Serialization Pharma: Meeting the global serialization requirements

The national regulations on the serialization and aggregation of drugs are possibly the most important criteria in the global marketing of pharmaceuticals and other related healthcare solutions. Optimum implementation requires complete and up-to-the-minute knowledge of the relevant obligations for pharma serialization and aggregation. WIPOTEC's large number of global projects have shown that successful serialization and aggregation projects are well planned and avoid unnecessary expenditures that oftentimes lead to implementation delays.

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Interactive world map on pharma serialization

Our experts for the serialization and aggregation of pharmaceuticals have collected for you all relevant data such as national regulations, underlying coding requirements, implementation deadlines and evaluations of the market situations in relation to future developments.

You’ll find all this information in a compact form and simply structured on the interactive world map. Simply click on a country to get all the relevant data on the global pharma serialization and aggregation requirements.

 

European Union
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialization Serialization
Deadline

February 09, 2019

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN/PPN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable).

Tamper Evident

Yes

Aggregation Aggregation
Deadline

Not mandatory

Austria
Regulation Name / Authority

Coding rules for Austria to be used for verifiable medicinal products on the Austrian market according to EU Directive 2011/62 / EU and Delegated Regulation (EU) 2016/16 / AMVO

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data matrix code with human readable text elements

Data Elements

  • Product Code (GTIN or NTIN) (Al 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Belgium
Regulation Name / Authority

APB (Belgian Pharmaceutical Association) / Belgian MoH

Step 1
Serialisation Serialisation
Deadline

July 01, 2004

Data Carrier

Code 128 C on Vignette

Data Elements

7-digit national registration number (CNK) + Unique 8-digit serial number + 1 control digit

Step 2
Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Bulgaria
Regulation Name / Authority

Drug Act Amendment Law no. 67 dated of July 28, 2020

Serialisation Serialisation
Deadline

tbd

Data Carrier

tbd

Data Elements

A unique national identification number

Aggregation Aggregation
Deadline

not required

Denmark
Regulation Name / Authority

Danish Medicines Agency (DKMA)

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

Linear barcode / 2D Data Matrix

Data Elements

  • GTIN and / or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Finland
Regulation Name / Authority

Finnish Medicines Agency (Fimea)

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix,
Human readable interpretation

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

France
Regulation Name / Authority

CIP (Club Inter Pharmaceutique) - / ANSM (French National Agency for Medicines and Health Products Safety)

Batch Coding Batch Coding
Deadline

January 01, 2011

Data Carrier

GS1 Data Matrix ECC200

Data Elements

Unique product identification number (French CIP code / NTIN) - (AI 01), Expiry date (AI 17), Batch/Lot number (AI 10).

Serialisation Serialisation
Deadline

February 09, 2019

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identifier GTIN or NTIN

  • Product code
  • Serial number
  • Batch number
  • Expiry date
  • National reimbursement number, not applicable in France

Aggregation Aggregation
Deadline

Not mandatory

Germany
Regulation Name / Authority

NMVS (National System according to EU FMD) - ACS-MAH-System “securPharm”

Serialisation Serialisation
Deadline

February 09, 2019

Data Carrier

Data Matrix ECC200 (ASC/IFA- or GS1-Format)

Data Elements

Unique product identification number (PPN or NTIN), Batch/Lot number, Expiry date, Serial number.

Aggregation Aggregation
Deadline

Not mandatory

European Union / Greece
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Greece
Regulation Name / Authority

Greek Ministry of Health & Welfare

Serialisation Serialisation
Deadline

Apr 08, 2004

Data Carrier

Code 128 and EAN-13 on Vignette

Data Elements

Serial number (in Code 128) and Greek EOF code (9 digits) incl. NPO registration number (in EAN-13)

European Union / Italy
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Italy
Regulation Name / Authority

“Italian Bollini” / Italian MoH

Step 1
Serialisation Serialisation
Deadline

Jan 04, 2005 “old Bollino” / Dec 31, 2015 “new Bollino”

Data Carrier

2 linear barcodes (Code 39 and ITF) on Bollino (Vignette) and one 2D DataMatrix

Data Elements

New Bollino
3 barcodes: 2 linear barcodes (Code 39 and ITF) encoding the AIC code and the serial number and a 2D DataMatrix encoding the AIC and the serial number.

