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Saturday, December 10, 2011

PHARMA INDUSTRY GUIDLINES FOR BARCODE IN INDIA,


Complying with barcoding reqmts of DGFT and Min. of Health, Govt. of India


Summary of DGFT requirements

Packaging level
Barcoding requirements
Timeline
Tertiary level–definition
Comprises highest level of packaging containing secondary and other intermediate packages meant for transport/logistics(cartons/pallets/shipments)
Incorporation of barcodes (1D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton).
Phase 1 –by
1stOct 2011
Secondary level–definition
Packaging level containing primary level packages.
Incorporation of barcodes (1Dor2D) encoding unique product identification code (GTIN), Batch Number, Expiry date and Unique Serial Number of the secondary pack.
Phase 2 –by
1stJan 2012
Primary level–definition
Comprises first level of packaging indirect contact with the product e.g. medicine strip, vial, single therapy kit, or items packed in mono carton for sale to consumers.
Incorporation of2D (GS1DataMatrix) barcodes on medicines at strip/vial/bottle encoding unique product identification code Global Trade Identification Number (GTIN) and Unique Serial Number of the primary pack.
Phase 3 –by
1stJuly 2012





Packaging level

Barcoding  requirements

Timelines

Secondary

GTIN only

Phase 1 –by
1stOct 2011

Secondary

GTIN + Expiry Date + Batch No.

Tertiary

1stBarcode : GTIN + Expiry Date + Batch No.
2ndBarcode : SSCC

      Summary of Min of Health, Govt. of India requirements                           Phase 1

Phase 2


Primary

GTIN + Serial No.

Phase 2 –by
1stApril 2012

Secondary

GTIN + Expiry date + Batch No. + Serial No.

Tertiary

1st Barcode : GTIN + Expiry Date + Batch No.
2ndBarcode : SSCC





Procedure for generation of GTIN as per DGFT and Min of Health, Govt. of India requirements



·       Obtain GS1 Company Prefix (GCP) through registration with GS1India. For registration procedure, logon to: http://www.gs1india.org/Support/Get Registered
·       Use GCP to generate GTIN as per steps below:
·       Assign item reference number of applicant company’s choice to each product type/variant
·       Calculate check digit using online Check Digit Calculator available at the URL http://www.gs1india.org.in/calculater.aspx
·       Generate GTIN using GCP, item reference number and check digit. Find more about how to generate GTIN at the URL
·       http://www.gs1india.org.in/gs1barcodes/number_development_guide.htm




Implementing barcodes at primary level as per DGFT and Min of Health, Govt. of India reqmnts

Generate GTIN-14 for primary pack.

a)    GTIN (Global Trade Item Number) is the GS1 identification key used to uniquely identify each product type/variant.

b)    GTIN-14 is generated from GTIN-13,using prefix of “0” to convert to14digitcode.

c)Generating GTIN-13

                                          GTIN-13 structure (e.g.8901107000011)
                                                       
                                                        8901107                   00001              1
                                                  
                                                       Company                 ItemRef.        Check
                                                  
                                                         Prefix No.                   No.               digit

8901107-Company prefix no. allocated by GS1India
00001- item Ref.No. allocated for each product type/variant/SKU by manufacturer/brand owner
1-     check digit calculated based on preceding digits(calculator availableatwww.gs1india.org)


d) Generating GTIN-14from GTIN-13 by prefixing “0”

                                         GTIN-14 structure (from GTIN-13 illustrated above)

                                                                     0 8901107000011


GTIN-14structure evolved out of GTIN-13 structure as above










Encoding product information in 2D (GS1 DataMatrix) barcode symbology as per DGFT reqmnts for primary level

UseGS1generalspecsavailableat:


                               Schematic representation of GS1
                                      DataMatrix at primary level
                                                   

                                       (01)08901107000011(21)abcd12345




(01)

Application Identifier to be prefixed to indicate GTIN information which follows it

08901107000011

GTIN-14 of the primary pack

(21)

Application Identifier to be prefixed to indicate serial number of primary pack.

Abcd12345

Serial no. of primary pack. Serial number should be alpha-numeric up till 20 digits.











                  Implementation as per DGFT mandate –Secondary Pack

Unique identification of secondary pack.


·         GTIN using application identifier (01)
·         Expiry Date in YYMMDD format using application identifier (17)
·         Batch/Lot Number using application identifier (10)
·         Serial No. of the secondary package using application identifier (21) Points to be noted:
·         GTIN of secondary level packaging should be different from GTIN of primary and shipper package.
·         The above barcoding requirements shall be in addition to existing statutory labeling & marking requirements.
·         The parentheses (brackets) are not encoded in the barcode and they are represented in human readable form only for highlighting the application identifier number within the brackets.
·         Fixed length data fields will always precede variable length fields.
·         It is mandatory to print data encoded in barcodes as human readable information.
·         In case the importing country has mandated a specific requirement, the exporter can adhere to the same and it would not be necessary to comply with the above requirement



                    
                       






                      Implementation as per DGFT mandate –secondary Pack
Generation of (GTIN)
Refer to steps mentioned in the previous slides on implementation at primary pack
Encoding of GTIN, Expiry Date, Batch number and serial number
GS1 DataMatrix(2D):
       
(01)08901107000028 (17)090400
(10)ab12345 (21)mnop09876                                OR
GS1-128 barcode symbology(1D):                                                                                                                                                                                                                                                                                               
Not more than 48 characters can been coded inasingleGS1–128barcode.If the total number of character sexceeds48,it should be split in two barcode sonasingle label.

