Case study — pharmaceutical production, drug traceability
130 packs of medication verified per minute, each one traceable in detail
How Galvex replaced its original serialization system with a new Track & Trace solution, connected directly to the European Medicines Verification System EMVS — and met the requirements of the EU Falsified Medicines Directive.
130 / min
packages marked and checked per minute
4 levels
Traceable packaging — piece, group, carton, pallet
2022
signing of a contract for the implementation of a new serialization system
GALVEX AT A GLANCE
Location Banská Bystrica
Manufacturing Medicines, health and nutritional supplements
Regulation EU Directive 2011/62 (FMD), EMVS
Systems in use Drug serialization (Track & Trace)
When drug counterfeiting ceases to be a theory
The risk of counterfeit medicines was increasing worldwide before 2019. The European Union responded to this with Directive 2011/62/EU, which set out a set of measures to prevent counterfeit medicines from entering the legal supply chain. From 9 February 2019, only prescription medicines carrying new safety features may be placed on the market.
The European Medicines Verification Organisation (EMVO) has taken responsibility for the development of the European Medicines Verification System (EMVS), to which every manufacturer must be connected. Galvex spol. s r.o. decided in 2022 to replace its original medicine serialisation system with a new one — a contract for its implementation was signed in May 2022.
Galvex needed a system that could generate and verify unique serial numbers at all levels of packaging, communicate with a central European database, and also handle administrative exceptions such as laboratory samples.
Do you solve the same problem in your production
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Do you need to generate and verify unique serial numbers on packaging according to EU standards?
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Do you need to ensure traceability of packaging at the level of piece, group packaging, carton and pallet at the same time?
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Do you need to check the correctness and readability of the label and check the anti-tampering tape directly on the line?
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Do you need to automatically send data to a central European database, instead of manually searching and writing it?
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Do you also need to package for external customers and manage the import and export of their serial numbers?
Good news: the system can handle both the automated and manual part of the process — including exceptions such as taking samples to the laboratory.
Four levels of traceability, one communication with EMVS
The system works with four communication lines corresponding to the packaging levels — from individual pieces through group packaging and cartons to pallets. For each input and output of a package at a given level, the system supplies a generated code to the printer and receives information about the result. Thanks to this, Galvex has a unified overview from individual packages to the entire pallet, with messages directly to the central European databank.
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Automated communication for all four packaging levels (piece, group, carton, pallet).
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Approval of the list of produced packages intended for shipment.
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Export to external customer applications, including import and export of serial numbers for external customers.
Drug serialization system (Track & Trace)
Marking and control directly on the line
The solution is based on a central application connected to an automated production line — industrial code printers, industrial and hand-held scanners and a control PLC with an HMI console. The operator PC and hand-held terminal with a scanner also cover administrative tasks, such as taking samples to the laboratory or discarding packages.
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Generation of numbers for drug packages according to EU standards.
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Verification of numbers directly on packages, with the possibility of automatic and manual marking.
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Records of all manufactured, discarded and transferred packages.
130 / min
packages marked and checked per minute
4 levels
Traceable packaging — piece, group, carton, pallet
2022
signing of a contract for the implementation of a new serialization system
What did it bring to Galvex?
Thanks to the deployment of a drug serialization system, Galvex is now able to label and register all manufactured drugs in the EU database.
Other operational improvements
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Full compliance with the EU directive on falsified medicines and connection to EMVS.
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Unified records and reports of produced and discarded packages instead of manual tracking.
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Readiness to package also for external customers with import and export of their serial numbers.
After the successful deployment of the system, Galvex plans to expand the functionality to connect to the systems of other external customers.
A new level of traceability from M2M Solutions
Compliance with EU legislation verified in operation
The system is not just a technical solution on paper — it runs in real production and meets the requirements of Directive 2011/62/EU and the connection to EMVS.
All packaging levels in one system
Piece, group packaging, carton and pallet are covered by one central application — not four separate tools that need to be manually reconciled.
Automation and room for exceptions
The solution combines a fully automated line with the possibility of manual intervention — for example, when taking samples to the laboratory or discarding packaging.
Ready for growing collaboration
The system is designed to be expandable to connect with external customers — without the need to build a new solution from scratch.