MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	CRPT (Center for Research in Perspective Technologies) under the Russian Ministry of Health regulates the medicinal track & trace system.
REGULATION NAME	Implementation Guideline for Barcode Labeling of Prescription Drugs
COMPLIANCE DATES	Electronic leaflet deadline: 1 August 2021 Barcoding for drugs & medical devices: 1 December 2022
APPLIES TO	Drug manufacturers with manufacturing and/or packaging facilities in Japan, including exporters.

SECONDARY PACKAGING

BARCODE SYMBOLOGY	GS1 DataMatrix
BARCODE CONTENTS	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.
SERIAL NUMBER RANDOMIZATION	No
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	For mono cartons containing one primary pack, barcode affixing is optional until further notice.
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	GS1-128 with SSCC or sGTIN
BARCODE CONTENTS	GS1-128 (SSCC)
AGGREGATION REQUIRED	Yes

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING CAPTURED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (Chestny Znak)
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	CRPT
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Imports & Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes

MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	Ministry of Health (Kazakhstan), in collaboration with Kazakh Telecom (KZ Telecom), oversees and regulates the national pharmaceutical traceability program.
REGULATION NAME	Draft Pharmaceutical Serialization & Traceability Regulation
COMPLIANCE TIMELINE	Phased implementation roadmap: 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
APPLIES TO	Pharmaceutical manufacturers, importers, exporters, and marketing authorization holders supplying medicines to the Kazakhstan market.

PRIMARY PACKAGING

(Packaging in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	Not applicable (may be introduced in future phases)
BARCODE CONTENTS	Not Applicable
SERIAL NUMBER RANDOMIZATION	Not Applicable
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	Not Applicable
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Primary-level coding currently exempted
FREE SAMPLES MUST BE MARKED?	Not Specified

SECONDARY PACKAGING

(Sales or outer packaging)

BARCODE SYMBOLOGY	Linear or 2D DataMatrix compliant with GS1 standards
BARCODE CONTENTS	2D Code Encoding: GTIN (14 digits) Serial Number (13 digits) Verification Key (4 digits) Verification Code (44 digits) Human Readable Information: GTIN Batch / Lot Manufacturing Date Expiry Date Serial Number
SERIAL NUMBER RANDOMIZATION	Yes
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Barcode labelling at primary level remains exempt. Human-readable data printing may become mandatory in future phases; currently optional depending on product-specific timelines.
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

(Shipper or logistic packaging)

BARCODE SYMBOLOGY	GS1-128 (Linear)
BARCODE CONTENTS	Product Code (GTIN optional), Batch Number, Expiry Date, and GS1 SSCC (may appear in a separate barcode)

AGGREGATION DATA CAPTURE

PARENT–CHILD AGGREGATION REQUIRED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Government Platform (Kazakh Telecom / KZ Telecom)
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Imports & Exports as applicable)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes (Across the supply chain)

MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	National Agency of Drug and Food Control (BPOM), Indonesia, responsible for pharmaceutical supervision and traceability.
REGULATION NAME	BPOM Regulation No. 33/2018 – Implementation of 2D Barcodes to strengthen supervision of medicines and processed food.
COMPLIANCE TIMELINE	2023: Mandatory Identification Barcode for all products 2025: Mandatory Authentication Barcode for all products
APPLIES TO	Domestic and foreign pharmaceutical manufacturers, wholesalers, distributors, and pharmacies operating in Indonesia.

PHARMACEUTICAL PACKAGING

BARCODE SYMBOLOGY	GS1-compliant 2D Barcode
BARCODE CONTENTS	Identification Barcode (QR Code): Marketing Authorization Number (NIE) Authentication Barcode (QR Code / 2D DataMatrix): GTIN Serial Number Batch Number Expiry Date
SERIAL NUMBER RANDOMIZATION	Not Specified
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	Not Specified
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	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
FREE SAMPLES MUST BE MARKED?	Not Specified

CASE PACKAGING

BARCODE SYMBOLOGY	GS1 2D Barcode (QR Code / DataMatrix)
BARCODE CONTENTS	Same data elements as secondary-level packaging

AGGREGATION DATA CAPTURE

PARENT–CHILD AGGREGATION CAPTURED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	No
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	No
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Proposed (Future implementation)
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	No (Planned for future phase)
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	No
DOWNSTREAM PARTNER ACTIVITY REPORTED?	No

MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	United States Food and Drug Administration (FDA), responsible for enforcing pharmaceutical supply chain security requirements.
REGULATION NAME	Drug Supply Chain Security Act (DSCSA)
COMPLIANCE TIMELINE	Past Milestones: Jan 2015: Lot-level traceability requirements Nov 2017: Serialized product identifiers (with FDA enforcement discretion) Upcoming Milestone: Nov 2023: Full package-level (item-level) electronic traceability
APPLIES TO	Drug manufacturers, repackagers, wholesale distributors, dispensers (including hospitals and pharmacies), and third-party logistics providers (3PLs).