Step 2
Serialisation Serialisation
Deadline

February 09, 2025

Data Carrier

Data Matrix ECC200

Data Elements

Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)

Island
Regulation Name / Authority

Icelandic Medicines Agency

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix and optionally linear barcode
Human readable interpretation

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Sweden
Regulation Name / Authority

LIF Sweden

Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix,
Human readable interpretation

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Argentina
Regulation Name / Authority

ANMAT drug traceability system / Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Serialisation Serialisation
Deadline

August 30, 2015

Data Carrier

GS1 Data Matrix ECC200, GS1 128, RFID tag

Data Elements

  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)-optional
  • Exp. Date (AI 17)-optional

Australia
Regulation Name / Authority

Guidance on TGO 92 / Therapeutic Goods Administration (TGA)

Batch coding Batch coding
Deadline

Sep 01, 2020

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Bahrain
Regulation Name / Authority

System for Tracking and Tracing Medicine Provision and Supply Chain inside the Kingdom of Bahrain

Serialisation Serialisation
Deadline

December, 31 2019

Data Carrier

GS1 Data Matrix ECC200

Data Elements

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

Tamper Evident

no

Aggregation Aggregation
Deadline

September 01, 2021

Brazil
Regulation Name / Authority

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

Serialisation Serialisation
Deadline

August 01, 2018 (3 batches / see expert view)
April 01, 2022 (All products / see expert view)

Data Carrier

Data Matrix ECC200

Data Elements

GTIN (AI 01) or National Number (NHRN) - (AI 713), Expiration Date (AI 17), Batch/Lot Number (AI 10), Serial Number (AI 21)

Aggregation Aggregation
Deadline

Aug 01, 2018 (3 batches / see expert view)
Apr 01, 2022 (All products / see expert view)

Data Carrier

Possibly GS1 128

Data Elements

Possibly SSCC (AI 00)

China - Human
Regulation Name / Authority

Draft traceability system guide by NMPA (former: CNDA), dated of 24 August 2018

Historic record: CFDA Decree No.28 / “National e-coding system” / CFDA

Serialisation Serialisation
Deadline

Jan 01, 2022

Data Carrier

Other, GS1 Standards are accepted

Data Elements

National Number that includes a data thread including a unique serial number

Historic record
Serialisation Serialisation
Deadline

Dec 31, 2015
ON HOLD since Feb 20, 2016

Data Carrier

Linear Code 128 C / 2D barcode / RFID tag

Data Elements

NATIONAL product code (country number, drug category number, company ID, drug identification number and the check number (14 digits))

Aggregation Aggregation
Deadline

Dec 31, 2015
ON HOLD since Feb 20, 2016

Data Carrier

Linear Code 128 C / 2D barcode / RFID tag

Data Elements

NATIONAL product code (country number, drug category number, company ID, drug identification number and the check number (14 digits))

China - Vaccine
Regulation Name / Authority

Article 10 The State implements a full electronic traceability system for vaccines by NPC

Serialisation Serialisation
Deadline

December 01, 2019

Data Carrier

vaccine electronic traceability system

Data Elements

The drug regulatory department of the State Council, in conjunction with the State Council's health and health authorities, will develop a unified vaccine traceability standards and norms, establish a national vaccine electronic traceability collaboration platform, integrated traceability information on vaccine production, circulation and vaccination to achieve traceability of vaccines.

China - Medical instruments
Regulation Name / Authority

Rules for Unique Device Identification (UDI) System by NMPA, dated of 27 August 2019

Serialisation Serialisation
Deadline

October 10, 2019

Data Carrier

1-D code, 2-D code or RF labels

Data Elements

The unique device identification refers to a code consisting of numbers, letters or symbols attached to a medical device product or package for unique device identification

China - Veterinary
Regulation Name / Authority

Ministry of Agriculture of the People’s Republic of China

Serialisation Serialisation
Deadline

Jun 30, 2016

Data Carrier

QR Code (UTF-8)

Data Elements

Veterinary drug product tracing code (24-digit number randomly generated by the national veterinary drug product tracing system) containing tracing code, product name, product approval number or registration certificate number of import veterinary drugs, abbreviation of the manufacturing enterprise and contact telephone

