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: GS1 DataMatrix (if compliant with TGO106)
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number optional
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Accepted
  • 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: Awaiting update
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/lot number
    • Expiry date
    • Serial number
    • ANVISA registration number
  • Aggregation: Awaiting update
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Awaiting update

Canada

Serialization

  • Status: Dec. 31, 2021 (extended to 2023 if manufacturers are not ready)
  • Data Carrier: GS1 DataMatrix (proposed)
  • Coding Requirements: GS1 standards accepted, serial number optional
  • 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: 2022 (Pending)
  • 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: 2022 (Pending)
  • Traceability: 1 up, 1 down
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes
  • Vaccines: Full track and trace of the smallest saleable packing unit should be implemented by March 31, 2020, with national code and with GS1 by July 2022

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: Feb. 19, 2024, for listed products; Feb. 19, 2027, for full serialization
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements: GTIN, Batch number, Expiry date, Serial number required in Phase 2 of rollout
  • Aggregation: Required
  • Traceability: N/A
  • GS1 Standard: Required
  • Key Dates:
    • Aug. 19, 2022: For locally manufactured pharmaceuticals
    • Aug. 19, 2023: Data standard compliance (imported medicines)
    • Aug. 19, 2023: Batch/Lot (manufacturers, wholesalers, health care providers)
    • Feb. 19, 2024: Serialization (for certain medicines)
    • Feb. 19, 2027: Full 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 for drug exports
  • Data Carrier: GS1 DataMatrix or QR Code
  • Coding Requirements for Exports:
    • 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)
  • Coding Requirements for APIs:
    • Unique product identification code
    • Name of the API
    • Brand name (if any)
    • Name and address of the manufacturer
    • Batch no.
    • Batch size
    • Date of manufacturing
    • Date of expiry or retesting
    • Serial shipping container code
    • Manufacturing license no. or import license no.
    • Special storage conditions required (if any)
  • Aggregation: Required
  • Traceability: 1 up, 1 down
  • GS1 Standard: Accepted, not required
  • Reporting Requirements: Yes (to IVEDA portal)

Indonesia

Serialization

  • Status: Must comply with identification requirements (GTIN, etc.) by Jan. 1, 2023; serialization by 2025-2027
  • Data Carrier: QR Code or DataMatrix issued by Food and Drug Authority (POM) or GS1 DataMatrix (at client’s request)
  • Coding Requirements:
    • GTIN or AI (distribution permit number)
    • Serial number
    • Expiry date
    • Batch/Lot
    • Distribution License for Medical Devices (NIE) AI 90
    • 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) then to central BPOM database

Japan

Serialization

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

Jordan

Serialization

  • Status: Dec. 31, 2021
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements:
    • GTIN
    • Serial number
    • Expiry date
    • Batch/lot number
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: N/A

Kazakhstan (EAEU)

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: Identification (GTIN, etc.) required January 2020; serialization optional
  • Data Carrier: GS1 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); all pharma products December 2024
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements: N/A
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Required
  • 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: GS1 DataMatrix
  • Coding Requirements:
    • GTIN
    • Expiry date
    • Batch/lot number
    • Serial number
  • Aggregation: Required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Yes (to DRAP portal)

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: Identification required (GTIN, etc.), serialization if applicable
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements:
    • GTIN
    • Batch/Lot
    • Expiry date
    • Serial number if applicable
  • 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 date
    • 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 Africa

Serialization

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

South Korea

Serialization

  • Status: January 2016
  • Data Carrier: GS1 DataMatrix, GS1 128, or EPC/RFID tags
  • Coding Requirements:
    • GTIN
    • Lot/Batch
    • Expiry date
    • Serial Number
  • Aggregation: Yes
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: Yes (to MOH drug serial number system)

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 with EU FMD since 2019
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements:
  • Aggregation: Not required
  • Traceability: N/A
  • GS1 Standard: Required
  • Reporting Requirements: Yes

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: In draft stages
  • Data Carrier: DataMatrix
  • Coding Requirements: Currently EAN-13
  • Aggregation: N/A
  • Traceability: N/A
  • GS1 Standard: Accepted
  • Reporting Requirements: N/A

Türkiye (Turkey)

Serialization

  • Status: Active since 2010
  • Data Carrier: GS1 DataMatrix
  • Coding Requirements:
    • GTIN
    • Lot/Batch
    • Expiry date
    • Serial number
  • Aggregation: Yes
  • Traceability: 1 up, 1 down
  • GS1 Standard: Required
  • Reporting Requirements: Yes [to Pharmaceutical Track & Trace System (ITS)]

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: Required
  • Reporting Requirements: Yes