Life Sciences: Pharmaceuticals & Medical Devices
Secure your supply chain with the industry’s longest-tenured track and trace solutions.
Popular Features
- Raw ingredients to finished goods traceability
- Real-time cold chain monitoring
- Compliance management
- Predictive analytics
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: 2025 (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: Full track & trace February 19, 2027
- 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: Identification requirements began Dec. 7, 2023; authentication (serialization) deadlines Dec. 7, 2025 & Dec. 7, 2027
- Data Carrier: GS1 QR Code (identification) and 2D DataMatrix code (authentication)
- Coding Requirements (identification):
- Marketing Authorization Number
- NIE (distribution permit number)
- Coding Requirements (authentication):
- GTIN
- Marketing Authorization Number
- Production code or batch number
- Expiration date
- Serial number
- 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: Yes
- Reporting Requirements: Yes, to BPOM Track and Trace Anti-Counterfeit (TTAC) system
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: By June 30, 2023, for local and imported drugs
- 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: January 1, 2024, for local and imported drugs
- Data Carrier: GS1 DataMatrix
- 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 on imported and exported drugs; 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
Rwanda
Serialization
- Status: Not active
- Data Carrier: GS1 DataMatrix or GS1-128 barcodes on tertiary packages
- Coding Requirements: GTIN, batch number, expiry date, serial number
- Aggregation: Not active
- Traceability: Not active
- GS1 Standard: Required
- Key Dates:
- Aug. 29, 2024: Master data upload
- Aug. 29, 2025: Identification
- Aug. 29, 2026: Serialization mandatory on secondary packaging
- Aug. 29, 2027: SSCC is mandatory for logistics units at tertiary packaging
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:
- Product code [GTIN and National Trade Item Number (NTIN)]
- SN
- Expiry date
- Batch/Lot
- 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: Required
- Traceability: N/A
- GS1 Standard: Required
- Reporting Requirements: Yes (to Tatmeen platform; Master Data to GS1’s UAE BrandSync Portal)
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
