Productive System Is Live Now

Two weeks before the implementation deadline of the Falsified Medicines Directive (FMD), our productive system went live on Friday. The migration of customer data from our test system has now been successfully completed. Our customers can already start working in the productive system. […]

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Serialization for hospitals – what changes in everyday life?

Hospitals work with a large number of Rx drugs on a daily basis, in addition, processes are closely timed. So how will the Falsified Medicines Directive affect hospital pharmacies? The Falsified Medicines Directive (FMD) stipulates that every prescription-only drug in hospital pharmacies must be scanned and verified via the database. The Bundesverband Deutscher Krankenhausapotheken (ADKA), […]

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China Plans New Start for Serialization in 2022

The China National Drug Administration (CNDA) is working on a new implementation of serialization guidelines. The first attempt at traceability was suspended in 2016. China’s first serialization plan intended a 20-digit serial number for all products sold domestically, at the individual, bundle, box, and pallet level. This serial number was assigned by the government. The […]

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EMVO Calls for On-boarding

Five months before the EU Regulation 2016/161 becomes effective, EMVO (European Medicine Verification Organization) is calling for an immediate start of the onboarding process. In a current press release, manufacturers and parallel importers of the pharmaceutical industry are requested to start their onboarding process as soon as possible. The process consists of a contractual and […]

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Is the pharmaceutical industry a role model for other industries?

3 Glühbirnen. Eine leuchtet.

Traceability and a transparent supply chain play a key role in many industries. The pharmaceutical industry can act as a role model. The key questions amongst all are the provenance and pedigree of a product as well as providing a secure and traceable path from the producer to the consumer. The pharmaceutical industry tries to […]

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What are the benefits of serialization?

Frau nimmt serialisiertes Rx Medikament ein

The primary objective of serialization is to protect patients. This is ensured by processes and control mechanisms that ensure that only original and manufacturer-approved drugs reach pharmacies and hospitals. Sustainable changes in almost all areas Manufacturers, contract manufacturers, wholesalers, repackagers, parallel importers – or in other words: the entire pharmaceutical industry need to invest in […]

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Why serialization from the Ruhr area?

Das Ruhrgebiet. Ein Förderturm vor einem Sonnenuntergang.

In Germany’s “deep West”, the Ruhrgebiet, honest work has always been part of the DNA. What used to be coal and steel are now innovations and the people who implement them. With over 5.1 million people in more than 50 municipal communities, the Ruhr area is the largest metropolitan region in Germany and one of […]

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What effect does the EU directive have on the pharmaceutical industry?

Pharmacists gives serialised medicine to a customer

With the publication of the Delegated Regulation (EU) 2016/161 in the Official Journal of the European Union, the deadline for transposition of the new EU Counterfeiting Directive has been set. Beginning on 9.2.2019, prescription drugs must be clearly identifiable and traceable – every single package. EU Counterfeiting Directive: Increasing drug safety for consumers Antibiotics, anticancer […]

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tracekey Receives Technical Certification as EMVO Connection Provider

One step forward against counterfeit medicine: The European Medicines Verification Organisation (EMVO) technically certified tracekey as an IT connection provider. After passing a series of tests, tracekey is now one of five companies worldwide which received the certification. That means pharmaceutical companies who use the tracekey software can now upload their serialization data to the […]

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tracekey And IMVO Join For Webinar on FMD

What are the FMD requirements my company has to fulfill? How do we get serial numbers from the manufacturer to the EMVO? These and more questions are being answered by tracekey managing director Stefan Hoffmann, who will join David Doyle from the Irish Medicines Verification Organisation (IMVO) for three webinar dates, hosted by technology consultants […]

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