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. […]
tracekey is one step further on the way to facilitate a smoothly-operating pharma serialization in 2019. We successfully tested the interface to the product data transmission to the ACS-MAH-System and as a result, we are now certified users of the ACS-MAH-System. […]