Note: Suppliers may chose either 2D or 1D symbology
as illustrated below:





(01)
The Application Identifier to indicate that the data following it is the  GTIN
08901107000028
GTIN
(17)
The Application Identifier to indicate that the data following it is the expiration date of
 the product in YYMMDD format.
090400
The expiration date of the product in YYMMDD format(April2009inthiscase)
(10)
The Application Identifier to indicate that the data following it is batch or lot number of
product.
ab12345
The batch/lot number of the product
(21)
The Application Identifier to indicate that the data following it is the serial number of the product which should be alpha-numeric and of variable length field varying from1to20digits
mnop09876
The serial no. of secondary package.
















Implementation as per DGFT mandate -at carton/shipper level
Allocation of Serial Shipping Container Code(SSCC)
SSCC Is used for the unique identification of each Shipper/Carton/Tertiary level package as a logistic unit.


Steps to generate, SSCC (18 digits shipper identification code):-
Assign the Extension digit ranging from 0-9 to increase the capacity of the Serial Reference within the SSCC  
Use GCP issued by GS1 India or any other GS1 member organizations in other countries
Generated unique serial reference number to identify each Shipper/Carton/Tertiary level package..
Calculate check digit using online Check Digit Calculator available at http://www.gs1india.org.in/calculateeer.aspx











Implementation at carton/shipper level -Homogeneous pack
Homogeneous Packs contain same type of secondary packs
Requirement for homogeneous packs
Two GS1-128 barcodes The first barcode contains:                 
Product Identification code (Unique GTIN- 14 product code of the Shipper/Carton/Tertiary level packaging) using application identifier (01)
Expiry Date in YYMMDD format using application identifier (17)
Batch/Lot Number using application identifier (10)
 The second barcode:
SSCC to identify individual Shipper/Carton/Tertiary level packaging uniquely using application identifier (00)

Note: GTIN of shipper level packaging should be different from GTIN of primary and secondary package. Refer to steps mentioned in the ‘Implementation at primary pack’ section for generation of GTIN in 14 digit format.


(01)
The Application Identifier to indicate that the data following it is the GTIN-14 data format.
08901107000035
The GTIN of Shipper/Carton/Tertiary level packaging.
(17)
The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format.
090400
The expiration date of the product in YYMMDD format(April2009thiscase)
(10)
The Application Identifier to indicate that the data following it is batch or lot number of the product.
ab12345
The batch/lot number of the product.
The second barcode represents:
(00)
The Application Identifier to indicate that the data following it is the numeric serial number of the Shipper/Carton/Tertiary level packaging.
189011070000000018
The18digit numeric serial no. of the Shipper/Carton/Tertiary level packaging.





Implementation as per DGFT: carton/shipper level-Heterogeneous pack

Homogeneous Packs contain different types of secondary packs
Requirement for homogeneous packs
A GS1-128 barcode encoding
SSCC (Serial Shipping Container Code) to
Identify individual Shipper/Carton/Tertiary
Level packaging uniquely using application
identifier(00)
                                                                                                                                                                       

In the above example

(00)
Is the Application Identifier to indicate that the data following it is the numeric serial number of the Shipper/Carton/Tertiary level packaging.
189011070000000018
Is the 18 digit numeric serial no. of the Shipper/Carton/Tertiary level packaging.












Points to be noted



      Allocate different GTIN for different pack level, i.e.-primary , secondary and           shipper package.
        The above barcoding requirements shall be in addition to existing statutory labeling & marking requirements.
       The parentheses (brackets) are not encoded in the barcode and they are represented in human readable form only for highlighting the application identifier number with in the brackets.
       Fixed length data fields will always precede variable length fields.
       It is mandatory to print data encoded in barcodes as human readable information.
      In case the importing country has mandated a specific requirement, the exporter can adhere to the same and it would not be necessary to comply with the above requirement.


