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TRACK & TRACE AROUND THE GLOBE
What is key for you to know?
Track and Trace solutions include any additional information generated at each packaging step
during the various aggregation levels in the distribution chain and record it in the corresponding code sent to the central database (traceable, transparent, secure).
Batch Coding
with data elements without
serial number.
Serialisation
of single packs with data
elements including serial
number (= unique identifier).
Aggregation
of secondary level (e.g. single packs) into tertiary level (e.g.
bundle packs, cartons or pallets). Summarisation of different
serialised codes (single pack) into a new individual serialised
code of the next packaging level (= complete traceability).
WHY SERIALISATION?
Get your business ready for country-specific guidelines
Legal compliance
Eliminate counterfeit pharmaceuticals
Defend market position
Brand & consumer protection
CODING
Possible types of serial codes
Code examples
Code examples
Data Matrix
Code 128
The Data Matrix is pursuant to
ISO/IEC 16022. The error correction is done according to ECC200.
Code 128 is a high-density barcode symbology and can encode all 128 characters of ASCII.
GTIN:04053213000004
SN:6585HR7C08XNA5D
EXP:09.02.2019
LOT:321TQS
Bundle Wipotecin 20mg
(01) 08691234567890
(21) 111111111123
1234567890ABCDEF
48E036C
08 . 2021
EXP: 190209
LOT: 321TQS
Bundle Wipotecin 20mg
(01) 08691234567890
(21) 111111111123
EXP: 190209
LOT: 321TQS
Tamper evident
Makes unauthorized access to the protected object easily detected (e.g. seal). It
is necessary to meet European regulations regarding drug safety.
WORLDWIDE GUIDELINES
What is your deadline?
EUROPE
EU
RU
EUROPEAN UNION
Directive 2011/62/EU
Regulation Name /
Authority:
RUSSIA
Regulation Name /
Authority
Federal Law № 61-FZ „Circulation of Medicines“ / Federal Service for Surveillance in
Healthcare
SERIALISATION
SERIALISATION
REQUIRES:
TAMPER
EVIDENT
DEADLINE:
FEB 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)
AGGREGATION
DEADLINE:
JAN 01, 2017 (PILOT – SELECTED PRODUCTS)
JAN 01, 2018 (ESSENTIAL LIST)
JAN 2019 (OTHER DRUGS)
Data carrier:
Data Matrix (possibly GS1 – TBD)
Data elements:
Country of manufacture, the manufacturing
company, batch number, expiry date, an
unique identifier (TBD)
AGGREGATION
Not mandatory
TBD
IMPORTANT NOTE:
Additional valid regulations in EU: Belgium (Code 128C on
vignette; Jul 01, 2004), France (Batch Coding; GS1 Data Matrix
ECC200; January 01, 2011), Greece (Code 128 & EAN-13 on
vignette; Apr 08, 2004) , Italy (Code 39 & ITF on vignette; Jan 04,
2005)
AMERICA
AR
BR
ARGENTINA
Regulation Name /
Authority
BRAZIL
Regulation Name /
Authority
ANMAT drug traceability system / Administración Nacional de Medicamentos, Alimentos y
Tecnología Médica
SNCM “Sistema Nacional de Controle de
Medicamentos” Law No. 11.903/2009 /
ANVISA
SERIALISATION
SERIALISATION
DEADLINE:
AUG 30, 2015 (AND SEVERAL FOR SELECTED
PRODUCTS BEFORE)
DEADLINE:
FEB 01, 2018 (3 BATCHES )
OCT 01, 2021 (ALL PRODUCTS)
Data carrier:
GS1 Data Matrix ECC200, GS1 128, RFID tag
Data carrier:
Data Matrix ECC200
Data elements:
GTIN (AI 01), Serial Number (AI 21)
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
Not mandatory
US
USA
Regulation Name /
Authority
DEADLINE:
FEB 01, 2018 (3 BATCHES)
OCT 01, 2021 (ALL PRODUCTS)
Data carrier:
Possibly GS1 128
Data elements:
Possibly SSCC (AI 00)
Drug Quality and Security Act (HR 3204) –
Title II: Drug Drug Supply Chain Security
Act (DSCSA) / US FDA
SERIALISATION
DEADLINE:
NOV 27, 2017
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
NOV 01, 2023
DEADLINE:
MIDDLE EAST & AFRICA
AE
EG
UNITED ARAB EMIRATES
Regulation Name /
Authority
EGYPT
Regulation Name /
Authority
Dubai Health Authority – DHA
BATCH CODING
Project on Tracing & Tracking Pharmaceutical
Preparations; Inside Arab Republic of Egypt
SERIALISATION
DEADLINE:
JAN 01, 2017
DEADLINE:
JUN 30, 2018 (UNDER DISCUSSION)
Data carrier:
GS1 Data Matrix ECC200
Data carrier:
GS1 Data Matrix ECC200
Data elements:
GTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10)
Data elements:
GTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10)
SERIALISATION
AGGREGATION
TBD
IR
DEADLINE:
JUN 30, 2018 (UNDER DISCUSSION)
Data carrier:
GS1 128
Data elements:
SSCC (AI 00)
IRAN
Regulation Name /
Authority
JR
TTAC Executive guideline No. 660/11873
dated Sept. 7, 2014
JORDAN
Regulation Name /
Authority
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)
Guidelines of Identification and Bar coding
of Medicinal Products for Human Use/JFDA
BATCH CODING
AGGREGATION
DEADLINE:
JUL 01, 2018
Data carrier:
GS1 Data Matrix
Data elements:
GTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10)
Not mandatory
SERIALISATION
OM
OMAN
TERTIARY LEVEL PACKAGING
Regulation Name /
