Stockholm-based Contract development and manufacturing organization (CDMO) Recipharm has received European Medicines Verification Organisation (EMVO) approval to submit serialization data to the European Hub.
While clients of Recipharm’s CDMO business must establish their own connections to the EU Hub for their products, the connection allows Recipharm Group’s marketing authorization holders to continue to supply medicines to patients after the EU FMD implementation date.
Staffan Widengren, Director Corporate Projects and leader of Recipharm’s serialization program, says, “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.
“This project milestone reaffirms Recipharm’s global leadership in serialization and our commitment to meeting the compliance requirements well ahead of the February 2019 deadline,” adds Widengren. “We will be using our knowledge to advise our customers on their own connections over the coming months in line with EMVO’s requirements.”
In an Aug. 6 announcement, EMVO stated that only 106 of the EU’s 2,000-plus pharmaceutical companies have completed the on-boarding process with their National Medicines Verification Organisations (NMVOs) and developed their connection to the EU Hub.
TraceLink acted as Recipharm’s gateway provider to the EU Hub. The firm has developed a streamlined program for its customers to rapidly complete conformance testing and successfully receive EMVO approval to submit data to the EU Hub. The company says that today, 56% of the companies connected to the hub are TraceLink customers.
Shabbir Dahod, TraceLink President and CEO, says, “Recipharm is a great example of an organization that is taking a proactive approach to serialization compliance and it was a pleasure to support the team with their connection to the EU Hub.”
Recipharm indicates that it has delivered more than two million serialized packs to markets such as China, South Korea, Saudi Arabia and Turkey, where serialization regulations are currently in place, as well as serializing over 500,000 packs for the U.S. Read more about Recipharm’s serialization services here.