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The national regulations on the serialisation of drugs are possibly the most important criteria in the global marketing of pharmaceuticals and other pharmaceutical solutions. Optimum implementation requires complete and up-to-the-minute knowledge of the relevant obligations for pharma serialisation. A large number of global projects have shown that it is in this context that too often avoidable planning mistakes are made that can often only be corrected with high expenditure and a large amount of time.
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Our experts for the serialisation 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 serialisation requirements. Complexity reduced to the essential.
Directive 2011/62/EU / EU Commission
February 09, 2019
Data Matrix ECC200
Unique product identification number (e.g. GTIN/NTIN/PPN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable).
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
February 9, 2019
2D Data matrix code with human readable text elements
APB (Belgian Pharmaceutical Association) / Belgian MoH
July 01, 2004
Code 128 C on Vignette
7-digit national registration number (CNK) + Unique 8-digit serial number + 1 control digit
February 09, 2025
Unique product identification number (e.g. GTIN/NTIN), Batch/Lot number, Expiry date, Serial number, National reimbursement number (if applicable)
Danish Medicines Agency (DKMA)
Linear barcode / 2D Data Matrix
Finnish Medicines Agency (Fimea)
2D Data Matrix, Human readable interpretation
CIP (Club Inter Pharmaceutique) - / ANSM (French National Agency for Medicines and Health Products Safety)
January 01, 2011
GS1 Data Matrix ECC200
Unique product identification number (French CIP code / NTIN) - (AI 01), Expiry date (AI 17), Batch/Lot number (AI 10).
Unique product identifier GTIN or NTIN
NMVS (National System according to EU FMD) - ACS-MAH-System “securPharm”
Data Matrix ECC200 (ASC/IFA- or GS1-Format)
Unique product identification number (PPN or NTIN), Batch/Lot number, Expiry date, Serial number.
Greek Ministry of Health & Welfare
Apr 08, 2004
Code 128 and EAN-13 on Vignette
Serial number (in Code 128) and Greek EOF code (9 digits) incl. NPO registration number (in EAN-13)
“Italian Bollini” / Italian MoH
Jan 04, 2005 “old Bollino” / Dec 31, 2015 “new Bollino”
2 linear barcodes (Code 39 and ITF) on Bollino (Vignette) and one 2D DataMatrix
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.
Icelandic Medicines Agency
2D Data Matrix and optionally linear barcode Human readable interpretation
2D Data Matrix, Human readable interpretation
ANMAT drug traceability system / Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
August 30, 2015
GS1 Data Matrix ECC200, GS1 128, RFID tag
Guidance on TGO 92 / Therapeutic Goods Administration (TGA)
Sep 01, 2020
GTIN (AI 01), Expiration Date (AI 17), Batch/Lot Number (AI 10)
SNCM “Sistema Nacional de Controle de Medicamentos” Law No. 11.903/2009 / ANVISA
August 01, 2018 (3 batches / see expert view) April 01, 2022 (All products / see expert view)
GTIN (AI 01) or National Number (NHRN) - (AI 713), Expiration Date (AI 17), Batch/Lot Number (AI 10), Serial Number (AI 21)
Aug 01, 2018 (3 batches / see expert view) Apr 01, 2022 (All products / see expert view)
Possibly GS1 128
Possibly SSCC (AI 00)
Draft traceability system guide by NMPA (former: CNDA), dated of 24 August 2018
Historic record: CFDA Decree No.28 / “National e-coding system” / CFDA
Jan 01, 2022
Other, GS1 Standards are accepted
National Number that includes a data thread including a unique serial number
Dec 31, 2015 ON HOLD since Feb 20, 2016
Linear Code 128 C / 2D barcode / RFID tag
NATIONAL product code (country number, drug category number, company ID, drug identification number and the check number (14 digits))
Article 10 The State implements a full electronic traceability system for vaccines by NPC
December 01, 2019
vaccine electronic traceability system
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.
