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OCS Checkweighers blog on the subject of serialisation
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    All global serialisation requirements at a glance - compact and comprehensible

    44

    Countries

    61

    Deadlines

    Infographic

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TQS world map
As a starting point, our serialisation experts have brought together for you, in a compact and comprehensible form, all relevant data such as national regulations against medicine counterfeiting, underlying coding requirements, implementation deadlines and evaluations of the market situations in relation to future developments. You will find all this information in interactive form and simply structured on the TQS map. Simply click a country and you will receive all the relevant data.

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

Expert View

Even if the European Falsified Medicine Directive (FMD) is an end-to-end system, the wholesalers and hospital pharmacies will claim for aggregation. This will allow the wholesaler to easily meet the risk-based verification approach if cases or even pallets of the related products are not directly supplied from a manufacturing or marketing authorization holder (or a person supplying on their behalf) and if the product is returned by another wholesale distributor or a pharmacy. Aggregation will also allow the hospital pharmacies to easily decommission their incoming shipments in cases or even pallets.


Belgium

Regulation Name / Authority

APB (Belgian Pharmaceutical Association) / Belgian MoH

Serialisation Serialisation

Deadline

Jul 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

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in Belgium need to be labeled with the vignettes. As Belgium has +6 years more time for the implementation (Feb 09, 2025), labeling equipment will be mandatory for the time being.


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

cip13code

Beispielcodierung

Data Elements

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

Serialisation Serialisation

Deadline

Not mandatory

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in France need to be batch coded according to CIP guideline.


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.

Tamper Evident

Yes

Aggregation Aggregation

Deadline

Not mandatory

Expert View

securPharm is the National Medicines Verification System (NMVS) of Germany. Since 2013, pharmaceutical companies are able to use securPharm and practice their own processes. As such, it serves as a partner within the safety network in Europe provided by the European Medicines Verification Organisation (EMVO). In the Delegated Regulation the national reimbursement number is mentioned. For pharmaceuticals destined for the German market, it is included in the product code in form of the PZN and therefore does not need to be listed as a separate fifth element pursuant to Article 4 (e) of the Delegated Regulation.


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)

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in Greece need to be labeled with the respective vignettes. This sticker is issued by EOF (“Ethnikos Organismos Farmakon” / National Organisation for Medicines) free of charge to companies. It is produced by a special aquarelled paper incl. the national emblem and the name of EOF (solely visible by UV). The sticker is 27 x 24mm and contains (typed by EOF): name of the company, production year and sticker number. The manufacturer is obliged to type the following: product name, pharmaceutical form and strength, code number (assigned by EOF and unique to the product) and the retail price. As Greece has +6 years more time for the implementation (Feb 09, 2025), labeling equipment will be mandatory for the time being.


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)

Data Elements

“Old Bollino”: National market authorisation code (AIC), Serial number; “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.

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

Until the EU Falsified Medicine Directive is not implemented, all products in Italy need to be labeled with the “New Bollini” vignettes. As Italy has +6 years more time for the implementation (Feb 09, 2025), labeling equipment will be mandatory for the time being.

Argentina

Regulation Name / Authority

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

Serialisation Serialisation

Deadline

Aug 30, 2015 (and several for selected products before)

Data Carrier

GS1 Data Matrix ECC200, GS1 128, RFID tag

gs1DataMatrix

Beispielcodierung

Data Elements

GTIN (AI 01), Serial Number (AI 21)

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

„The regulation Disposición 963/2015 on traceability, released by ANMAT on January 30, 2015, expended the scope and the specifications of the drug traceability system. Since then, the drugs also have to be marked with lot number and expiry date (format (DD/MM/YY or DD/MM/YYYY). Deadline for implementation of these requirements was March 02, 2015.“

Brazil

Regulation Name / Authority

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

Serialisation Serialisation

Deadline

Under discussion

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)

Tamper Evident

No

Aggregation Aggregation

Deadline

Under discussion

Data Carrier

Possibly GS1 128

Data Elements

Possibly SSCC (AI 00)

Expert View

GS1 standards are not a regulation requirement in Brazil. But as the usage of a GTIN, the data carries GS1 Data Matrix, GS1 128 and SSCC are market recommendations. There is a requirement for secondary packaging, that manufacturing date needs to be printed solely in clear text (Regulation RDC 71). The deadline for serialization and tracking for all pharmaceuticals is still in force.

