Recipharm, a leading contract development and manufacturing organisation (CDMO) has successfully received European Medicines Verification Organisation (EMVO) approval to submit serialisation data to the European Hub.
The connection, which was facilitated by the company’ strategic partner TraceLink, is a key milestone in Recipharm’s preparations for the Falsified Medicines Directive (FMD).
While clients of Recipharm’s CDMO business must establish their own connections to the EU Hub for their products, the connection allows the marketing authorisation holders within the Recipharm Group to continue to supply medicines to patients post 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’s three-year serialisation programme began in January 2016 and involves a 40-million-euro investment.
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.”
In an announcement on 6th August, the EMVO stated that only 106 of the EU’s 2000-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 programme for its customers to rapidly complete conformance testing and successfully receive EMVO approval to submit data to the EU Hub. Today, 56% of the companies connected to the hub are TraceLink customers.
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.”
Recipharm has already delivered over 2 million serialised packs to markets such as China, South Korea, Saudi Arabia and Turkey where serialisation regulations are currently in place as well as serialising over 500,000 packs for the US.