Rules for Unique Device Identification (UDI) System by NMPA, dated of 27 August 2019
October 10, 2019
1-D code, 2-D code or RF labels
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
Ministry of Agriculture of the People’s Republic of China
Jun 30, 2016
QR Code (UTF-8)
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
Ministry of health 24/10/2019
Dec 31, 2018
GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17), Batch/Lot Number (AI 10)
DGFT (Directorate General of Foreign Trade) - System Development handed over to PHARMACEUTICAL EXPORT PROMOTION COUNSIL OF INDIA (PHARMEXCIL)
Apr 01, 2015 (on optional basis also for solely mono-cartons containing one primary pack); Remaining delayed until further notice
EAN/UPC or GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar
GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Serial Number (AI 21)
Oct 01, 2013
GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar
GS1 128 x 2
First code: GTIN (AI 01), Batch/Lot Number (AI 10), Expiration Date (AI 17) and Second code:Serial number as SSCC (AI00))
Oct 01, 2011
GS1 128 or GS1 Data Matrix ECC200 (first code) / GS1 128 (second code)
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)
National Agency of Drug and Food Control Regulation
January 1, 2023
2D Bar Code: GS1 DataMatrix
TTAC Executive guideline No. 660/11873 dated Sept. 7, 2014
Jan 01, 2015
GS1 Data Matrix
GTIN (AI 01), UID, Batch/Lot Number (AI 10), Expiration Date (AI 17)
Ministry for Health, Labour and Welfare (MHLW) - Japan
Jul 01, 2015, Apr 01, 2021 (or Apr 01, 2023 for those with special reasons)
GS1 DataBar Limited Composite Symbol CC-A or GS1 DataBar Stacked Composite Symbol CC-A or GS1 DataBar Limited or GS1 DataBar Stacked
(01) Product Code (14-digit code consisting of the JAN- Japanese Article Number) = uniform commodity code [UCC] (17) Expiry Date (10) Batch / Lot or (21) Serial Number
April, 2021 or April 2023 in special cases (when the product is manufactured only once a year)
(01) Product Code (14-digit code consisting of the JAN (Japanese Article Number)) (17) Expiry Date (30) Quantity (10) Batch / Lot or (21) Serial Number
Guidelines of Identification and Bar coding of Medicinal Products for Human Use / JFDA
Jul 01, 2018
January 01, 2020
Not mandatory. Only batch coding
Ministry of Public Health
December 31, 2019
GS1 2D DataMatrix
MoH Draft Rule
January 01, 2023
SSCC (AI 00)
Guideline of Usage and Control of Barcode and RFID for Pharmaceutical Product
January 01, 2015
Norwegian Medicines Agency
January 1, 2018
Linear barcode and optionally 2D Data Matrix barcode
2D Data Matrix, Human readable interpretation
MH/DGMS/DSS/M/7043 / Directorate General of Medicinal Supplies MoH Oman
Dec 31, 2017
Mar 1, 2019
GS1 Data Matrix ECC200 or GS1 128
Ministry of National Health Services, Regulations and Coordination
Dec 15, 2021
2D Bar Code : GS1 DataMatrix
GTIN AI (01) Batch/Lot Number - AI (10) Expiration Date - AI (17)Serial Number - AI (21)
December 15, 2023
GTIN (AI 01)Expiration Date (AI 17) Batch/Lot Number (AI 10) Product Identification Information (AI 240) Serial Number (AI 21)
December 15, 2021
December 15, 2025
GTIN (AI 01) Expiration Date (AI 17) Batch/Lot Number (AI 10) Product Identification Information (AI 240) Serial Number (AI 21)
December 15, 2021 (see comment)
Guidelines on Implementing FDA Circular No. 2014-011
Jun 30, 2016 - ON HOLD
Linear code or Data Matrix (possibly GS1)
GTIN (AI 01) , Expiration Date (AI 17), Batch/Lot Number (AI 10)
Hamad Medical Corporation
GS1 Data Matrix ECC200 or GS1-128
GS1 Data Matrix ECC200, Human readable interpretation
The Government of the russian Federation in Moscow Decree of December 14, 2015 No. 1556, amendment No. 1118 of August 30, 2019 and Federal Law 462-FZ of December 27, 2019
7 Nosologies: December 31, 2019 all drugs: July 01, 2020
7 Nosologies: December 31, 2019 all drugs: July 01, 2020<
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)
Guidance for the industry on Saudi Drug Code (SDC) and drug barcoding specifications / Saudi FDA
March 21, 2015
March 12, 2017
March 31, 2020
Republic of South Africa - Department of Health
December 30, 2018
1D Bar Code : GS1-128
June 30, 2022
GS1 128 Linear Barcode or GS1 Data Matrix
June 30, 2020
Jun 30, 2022
Korean Pharmaceuticals Information Service / Ministry for Food and Drug Safety (MFDS - formely Korean FDA)
Jan 01, 2010 (solely KDC coding) Jan 01, 2012 (specific products) Jan 01, 2013 (all Rx products)
KDC (Korean Drug Code / NTIN) - (AI 01), Expiration Date (AI 17) and Batch/Lot Number (AI 10)
January 01, 2015 (selected products) Jan 01, 2016 (all products)
GS1 Data Matrix ECC200 or GS1 128 or RFID
KDC (Korean Drug Code / NTIN) - (AI 01) Serial Number (AI 21) Batch/Lot Number (AI 10) Expiration Date (AI 17)
Swiss Federal Office of Public Health
Taiwan Food and Drug Administration (TFDA)
Secondary and tertiary level:Jan 01, 2018
Secondary level: GS1 Data Matrix ECC200 Tertiary level: GS1 Data Matrix ECC200 or GS1 128
GTIN (AI 01), Batch/Lot Number (AI 10) and Expiration Date (AI 17)
Secondary and tertiary level: Jan 01, 2019
GTIN (AI 01), Serial Number (AI 21), Batch/Lot Number (AI 10) and Expiration Date (AI 17)
Jan 01, 2020
Ministry of health
January 1, 2019
GS1 2D DataMatrix
Republic of Turkey, Ministry of Health Turkish Medicines and Medical Devices Agency
Jun 01, 2010
Jun 01, 2012
Dubai Health Authority - DHA
Jan 01, 2017
State Service of Ukraine on Medicines and Drug Control
2021 (not defined)
GS1 bar code, possibly Data Matrix