China - Human

Regulation Name / Authority

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

Serialisation Serialisation

Deadline

Dec 31, 2015 - ON HOLD since Feb 20, 2016

Data Carrier

Linear Code 128 C

code128c

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

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))

Expert View

Even if CFDA announced the suspension of the implementation of relevant provisions on drug electronic supervision, most companies still follow the regulation. GS1 wrote a recommendation letter to advocate for the usage of GS1 standards. New GSP (Good Supply Practice) regulation has been released, but new deadlines are still missing.

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

If the uniform veterinary drug two-dimensional code marks cannot be printed on the minimum sales package on the products due to the limitations of the package size for the products with special circumstances such as ampoules, vials less than 5 ml or irregular shaped bottles, the uniformly marked veterinary drug two-dimensional code should be printed on the package of the upper level on the minimum sales package. The specific products should be applied by the manufacturing enterprises of the veterinary drugs, reviewed and confirmed by the Veterinary Bureau of the Ministry of Agriculture.

India

Regulation Name / Authority

DGFT (Directorate General of Foreign Trade)

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)

Tamper Evident

No

Secondary Level Packaging

Serialisation Serialisation

Deadline

Oct 01, 2013

Data Carrier

GS1 Data Matrix ECC200 or GS1 128 or GS1 DataBar

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation 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)

Tertiary Level Packaging

Serialisation Serialisation

Deadline

Oct 01, 2011

Data Carrier

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

gs1DataMatrix

Beispielcodierung

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)

Tamper Evident

No

Expert View

Pharmaceutical manufacturers exporting medicines, need to follow the DGFT regulation. On Jan 05, 2016, the Indian DGFT has released the Public Notice 52/2015-2020. Primary level is still exempted from labelling with a 2D barcode. The data elements can optionally be printed in human readable format on primary level. However, this information needs to be provided to the DAVA portal, as the system requires its input and doesn’t except empty fields. In case having no “real” primary level data elements available, some “virtual” information needs to be provided. This “virtual” information set needs to be maintained by the manufacturer.

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

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

The GS1 Data Matrix and the originality number* in coated form will be in a specified place measuring 20 by 40 mm, with a white background and yellow margin. The UID is required to be a 20 digit number, whereas the first 4 or 5 digits of the UID identify the company generating the UID and the remaining numbers are randomly generated.

*In addition to GTIN, UID, Lot and Exp, a 16-digit number will be printed under the scratch label for the patient or end user to use for authentication purposes.

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

cip13code

Beispielcodierung

Data Elements

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

Serialisation Serialisation

Deadline

2020 (To be decided)

Data Carrier

GS1 Data Matrix

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

In human readable format, it is sufficient to print the GTIN close to the GS1 Data Matrix, if the expiration date and batch number are found elsewhere on the pack.

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)

Serialisation Serialisation

Tamper Evident

No

Expert View

The policy “Unique Global Product Identification Number for Drug Products'‘ requires the use of their so called “Global Product Identification Number” (GPIN) for drug products (which is a unique 14-digit code specific for a product presentation of a specific company that is secured from a global standards organization – similar to a GTIN), the batch number and expiry date. Since Jul 25, 2016 the implementation requirement is on hold.

Russia

Regulation Name / Authority

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

Serialisation Serialisation

Deadline

Jan 01, 2017 (selected products); Jan 01, 2018 (essential list); Jan 2019 (other drugs)

Data Carrier

Data Matrix (possibly GS1 - To be decided)

Data Elements

Country of manufacture, the manufacturing company, batch number, expiry date, and an unique identifier (TBD)

Tamper Evident

No

Expert View

The first deadline of the FGIS MDLP (Federal Public Information System for Monitoring the Movement of Drugs) concerns products related to hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher's disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis and those after transplantation of organs and/or tissues. Pilot by federal MoH planned with deadline for Oct 31, 2016. The scope contains (a) no less than one local, and one foreign producer; (b) no less than one pharmacy having several sales outlets in Moscow, Moscow region, and Saint Petersburg; (c) medical institutes which are treating patients with 7N diseases.

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

cip13code

Beispielcodierung

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

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

In the first draft regulation, SFDA was claiming for the coding of the pack size. Since Jul 07, 2014 this obsolete as a GTIN is already providing the pack size information.

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

cip13code

Beispielcodierung

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 (selected products); Jan 01, 2016 (all products)

Data Carrier

GS1 Data Matrix ECC200 or GS1 128 or RFID

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Not mandatory

Expert View

Reporting transition period of 6 months to Jul 01, 2016. Even if aggregation is not mandatory until now, all producers are already using aggregation systems for convenience during warehousing / release.