Aggregation Aggregation
Deadline

Not mandatory

Egypt
Regulation Name / Authority

Ministry of health 24/10/2019

Serialisation Serialisation
Deadline

Dec 31, 2018

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

India
Regulation Name / Authority

DGFT (Directorate General of Foreign Trade) - System Development handed over to PHARMACEUTICAL EXPORT PROMOTION COUNSIL OF INDIA (PHARMEXCIL)

Primary Level Packaging
Serialisation Serialisation
Deadline

Apr 01, 2015 (on optional basis also for solely mono-cartons containing one primary pack);
Remaining delayed until further notice

Data Carrier

EAN/UPC or GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21)

Secondary Level Packaging
Serialisation Serialisation
Deadline

Oct 01, 2013

Data Carrier

GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21)

Aggregation Aggregation
Deadline
Historic development:
Oct 01, 2015 changed to
Apr 01, 2016 for non-SSI
Apr 01, 2017 for SSI and then it has been postponed to July 1, .2019 and no it has been postponed to Apr 01, 2019

Data Carrier

GS1 128 x 2

Data Elements

First code: GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and
Second code:Serial number as SSCC (AI00))

Tertiary Level Packaging
Serialisation Serialisation
Deadline

Oct 01, 2011

Data Carrier

GS1 128 or GS1 Data Matrix ECC200 (first code) / GS1 128 (second code)

Data Elements

a) Shipping cases: First code – GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21) // Second code – SSCC (AI 00);

b) Pallets: SSCC (AI 00)

Indonesia
Regulation Name / Authority

National Agency of Drug and Food Control Regulation

Serialisation Serialisation
Deadline

January 1, 2023

Data Carrier

2D Bar Code: GS1 DataMatrix

Data Elements

  • GTIN - AI (01)
  • Batch/Lot Number - AI (10)
  • Expiration Date - AI (17)
  • Serial Number - AI (21)

Aggregation Aggregation
Deadline

Not required

Iran
Regulation Name / Authority

TTAC Executive guideline No. 660/11873 dated Sept. 7, 2014

Serialisation Serialisation
Deadline

Jan 01, 2015

Data Carrier

GS1 Data Matrix

Data Elements

GTIN (AI 01), UID, Batch/Lot Number (AI 10), Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Not mandatory

Jordan
Regulation Name / Authority

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

Batch Coding Batch Coding
Deadline

Jul 01, 2018

Data Carrier

GS1 Data Matrix

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

January 01, 2020

Data Carrier

GS1 Data Matrix

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

Not mandatory. Only batch coding

Lebanon
Regulation Name / Authority

Ministry of Public Health

Batch coding Batch coding
Deadline

December 31, 2019

Data Carrier

GS1 2D DataMatrix

Data Elements

  • GTIN (AI 01)
  • EXPIRY DATE (AI 17)
  • BATCH/LOT Number (AI 10)

Malaysia
Regulation Name / Authority

MoH Draft Rule

Serialisation Serialisation
Deadline

January 01, 2023

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

January 01, 2023

Data Carrier

GS1 128

Data Elements

SSCC (AI 00)

North Korea
Regulation Name / Authority

Guideline of Usage and Control of Barcode and RFID for Pharmaceutical Product

Serialisation Serialisation
Deadline

January 01, 2015

Data Carrier

GS1 DataMatrix

Data Elements

  • NTIN
  • Batch/Lot Number - AI (10)
  • Expiration Date - AI (17)
  • Serial Number - AI (21)

Norway
Regulation Name / Authority

Norwegian Medicines Agency

Step 1
Serialisation Serialisation
Deadline

January 1, 2018

Data Carrier

Linear barcode and optionally 2D Data Matrix barcode

Data Elements

  • GTIN or unique NTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Step 2
Serialisation Serialisation
Deadline

February 9, 2019

Data Carrier

2D Data Matrix,
Human readable interpretation

Data Elements

  • GTIN
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Tamper Evident

yes

Oman
Regulation Name / Authority

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

Secondary Level Packaging
Batch coding Batch coding
Deadline

Dec 31, 2017

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

Mar 1, 2019

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Tertiary level packaging
Batch coding Batch coding
Deadline

