Implementing serialization in your production line?

Europe / EMVS

securPharm / ACS Pharmaprotect

The serialized data exchange in Europe under the umbrella of the European EMVS for pharmaceutical products can be realized e.g. for sales in Germany via the European hub (router) or directly to the national verification system upload structure. In both cases the data arrives at ACS PharmaProtect GmbH operating the national verification system upload structure in cooperation with securPharm e.V. For a marketing authorization holder (MAH) putting a pharmaceutical product into the German market, a contract with the ACS PharmaProtect GmbH is required.

Practically the two options to upload codes can be viewed as: 

1. The multi-site/multi-national approach: here it may be recommended to manage the data exchange via a central IT hub in the ERP/Master Data environment (Level 4) and then upload via the European EMVS hub (router) interface.
2. The single-site/national-only solution: in addition to the EMVS hub, a direct upload from the site level 3 may be realized (through an optional module of the Omron solution concept) and manage the data upload on national level via the ACS interface directly.

SecurPharm and ACS consider themselves a model and component of the European shield against the falsification of medicines. As an MAH placing prescription medicines on the market in more than one European country, you need to ensure that the associated pack data are stored in the databases of the respective national verification systems. To make the process of data provision to the national verification systems easier, the so-called European-Hub (short: EU-Hub) is supposed to work in the form of a router: At the centralized upload of the data files, they will be prefixed with a country code, which enables the EU-Hub to transmit the data to the correct national database. As a result only one interface and single upload are required. Of course, the established interface to the ACS MAH system will remain operational.

ACS provides two interface functions: Via portal (HTTPS), or via machine interface (SFTP). Moreover a wealth of reports can be accessed in the ACS Portal.

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Turn-key serialization stations (including level 1)

With the experience of millions of serialized packages in their own company, Prestige Promotion has made its proven line serialization station commercially available to other companies. This solution provides printing and inspection, and also manages the serialized code communication. Moreover, it does so with a very high degree of flexibility and can easily adapt to different master data handling and communication concepts as well as upcoming changes. It is tailored to the requirements of small- and mid-sized CMOs, CPOs, repackers and pharmaceutical manufacturers.

Located in Kleinostheim, Germany, in the heart of Europe, Prestige Promotion and Prestige Packaging offer a wide range of outsourcing, re-packing, distribution and service solutions to cosmetic and pharmaceutical companies.

With over 20 years of experience and approx. 250 employees, Prestige Promotion and Prestige Packaging support pharmaceutical and cosmetic companies in managing the various hurdles to market their products in the European Union. Flexibility, reliability and a drive for innovation are thereby the guiding principles for all operations.

Read also our Customer reference.

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Turn-key serialization stations (including level 1)

The Masterprint PharmaJet series provides ready-to-use marking solutions for a wide range of pharmaceutical products including blisters, bottles, jars, vials, tubes and cardboard packages (flat (empty) and in erected (filled) state). Supporting GS1 compliant code serialisation, the PharmaJet series provides reliable and excellent value for money marking solutions for fulfilling the European Falsified Medicine Directive (other countries on request). Located in Ivancsa south of Budapest/ Hungary, Masterprint Kft has developed into a leading regional player for marking applications.

With sister companies providing machines and services for marking, printing, weighing, food cutting and secondary packaging, the Masterprint Group has become a trusted supplier to the Pharmaceutical, Food&Beverage and various other industries for Central and Eastern Europe.

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Serialization / Track&Trace Software

Facilityboss is located in southern Germany in Darmstadt. Founded as spin-off from the Fraunhofer Institut SIT, Facilityboss focuses on class-leading IT solutions, providing high customer satisfaction.

Facilityboss develops various standardized products, which can be customized to specific needs. The Facilityboss PLS track and trace (GS1 serialization) system, e.g. for the pharmaceutical industry, is already in use in various sites of leading DAX-listed pharmaceutical producers as well as smaller sized CMO/CPO sites.

Also for food & beverage applications the software is already in use for leading producers.

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Printing solutions (level 1)

Founded in 1978 and headquartered in Cambridge, UK, Domino has a global reputation for the development and manufacture of coding, marking and printing technologies that satisfy the requirements of manufacturers and commercial printers.

Domino’s year-on-year growth – both organic and through acquisition – is underpinned by an unrivalled commitment to product development, resulting in a portfolio that incorporates complete end-to-end coding solutions spanning primary, secondary and tertiary applications.

Innovative ink jet, laser, print & apply and thermal transfer overprinting technologies are deployed for the application of variable data, bar codes and unique traceability codes onto product and packaging, across many industrial sectors, including pharmaceutical, food, beverage and industrial products.

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Overall serialization / traceability consulting and compliance support

Vesdo Inc., a Swiss engineering and consulting firm, active since 2000 has its business focus on systems to fight product piracy. To prevent frauds with branded products, Vesdo’s customers successfully implement authentication technologies and product serialization. As a leading company in this industry, Vesdo has been a pioneer and involved in more than 100 implementation projects throughout Europe, serving small entities as well as global tier 1 companies. Over 20 patent applications for customers and Vesdo provide evidence of the company’s creativity. Core to the company is the highly qualified staff, all with university degree and comprehensive experience.

Vesdo Inc. has also developed a calibration reference for vision systems used in connection with code grading applications. These sets of compliance codes in the form of self-adhesive labels can be used to calibrate also in-line vision systems.

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