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Track and Trace Solutions

Fake medicines which contain the wrong active ingredients or none at all can have fatal consequences for patients. For pharmaceutical manufacturers, counterfeits result in severe damage to their reputation and in high expenses. Growing sales volumes of Internet pharmacies are one reason for the rise of fake drugs. Production outsourcing and longer supply chains also provide more opportunities for counterfeit pharmaceuticals to enter the market. And still, many go undetected. To make the drug supply chain safer, worldwide laws regulating the serialization and traceability of pharmaceutical packages have come – or will come – into force.

Regulations

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  • European Union
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    EUROPEAN UNION

    SERIALIZATION

    Deadline: February 09, 2019
    Data carrier: Data Matrix ECC200
    Data elements:
    Unique product identification number (e.g. GTIN/NTIN/PPN) (AI 01)
    Batch/Lot number (AI 10)
    Expiry date (AI 17)
    Serial number (AI 21 National reimbursement number (if applicable)

    AGGREGATION

    Not mandatory

  • Russia
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    RUSSIA

    SERIALIZATION

    Deadline: January 2020
    Data carrier: GS1 Data Matrix ECC200
    Data elements:
    GTIN (AI 01)
    Serial number (AI 21)
    Batch/Lot number (AI 10)
    Expiry date (AI 17)
    Additional item identification (AI 240)

    AGGREGATION

    Deadline: January 2020
    Data carrier: GS1 128
    Data elements:
    Manufacturers and wholesalers (members of GS1 Russia): SSCC (AI 00)
    Manufacturers only: sGTIN: GTIN (AI 01) and serial number (AI 21)

  • Brazil
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    BRAZIL

    SERIALIZATION

    Deadline: August 01, 2018 (3 batches); April 01, 2022 (all products)
    Data carrier: Data Matrix ECC200
    Data elements:
    GTIN (AI 01) or national number (NHRN) (AI 713)
    Expiry date (AI 17)
    Batch/Lot number (AI 10)
    Serial number (AI 21)

    AGGREGATION

    Deadline: August 01, 2018 (3 batches) April 01, 2022 (all products)
    Data carrier: Possibly GS1 128
    Data elements:
    Possibly SSCC (AI 00)

  • USA
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    USA

    SERIALIZATION

    Deadline: November 27, 2017
    Data carrier: Data Matrix ECC200
    Data elements:
    GTIN (AI 01)
    Serial number (AI 21)
    Expiry date (AI 17)
    Batch/Lot number (AI 10)

    AGGREGATION

    Deadline: November 01, 2023

  • Middle East
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    EGYPT

    BATCH CODING

    Deadline: June 01, 2018
    Data carrier: GS1 Data Matrix ECC200
    Data elements:
    GTIN (AI 01)
    Expiry date (AI 17)
    Batch/Lot number (AI 10)

    AGGREGATION

    Deadline: June 01,2018
    Data carrier: GS1 128
    Data elements: SSCC (AI 00)

    JORDAN

    BATCH CODING

    Deadline: July 01, 2018
    Data carrier: GS1 Data Matrix
    Data elements:
    GTIN (AI 01)
    Expiry date (AI 17),
    Batch/Lot number (AI 10)

    SERIALIZATION

    Deadline: January 01, 2020
    Data carrier: GS1 Data Matrix
    Data elements:
    GTIN (AI 01)
    Serial number (AI 21)
    Expiry date (AI 17)
    Batch/Lot number (AI 10)

    AGGREGATION

    Not mandatory

    LEBANON

    BATCH CODING

    Deadline: January 2019
    Data carrier: GS1 2D DataMatrix
    Data elements:
    GTIN (AI 01)
    Expiry date (AI 17)
    Batch/Lot number (AI 10),

    SAUDI ARABIA

    BATCH CODING

    Deadline: March 21, 2015
    Data carrier: GS1 Data Matrix ECC200
    Data elements:
    GTIN (AI 01)
    Batch/Lot number (AI 10)
    Expiry Date (AI 17)

    SERIALIZATION

    Deadline: March 12, 2017
    Data carrier: GS1 Data Matrix ECC200
    Data elements:
    GTIN (AI 01)
    Serial number (AI 21)
    Batch/Lot number (AI 10)
    Expiry date (AI 17)

