Global Pharma Regulations

One of the first pharma regulations was implemented by Turkey in 2009. Since then many countries followed and implemented various regulations for serialization and aggregation of pharmaceutical products. We, at Laetus, have been supporting our customers from the beginning, implementing solutions to ensure their compliance.

The graphic above highlights recent and upcoming regulatory requirements.

The following section lists all countries that have regulations for serialization & aggregation in place (a PDF is available for download at the bottom of this page):

Algeria

Ministry of Health, Population and Hospital Reform (MSPRH)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
DeadlinePlanned for 2025


Click here to go to local authority.

Argentina

Ministry of Health of the Argentine Republic (ANMAT)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 January 2023


Click here to go to local authority.

Australia

Department of Health and Aged Care

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 January 2023


Click here to go to local authority.

Bahrain

National Health Regulatory Authority (NHRA)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline31 December 2019

Aggregation

Data carrierGS1 128
Deadline01 September 2021

Click here to go to local authority.

Brazil

Brazilian Health Regulatory Authority (ANVISA) RDC 157 / 2017

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(713) – NHRN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 April 2022

Aggregation

Data elementsAI(00) – SSCC
Data carrierGS1 128
Deadline01 April 2022

Click here to go to local authority.

Canada

Canadian Institute for Safe Medication Practices (ISMP)

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
GS1 128
Deadline31 December 2023

Serialization

Data elementsoptional
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
Deadline31 December 2023

Click here to go to local authority.

Chile

Ministerio de Salud, Sub Secretaria de Salud Publica – Division Juridica

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
GS1 128
Deadline2013

Click here to go to local authority.

China

National Medicinal Products Administration (NMPA)

Serialization

Data elementsProprietary Chinese eCode or
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 128
DeadlineJune 2023

Aggregation

Data elementsProprietary Chinese eCode or
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 128
DeadlineJune 2023

Click here to go to local authority.

Columbia

INVIMA Ministry of Health and Social Protection

Serialization

Data elementsAI(01) – GTIN
AI(21) – Serial Number
Data carrierRFID
Deadline01 April 2018

Click here to go to local authority.

Ecuador

National Agency for Health Regulatory Control and Surveillance (ARCSA)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
Deadline26 May 2024

Click here to go to local authority.

Egypt

Egyptian Ministry of Health

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
Deadline31 December 2018

Click here to go to local authority.

Europe

EU Commission
Directive 2011/62/EU

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(713) – NHRN if applicable
AI(21) – Serial Number
Data carrierGS1 DataMatrix
DataMatrix
Deadline09 February 2019

Click here to go to local authority.

India

Ministry of Health and Family Welfare of India

Serialization

Primary
Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 Databar
Deadline01 April 2015
Secondary
Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
GS1 Databar
Deadline01 October 2013
Tertiary
Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
AI(00) – SSCC
Data carrierGS1 DataMatrix
GS1 128
Deadline01 October 2011

Aggregation

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(00) – SSCC
Data carrierGS1 128
Deadline01 July 2019

Click here to go to local authority.

Indonesia

National Agency for Pharmaceuticals and Food Control of the Republic of Indonesia

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 January 2023

Click here to go to local authority.

Iran

Ministry of Health and Medical Education

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
UID
Data carrierGS1 DataMatrix
Deadline01 January 2015

Click here to go to local authority.

Japan

Ministry of Health, Labour and Welfare

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataBar
Deadline01 July 2015

Aggregation

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
AI(30) – Quamtity
Data carrierGS1 128
Deadline01 April 2021

Click here to go to local authority.

Jordan

Jordanian Food and Drug Administration (JFDA)

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline01 July 2018

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 January 2020

Click here to go to local authority.

Kazachstan

Ministry of Finance / Health

Serialization

Data elementsAI(01) – GTIN
AI(21) – Serial Number
AI(91) – Crypto Key
AI(92) – Crypto Code
Data carrierGS1 DataMatrix
Deadline01 October 2011 (20%)
01 January 2023 (60%)
01 April 2023 (80%)
01 July 2023 (100%)

Aggregation

Data elementsAI(00) – SSCC
Data carrierGS1 128
Deadline01 October 2011 (20%)
01 January 2023 (60%)
01 April 2023 (80%)
01 July 2023 (100%)

Click here to go to local authority.