Authority
DEADLINE:
2020 (TBD)
Data carrier:
GS1 Data Matrix
Data elements:
GTIN (AI 01), Serial Number (AI 21), Expiration
Date (AI 17), Batch/Lot Number (AI 10)
MH/DGMS/DSS/M/7043/Directorate
General of Medicinal Supplies MoH Oman
AGGREGATION
BATCH CODING
Not mandatory
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)
SA
SAUDI ARABIA
Regulation Name /
Authority
OM
OMAN
BATCH CODING
SECONDARY LEVEL PACKAGING
Regulation Name /
Authority
MH/DGMS/DSS/M/7043/Directorate
General of Medicinal Supplies MoH Oman
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)
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:
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)
TR
Guidance for the industry on Saudi Drug
Code (SDC) and drug barcoding specifi
cations / Saudi FDA
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
Not mandatory
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
DEADLINE:
JUN 01, 2010
Data carrier:
Data Matrix ECC200
Data elements:
GTIN (AI 01), Serial Number (AI 21), Expiration
Date (AI 17), Batch/Lot Number (AI 10)
AGGREGATION
DEADLINE:
JUN 01, 2010
Data carrier:
GS1 128
Data elements:
SSCC (AI 00)
ASIA & AUSTRALIA
AU
CN
AUSTRALIA
Regulation Name /
Authority
CHINA (HUMAN)
Regulation Name /
Authority
Guidance on TGO 92 / Therapeutic
Goods Administration (TGA)
BATCH CODING
CFDA Decree No.28
“National e-coding system” / CFDA
SERIALISATION
DEADLINE:
SEP 01, 2020
DEADLINE:
DEC 31, 2015 – ON HOLD SINCE FEB 20, 2016
Data carrier:
GS1 Data Matrix ECC200
Data carrier:
Linear Code 128 C
Data elements:
GTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10)
Data elements:
NATIONAL product code (country number,
drug category number, drug identification
number and the check number (14 digits))
AGGREGATION
IN
INDIA
TERTIARY LEVEL PACKAGING
Regulation Name /
Authority
Pharmaceutical Export Promotion
Counsil of India (Pharmexcil)
DEADLINE:
DEC 31, 2015 – ON HOLD SINCE FEB 20, 2016
Data carrier:
Linear Code 128 C
Data elements:
NATIONAL product code (country number,
drug category number, drug identification
number and the check number (14 digits))
SERIALISATION
DEADLINE:
OCT 01, 2011
Data carrier:
First code – GS1 128 or GS1 Data Matrix ECC200
Second code – GS1 128
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)
IN
CN
CHINA (VETERINARY)
Regulation Name /
Authority
Ministry of Agriculture of the People’s
Republic of China
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
INDIA
SECONDARY LEVEL PACKAGING
Regulation Name /
Authority
Pharmaceutical Export Promotion
Counsil of India (Pharmexcil)
SERIALISATION
AGGREGATION
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)
Not mandatory
JP
AGGREGATION
Regulation
Name /
Authority
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)
IN
JAPAN
Implementation Guideline for Barcode Labeling of
Prescription Drugs / Ministry of Health, Labour and
Welfare (MHLW)
BATCH CODING
DEADLINE:
JUL 01, 2015
Data carrier:
EAN/UPC, GS1 DataBar, GS1 128
Data elements:
NTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10), Quantity - (AI 30)*
*
for Case/Shipper
INDIA
SERIALISATION
PRIMARY LEVEL PACKAGING
Regulation Name /
Authority
Pharmaceutical Export Promotion
Counsil of India (Pharmexcil)
DEADLINE:
APR 01, 2021
(OR APR 01, 2023 FOR THOSE WITH SPECIAL
REASONS)
Data carrier:
EAN/UPC, GS1 DataBar, GS1 128
Data elements:
NTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10), Quantity - (AI 30)* and
Serial Number (AI 21)
*
for Case/Shipper
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)
PH
KR
Regulation Name /
Authority
SOUTH KOREA
Regulation Name /
Authority
PHILIPPINES
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)
Guidelines on Implementing FDA Circular
No. 2014-011
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)
AGGREGATION
TBD
SERIALISATION
DEADLINE:
JAN 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)
TW
TAIWAN
Regulation Name /
Authority
BATCH CODING
AGGREGATION
DEADLINE:
JAN 01, 2018 (FOR SECONDARY
AND TERTIARY LEVEL)
Data carrier:
Secondary: GS1 Data Matrix ECC200 / GS1
Tertiary: Data Matrix ECC200 or GS1 128
Data elements:
GTIN (AI 01), Batch/Lot Number (AI 10) and
Expiration Date (AI 17)
Not mandatory
PK
PAKISTAN
Regulation Name /
Authority
SERIALISATION
Drug Regulatory Authority of
Pakistan (DRAP)
DEADLINE:
JAN 01, 2019 (FOR SECONDARY AND
TERTIARY LEVEL)
Data carrier:
Secondary: GS1 Data Matrix ECC200
Tertiary: 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)
BATCH CODING
DEADLINE:
TBD
Data carrier:
GS1 Data Matrix ECC200
Data elements:
GTIN (AI 01), Expiration Date (AI 17), Batch/
Lot Number (AI 10)
Taiwan Food and Drug Administration
(TFDA)
AGGREGATION
DEADLINE:
SERIALISATION
JAN 01, 2020
TBD
WHAT SERIALISATION
STAKEHOLDERS NEED
TO TAKE INTO ACCOUNT
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