Coding regulations for pharmaceuticals

Pharmaceutical marking and medical product coding

Serialization

In the context of the pharmaceutical supply chain, serialization refers to the assignment of a unique, random serial number to each saleable unit, conferring it with a distinctive identity that allows it to be effectively tracked at virtually at any point during its life cycle.

Aggregation

Aggregation refers to the grouping of individually serialized packaging into larger units such as bundles, cases or pallets. These units bear a code that contains information about the serialized packaging within the unit.

Argentina
ANMAT drug traceability system
Administración Nacional de Medicamentos

Serialization

Deadline:
Data Carrier:
Data Element:
30th August 2015
GS1-128, DataMatrix, RFID Tag
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
not mandatory

Click here to get to the website of the local authority.

Bahrain
Issuing a Track and Trace System for the Supply Chain of Medicine within the Kingdom of Bahrain
SCH Bahrain

Serialization

Deadline:
Data Carrier:
Data Element:
31st December 2019
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
1st September 2021

Click here to get to the website of the local authority.

Brazil
SNCM “Sistema Nacional de Controle de Medicamentos” Law No. 11.903/2009
ANVISA

Serialization

Deadline:
Data Carrier:
Data Element:
1st April 2022
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number
Anvisa Registration Number

Aggregation

Deadline:
Data Carrier:
1st April 2022
SSCC
SGTIN
Ad-hoc aggregator based on the CNPJ (national company ID)
Serial Number
Anvisa Registration Number

Click here to get to the website of the local authority.

China
CFDA Decree No. 28 “National e-coding system”
CFDA

Serialization

Deadline:
Data Carrier:
Data Element:
31st December 2015 (on hold)
Linear/2D Barcode, RFID, HRI
Serial Number
Batch/Lot Number
Expiry Date
Production Date

Aggregation

Deadline:
Data Carrier:
31st December 2015 (on hold)
Linear/2D Barcode
RFID
HRI

Click here to get to the website of the local authority.

Egypt
Project on Tracing & Tracking Pharmaceutical Preparations
Inside Arab Republic of Egypt

Aggregation

Deadline:
Data Carrier:
Data Element:
31st December 2019
GS1 128 or GS1 DataMatrix
SSCC (AI 00)

Click here to get to the website of the local authority.

European Union
Directive 2011/62/EU
EU Commission

Serialization

Deadline:
Data Carrier:
Data Element:
09th February 2019
DataMatrix
Unique product identification number (e. g. GTIN/NTIN/PPN)
Batch/Lot Number
Expiry Date
Serial Number
National reimbursement number (if applicable)

Click here to get to the website of the local authority.

India
Pharmaeutical Export Promotion Counsil of India

Serialization

Deadline:
Data Carrier:

Data Element:
1st October 2013
DataMatrix, (or GS1-128), (or GS1-Databar)
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:

Data Carrier:
Data Element:
1st April 2016 / 2017 (NON-SSI / SSI)
GS1-128 (x2)
GTIN
Batch/Lot Number
Expiry Date
Serial number as SSCC (AI 00) – for second code

Click here to get to the website of the local authority.

Indonesia
Regulation Number 33 of 2018
National Agency of Drug and Food Control

Serialization

Deadline:
Data Carrier:

Data Element:
2023 (to be defined)
QR Code issued by BPOM, (or own 2D data carrier)
Product Edition Permission Number
Batch/Lot Number
Expiry Date
Serial Number
ID of Production Facility

Click here to get to the website of the local authority.