Drug Quality and Security Act (HR 3204) Title II: Drug Supply Chain Security Act (DSCSA) / US FDA
November 27, 2017 (no FDA enforcement until Nov 26, 2019)
GTIN (AI 01), Serial Number (AI 21), Expiration Date (AI 17) and Batch/Lot Number (AI 10)
November 01, 2023 (To be decided)
To be decided
System for Tracking and Tracing Medicine Provision and Supply Chain inside the Kingdom of Bahrain
December, 31 2019
GS1 Data Matrix ECC200
September 01, 2021
The EU Falsified Medicines Directive 2011/62/EU stipulates that the manufacturer must provide pharmaceuticals with several safety features as of 9 February 2019. The EU Directive on the Serialisation 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 serialisation will no longer be able to sell medicinal products on the European market as of 2019.
Find out now which conditions will have to be met in the EU!
Implementation of the serialisation obligation will come 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 has now postponed the deadline by a year.
Find out now what conditions will have to be met in the USA.
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Our project engineers and serialisation experts use the national requirements for serialisation 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.
Your specific requirement could not be met with a standard solution. Please get in touch with our sales team . We are glad to consult you on defining the perfect solution for you.
Meet even tight deadlines without production losses:
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 Organisations) on the sales and service side. Thanks to our broad Track & Trace 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 serialisation 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 serialisation in the pharmaceutical industry to our customers.
Breakthrough in the serialisation of pharmaceutical products in the EU: From February 2019, and therefore three years after publication of the EU-wide Directive 2011/62, it will no longer be possible to place any counterfeit prescription-only medicinal product on the market. According to the EU Directive on Serialisation, from 2019 authenticity verification must cover the complete supply chain from pharmaceutical manufacturer to dispensing chemist. Pharmaceutical manufacturers will comply with this serialisation obligation simply by trusting the Track & Trace solutions from WIPOTEC-OCS. Our solutions for serialisation and aggregation combine machine-readable product codes and unique product assignment thanks to serial numbers. WIPOTEC-OCS with its global Track & Trace solution TQS (Traceable Quality System) provides the perfect answer to all questions regarding EU-wide and worldwide serialisation and aggregation in the pharma industry.
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Serialisation machines print drug packages with the necessary codes for serialisation: Depending on the guideline, these are machine-readable matrix codes or alphanumeric character strings. The Track & Trace systems of WIPOTEC-OCS, however, can contribute more towards serialisation than simply printing and verifying codes. They weigh the pharmaceutical product on the same installation surface and thus carry out a completeness check. The individual packages are additionally packaged so as to be tamper-evident. The same machine can also perform aggregation, that is the documented combination of product packages into larger packs (bundles, shipping boxes through to pallets). This ensures complete serialisation at every level. 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. Aim to be achieved: more functionality in the same space.
To the details
The serialisation 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 palletising of individual boxes prior to shipping.
Since February 2019, pharmaceutical companies in the EU have had to serialise their products in accordance with the EU Directive. They therefore had less than two years to implement a serialisation 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 serialisation 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 Track & Trace TQS solutions allows serialisation 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 serialisation obligation. As a result, there is hardly any faster way to meet the international requirements for serialisation in the pharmaceutical industry while at the same time avoiding proprietary stand-alone solutions.
To the serialisation solution
TQS stands for the open communication approach of the Track & Trace solutions from WIPOTEC-OCS. The Traceable Quality System underscores our philosophy of supporting the healthcare industry to satisfy global guidelines on serialisation 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 serialisation, 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.
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So along with the open system interface, it is not only the very short delivery times for best practice serialisation machines or the options for universal integration into other packaging machines which are the key benefits of the complete 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 serialisation 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+).
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 serialisation 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 serialisation pharma cannot be ruled out.
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