PRIMARY PACKAGING

(Packaging in direct contact with the active pharmaceutical ingredient)

BARCODE SYMBOLOGY	2D Barcode – GS1 DataMatrix
BARCODE CONTENTS	Machine-readable Product Identifier containing: 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.
SERIAL NUMBER RANDOMIZATION	Not Applicable
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	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
FREE SAMPLES MUST BE MARKED?	No

SECONDARY PACKAGING

(Carton containing one or more primary packs)

BARCODE SYMBOLOGY	2D Barcode – GS1 DataMatrix
BARCODE CONTENTS	Product Identifier encoded with: SNI or GTIN Serial Number Lot Number Expiration Date
SERIAL NUMBER RANDOMIZATION	Not Applicable
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Secondary-level packaging must comply with FDA DSCSA Product Identifier requirements and reflect barcode data in human-readable form.
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(Shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC (GS1-128)
BARCODE CONTENTS	Serialized Shipping Container Code (SSCC)

AGGREGATION DATA CAPTURE

PARENT–CHILD AGGREGATION REQUIRED?	Required (Effective from Nov 2017)

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	No
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	No
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Level-4 Interoperable Systems (Trading Partner Networks)
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Imports & Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	No
DOWNSTREAM PARTNER ACTIVITY REPORTED?	No

MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	European Medicines Agency (EMA) in coordination with national competent authorities across EU Member States.
REGULATION NAME	Falsified Medicines Directive (FMD) and Delegated Regulation (EU) 2016/161
COMPLIANCE TIMELINE	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)
APPLIES TO	Pharmaceutical manufacturers, Marketing Authorization Holders (MAHs), importers, parallel traders, wholesalers, and dispensers operating in the EU.

UNIT-LEVEL PACKAGING (UNITS OF SALE)

BARCODE SYMBOLOGY	DataMatrix (ECC200)
BARCODE CONTENTS	Unique Identifier consisting of: 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)
SERIAL NUMBER RANDOMIZATION	Mandatory – generated using deterministic or non-deterministic algorithms with negligible probability of duplication.
SERIAL NUMBER REUSE	Serial numbers must remain unique until at least one year after expiry or five years after sale or distribution.
HUMAN READABLE EXPIRY DATE FORMAT	Month and year (MM/YYYY or equivalent national format)
BARCODE DATA ENCODING	Encoding schemes compliant with ISO/IEC 15418 (e.g. GS1 Application Identifiers)
PRODUCT CODE NOTES	GTINs are widely accepted; however, some Member States may require National Trade Item Numbers (NTIN) or National Health Reimbursement Numbers (NHRN). Country-specific rules must be validated locally.
FREE SAMPLES MUST BE MARKED?	Yes – samples must be serialized and uploaded to the EU Hub, then decommissioned at the time of distribution.

HOMOGENEOUS PACKAGING

BARCODE SYMBOLOGY	Not Applicable
BARCODE CONTENTS	Not Applicable

LOGISTICS UNITS

LOGISTICS UNITS MUST BE SERIALIZED?	No

AGGREGATION DATA CAPTURE

UNIT-TO-CASE AGGREGATION REQUIRED?	Not required under FMD

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (National Medicines Verification Systems)
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	Yes (EU Hub managed by EMVO)
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Not Applicable
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	Not Applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	Not legally required, but commonly implemented for operational efficiency

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	EMVO and National Verification Systems
MANUFACTURERS MUST REGISTER SHIPMENTS?	No shipment reporting, but market distribution regions must be declared
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Mandatory for dispensers; optional for other partners unless risk is identified
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Required when exporting EU medicines outside the EU (decommissioning)

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes (based on role and transaction type)

MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	China National Medical Products Administration (NMPA)
REGULATION NAME	Guidelines for Drug Traceability Information System Construction and Encoding Requirements for Drug Traceability
COMPLIANCE TIMELINE	April 2019: Regulations effective upon publication 31 December 2020: Mandatory traceability for key drug products
APPLIES TO	Marketing Authorization Holders (MAHs), drug manufacturers, pharmaceutical distributors, and regulatory authorities. Exclusions: Traditional Chinese herbal medicines, raw materials, and special packaging preparations.