Dec 31, 2017

Data Carrier

GS1 Data Matrix ECC200 or GS1 128

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Pakistan
Regulation Name / Authority

Ministry of National Health Services, Regulations and Coordination

Tertiary level packaging
Batch Coding Batch Coding
Deadline

Aug 1, 2025

Data Carrier

2D Bar Code : GS1 DataMatrix

Data Elements

GTIN AI (01)
Batch/Lot Number - AI (10)
Expiration Date - AI (17)
Serial Number - AI (21)

Aggregation Aggregation
Deadline

Dec 15, 2023 - on hold

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01)
Expiration Date (AI 17)
Batch/Lot Number (AI 10)
Product Identification Information (AI 240)
Serial Number (AI 21)

Secondary level packaging
Batch Coding Batch Coding
Deadline

Aug 1, 2025

Data Carrier

2D Bar Code : GS1 DataMatrix

Data Elements

GTIN AI (01)
Batch/Lot Number - AI (10)
Expiration Date - AI (17)
Serial Number - AI (21)

Serialisation Serialisation
Deadline

Dec 15, 2025 - on hold

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01)
Expiration Date (AI 17)
Batch/Lot Number (AI 10)
Product Identification Information (AI 240)
Serial Number (AI 21)

Primary level packaging
Batch Coding Batch Coding
Deadline

Aug 1, 2025

Data Carrier

2D Bar Code : GS1 DataMatrix

Data Elements

GTIN AI (01)
Batch/Lot Number - AI (10)
Expiration Date - AI (17)
Serial Number - AI (21)

Serialisation Serialisation
Deadline

Dec 15, 2025 - on hold

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01)
Expiration Date (AI 17)
Batch/Lot Number (AI 10)
Product Identification Information (AI 240)
Serial Number (AI 21)

Philippines
Regulation Name / Authority

Guidelines on Implementing FDA Circular No. 2014-011

Batch Coding Batch Coding
Deadline

Jun 30, 2016 - ON HOLD

Data Carrier

Linear code or Data Matrix (possibly GS1)

Data Elements

GTIN (AI 01) , Expiration Date (AI 17), Batch/Lot Number (AI 10)

Qatar
Regulation Name / Authority

Hamad Medical Corporation

Tertiary packaging level
Batch coding Batch coding
Deadline

January 1, 2018

Data Carrier

GS1 Data Matrix ECC200 or GS1-128

Data Elements

  • GTIN (AI 01)
  • EXPIRY DATE (AI 17)
  • BATCH/LOT Number (AI 10)

Secondary level
Batch coding Batch coding
Deadline

January 1, 2018

Data Carrier

GS1 Data Matrix ECC200,
Human readable interpretation

Data Elements

  • GTIN (AI 01)
  • EXPIRY DATE (AI 17)
  • BATCH/LOT (AI 10)

Russia
Regulation Name / Authority

The Government of the russian Federation in Moscow
Decree of December 14, 2018 No. 1556, amendment No. 1118 of August 30,
2019 and Federal Law 462-FZ of December 27, 2019

Serialisation Serialisation
Deadline

7 Nosologies: December 31, 2019
all drugs: July 01, 2020

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Verification key (AI 91), Crypto-key (AI 92)

Aggregation Aggregation
Deadline

31. Dec 2019 - 7 Nosologies
01. July 2020 - all drugs

Data Carrier

GS1 128 or sGTIN

Data Elements

Manufacturers and wholesalers (members of GS1 Russia):
SSCC (AI 00)

Manufacturers only:
sGTIN: GTIN (AI 01) and Serial Number (AI 21)

Wholesalers only (non-members of GS1 Russia):
Identification Code of the tertiary packaging (AI 999): Package extension indicator (N1), wholesale organization identifier (N2-N10), control number (N18)

Saudi Arabia
Regulation Name / Authority

Guidance for the industry on Saudi Drug Code (SDC) and drug barcoding specifications / Saudi FDA

Batch Coding Batch Coding
Deadline

March 21, 2015

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • GTIN (AI 01)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Serialisation Serialisation
Deadline

March 12, 2017

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)

Aggregation Aggregation
Deadline

March 31, 2020

Data Carrier

GS1 128

Data Elements

SSCC (AI 00)

