Complying with barcoding

Transcription

1 Complying with barcoding requirements of DGFT

2 GS1 India indicates India as country of origin GS1 India is a Standards based not-for-profit organisation set up by the Ministry of Commerce, Govt. of India with Board members comprising: Ministry of Commerce CII FICCI ASSOCHAM FIEO Spices Board BIS IMC IIP APEDA Representations from all Industries Affiliated to GS1 Global Office, based in Brussels, Belgium overseeing operations of over 100 GS1 organisations worldwide.

3 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 1 st Oct 2011 Secondary level definition Packaging level containing primary level packages. There can be more then one secondary level in a packaging hierarchy Incorporation of barcodes (1D or 2D) encoding unique product identification code (GTIN), Batch Number, Expiry date and Unique Serial Number on the secondary pack. Phase 2 by 1 st July 2012 Primary level definition Comprises first level of packaging in direct contact with the product e.g. medicine strip, vial, single therapy kit, or items packed in mono carton for sale to consumers. Incorporation of 2D (GS1 DataMatrix) barcodes on medicines at strip/vial/bottle etc encoding unique product identification code Global Trade Identification Number(GTIN) and Unique Serial Number on the primary pack. Phase 3 by 1 st January 2013

4 Procedure for generation of GTIN as per DGFT GS1 company prefix (GCP) is the unique number issued by GS1 organisation (In India it will be issued by GS1 India) to each subscriber applying for the same. GCP is used to generate GS1 identification keys including Global Trade Item Number(GTIN), Serial Shipping Container Code(SSCC), etc. For registration procedure of GCP, log on to: Use GCP to generate GTINs as per steps in subsequent slides. GTIN (Global Trade Item Number) is the GS1 identification key used to uniquely identify each product type/variant and its packaging configuration. It has tobeassignedbythebrandowner.dgfthasmandatedgtin14tobeusedatallpackaginglevels. GTIN has to be different for packaging variants of same product and also for different packaging levels.

5 Implementing barcodes at primary level Generate GTIN for primary pack. a) Generating GTIN-14 N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14 N1: Package level indicator. It can vary from 1 to 8 N2 N13 : GS1 company prefix + item reference no. N14 : Check digit calculated based on preceding digits Company prefix no. allocated by GS1 India Item Ref. No. allocated for each product type/variant/sku by manufacturer/brand owner 1 - Check digit (calculator available at b) In case GTIN 13 is already there on the pack, then it can be converted to GTIN 14 by adding 0 as the preceding digit.

6 Generation of SSCC SSCC(18 digits shipper identification code) is used for the unique identification of each Tertiary/ logistic level package. Steps to generate, SSCC:- Extension digit can be any number ranging from 0-9. It provides flexibility to increase the serialisation capacity of the Serial Reference within the SSCC. With each extension digit, you can generate a fresh set of serial reference numbers. Use GCP issued by GS1 India or any other GS1 member organizations in other countries Generated unique serial reference number to identify each Tertiary/logistic level package. Calculate check digit using online Check Digit Calculator available at Example:- 8

7 GS1 Application Identifiers GS1 application identifiers (AI s) are used to identify the type / structure of the data following it. Over 100 AI s are available as a part of GS1 standards. Some of these related to healthcare sector are as below:- 00 SSCC (Serial Shipping Container Code) 01 GTIN (Global Trade Item Number) 10 Lot / Batch 17 Expiry Date 21 Serial Number

8 GS1 Application Identifiers capturing info beyond the identification key Item identifier Expiry date (01) (17) (10)ab12345 (21)mnop09876 Batch number Serial number Note : it is mandatory to write information in human readable form along with the barcode The same is required to do manual processing if the barcode is not getting scanned due to wear and tear. 8

9 Data structure of additional information to be encoded along with GTIN in a barcode Date of expiry : YYMMDD YY: year of expiry MM: Month of expiry DD: Date of expiry Note : If expiry for any drug is denoted by year and month then in date format, DD is required to be written as 00. Batch no. and serial no.: It is a variable structure format ranging from 1 to 20 Batch no. and serial no.: It is a variable structure format ranging from 1 to 20 Characters which can be alphanumeric. X1 variable length X20

10 Homogeneous / Heterogeneous Packs at Tertiary Level Homogeneous:-Only one type of item inside the tertiary level pack. For the same item, if there are multiple batches then it is not homogeneous. Heterogeneous:-More than one type of items inside the tertiary level Heterogeneous:-More than one type of items inside the tertiary level pack.

11 Implementation at tertiary/logistic level - Homogeneous pack Homogeneous Packs contain same type of secondary packs Requirement for homogeneous packs GS1-128 is a linear barcode symbology used to represent GTIN along with additional information like expiry date, batch no. using application identifiers. 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. (01) The Application Identifier to indicate that the data following it is the GTIN-14 data format 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 The expiration date of the product in YYMMDD format (April 2009 this case) (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 The 18 digit numeric serial no. of the Shipper/Carton/Tertiary level packaging.

12 Implementation as per DGFT: tertiary/logistic level-heterogeneous pack Hetrogeneous Packs contain different types of secondary packs Requirement for Hetrogeneous 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. Is the 18 digit numeric serial no. of the Shipper/Carton/Tertiary level packaging.

13 requirementsmnts secondary Pack Encoding of GTIN, Expiry Date, Batch number and serial number GS1 DataMatrix (2D): is a 2d barcode symbology used to encode GTIN along with additional information like expiry date, batch no., serial no. using application identifiers GS1-128 barcode symbology(1d): (01) (17) (10)ab12345 (21)mnop09876 OR Note: Suppliers may chose either 2D or 1D symbology as illustrated below 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. (01) The Application Identifier to indicate that the data following it is the GTIN GTIN (17) The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format 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 (21) mnop09876 The batch / lot number of the product 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 from 1 to 20 digits The serial no. of secondary package

14 Implementation as per DGFT mandate reqmnts - primary pack Schematic representation of GS1 DataMatrix at primary level (01) (21)abcd12345 (01) Application Identifier to be prefixed to indicate GTIN information which follows it GTIN-14 of the primary pack (21) Abcd12345 Application Identifier to be prefixed to indicate serial number of primary pack. Serial no. of primary pack. Serial number should be alphanumeric up till 20 digits. In case if pack size is very small in case of ampules and vials to accommodate a barcode, then information in humanreadableformisnecessarytobeprintedonthelabeloftheprimarypack. Use GS1 general specs available at: for technical details on GS1 DataMatrix symbology.

15 Points to be noted Each packaging level, i.e.- primary, secondary and tertiary requires assignment of different GTIN s. DGFT requirements on barcoding shall be in addition to existing statutory labeling& marking requirements. Theparentheses(brackets)ofAI sshouldnotbeencodedinthebarcodeandaremeanttoberepresentedonlyin human readable form. It is mandatory to print data encoded in barcodes as human readable information. Please refer to GS1 specifications for further details. List of solution providers is available at: As per the notification, 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 stipulations for primary, secondary and tertiary packaging level barcodingas articulated in the DGFT notification. It may be noted that exemption is allowed only if the specific requirement is from the Government/Regulator in the importing country. Such exemption is not permitted based on importer/buyer requirements only.

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