SECONDARY PACKAGING

(Carton containing one or more primary packs)

BARCODE SYMBOLOGY	Linear Barcode, 2D Barcode, RFID, Human Readable Information (HRI)
BARCODE CONTENTS	Drug Traceability Code Structure: Drug Identification Code Production Identification Code Check Digit Supported Coding Systems: 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
SERIAL NUMBER RANDOMIZATION	Not Applicable
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Drug identification codes must be unique at each packaging level. Production identification codes must include a serial number and may include batch number, production date, and expiry date based on regulatory requirements.
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(Shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC (GS1-128)
BARCODE CONTENTS	Serialized Shipping Container Code (SSCC)

AGGREGATION DATA CAPTURE

PARENT–CHILD AGGREGATION REQUIRED?	No

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Proposed
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	Not Specified
SEND UNIT DATA TO TRADING PARTNER?	Not Specified
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes (via AliHealth)
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	Not Specified
SEND AGGREGATION DATA TO TRADING PARTNER?	Not Specified

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	NMPA
MANUFACTURERS MUST REGISTER SHIPMENTS?	Proposed (Imports & Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Not Specified
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Not Specified

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes (Proposed)
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Not Specified

MEDICINES TRACEABILITY VISION AND STRATEGY

REGULATORY AGENCY	CRPT Turon
REGULATION NAME	Serialization Guideline
COMPLIANCE DATES	Group 1: From 1 September 2022 Group 2: From 1 November 2022 Group 3: From 1 March 2023 Group 4: From 1 February 2025
APPLIES TO	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

PRIMARY PACKAGING

(Packaging in direct contact with the active ingredient)

BARCODE SYMBOLOGY	Not applicable (may be required in future)
BARCODE CONTENTS	Not Applicable
SERIAL NUMBER RANDOMIZATION	Not Applicable
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	Not Applicable
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Not Specified
FREE SAMPLES MUST BE MARKED?	Not Specified

SECONDARY PACKAGING

(Packaging containing one or more primary packs)

BARCODE SYMBOLOGY	Linear or 2D DataMatrix following GS1 standards
BARCODE CONTENTS	2D Code Encoding: GTIN (AI 01 – 14 digits) Serial Number (AI 21 – 13 digits) Verification Key (AI 91 – 4 digits) Verification Code (AI 92 – 44 digits) Human Readable Information: GTIN Lot Expiry Date Manufacturing Date Serial Number
SERIAL NUMBER RANDOMIZATION	Yes
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Barcode labeling at primary level is exempt until further notice. Human-readable printing may become mandatory later but is optional during the transition period. Refer to individual product timelines.
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

(Shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	GS1-128 (SSCC)
BARCODE CONTENTS	Product Code (GTIN optional), Lot Number, Expiry Date, and SSCC (may appear in a separate barcode)

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING REQUIRED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	NIS–MPT
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Imports & Exports as applicable)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes (Supply Chain)

INDIA DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY	India Ministry of Commerce and Industry – Department of Commerce, Directorate General of Foreign Trade (DGFT)
REGULATION NAME	Pharmaceuticals and Drug Consignments
COMPLIANCE DATES	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).
APPLIES TO	Drug manufacturers exporting pharmaceutical products to other countries.

SECONDARY PACKAGING

(A carton containing one or more primary packs)

BARCODE SYMBOLOGY	Previously: Linear or 2D DataMatrix (GS1 standards) (Regulation withdrawn as per latest update)
BARCODE CONTENTS	GTIN Serial Number Batch Number Expiry Date
SERIAL NUMBER RANDOMIZATION	No
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	Earlier GS1 Standards (Regulation withdrawn as per latest update)
PRODUCT CODE NOTES	For mono cartons, barcode application is optional until further notice.
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	Earlier GS1-128 Linear (Regulation withdrawn as per latest update)
BARCODE CONTENTS	Product Code (GTIN optional), Lot Number, Expiry Date, and GS1 SSCC (SSCC may appear in a separate barcode)

