Life Sciences: Pharmaceuticals & Medical Devices Global Compliance 2020 - rfxcel.com
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Life Sciences: Pharmaceuticals & Medical Devices

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Serialization

Serialization is the process of assigning unique identifiers to individual products and/or individual product packages in order to be able to readily identify and track the products and/or packages. Serialization bestows a unique, protected identity to each serialized item.

Aggregation

Aggregation is the process of bundling or assembling serialized products and/or product packages into larger units such as boxes, cases, and pallets. Each aggregated unit is labeled with a code that contains information about the serialized products in the aggregation.

Traceability

Traceability is the process of creating an indelible provenance of every ingredient/input and/or finished product that supply chain actors can use to verify safety, efficacy, legitimacy, regulatory compliance, and other important characteristics. Serialization and aggregation are key aspects of traceability, as are software and hardware solutions that enable stakeholders to follow items at every node of the supply chain.

Global Compliance Requirements

The industry’s most comprehensive compliance reporting solutions.

Serialization. Traceability. Compliance.

rfxcel is committed to improving patient health and safety, combatting counterfeit drugs, and securing supply chains. Our compliance solutions report into all global government agencies, so you will be compliant no matter where you do business.

Argentina

Serialization

  • Status: Required
  • Data Carrier: GS1-128, DataMatrix, RFID
  • Coding Requirements:
    • GTIN
    • Lot number
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Australia

Serialization

  • Status: Must comply by Jan. 1, 2023
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: No

Bahrain

Serialization

  • Status: Required
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Brazil

Serialization

  • Status: Must comply by April 1, 2022
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number
    • ANVISA registration number
  • Aggregation: Supported but not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: No

China

Serialization

  • Status: No deadline announced
  • Data Carrier: Linear barcode, DataMatrix, RFID, HRI
  • Coding Requirements:
    • Proprietary Chinese eCode: 20-digit code (7-digit product ID + 9-digit SN + 4-digit check digits) in a linear barcode
    • GS1 standards using a GTIN as product code with the relevant application identifiers in a 2D DataMatrix code
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes

Egypt

Serialization

  • Status: No deadline announced
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot
    • Expiry date
    • Serial number
  • Aggregation: Required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Europe

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number
    • Optional elements (e.g., reimbursement number)
  • Aggregation: Not required
  • Traceability: Yes
  • GS1 Standard: Required
  • Reporting Requirements: Yes

India

Serialization

  • Status: Required now
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • 16-digit secondary pack coding:
    • Pack level (1)
    • Packager code (3)
    • Pack type (1)
    • Serial number (10)
    • Check digit (1)
    • 14-digit shipper code:
    • Pack level (1)
    • Packager code (3)
    • Pack type (1)
    • Serial number
    • Check digit (1)
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes

Indonesia

Serialization

  • Status: Must comply by Jan. 1, 2023
  • Data Carrier: QR Code or DataMatrix
  • Coding Requirements:
    • GTIN or AI (distribution permit number)
    • Serial number
    • Expiry date
    • Batch/Lot
    • Requirements at tertiary, secondary & primary (including SN) levels
    • Requirement on primary packaging only if there is not an anti-tampering device on the packaging level above
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes (via CSV file upload)

Japan

Serialization

  • Status: No deadline announced
  • Data Carrier: N/A
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: No

Kazakhstan

Serialization

  • Status: No deadline announced
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes

Lebanon

Serialization

  • Status: Does not seem required
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Malaysia

Serialization

  • Status: Must comply by Jan. 1, 2023
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Oman

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: No

Qatar

Serialization

  • Status: Does not seem required
  • Data Carrier: DataMatrix (secondary); DataMatrix or GS1 128 (tertiary)
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number if applicable or secondary
  • Aggregation: Required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: No

Russia

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key (AI 91)
    • Crypto signature (AS 92)
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Saudi Arabia

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
    • GLN for local factories and warehouses
  • Aggregation: Required
  • Traceability: Yes
  • GS1 Standard: Required
  • Reporting Requirements: Yes

South Africa

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: No

Switzerland

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Voluntary

Taiwan

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Yes

United Arab Emirates

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
    • GLNs required for manufacturers, dispatchers/warehouses, importers, wholesalers/distributors, pharmacies, hospital pharmacies
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Yes (to BrandSync)

Ukraine

Serialization

  • Status: No deadline announced
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • Drug code (identifies name of drug, INN, dosage, formulation, SKU)
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: Yes

United States

Serialization

  • Status: Must comply by Nov. 27, 2023
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number
  • Aggregation: Must comply by Nov. 27, 2023
  • Traceability: Yes
  • GS1 Standard: Required
  • Reporting Requirements: Yes

Uzbekistan

Serialization

  • Status: TBD after pilot
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key (AI 91)
    • Crypto signature (A! 92)
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: Yes

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