Online-Track-&-Trace

Encoded in GS1 DataMatrix:

• GTIN
• Serial Number
• Crypto Code (44 or 88 characters – AI(91) & AI(92))

Crypto codes must be obtained from a government subcontractor’s cloud service or government-supplied hardware for local manufacturers.

• 1 July 2022: Labelling of approved medicines (~1% of total drugs)
• 1 Oct 2022: Expansion to at least 20% of medicines
• 1 Jan 2023: Coverage extended to 60% with traceability enabled
• 1 Apr 2023: Expansion to 80% of products
• 1 Jul 2023: Full (100%) marking and traceability enforcement

• GTIN (14 digits)
• Serial Number (13 digits)
• Verification Key (4 digits)
• Verification Code (44 digits)

• GTIN
• Batch / Lot
• Manufacturing Date
• Expiry Date
• Serial Number

• 2023: Mandatory Identification Barcode for all products
• 2025: Mandatory Authentication Barcode for all products

• Marketing Authorization Number (NIE)

• GTIN
• Serial Number
• Batch Number
• Expiry Date

• Barcodes must be printed in black ink on a white or light-colored background
• If two 2D barcodes are present, one must contain the text “BPOM RI”
• Barcodes must be scannable using the BPOM Track & Trace application
• Minimum barcode size: 0.6 × 0.6 cm, placed proportionally on packaging

• Jan 2015: Lot-level traceability requirements
• Nov 2017: Serialized product identifiers (with FDA enforcement discretion)

• Nov 2023: Full package-level (item-level) electronic traceability

• Standardized Numerical Identifier (SNI) or GTIN
• Serial Number (up to 20 characters)
• Lot / Batch Number
• Expiration Date

The 10-digit NDC may be encoded within a GS1 GTIN structure.

• SNI values may be generated using GS1 or ICCBBA standards (for certain biologics)
• Human-readable data must exactly match barcode contents
• Healthcare Distribution Alliance (HDA) guidance applies for product and case marking

• SNI or GTIN
• Serial Number
• Lot Number
• Expiration Date

• 9 February 2019: Mandatory serialization and verification for most EU Member States
• 9 February 2025: Transition deadline for countries with pre-existing national traceability systems (e.g. Italy, Belgium, Greece)

• Product Code (GTIN or approved national code)
• Randomized Serial Number (up to 20 alphanumeric characters)
• Batch / Lot Number
• Expiry Date
• National reimbursement number (where required)

• April 2019: Regulations effective upon publication
• 31 December 2020: Mandatory traceability for key drug products

• Drug Identification Code
• Production Identification Code
• Check Digit

• GS1 Standards using GTIN with Application Identifiers encoded in a DataMatrix
• AliHealth eCode – 20-digit code (7-digit Product ID, 9-digit Serial Number, 4-digit Check Digit) encoded in GS1-128

• Group 1: From 1 September 2022
• Group 2: From 1 November 2022
• Group 3: From 1 March 2023
• Group 4: From 1 February 2025

• Group 1: Medicinal products with secondary (outer) packaging (except orphan drugs)
• Group 2: Medicines with only primary packaging (except orphan drugs)
• Group 3:
  • Medicines and medical devices for orphan diseases
  • Medicines registered under foreign approvals
• Group 4: Medical products as defined by the Ministry of Health

• GTIN (AI 01 – 14 digits)
• Serial Number (AI 21 – 13 digits)
• Verification Key (AI 91 – 4 digits)
• Verification Code (AI 92 – 44 digits)

• GTIN
• Lot
• Expiry Date
• Manufacturing Date
• Serial Number

DGFT has withdrawn the mandated Track & Trace system for export consignments of drug formulations.

Authentication system for exported drug formulations will be implemented by the Ministry of Health & Family Welfare under Drug Rules, 1945 (applicable to selected 300 drug brands).

• GTIN
• Serial Number
• Batch Number
• Expiry Date

• From 2010: All drugs must carry GS1 barcode with KDC (NTIN).
• From 2012: Specified drugs marked with GS1 DataMatrix or GS1-128 (KDC, expiry date, lot).
• From 2013: All ethical drugs marked with GS1 DataMatrix or GS1-128.
• From 1 Jan 2015: Serialization of biologics, narcotics & psychoactive drugs.
• By end 2018: All products serialized.
• New deadline: Not declared.

• Korea Drug (KD) Code
• GS1 Serial Number (up to 20 alphanumeric characters)
• Expiry Date
• Lot / Batch Number (up to 20 alphanumeric characters)

• Korea Drug (KD) Code
• GS1 Serial Number
• Expiry Date
• Lot / Batch Number

• GTIN
• Expiry Date
• Batch Number
• Serial Number

• GTIN
• ANVISA medication registry number
• Unique serial number
• Expiry date
• Batch / lot number

• GTIN
• Expiry date
• Batch / Lot number
• Unique serial number

• SFDA defines a 10-character Saudi Drug Code (SDC), but it is not required to be encoded in the barcode.
• GS1 DataMatrix should be printed on one flat side of the secondary package, preferably on the same side for all packs.

• GTIN
• Serial Number
• Batch Number
• Expiry Date

• GTIN + SN + Expiry Date + Batch Number
• GTIN + Expiry Date + SN + Batch Number
• GTIN + Batch Number + Expiry Date + SN
• GTIN + Batch Number + SN + Expiry Date
• GTIN + SN + Batch Number + Expiry Date

• GTIN (AI 01)
• Expiry Date (AI 17)
• Batch Number (AI 10)
• Serial Number (AI 21)

• GTIN (AI 01)
• Expiry Date (AI 17)
• Batch Number (AI 10)
• Serial Number (AI 21)

• Single device in primary packaging within one outer carton
• Multiple identical devices, each in primary packaging, within one carton
• Multiple different devices for one therapy packed as a kit
• Multiple kits packed within one outer carton

• GTIN
• Unique Serial Number
• Batch / Lot Number
• Expiry Date

• National Product Code
• Lot Number
• Expiry Date
• Serial Number

National product code encoded in a QR code with additional attributes: Drug type, Special Control, License sequence in year, and Year of MA grant.