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING REQUIRED?	Not Required

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	No (Regulation withdrawn)
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	No (Regulation withdrawn)
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	No (Regulation withdrawn)
MANUFACTURERS MUST REGISTER SHIPMENTS?	No (Regulation withdrawn)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	No (Future)
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	No (Regulation withdrawn)
DOWNSTREAM PARTNER ACTIVITY REPORTED?	No

DRUG SERIALIZATION SYSTEM

REGULATORY AGENCY	Ministry of Health and Welfare (MoHW), Ministry of Food and Drug Safety (MFDS), South Korea
REGULATION NAME	Korea Drug Serialization System (KPIS – Korea Pharmaceutical Information Services)
COMPLIANCE DATES	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.
APPLIES TO	Prescription drug suppliers including manufacturers, importers, and wholesalers.

PRIMARY PACKAGING

(Packaging which is in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	2D GS1 DataMatrix, GS1-128 (linear), or GS1 RFID tag
BARCODE CONTENTS	Korea Drug (KD) Code GS1 Serial Number (up to 20 alphanumeric characters) Expiry Date Lot / Batch Number (up to 20 alphanumeric characters)
SERIAL NUMBER RANDOMIZATION	No
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	KD Code is a GTIN-13 assigned by GS1 South Korea or the government. It is converted to GTIN-14 by prepending a zero.
FREE SAMPLES MUST BE MARKED?	No

SECONDARY PACKAGING

(A carton containing one or more primary packs)

BARCODE SYMBOLOGY	Linear or 2D DataMatrix following GS1 standards
BARCODE CONTENTS	Korea Drug (KD) Code GS1 Serial Number Expiry Date Lot / Batch Number
SERIAL NUMBER RANDOMIZATION	No
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	KD Code is a GTIN-13 converted to GTIN-14 by prepending a zero.
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	GS1-128 (Linear)
BARCODE CONTENTS	KD Code (GTIN-14), encoded as GS1-128

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING CAPTURED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Korea MFDS
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	No (Future)
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	No

AZERBAIJAN REGULATORY

REGULATORY AGENCY	Ministry of Health (MoH), Azerbaijan
REGULATION NAME	Decree on the “Pharmaceuticals Track and Trace System”
COMPLIANCE DATES	Serialization for first group of products: 1 June 2024. Full Track & Trace implementation by end of 2024.
APPLIES TO	All pharmaceutical products.

SECONDARY PACKAGING

(A carton containing one or more primary packs)

BARCODE SYMBOLOGY	GS1 DataMatrix
BARCODE CONTENTS	GTIN Expiry Date Batch Number Serial Number
SERIAL NUMBER RANDOMIZATION	No
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	NA
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	GS1-128 (Linear)
BARCODE CONTENTS	Product code (GS1 GTIN optional), Lot Number, Expiration Date, GS1 SSCC (may appear in a separate barcode)

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING CAPTURED?	Not Required

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	No
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	No
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Proposed
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	No (Future)
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	No
DOWNSTREAM PARTNER ACTIVITY REPORTED?	No

BRAZIL DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY	Brazil National Agency of Sanitary Surveillance (ANVISA)
REGULATION NAME	Federal Law No. 11,903/2009 & 13,410/2016
COMPLIANCE DATES	28 April 2022: All drugs must be serialized and supply-chain movements reported to ANVISA (as per draft regulation).
APPLIES TO	Domestic manufacturers and importers of prescription pharmaceutical products.

SALEABLE UNIT PACKAGING

BARCODE SYMBOLOGY	DataMatrix (ISO / IEC 16022)
BARCODE CONTENTS	Unique Medication Identifier (IUM) consisting of: GTIN ANVISA medication registry number Unique serial number Expiry date Batch / lot number Note: Final normative instructions pending.
SERIAL NUMBER RANDOMIZATION	No
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
FREE SAMPLES MUST BE MARKED?	Not Specified

HOMOGENEOUS PACKAGING

BARCODE SYMBOLOGY	GS1 Standards
BARCODE CONTENTS	Expected to be similar to unit-level packaging

LOGISTICS UNIT

LOGISTICS UNITS MUST BE SERIALIZED?	Yes — aggregation may be performed using SSCC, SGTIN, or CNPJ-based aggregators.