South Africa
Regulation Name / Authority

Republic of South Africa - Department of Health

Tertiary packaging
Batch coding Batch coding
Deadline

December 30, 2018

Data Carrier

1D Bar Code : GS1-128

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)

Aggregation Aggregation
Deadline

June 30, 2022

Data Carrier

GS1 128 Linear Barcode or GS1 Data Matrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)
  • SERIAL NUMBER (21)

Secondary packaging
Batch coding Batch coding
Deadline

June 30, 2020

Data Carrier

GS1 DataMatrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)

Serialisation Serialisation
Deadline

Jun 30, 2022

Data Carrier

GS1 DataMatrix

Data Elements

  • GTIN (01)
  • BATCH/LOT (10)
  • EXPIRATION DATE (17)
  • SERIAL NUMBER (21)

South Korea
Regulation Name / Authority

Korean Pharmaceuticals Information Service / Ministry for Food and Drug Safety (MFDS - formely Korean FDA)

Batch Coding Batch Coding
Deadline

Jan 01, 2010 (solely KDC coding)
Jan 01, 2012 (specific products)
Jan 01, 2013 (all Rx products)

Data Carrier

GS1 Data Matrix ECC200 or GS1 128

Data Elements

KDC (Korean Drug Code / NTIN) - (AI 01), Expiration Date (AI 17) and Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

January 01, 2015 (selected products)
Jan 01, 2016 (all products)

Data Carrier

GS1 Data Matrix ECC200 or GS1 128 or RFID

Data Elements

KDC (Korean Drug Code / NTIN) - (AI 01)
Serial Number (AI 21)
Batch/Lot Number (AI 10)
Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Not mandatory

Switzerland
Regulation Name / Authority

Swiss Federal Office of Public Health

Serialisation Serialisation
not established yet
Taiwan
Regulation Name / Authority

Taiwan Food and Drug Administration (TFDA)

Secondary level
Batch Coding Batch Coding
Deadline

Secondary and tertiary level:
Jan 01, 2018

Data Carrier

Secondary level: GS1 Data Matrix ECC200
Tertiary level: GS1 Data Matrix ECC200 or GS1 128

Data Elements

GTIN (AI 01), Batch/Lot Number (AI 10) and Expiration Date (AI 17)

Serialisation Serialisation
Deadline

Secondary and tertiary level:
Jan 01, 2019

Data Carrier

Secondary level: GS1 Data Matrix ECC200
Tertiary level: GS1 Data Matrix ECC200 or GS1 128

Data Elements

GTIN (AI 01), Serial Number (AI 21), Batch/Lot Number (AI 10) and Expiration Date (AI 17)

Aggregation Aggregation
Deadline

Jan 01, 2020

Tunisia
Regulation Name / Authority

Ministry of health

Batch coding Batch coding
Deadline

January 1, 2019

Data Carrier

GS1 2D DataMatrix

Data Elements

  • (01) GTIN
  • (10) Batch/Lot Number
  • (17) Expiry Date

Serialisation Serialisation
Serialisation is under discussion

Turkey
Regulation Name / Authority

Republic of Turkey, Ministry of Health
Turkish Medicines and Medical Devices Agency

Serialisation Serialisation
Deadline

Jun 01, 2010

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

Jun 01, 2012

Data Carrier

GS1 128

Data Elements

SSCC (AI 00)

United Arab Emirates
Regulation Name / Authority

Dubai Health Authority - DHA

Batch Coding Batch Coding
Deadline

Jan 01, 2017

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • GTIN (AI 01)
  • Expiration Date (AI 17)
  • Batch/Lot Number (AI 10)

Serialisation Serialisation
Deadline

January 01, 2020

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Expiration Date (AI 17)
  • Batch/Lot Number (AI 10)

Ukraine
Regulation Name / Authority

State Service of Ukraine on Medicines and Drug Control

Serialisation Serialisation
Deadline

2021 (not defined)

Data Carrier

GS1 bar code, possibly Data Matrix

Data Elements

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

USA
Regulation Name / Authority

Drug Quality and Security Act (HR 3204)
Title II: Drug Supply Chain Security Act (DSCSA) / US FDA

Serialisation Serialisation
Deadline

November 27, 2017
(no FDA enforcement until Nov 26, 2019)