    AGGREGATION

    Not mandatory

  • South Africa
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    SOUTH AFRICA

    SECONDARY PACKAGING
    BATCH CODING

    Deadline: September 01, 2020
    Data carrier: GS1 DataMatrix
    Data elements:
    GTIN (AI 01)
    Batch/Lot Number (AI 10)
    Expiry date (AI 17)

    SERIALIZATION

    Deadline: June 30, 2022
    Data carrier: GS1 DataMatrix
    Data elements:
    GTIN (AI 01)
    Batch number (AI 10)
    Expiry date (AI 17)
    Serial number (AI 21)

    TERTIARY PACKAGING
    BATCH CODING

    Deadline: December 30, 2018
    Data carrier: GS1 128 Linear Barcode or GS1 Data Matrix
    Data elements:
    GTIN (AI 01)
    Batch/Lot number (AI 10)
    Expiry date (AI 17),n

    AGGREGATION

    Deadline: June 30, 2022
    Data carrier: GS1 128 or GS1 Data Matrix
    Data elements:
    GTIN (AI 01)
    Batch number (AI 10)
    Expiry date (AI 17)
    Serial number (AI 21)

  • South Korea
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    SOUTH KOREA

    BATCH CODING

    Deadline: January 01, 2013
    Data carrier: GS1 Data Matrix ECC200 or GS1 128
    Data elements:
    KDC (Korean Drug Code/NTIN) (AI 01)
    Expiry date (AI 17)
    Batch/Lot number (AI 10)

    SERIALIZATION

    Deadline: January 01, 2016
    Data carrier: GS1 Data Matrix ECC200 or GS1 128 or RFID
    Data elements:
    KDC (Korean Drug Code/NTIN) (AI 01)
    Serial number (AI 21)
    Batch/Lot number (AI 10)
    Expiry Date (AI 17)

    AGGREGATION

    Not mandatory

  • Japan
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    JAPAN

    SERIALIZATION

    Deadline: July 01, 2015
    Data carrier: GS1 DataBar Limited Composite Symbol CC-A GS1 DataBar Stacked Composite Symbol CC-A GS1 DataBar Limited or GS1 DataBar Stacked
    Data elements:
    Product Code (14-digit code consisting of the JAN – Japanese Article Number) (AI 01) = uniform commodity code [UCC]
    Expiry date (AI 17)
    Batch/Lot number (AI 10)
    Serial Number (AI 21),

    AGGREGATION

    Deadline: April, 2021
    Data carrier: GS1-128-Barcode
    Data elements:
    Product Code (14-digit code consisting of the JAN (Japanese Article Number))
    Expiry Date
    Quantity
    Batch / Lot or serial number

  • Indonesia
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    INDONESIA

    SERIALIZATION

    Deadline: 2020 (Only drugs with secondary packaging and drugs packed in bottles > 5 ml volume
    Data carrier: QR code issued by BPOM or own 2D data carrier which is published independently (can be however must not be DataMatrix)
    Data elements:
    Product Edition Permission Number (AI 90)
    Batch number (AI 17)
    Expiry date (AI 10)
    Serial number (AI 21)
    ID of Production Facility (AI 91)

OUR SOLUTIONS

Serialization, Aggregation and Data Handling: From carton to pallet - flexible in-line and stand-alone solutions

We are very satisfied with the Bosch solution. The machines not only have a compatible design but also run with minimum downtime and highest efficiency. Bosch provided us with exactly the solution we needed for all serialization requirements.

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Ayman Abusalem
MENA Technical Purchasing Manager at Hikma Pharmaceuticals

We provide solutions that excite!

  • Flexible in-line and stand-alone equipment
  • Standardized and customized solutions
  • High usability, excellent user experience and low training requirements for operators
  • Low TCO: reduced downtime and rejects, fast format changes, easy maintenance
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    Get in touch with us!

    We´re looking forward to get in contact with you and provide you with further information about Track & Trace! Please contact:

    Robert Bosch Packaging Technology GmbH
    Stuttgarter Straße 130
    71332 Waiblingen
    Telephone: +49 711 811-0
    pharma.trackandtrace@de.bosch.com