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)

cip13code

Beispielcodierung

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)

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Jan 01, 2020

Expert View

The requirements on primary level packaging have been removed.

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

gs1DataMatrix

Beispielcodierung

Data Elements

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

Tamper Evident

No

Aggregation Aggregation

Deadline

Jun 01, 2010

Data Carrier

GS1 128

Data Elements

SSCC (AI 00)

Expert View

Turkey requires full aggregation. So also bundles, shipping cases and pallets need to be serialized. These packaging levels are called transportation units and are numbered using the SSCC (Serial Shipping Container Code).

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

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)

Tamper Evident

No

Aggregation Aggregation

Deadline

Nov 01, 2023 (To be decided)

Data Carrier

To be decided

Data Elements

To be decided

Expert View

Even if aggregation is not mandatory until now, the “big 3 wholesalers” already claimed for using aggregation systems and to follow the HDMA guidelines. They wrote a letter to all their customers (pharmaceutical manufacturers).

TQS-Infographic

All global serialisation requirements at a glance - compact and comprehensible. You can download the TQS information graphic as a PDF and print it out; please feel free to distribute it as well.

Download Infographic

With TQS, OCS Checkweighers has a flexible, modular track & trace system that has been perfectly tailored to our needs. […] We are optimally prepared in relation to future global track & trace requirements with TQS.

Dr. Marco Klingele | Track & Trace Program Lead / Head of Administration | Losan Pharma GmbH

[…] It is a major advantage that it is no longer necessary to set-up the individual print layouts and image processing separately in all TQS modules due to the fully integrated operating software ConfigureFast. Extremely short changeover times are the result and as a consequence significantly higher productivity on the line.

Alexander Pohl | Technical Expert Packaging | Aenova-Group

With TQS we are optimally equipped in relation to consistent serialisation and complete aggregation. In particular, due to the quality and flexibility of our space-saving system, we do not need to be concerned about any of the global marking requirements to be expected in relation to future export to the Far East.

Jürgen Back | Packaging Production Engineer | MEDA Manufacturing GmbH

Your advantages at a glance
OCS Checkweighers is a solution provider to GS1 Germany and also a voting member in the GS1 Global Healthcare User Group. We cooperate with the major pharmaceuticals and immediately implement relevant targets and changes regarding serialisation and aggregation.

As a member of the Open SCS Working Group, OCS Checkweighers advocates for flexible means of integration with existing production infrastructures and, in addition, for a philosophy of open and standardised links to higher-level systems.

OCS fights for improved industry standards rather than proprietary island solutions, which are still used far too often: Specifically, the artificial dependence on many suppliers sooner or later leads to very risky availability bottlenecks. Each pharmaceutical player must be independent and able to freely choose their equipment.

For more than 20 years, the weighing and inspection solutions from OCS Checkweighers have been the reliable standard for dynamic, fast, and highly accurate weight and completeness controls in the production lines of the leading producers in the pharmaceutical, cosmetic, food, and chemical sectors.

Building on this experience with custom high-tech applications and with a view to the coming mandated serialisation for prescription drugs, OCS Checkweighers expanded its product portfolio with the very successful Track & Trace solution known as TQS (Traceable Quality System).

TQS stands for top reliability and ease of use while providing all drug manufacturers a customised solution to meet the serialisation and aggregation requirements for medicinal preparations. The operation of the functional units for product handling, coding, and camera inspection is convenient and fully integrated in one software package.

OCS Checkweighers attaches great importance on the development of all required technologies and the ability to manufacture all core components in-house. The result is an extraordinary manufacturing depth and expertise which allows us to be supplier-independent and forms the basis of our delivery reliability.

Design, development and assembly are performed in-house at OCS Checkweighers. The philosophy of short chains is what ensures the greatest flexibility in implementing each individual product configuration.

As an OCS Checkweighers customer, you benefit from our global service network. We provide support in implementing your customised TQS solution by offering instruction and training of your operators and by performing preventive maintenance of the units.

We would be pleased to personally advise you about the details of the scope and effort of the individual services.

Safe drugs are a valuable commodity which, in times of need, can ensure survival. Far from any economic consideration, this implies a pure ethical responsibility to undertake every effort to put an end to the global counterfeiting of medicinal products. OCS Checkweighers is very proud to meet these challenging tasks with a priority on supplying the best possible consumer protection.

Our current customers include well-known, demanding pharmaceutical companies. If Track & Trace is an important topic for your business, then please get in touch with us. We will give our very best to support you.

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