Iran
Executive guideline No. 660/11873
TTAC

Serialization

Deadline:
Data Carrier:
Data Element:
1st January 2015
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

Japan
Implementation Guideline for Barcode Labeling of Prescription Drugs
Ministry of Health, Labour and Welfare (MHLW)

Serialization

Deadline:
Data Carrier:
Data Element:
1st December 2022
GS1 DataBar Limited / Stacked
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
Data Carrier:
Data Element:
1st December 2022
GS1-128
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

Jordan
Guidelines of Identification and Bar coding of Medicinal Products for Human Use
JFDA

Serialization

Deadline:
Data Carrier:
Data Element:
1st July 2018
DataMatrix
GTIN
Batch/Lot Number
Expiry Date

Aggregation

Deadline:
Data Carrier:
Data Element:
1st January 2020
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

Norway
Norwegian Medicines Agency

Serialization

Deadline:
Data Carrier:
Data Element:
1st January 2018
Linear/2D Barcode
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
Data Carrier:
Data Element:
09th February 2019
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

Oman
MH/DGMS/DSS/M/7043
Directorate General of Medicinal Supplies MoH Oman

Serialization

Deadline:
Data Carrier:
Data Element:
31st December 2018
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

Pakistan
Ministry of National Health Services, Regulations and Coordination

Serialization

Deadline:
Data Carrier:
Data Element:
15th December 2023
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number
Product Identification Information

Aggregation

Deadline:
Data Carrier:
Data Element:
15th December 2023
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number
Product Identification Information

Click here to get to the website of the local authority.

Russia
Federal Law No 488-FZ
Federal Service for Surveillance in Healthcare

Serialization

Deadline:
Data Carrier:
Data Element:
1st July 2020
DataMatrix
GTIN
Batch/Lot Number (optional)
Expiry Date (optional)
Serial Number

Aggregation

Deadline:
Data Carrier:
Data Element:
1st July 2020
GS1-128
SSCC (AI 00) – for manufacturers and wholesalers
sGTIN (GTIN + Serial Number) – manufacturers only
Identification Code of the tertiary packaging (AI 999): Package extension indicator (N1), wholesale organitazion identifier (N2-N10), control number (N18)

Click here to get to the website of the local authority.

Saudi Arabia
Guidance for the industry on Saudi Drug Code (SDC) and drug barcoding specifiations
Saudi FDA

Serialization

Deadline:
Data Carrier:
Data Element:
1st October 2019
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
Data Carrier:
Data Element:
30th June 2020
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

South Africa
National Department of Health South Africa

Serialization

Deadline:
Data Carrier:
Data Element:
30th June 2022
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
Data Carrier:
Data Element:
30th June 2022
GS1-128(or DataMatrix)
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

South Korea
Korean Pharmaceuticals Information Service
Ministry for Food and Drug Safety (MFDS)

Serialization

Deadline:
Data Carrier:
Data Element:
1st January 2016
DataMatrix, (or GS1-128) ,(or RFID)
KDC (Korean Drug Code)
Batch/Lot Number (optional)
Expiry Date (optional)
Serial Number

Click here to get to the website of the local authority.

Taiwan
Taiwan Food and Drug Administration (TFDA)

Serialization

Deadline:
Data Carrier:
Data Element:
1st January 2019
DataMatrix, (or GS1-128),
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
1st January 2020

Click here to get to the website of the local authority.

Turkey
“Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use”, Official Gazette 25904
Turkey MoH

Serialization

Deadline:
Data Carrier:
Data Element:
1st June 2010
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
Data Carrier:
Data Element:
1st June 2010
GS1-128
SSCC (AI 00)

Click here to get to the website of the local authority.

Ukraine
State Service of Ukraine on Medicines and Drug Control

Serialization

Deadline:
Data Carrier:
Data Element:
2021 (to be defined)
GS1 bar code,Data Matrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Click here to get to the website of the local authority.

USA
Drug Quality Security Act (HR 3204)
US FDA

Serialization

Deadline:
Data Carrier:
Data Element:
27th November 2017
DataMatrix
GTIN
Batch/Lot Number
Expiry Date
Serial Number

Aggregation

Deadline:
1st November 2023

Click here to get to the website of the local authority.

This website is intended to outline the legislative landscape in terms of pharmaceutical serialization and aggregation. The site raises no claim to completeness. For the most up to date information, please contact the relevant regulatory authority. Last update: 2019/11/04