Data Carrier

Data Matrix ECC200

Data Elements

GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17) and Batch/Lot Number (AI 10)

Aggregation Aggregation
Deadline

November 01, 2023 (To be decided)

Data Carrier

To be decided

Data Elements

To be decided

EU DIRECTIVE ON SERIALIZATION PHARMA

The EU Falsified Medicines Directive 2011/62/EU enforced on February 9, 2019 stipulates that the manufacturer must provide pharmaceuticals with several safety features. The EU Directive on the Serialization of Medicinal Products aims to guarantee complete authenticity verification and effectively curb the occurrence of falsified medicinal products on the market. For producers of pharmaceuticals this means that anyone not complying with the requirements for pharma serialization cannot sell medicinal products on the European market.

Find out now which conditions will have to be met in the EU!

US DSCSA DEADLINE REQUIREMENTS

Implementation of the serialization obligation came in even earlier in the USA than in the EU. Since many national pharmaceutical manufacturers could not meet the very tight deadline by the end of 2017 and there were threats of a supply shortage, the FDA had postponed the deadline by a year.

Find out now what conditions will have to be met in the USA.

 

All global requirements for serialisation pharma at a glance

Information graphic Serialization Pharma: All global serialization requirements at a glance – compact and comprehensible

Our project engineers and serialization and aggregation experts use the national requirements for serialization in the pharma industry as the basis for preparing the right machine and line configuration for you. They will be at your side during order processing and subsequently help, together with our service department, during implementation in your production lines. In this way we ensure that the agreed product and customer-specific requirements are met and completion is on schedule.

 

Find your suitable Serialization & Aggregation Solution

Why you should opt for the pharmaceutical serialization solution from WIPOTEC-OCS

  • All key functions for the serialization and aggregation of drugs in a compact area
  • Fastest possible commissioning of the Serialization & Aggregation systems within six weeks
  • Smooth integration in existing production lines thanks to open interfaces
  • Lifetime software updates and maintenance free of charge
  • Best advice thanks to our networking with decision-makers and experts on the international serialization guidelines
  • Whole system comes from a single source which we develop and produce on site

Meet country-specific serialization requirements without losses in production efficiency:

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Serialization Pharma with WIPOTEC-OCS

Expert know-how at WIPOTEC-OCS – always up-to-date

WIPOTEC-OCS is very well positioned globally. With more than 100 branch offices and partner companies, we are very close to pharmaceutical customers and CMOs (Contract Manufacturing Organizations) on the sales and service side. Thanks to our broad Serialization & Aggregation portfolio, many doors open up to us worldwide, benefitting not least our customers.

We concentrate here on participating in working groups of the VDMA (Protect-ing) and on our status as a solution partner for GS1 Germany. Together with GS1, we work out solutions for implementing pharma serialization and aggregation smoothly and in compliance with regulations. Our international activities also provide our customers with additional benefits. These are, for example, our active participation in the GS1 Global Healthcare User Group and our founding membership of the steering committee in the Open-SCS Working Group. Our active participation in a large number of national and international associations and groups means that we are always on the ball and able to pass on the latest developments and findings regarding serialization and aggregation in the pharmaceutical industry to our customers.

Use the expert know-how of WIPOTEC-OCS

  • Extensive experience thanks to over 3,000 successful Serialization & Aggregation projects
  • Premium partner of GS1 in the field of pharma serialization & aggregation and member of the Open-SCS Working Group
  • Premium engineering for high performance – 100% German workmanship and engineering at the highest level
  • Complete Serialization & Aggregation solution for all global requirements and regulations, reliable and future-proof
  • Open solution with standard interfaces for leading level 3 suppliers
  • Modular, scalable and easily integrated into existing lines
  • Excellent local technical support and engineering services

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Compact serialization pharma solution for greater drug safety

Serialization machines print drug packages with the necessary codes for serialization: Depending on the guideline, these are machine-readable matrix codes or alphanumeric character strings. The Serialization & Aggregation (i.e. Track & Trace) systems of WIPOTEC-OCS, however, can contribute more towards serialization than simply printing and verifying codes. They weigh the pharmaceutical product on the same installation surface and thus carry out a simultaneous package completeness check. The individual packages are additionally packaged so as to be tamper-evident. The TQS can also perform aggregation, that is the documented combination of product packages into larger packs (bundles, shipping boxes, and cases through to pallets). This ensures complete serialization at every level. Many pharmaceutical products require some of the most expensive production areas in the world. As a result, the machines to be installed have to make do with minimum space even when machines are replaced. WIPOTEC-OCS serialization and aggregation solutions successfully achieve more functionality in the same production space.

