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.

Algeria

Serialization

  • Status: 2023 (expected)
  • Data Carrier: Barcode (DataMatrix)
  • Coding Requirements:
    • GTIN
    • and other elements
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A

Angola (SADC)

Serialization

  • Status: N/A
  • Data Carrier: Barcode (QR code)
  • Coding Requirements: N/A
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A
  • Expected to follow final SADC requirements

Armenia (EAEU)

Serialization

  • Status: Required
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key
    • Crypto code
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: yes
  • Expected to follow final EAEU requirements

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

Azerbaijan

Serialization

  • Status: In progress
  • Data Carrier: N/A
  • Coding Requirements: N/A
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Proposed
  • Reporting Requirements: N/A

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

Belarus (EAEU)

Serialization

  • Status: Required (not yet for pharma)
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key
    • Crypto code
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: yes
  • Expected to follow final EAEU requirements

Brazil

Serialization

  • Status: Must comply by April 28, 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

Canada

Serialization

  • Status: In progress (2025 proposed)
  • Data Carrier: DataMatrix (proposed)
  • Coding Requirements: GS1 standards (proposed)
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Proposed
  • Reporting Requirements: N/A
  • See GS1 Canada Roadmap

Chile (see Argentina)

  • No published requirements
  • Expected collaboration with Argentina National Administration of Drugs, Foods and Medical Devices (ANMAT)

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

Colombia

Serialization

  • Status: In progress
  • Data Carrier: DataMatrix (proposed)
  • Coding Requirements: GS1 standards (proposed)
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Proposed
  • Reporting Requirements: N/A

Ecuador

Serialization

  • Status: On Hold
  • Proposed Phases (on hold):
    • Nov. 26, 2022: Phase 1
    • May. 26, 2023: Phase 2
    • Nov. 26, 2023: Phase 3
    • May. 26, 2024: Phase 4

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

Ethiopia

Serialization

  • Status: In progress
  • Data Carrier: DataMatrix (proposed)
  • Coding Requirements: GS1 standards (proposed)
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Proposed
  • Key Dates:
    • Aug. 19, 2023: Data standard compliance (imported medicines)
    • Aug. 19, 2023: Batch/Lot
    • Feb. 19, 2024: Serialization (for certain medicines)
    • Aug. 19, 2024: Batch/Lot
    • Feb. 19, 2027: Traceability

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

Eurasian Economic Union (EAEU)

  • Member Countries:
    • Armenia
    • Belarus
    • Kazakhstan
    • Kyrgyzstan
    • Russia
  • Key Dates:
    • Aug. 4, 2019:
    • Eurasian Economic Commission discussed adopting serialization and cryptographic requirements for all member countries based on Russia’s regulations.

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: Barcodes & traceability required Dec. 1, 2022
  • Data Carrier: DataMatrix (suggested by GS1)
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: Not required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: No

Jordan

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements: GS1 standards (proposed)
  • Aggregation: Yes
  • Traceability: Yes
  • GS1 Standard: Yes
  • Reporting Requirements: Expected

Kazakhstan

Serialization

  • Status: Phased approach in progress to 2023
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key
    • Crypto code
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes
  • Key Dates:
    • July 1, 2022: 93 medicines serialized
    • Oct. 1, 2022: 20% of all drugs serialized
    • Jan. 1, 2023: 60% of all drugs serialized
    • April 1, 2023: Min. 80% of all drugs serialized
    • July 2023: 100% serialization
  • Expected to follow final EAEU requirements

Kuwait

Serialization

  • Status: Not active
  • Data Carrier: N/A
  • Coding Requirements: GS1 standards (proposed)
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Proposed
  • Reporting Requirements: Expected

Kyrgyzstan (EAEU)

Serialization

  • Status: Required (not yet for pharma)
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key
    • Crypto code
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: Yes
  • Expected to follow final EAEU requirements

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

Libya

Serialization

  • Status: Being evaluated
  • Data Carrier: N/A
  • Coding Requirements:
    • GTIN
    • Lot
    • Expiry Date
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A
  • Proposed Name: National Project for a Pharmaceutical Verification System

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

Mauritius (SADC)

  • Majority of pharma products are imported
  • Most imported products use GS1 coding standards
  • Expected to follow final SADC requirements

New Zealand

Serialization

  • Status: Not active
  • Data Carrier: “machine-readable codes”
  • Coding Requirements:
    • GTIN
    • Product Information
    • Batch
    • Expiry Date
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A
  • Pharmaceutical Management Agency (Pharmac) established labeling preferences Working with Australia New Zealand Therapeutic Products Agency (ANZTPA) to develop requirements

Nigeria

Serialization

  • Status: Antimalarials and antibiotics only (2014)
  • Data Carrier: N/A
  • Coding Requirements: N/A
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A
  • Key Dates: May 2020: Nigeria National Pharmaceutical Traceability Strategy & 5-year roadmap

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

Pakistan

Serialization

  • Status: Aug. 27, 2025 (proposed)
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Expiry Date
    • Batch
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A

Philippines

Serialization

  • Status: On hold since July 2016
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • 14-digit “Global Product ID Number” (GPIN),
    • Expiry Date
    • Batch
  • See FDA Circular No. 2016-011 for details, including GPIN requirements

Qatar

Serialization

  • Status: In progress
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Yes
  • Reporting Requirements: N/A

Russia

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key
    • Crypto code
  • 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

Singapore

Serialization

  • Status: No deadline announced
  • Data Carrier: N/A
  • Coding Requirements:
    • Name
    • Active ingredients
    • Control number
    • Expiry data
    • Registration information
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A

Southern African Development Community (SADC)

  • SADC is developing guidelines for its 16 member countries
  • Members: Angola, Botswana, Comoros, Democratic Republic of Congo, Eswatini, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Tanzania, Zambia, Zimbabwe

South Korea

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Lot/Batch
    • Expiry Date
    • Serial Number
  • Aggregation: Yes
  • Traceability: 1 up, 1 down
  • GS1 Standard: Yes
  • 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

Sri Lanka

Serialization

  • Status: Proposed
  • Data Carrier: N/A
  • Coding Requirements: N/A
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: Yes

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

Tajikistan

Serialization

  • Status: Not yet required
  • Data Carrier: DataMatrix (proposed)
  • Coding Requirements: N/A
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: N/A
  • Reporting Requirements: N/A
  • Expected to follow final EAEU requirements

Tunisia

Serialization

  • Status: Not yet required
  • Data Carrier: DataMatrix (expected)
  • Coding Requirements: Batch variable (proposed)
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Expected
  • Reporting Requirements: N/A

Turkey

Serialization

  • Status: Active
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Lot/Batch
    • Expiry date
    • Serial number
  • Aggregation: Yes
  • Traceability: 1 up, 1 down
  • GS1 Standard: Yes
  • 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: January 1, 2023 (proposed)
  • 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: On hold
  • Data Carrier: DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Crypto key
    • Crypto code
  • Aggregation: Yes
  • Traceability: 1 up, 1 down
  • GS1 Standard: Yes
  • Reporting Requirements: Yes

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