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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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 […]
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. Why serialize from the Ruhr area? With over 5.1 million people in more than 50 municipal communities, the Ruhr area is the largest metropolitan […]
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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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 […]
Read More… from tracekey Receives Technical Certification as EMVO Connection Provider
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 […]
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. […]
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 […]
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. […]
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. […]