Contract development and manufacturing organisation (CDMO) Recipharm has received approval by the European Medicines Verification Organisation (EMVO) to submit serialisation data to the European Hub.
Europe Vector
The move was facilitated by the company’s strategic partner, Tracelink, to help prepare for the Falsified Medicines Directive (FMD). The connection to the EU Hub allows the marketing authorisation holders within Recipharm to continue to supply medicines to patients after the EU FMD implementation date.
Staffan Widengren, director corporate Projects and leader of Recipharm’s serialisation programme said: “The process of connecting to the EU Hub should not be underestimated as it takes a lot of time and effort to complete. We began the connection process in October 2017 and the past 10 months have involved a series of contractual and technical on-boarding steps.”
Recipharm began its serialisation programme in January 2016 and has so far invested €40 million in the process.
Staffan added: “This project milestone reaffirms Recipharm’s global leadership in serialisation and our commitment to meeting the compliance requirements well ahead of the February 2019 deadline. We will be using our knowledge to advise our customers on their own connections over the coming months in line with EMVO’s requirements."
The EMVO has confirmed that only 106 of Europe’s 2000+ pharmaceutical companies have completed the on-boarding process and developed their connection to the EU Hub.
Shabbir Dahod, president and CEO of TraceLink, said: ”TraceLink’s history integrating with the EU Hub dates back two years, with nearly 650,000 serial numbers submitted to the EU Hub by our customers since 2016. Today, while other solution providers are in the midst of conducting pilot tests, TraceLink customers are out front, already live in production with serialisation and officially approved to submit data to the EU Hub. Recipharm is a great example of an organisation that is taking a proactive approach to serialisation compliance and it was a pleasure to support the team with their connection to the EU Hub.”