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING CAPTURED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	ANVISA
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes

SAUDI DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY	Saudi Food and Drug Authority (SFDA)
REGULATION NAME	Saudi Drug Code (SDC) & Barcoding Specifications – Version 6.1
COMPLIANCE DATES	12 March 2017: All GS1 DataMatrix barcodes must include a GS1 serial number. Mandatory aggregation deadlines postponed until further notice.
APPLIES TO	Domestic and foreign manufacturers of human and veterinary drugs, including prescription and over-the-counter products.

SECONDARY PACKAGING

BARCODE SYMBOLOGY	GS1 DataMatrix
BARCODE CONTENTS	GTIN Expiry date Batch / Lot number Unique serial number
SERIAL NUMBER RANDOMIZATION	Not Specified
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	Month / Year
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	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.
FREE SAMPLES MUST BE MARKED?	No
STICKERING AFTER MANUFACTURING ALLOWED?	Yes

HOMOGENEOUS CASES

BARCODE SYMBOLOGY	GS1 DataMatrix or GS1-128
BARCODE CONTENTS	GTIN + Serial Number

LOGISTICS UNIT

LOGISTICS UNITS MUST BE SERIALIZED?	Yes — SSCC

DATA CAPTURE

UNIT-TO-CASE AGGREGATION CAPTURED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	SFDA
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Not Specified
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Not Specified

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Not Specified

THE MINISTRY OF HEALTH AND PREVENTION, UAE (MOHAP)

REGULATORY AGENCY	The Ministry of Health and Prevention, UAE (MOHAP)
REGULATION NAME	Tatmeen Project – a national platform for tracking and tracing serialized pharmaceutical products to secure the UAE healthcare supply chain.
COMPLIANCE DATES	13 December 2022 – Deadline for uploading and transferring data to Tatmeen portal.
APPLIES TO	All conventional medicines sold, distributed, or stored in the UAE.

SECONDARY PACKAGING

BARCODE SYMBOLOGY	2D DataMatrix (GS1 standard)
BARCODE CONTENTS	GTIN Serial Number Batch Number Expiry Date
BARCODE SEQUENCE	Any of the following sequences are permitted: 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
SERIAL NUMBER RANDOMIZATION	Yes
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Logistic units must be aggregated and identified using SSCC. Aggregation is mandatory at all applicable packaging levels. Distributors, wholesalers, and healthcare facilities that unpack and re-pack products must aggregate logistic units using their own SSCCs. If a logistic unit is also considered a trade item, it may additionally be identified using a GTIN.
FREE SAMPLES MUST BE MARKED?	Not Specified
EXEMPTED PRODUCTS	Free pharmaceutical samples, medicines imported for personal use, medical devices and supplies, and GSL products.

TERTIARY PACKAGING (SHIPPER LEVEL)

BARCODE SYMBOLOGY	GS1-128 (Linear)
BARCODE CONTENTS	SSCC

AGGREGATION DATA CAPTURE

PARENT-CHILD MAPPING AGGREGATION CAPTURED?	Yes
HOMOGENEOUS LOGISTIC UNIT	Yes (SSCC)
HETEROGENEOUS LOGISTIC UNIT	Yes (SSCC)

TERTIARY PACKAGING (PALLET LEVEL)

BARCODE SYMBOLOGY	GS1-128 (Linear)
BARCODE CONTENTS	SSCC

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	Yes
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Tatmeen
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Domestic & Export)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	No (Future)
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	No

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	No

EGYPT REGULATORY

REGULATORY AGENCY	EDA – Egyptian Drug Authority
REGULATION NAME	UDI Decree
COMPLIANCE DATES	The deadline for use of GTIN for all medical supplies traded in the local market is one year from the publication of the decree.
APPLIES TO	All medical devices, accessories, and IVDs supplied to the Egyptian market, except devices and IVDs for research use, investigational use, or custom-made products.

