European Commission

Regulatory Body European Commission
Product Scope All prescription drug products
Effective Date / Implementation Deadline February 2019
Status Upcoming
2. Secondary Serialisation (Carton) Yes
Code Type GS1 DataMatrix
Code Information GTIN, SN, NHRN, LOT, EXP
5. Reporting To European Hub & National/ Supranational Repository

Turkish Ministry of Health

Regulatory Body Turkish Ministry of Health
Product Scope All pharmaceutical products for the Turkish market
Effective Date / Implementation Deadline Regulation in effect since 2011
Status In effect
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix
Code Information GTIN, SN, EXP, LOT
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes, Bundle Case Pallet
Code Type GS1-128
Code Information SSCC
4. Aggregation Yes
5. Reporting To ITS Central Database & PTS Central Database

Russia

Regulatory Body Health Ministry of the Russian Federation
Product Scope Selected drugs from January 2018. All other prescription drugs from January 2020.
Effective Date / Implementation Deadline Phase 1: Pilot January 2018 / Phase 2–4: Serialization of all other pharmaceutical products January 2020
Status Concept
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix or QR Code
Code Information Product Code, GTIN, EXP, LOT, SN
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes

Jordan

Regulatory Body Jordan Food & Drug Administration (JFDA)
Product Scope All medicinal products for human use.
Effective Date / Implementation Deadline Phase 1: Codification June 2018 / Phase 2: Serialization: 2020
Status Upcoming
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix
Code Information GTIN, EXP, LOT, SN

Egypt

Regulatory Body Ministry of Health & Population Arab Republic of Egypt
Product Scope All medications subject to registration with the Ministry of Health and Population
Effective Date / Implementation Deadline Phase 1 Serialization: June 2018 / Phase 2: Aggregation: June 2019
Status Upcoming
2. Secondary Serialisation (Carton) Yes
Code Type GS1 DataMatrix
Code Information GTIN, EXP, LOT, SN
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes, Case
Code Type GS1-128
Code Information SSCC
4. Aggregation Yes

Saudi-Arabia

Regulatory Body Saudi Food & Drug Authority (SFDA)
Product Scope All human and veterinarian drugs
Effective Date / Implementation Deadline Phase 1 Codification: March 2015 / Phase 2 Serialisation: March 2017
Status Upcoming
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix
Code Information Phase 1 Codification: GTIN, EXP, LOT / Phase 2 Serialisation: GTIN, EXP, LOT, SN

China

Regulatory Body China Food and Drug Administration (CFDA)
Product Scope All pharmaceutical products included in national or provincial essential drug lists for the Chinese market.
Effective Date / Implementation Deadline December 2015
Status In effect
2. Secondary Serialisation (Carton) Yes
Code Type EDMC (Electronic Drug Monitoring Code) - 1D Barcode
Code Information Digits 1–7: Product Resources Code / Digits 8–16: Serial Number / Digits 17–20: Check bits
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes, Bundle (optional) Case
Code Type EDMC (Electronic Drug Monitoring Code) - 1D Barcode
Code Information Digits 1-7: Product Resources Code Digits 8-16: Serial Number Digits 17-20: Check bits
4. Aggregation Yes
5. Reporting To CFDA Central Database

India

Regulatory Body Directorate General of Foreign Trade
Product Scope Applicable only for pharmaceutical exports out of India.
Effective Date / Implementation Deadline July 20111
Status In effect
1. Primary Serialisation (Single Unit) Optional
Code Type GS1 Data Matrix
Code Information GTIN, SN, EXP, LOT
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix or GS1-128
Code Information GTIN, SN, EXP, LOT
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes
Code Type GS1-128
Code Information GTIN, EXP, LOT & SSCC
4. Aggregation Yes
5. Reporting To DAVA Central Database Portal

South Korea

Regulatory Body Ministry of Health and Welfare
Product Scope * Designated Drugs: Narcotics, psychotropic medicines, flammable/explosive medicines, and biologics * Ethical Drugs
Effective Date / Implementation Deadline January 2016
Status In effect
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix or GS1-128
Code Information NTIN, EXP, LOT, SN
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes, Case
Code Type GS1-128
Code Information NTIN, EXP, LOT & SSCC
4. Aggregation Not yet but expected to be required
5. Reporting To KPIS Central Database:July 2016 (manufacturers)

Brasil

Regulatory Body National Agency for Sanitary Surveillance in Brazil (ANVISA)
Product Scope To be defined
Effective Date / Implementation Deadline Pilot Project starts in 2017 / Full Rollout planned for 2022
Status Concept
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix
Code Information GTIN, ANVISA Number, SN, EXP, LOT
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes, Case
Code Type GS1-128
Code Information GTIN, EXP, LOT & SSCC
4. Aggregation Yes

Argentinia

Regulatory Body Argentina Health Authority (ANMAT)
Product Scope Now: Catalogue of drugs which require a serial number / In future: All pharmaceutical products
Effective Date / Implementation Deadline December 2011
Status In effect
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix
Code Information GTIN, SN, Optional: EXP, LOT
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Optional
Code Type GS1-128
Code Information SSCC
4. Aggregation Implicit
5. Reporting To ANMAT Central Database

Mexico

Product Scope All prescription drug products
Status Concept
2. Secondary Serialisation (Carton) Yes
Code Type GS1 Data Matrix
Code Information GTIN, EXP, LOT, SN

U.S.

Regulatory Body Food and Drug Administration (FDA)
Product Scope Prescription drug products which are produced for the U.S. market
Effective Date / Implementation Deadline Phase 1 Batch Tracebility: January 2015 / Phase 2 Batch Tracebility and Serialisation: November 2017 / Phase 3 Unit Tracebility Interoperable: November 2023
Status Phase 1: In effect Phase 2+3: Upcoming
2. Secondary Serialisation (Carton) Yes (Phase 2+3)
Code Type GS1 Data Matrix
Code Information NTIN, SN, LOT, EXP
3. Tertiary Serialisation (Bundle/Case/Shipper/Pallet) Yes (Phase 2+3)
Code Type GS1 DataMatrix or GS1-128
Code Information NTIN, SN, LOT, EXP
4. Aggregation Phase 1: No Phase 2: Implicit Phase 3: To be defined
5. Reporting Phase 2: Lot Level Tracing + Serialisation Phase 3: Unit Level Tracing +Serialisation +Interoperable system

Canada

In Preperation

Canada

In Preperation

Lybia

In Preperation

Japan

In Preperation

Colombia

In Preperation