The serialization solutions from WIPOTEC-OCS provide up to four key functions for the serialization of drugs in a compact area:

  • Serialization: Generating, applying and verifying serial numbers and codes.
  • Applying country-specific vignettes and labels provides maximum flexibility when printing
  • Completeness check using package weight acquisition
  • Tamper-evident: Tamper-proof sealing of individual packages

TQS Fast Track – Implement fully automated serialization solutions within 6 weeks

The serialization of pharmaceuticals is highly strategic and is assigned a key role in the production environment. It ultimately depends on this whether a product is saleable at all. A completely controlled production flow can still fail right up to the last stage in the product design process, possibly the palletizing of individual boxes prior to shipping.

Since February 2019, pharmaceutical companies in the EU have had to serialize their products in accordance with the EU Directive. They therefore had less than two years to implement a serialization solution. For the US market, the deadline was set for November 2018 – American pharmaceutical companies had to comply with the requirements of the DSCSA guidelines by then.

This is where best practice from WIPOTEC-OCS comes into play. We provide standardised serialization machines which perform the greatest possible number of required market- and manufacturer-specific functions. Pre-engineering thus enables a lead time of six weeks. The delivery and configuration of an open XML interface which is included in all Serialization & Aggregation (i.e. Track & Trace) TQS solutions allows serialization machines to be installed and commissioned in the shortest time possible. The solutions from WIPOTEC-OCS are perfectly tailored to meet the needs of pharmaceutical companies, enabling them to achieve timely compliance with guidelines on the serialization obligation. As a result, there is hardly any faster way to meet the international requirements for serialization in the pharmaceutical industry while at the same time avoiding proprietary stand-alone solutions.

 

TQS Fast Track- the fast response to tight serialization deadlines

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TQS FAST TRACK – fully automated serialisation pharma solution

 

Supplier independence due to highly flexible serialization software solution with open interfaces

TQS stands for the open communication approach of the Serialization & Aggregation solutions from WIPOTEC-OCS. The Traceable Quality System underscores our philosophy of supporting the healthcare industry to satisfy global guidelines on serialization in the pharma sector in the best way possible. The open interfaces of the TQS solutions enable the flexible use of products from different manufacturers and thus avoid so-called vendor lock-in. The interoperability standards created as a result permit data exchange and collaboration across many systems. This approach gives you the flexibility to choose and apply the vendor solutions that you need in order to respond to different requirements in pharma serialization, production and packaging.

These open solutions avoid issues caused by involuntary manufacturer dependencies, such as the risk of production losses due to delayed software adaptations or difficulties in responding to changing regulations.

 

TQS Line Manager - open interfaces for avoiding lock-ins

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The certain EXTRA: that makes serialization pharma with WIPOTEC-OCS so unique

So along with the open system interface, it is not only the very short delivery times for best practice serialization and aggregation machines or the options for universal integration into other packaging machines which are the key benefits of the complete Serialization & Aggregation (i.e.Track & Trace) solutions from WIPOTEC-OCS. The fact that the overall system originates from a single source, is built in a single location and is controlled via a single interface is at least equally important. In addition to serialization parameters, it is possible to detect other product attributes such as weight and code quality for a truly unique selling point. All attributes can be stored together with the serial number (TQS Traceability+).

 

Outstanding features of Track & Trace TQS: Free software updates

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Less obvious, and therefore all the more noteworthy, is the fact that we charge no fees for software updates and maintenance. We ensure that the software of your WIPOTEC-OCS machines is always up-to-date so that you easily comply with the country-specific guidelines on the serialization of pharmaceuticals even if they change. This additional unique selling point of TQS is a significant cost benefit at a time when new catalogues of measures and legislative adaptations in the field of serialization pharma cannot be ruled out.

Choose your solution: serialization, aggregation, integration solutions

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