Globale Serialisierungsanforderungen – ein entscheidender Faktor in der Applikationswahl

Die Kenntnisse der nationalen Serialisierungs-Regularien im Hinblick auf die zukünftige Vermarktung in den entsprechenden Zielmärkten ist vielleicht das wichtigste Kriterium in der Definition der optimalen Track & Trace Lösung. Viele globale Projekte haben uns gezeigt, dass es speziell in diesem Kontext zu Fehlplanungen kommt, die oft nur mit hohem Investitions- und Zeitaufwand korrigiert werden können.

Unsere Serialisierungsexperten haben für Sie als "Einstieg" alle relevanten Daten wie nationale Richtlinien, zugrundeliegende Codieranforderungen, Fristen und Bewertungen der Marktsituationen hinsichtlich zukünftiger Entwicklungen zusammengetragen.

All dies finden Sie interaktiv und einfach strukturiert in der TQS-Weltkarte. Klicken Sie einfach auf ein Zielland und erhalten Sie alle relevanten Daten. Komplexität reduziert auf das Wesentliche.

Natürlich stehen wir Ihnen für weitergehende Fragen zur Verfügung, gleich ob es sich um ein länderspezifische Planungen oder ein konkretes Projekt handelt. Kontaktieren Sie uns per E-Mail und ein Track & Trace Experte wird sich umgehend bei Ihnen melden.

TQS-Infografik: Alle weltweiten Serialisierungsanforderungen auf einen Blick – Kompakt und verständlich

Bitte melden Sie sich an, um die TQS-Infografik „Serialisierungsanforderungen auf einen Blick“ herunterzuladen

European Union
Regulation Name / Authority

Directive 2011/62/EU / EU Commission

Serialisation Serialisation
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)

Tamper Evident

ja

Belgium
Regulation Name / Authority

APB (Belgian Pharmaceutical Association) / Belgian MoH

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)

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)

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

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.

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)

Serialisation Serialisation
Deadline

TBD

Data Carrier

TBD

Data Elements

TBD

Bahrain
Regulation Name / Authority

SCH Bahrain (Supreme Council for Health). Issuing the 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

Not required

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

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

Aggregation Aggregation
Deadline

Not mandatory

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

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

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)

Aggregation Aggregation
Deadline

Dec 31, 2018

Data Carrier

GS1 128 or GS1 DataMatrix

Data Elements

SSCC (AI 00)

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 (solely mono-cartons); 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

1 July, 2019
Historic development:
Oct 01, 2015
changed to
Apr 01, 2016 for non-SSI
Apr 01, 2017 for SSI and then postponed to July 1, 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
Badan Pengawas Obat dan Makanan (BPOM)

Serialisation Serialisation
Deadline

January 1, 2023

Data Carrier

QR Code or DataMatrix

Data Elements

  • GTIN or Product Edition Permission Number (AI 90)
  • (AI 90) Product Edition Permission Number
  • (AI 10) Batch Number;
  • (AI 17) Expiration Date;
  • (AI 21) Serial Number

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), Serial Number (AI 21), 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

31 December 2019 (imported)
1 Jan 2023 (domestic)

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)

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)

Aggregation Aggregation
Deadline

Not required

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)

Serialisation Serialisation
Deadline

Dec 31, 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)

Aggregation Aggregation
Deadline

Not required

Pakistan
Regulation Name / Authority

Drug Regulatory Authority of Pakistan (DRAP)

Tertiary level packaging
Batch Coding Batch Coding
Deadline

Dec 15, 2023

Data Carrier

GS1 Code 128

Data Elements

First code: GTIN (AI 01), Batch Number (10), Manufacturing Date (11), Expiration Date (17)
Second code: SSCC (AI 00)

Aggregation Aggregation
Deadline

Dec 15, 2023

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

December 15, 2019

Data Carrier

GS1 Data Matrix ECC200

Data Elements

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

Serialisation Serialisation
Deadline

December 15, 2023

Data Carrier

GS1 Data Matrix ECC200

Data Elements

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

Primary level packaging
Batch Coding Batch Coding
Deadline

Dec 15, 2019 or Dec 15, 2023 (see comment)

Data Carrier

GS1 Data Matrix ECC200

Data Elements

GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)
Information (AI 240)

Serialisation Serialisation
Deadline

December 15, 2023

Data Carrier

GS1 Data Matrix ECC200

Data Elements

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

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

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

Federal Law № 61-FZ "Circulation of Medicines" / Federal Service for Surveillance in Healthcare

Serialisation Serialisation
Deadline

January 2020 (all drugs)
Essential list might be earlier

Data Carrier

GS1 Data Matrix ECC200

Data Elements

  • GTIN (AI 01)
  • Serial Number (AI 21)
  • Batch/Lot Number (AI 10)
  • Expiration Date (AI 17)
  • Verification key (AI 91) – only in DataMatrix
  • Crypto-key (AI 92) – only in DataMatrix

Aggregation Aggregation
Deadline

January 2020 (all drugs)

Data Carrier

GS1 128

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

Mar 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

Mar 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

Not mandatory

South Africa
Regulation Name / Authority

National Department of Health South Africa

Tertiary packaging
Batch coding Batch coding
Deadline

December 30, 2018

Data Carrier

GS1 128 Linear Barcode or GS1 Data Matrix

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

Sep 01, 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

Jan 01, 2015

Data Carrier

GS1 Data Matrix

Data Elements

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

Aggregation Aggregation
Deadline

Not mandatory

Taiwan
Regulation Name / Authority

Taiwan Food and Drug Administration (TFDA)

Batch Coding Batch Coding
Deadline

Jan 01, 2018 (for secondary and tertiary level)

Data Carrier

GS1 Data Matrix ECC200 (secondary) / GS1 Data Matrix ECC200 or GS1 128 (tertiary)

Data Elements

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

Serialisation Serialisation
Deadline

Jan 01, 2019 (for secondary and tertiary level)

Data Carrier

GS1 Data Matrix ECC200 (secondary) / GS1 Data Matrix ECC200 or GS1 128 (tertiary)

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

Turkey
Regulation Name / Authority

“Regulation Regarding the Packaging and Labeling of Medicinal Products for Human Use” Official Gazette 25904 from 12/08/2005 – İTS „ilaç takip sistemi“ / Turkey MoH

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, 2010

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)

Aggregation Aggregation
Deadline

TBD

Ukraine
Regulation Name / Authority

State Service of Ukraine on Medicines and Drug Control

Serialisation Serialisation
Deadline

October 18, 2018

Data Carrier

GS1 bar code, possibly Data Matrix

Data Elements

  • (01) GTIN
  • (21) Serial number
  • (10) Batch number
  • (17) Expiry date

Other data to be included to the packaging:

  • the name of the medicinal product
  • the name and address of its manufacturer
  • registration number
  • methods of application; dose of the active substance in each unit and their amount in the package
  • storage conditions;precautions

Tamper Evident

no

USA
Regulation Name / Authority

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

Serialisation Serialisation
Deadline

November 27, 2017
(no FDA enforcement until Nov 26, 2018)

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

Produktfinder

In 3 Schritten zu Ihrer Lösung

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