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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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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365 Days Until Serialization Starts in EU

From today on, it’s only 365 days until the EU regulation 2016/161 has to be implemented.Its core feature is that from February 9, 2019, nearly all prescription medicines have to be labeled with randomized serial numbers as additional safety and identifying features. A transitional period, like in the US, is not intended. […]

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Russia Postpones Serialization to 2020

A new law by the Russian government postpones the start of the serialization obligation from January 1, 2019, to January 1, 2020.This delay allows the pharma industry more time to implement the legal requirements. Nevertheless, with this new law, which was published on December 29, the Russian government retains the possibility of determining an earlier […]

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New FAQ for Falsified Medicines Directive

The European Commission updated the FAQs about the Falsified Medicines Directive (FMD) 2011/62/EU and the Delegated Regulation 2016/161. This version (version 8) aims to answer further open questions regarding the implementation of the Directive in February 2019. Find the document here. […]

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We Officially Are a Training Firm

We had the pleasure of welcoming our first apprentice, Ingo Herbrich, in August. In his apprenticeship as an IT specialist for system integration, he supports the setting up and maintenance of our servers. He likes most of all that he can bring in his own ideas and work on them. For example, in the optimization […]

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Data Security Precedes Digital Innovation

60 percent of German citizens are skeptical of digital innovation because they are worried about lacking data protection. A recent study by consulting agency BearingPoint found out that many Germans are skeptical about digitalization in the life sciences. Step counter or heartbeat measure apps are already being used, but beyond that, most are still hesitant. […]

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tracekey Supports DSCSA Regulations

About six weeks before the next major DSCSA serialization deadline becomes effective on November 27, 2017, tracekey released their new mytracekey PHARMA software version. The 2017.3 upgrade enables our clients to meet the US Food and Drug Administration (FDA) requirements for serialization, reporting, and verification of RX medicines. […]

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