Mandatory)
Any of the following GS1 bar code symbologies (EAN-13, EAN-8, UPC-A, UPC-E) can
be used, this is mandatory for Secondary items that are sold at Retail POS.
EAN-13
EAN-8
© 2011 GS1
UPC-A
UPC-E
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Procedures
II.
Healthcare Secondary Packaging
b) Using Additional Information with GTIN on Healthcare Secondary Packaging (Optional)
Any of the following GS1 bar code symbologies (GS1-128, GS1 DataMatrix, GS1 DataBar ) can be used
to encode the GTIN and the example additional data shown in bar code symbols at Secondary level
packaging:GS1 DataBar
GS1 DataMatrix
GS1-128
(17)010115(10) abc234
(01)0625123450011
(17)010115(10) abc2345
(01)06251234560011
1) Unique Product identification code (GTIN-14 of secondary pack) using application identifier (01)
2) Expiry Date in YYMMDD format using application identifier (17)
3) Batch/Lot Number using application identifier (10)
4) Serial No using application identifier (21)
5) Note that different combinations of the above can be used as needed.
Note: Each packaging level should have a different GTIN assigned per the GTIN Allocation Rules. For
details refer to GS1 General Specification and the GS1 Healthcare GTIN Allocation Rules.
© 2011 GS1
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Procedures
II. Healthcare Secondary Packaging
GS1 DataMatrix (two dimensional) symbology is the preferred option.
GS1 DataMatrix symbology can encode product data in much smaller space than what is
possible with one dimensional bar code symbology. This is an important consideration in
healthcare sector due to very limited availability of printing space on product packaging,
after complying with other statutory labeling & marking requirements.
JFDA mandates the implementation of Data Matrix in Jordan for all pharmaceutical products on
Secondary Packaging in 2017.
© 2011 GS1
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Procedures
III. Cases/Shipper (Optional )
a) Case / Shipper must be identified by GTIN, the following bar code Symbologies (GS1-128
or GS1 DataMatrix) with Application Identifier (01) should be used to encode a GTIN-13,
GTIN-12, GTIN-8, GTIN-14.
Additional Information can be used as needed, such as:
1) Serial No using application identifier (21)
2) Batch/Lot Number using application identifier (10)
3) Expiry Date in YYMMDD format using application identifier (17)
Example of GS1 bar code symbologies (GS1-128, GS1 DataMatrix)
GS1-128
GS1 DataMatrix
(01)06251234500024
(21)ABC205001
© 2011 GS1
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Procedures
b) If logistic unit:
1- the requirements for the orderable trade item (homogeneous pack) as follows:
- To generate the first barcode, GS1-128 and GS1 Data Matrix symbologies can be used with Product
Identification (Unique GTIN-14 of Shipper pack) using application identifier (01)
- Other additional information can be used such as Serial Number, Batch Number, Expiry date.
- The second bar code: Serial Shipping Container Code(SSCC) must be used to identify
individual carton uniquely using application identifier (00) that requires GS1-128.
(Single Label for each shipper)
Note: Each packaging level should have a different GTIN assigned per the GTIN Allocation Rules. For details
refer
©
2011 to
GS1GS1 General Specification and the GS1 Healthcare GTIN Allocation Rules.
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Procedures
2) The requirements for the logistics unit (heterogeneous pack):
If multiple items are packed in a shipper (heterogeneous pack), and / or the shipper level
packaging is not an orderable unit, only second bar code should be present (i.e. SSCC ).
Human readable information on the label will be as per existing statutory labeling & marking
requirements.
Schematic example of GS1-128 symbology for the logistics unit (heterogeneous pack) encoding above
stated data at Case / Shipper is as below:
SSCC (Serial Shipping Container Code) to identify individual carton uniquely using application
identifier (00)
© 2011 GS1
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5. General Notes
•
JFDA however reserves the right to modify the implementation of level of AIDC
marking in future according to the market requirements.
•
Complete details on GS1 standards along with technical guidelines can be
downloaded from (www.gs1jo.org.jo) or (www.gs1.org)
•
For any assistance, you can contact GS1 Jordan at 009626 562003 email –
info@gs1jo.org.jo
© 2011 GS1
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