PRIMARY PACKAGING

(Packaging in direct physical contact with the active ingredient)

BARCODE SYMBOLOGY	GS1 DataMatrix (ID/Linear, 2D/Matrix, RFID allowed)
BARCODE CONTENTS	GTIN (AI 01) Expiry Date (AI 17) Batch Number (AI 10) Serial Number (AI 21)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
PRODUCT CODE NOTES	Primary packaging is the first level of packaging in direct contact with the product and marked with an AIDC data carrier either on the packaging or via an affixed label. It may consist of a single item or a group of items for a single therapy (e.g., kits). For retail trade items, primary packaging is a level below the retail package.
FREE SAMPLES MUST BE MARKED?	Not Specified

SECONDARY PACKAGING

(Outer packaging not in direct contact with the active ingredient)

BARCODE SYMBOLOGY	GS1 DataMatrix (ID/Linear, 2D/Matrix, RFID allowed)
BARCODE CONTENTS	GTIN (AI 01) Expiry Date (AI 17) Batch Number (AI 10) Serial Number (AI 21)
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	UDI – PI
PRODUCT CODE NOTES	Secondary packaging configurations include: 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
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	GS1-128 (SSCC)
BARCODE CONTENTS	SSCC

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING AGGREGATION CAPTURED?	Yes

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes (EDA)
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	EDA
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Exports & Imports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Yes

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes

MALAYSIA DRUG BARCODING REQUIREMENTS

REGULATORY AGENCY	National Pharmaceutical Regulatory Agency (NPRA)
REGULATION NAME	National Pharmaceutical Track & Trace System
COMPLIANCE DATES	January 2023 – Complete national track & trace system to be functional
APPLIES TO	Domestic manufacturers of all registered pharmaceutical products Foreign manufacturers of all registered pharmaceutical products

SALEABLE UNIT PACKAGING

BARCODE SYMBOLOGY	GS1 DataMatrix
BARCODE CONTENTS	GTIN Unique Serial Number Batch / Lot Number Expiry Date
SERIAL NUMBER RANDOMIZATION	Not Specified
SERIAL NUMBER REUSE	Not Specified
HUMAN READABLE EXPIRY DATE FORMAT	Not Specified
BARCODE DATA ENCODING	GS1 Standards
PRODUCT CODE NOTES	Not Specified
FREE SAMPLES MUST BE MARKED?	Not Specified

TERTIARY PACKAGING

BARCODE SYMBOLOGY	GS1-128 (1D)
BARCODE CONTENTS	Same as secondary packaging

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING AGGREGATION CAPTURED?	Not Specified

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Government (Ministry of Health)
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	Dispenser authentication at time of dispense
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	Not Specified

GOVERNMENT REPORTING

MASTER DATA UPLOAD?	Yes
MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes

DRAFT GUIDANCE

REGULATORY AGENCY	The Drug Administration of Vietnam (DAV)
REGULATION NAME	The Draft Drug Registration Circular
COMPLIANCE DATES	This circular includes technical details but does not define final deadlines.
APPLIES TO	Drug manufacturers, re-packagers, wholesale distributors, and dispensers

SECONDARY PACKAGING

(A carton containing one or more primary packs, including mono cartons)

BARCODE SYMBOLOGY	2D Barcode – GS1 DataMatrix
BARCODE CONTENTS	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.
SERIAL NUMBER RANDOMIZATION	NA
SERIAL NUMBER REUSE	No
HUMAN READABLE EXPIRY DATE FORMAT	YYMMDD
BARCODE DATA ENCODING	GS1 Standard
PRODUCT CODE NOTES	Encoding of a national product code in a QR code on carton box with Drug type, Special Control, License sequence, and MA grant year.
FREE SAMPLES MUST BE MARKED?	No

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

BARCODE SYMBOLOGY	SSCC
BARCODE CONTENTS	GS1-128 (SSCC)

AGGREGATION DATA CAPTURE

PARENT–CHILD MAPPING AGGREGATION CAPTURED?	NA

DATA EXCHANGE

SEND UNIT DATA TO GOVERNMENT REPOSITORY?	NA
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND UNIT DATA TO TRADING PARTNER?	As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?	Proposed
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?	As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?	As applicable

AUTHENTICATION

AUTHENTICATION REPOSITORY PROVIDER	Proposed
MANUFACTURERS MUST REGISTER SHIPMENTS?	Yes (Imports & Exports)
DOWNSTREAM PARTNERS AUTHENTICATE ON RECEIPT?	NA
DOWNSTREAM PARTNERS AUTHENTICATE ON SHIPMENT?	NA

GOVERNMENT REPORTING

MANUFACTURER ACTIVITY REPORTED?	Yes
DOWNSTREAM PARTNER ACTIVITY REPORTED?	Yes

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OCR/OCV-Klarschriftprüfung für verschlüsselte Codes

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