                       











Summary of MoHFW Mandate
Phase I

Packaging level
Requirements
Timeline
Primary:
The first level of packaging indirect contact with the product.
Example: a single item such as a medicine strip, a vial etc or group of items for a single therapy such as a Kit.
Incorporation of GS1 barcodes encoding unique product identification code, i.e.-Global Trade Identification Number (GTIN).
(Phase1)– 1st October 2011 onwards
Secondary:
A group of primary packages containing a single item.
Incorporation of barcodes (GS1–128 i. e .1D or GS1 Data Matrix i .e.2D) encoding unique product identification code (GTIN), Expiry Date ,Batch Number
(Phase1)–1stOctober2011onwards
Tertiary:
Shipper/Carton level packaging meant for transport & logistics purpose
Incorporation of GS1-  128 barcode symbology (1D) encoding GTIN of the Shipper/Carton/Tertiary level packaging package, expiry date, batch number of the product and Serial Shipping containers code (SSCC) of the Shipper/Carton/Tertiary level packaging
(Phase1)–1stOctober2011onwards
Primary & Secondary
Serial isation through the (check previous presentation)
(Phase2)–Not yet decided


Note: There may be additional intermediate packaging levels between secondary and Shipper/Carton/Tertiary level packaging. These intermediate packaging levels are not required to be barcode at this time. Examples of these exclusions include:
•Inner packs (bundles)
•Intermediate packs (inner case).


                                                                     










Implementation as per MoHFW mandate –
                         Primary pack

    Get registered with GS1 India to obtain your GS1 Company Prefix (GCP)
   Generate unique GTIN in 14 digit format using your GS1 Company Prefix (GCP) as per the procedure explained in the DGFT section if you are using GS1 Data Matrix.
OR
      GTIN-13 format can been coded as EAN-13 barcode
Encode data in suitable GS1 barcodes (1D: EAN-13,2D:GS1DataMatrix)





GS1 Data Matrix symbology encoding GTIN-14 using
Application Identifier (01)
                        EAN- 13 barcode encoding GTIN-13
                                                                                                                               
                                                                                               
Acceptable till 31stMarch,2012

                                                










Implementation at secondary pack level

Generation of (GTIN) at Secondary Level Packaging:
Refer to steps mentioned in the Implementation at primary pack section’ for generation of GTIN and in 14 digit format
Encoding of GTIN, Expiry Date, Batch number and serial number
A)      In GS1 Data Matrix (2D):
(01)08901107000028 (17)090400(10)ab12345

Not more than 48 characters can be encoded
In a single GS1–128 barcode. If the total number of characters exceeds 48, it should be split in two barcodes on a single label.

B)       In GS1-128 barcode symbology (1D):
                  

(01)
The Application Identifier to indicate that the data following it is the GTIN
08901107000028
GTIN
(17)
The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format
090400
The expiration date of the product in YYMMDD format (April 2009 in this case)
(10)
The Application Identifier to indicate that the data following it is batch or lot number of product.
ab12345
The batch/lot number of the product














Implementation at carton/shipper level
Allocation of Serial Shipping Container Code (SSCC)
SSCC is used for the unique identification of each Shipper/Carton/ Tertiary level package as a logistic unit.






Steps to generate, SSCC (18 digits shipper identification code):-
      Assign the Extension digit ranging from0-9 to increase the capacity of the Serial Reference within the SSCC
      Use GCP issued by GS1 India or any other GS1 member organizations in other countries
      Generated unique serial reference number to identify each Shipper/Carton/Tertiary level package.
      Calculate check digit using on line Check Digit Calculator available at http://www.gs1india.org.in/calculater.aspx





Implementation at carton/shipper level-Homogeneous pack
Homogeneous Packs contain same type of secondary packs Requirement for homogeneous packs Two GS1-128 barcodes The first barcode contains:
        Product Identification code (UniqueGTIN-14 product code of the Shipper/Carton/Tertiary level packaging) using application identifier (01)
        Expiry Date in YYMMDD format using application identifier (17)
        Batch/Lot Number using application identifier (10)
The second barcode:
•SSCC to identify individual Shipper/Carton/Tertiary level packaging uniquely using application identifier (00)

Note: GTIN of shipper level packaging should be different from GTIN of primary and secondary package. Refer to steps mentioned in the Implementation at primary pack’ section for generation of GTIN in 14 digit format

(01)
The Application Identifier to indicate that the data following it is the GTIN-14 data format
08901107000035
The GTIN of Shipper/Carton/Tertiary level packaging.
(17)
The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format
090400
The expiration date of the product in YYMMDD format (April2009thiscase)
(10)
The Application Identifier to indicate that the data following it is batch or lot number of the product.
ab12345
The batch/lot number of the product.
The second barcode represents:
(00)
TheApplicationIdentifiertoindicatethatthedatafollowingitisthenumericserialnumberoftheShipper/Carton/Tertiarylevelpackaging.
189011070000000018
The18digitnumericserialno.oftheShipper/Carton/Tertiarylevelpackaging.



Implementation at carton/shipper level-Heterogeneous pack
Homogeneous Packs contain different types of secondary packs

Requirement for homogeneous packs
A GS1-128 barcode encoding     
      SSCC (Serial Shipping Container Code) to identify individual Shipper/Carton/Tertiary level packaging uniquely using application identifier (00)



In the above example

 (00)
Is the Application Identifier to indicate that the data following it is the numeric serial number of the Shipper/Carton/Tertiary level packaging.
189011070000000018
Is the 18 digit numeric serial no. of the Shipper/Carton/Tertiary level packaging.




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