Lebanon

Ministry of Public Health

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline31 December 2019

Click here to go to local authority.

Malaysia

Malaysian Ministry of Health

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 January 2023

Aggregation

Data elementsAI(00) – SSCC
Data carrierGS1 128
Deadline01 January 2023

Click here to go to local authority.

Norway

The Norwegian Medicines Agency

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline09 February 2019

Click here to go to local authority.

Oman

Directorate General of Medical Supplies MoH

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline31 December 2017

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 March 2019

Click here to go to local authority.

Pakistan

Pakistan Drug Regulatory Authority (DRAP)

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline01 August 2025

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 August 2025

Aggregation

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
AI(240) – Product
Data carrierGS1 DataMatrix
Deadline15 September 2025

Click here to go to local authority.

Philippines

Food and Drug Administration Philippines

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
GS1 128
Deadline30 June 2016

Click here to go to local authority.

Quatar

Hamad Medical Corporation (HMC)

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
GS1 128
Deadline01 January 2018

Serialization

Data elementsAI(21) – Serial Number, if applicable
Data carrierGS1 DataMatrix
GS1 128
Deadline01 January 2018

Click here to go to local authority.

Russia

Ministry of Health of the Russian Federation

Serialization

Data elementsAI(10) – Batch/Lot
AI(21) – Serial Number
AI(91) – Crypto Key
AI(92) – Crypto Code
Data carrierGS1 DataMatrix
Deadline01 July 2020

Aggregation

Data elementsAI(00) – SSCC
or
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
Deadline01 July 2020

Click here to go to local authority.

Saudi Arabia

Saudi Food and Drug Administration (SFDA)

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline21 March 2015

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline12 March 2017

Aggregation

Data elementsAI(00) – SSCC
Data carrierGS1 128
Deadline31 March 2020

Click here to go to local authority.

South Africa

Ministry of Health of the Republic of South Africa (NDOH)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 QR
Deadline01 June 2022

Click here to go to local authority.

South Korea

Ministry for Food and Drug Safety

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
GS1 128
Deadline01 January 2013

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
RFID
Deadline01 January 2016

Click here to go to local authority.

Switzerland

Swiss Federal Office of Public Health (FOPH)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTINoptional
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline2018

Click here to go to local authority.

Tunesia

Ministry of Public Health

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline01 January 2019

Click here to go to local authority.

Turkey

Republic of Turkey Ministry of Health – Turkish Medicines and Medical Devices Agency (TİTCK)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 June 2010

Aggregation

Data elementsAI(00) – SSCC
Data carrierGS1 128
Deadline01 June 2012

Click here to go to local authority.

Ukraine

State Service of Ukraine on Medicines and Drug Control

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline2021 (not defined)

Click here to go to local authority.

UAE

Department of Health – Abu Dhabi

Batch constant

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
Data carrierGS1 DataMatrix
Deadline01 January 2017

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
Deadline01 January 2020

Click here to go to local authority.

USA

U.S. Food and Drug Administration (FDA)

Serialization

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
Deadline27 November 2017

Aggregation

Data elementsAI(10) – Batch/Lot
AI(17) – Expiration Date
AI(01) – GTIN
AI(21) – Serial Number
Data carrierGS1 DataMatrix
GS1 128
Deadline27 November 2023

Click here to go to local authority.

Uzbekistan

The State Tax Committee of the Republic of Uzbekistan, the Ministry of Finance and the Ministry of Health

Serialization

Data elementsAI(01) – GTIN
AI(21) – Serial Number
AI(91) – Crypto Key
AI(92) – Crypto Code
Data carrierGS1 DataMatrix
Deadline01 September 2022

Click here to go to local authority.


Download our PDF which summarizes the information and provides links to individual regulations.

Please provide us with the following information to download our complete regulations overview.

Last updated January 2023 – all data without guarantee