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Recipharm Receives EMVO Approval

contractpharmaSeptember 14, 2018

Tag: Shabbir Dahod

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Recipharm has successfully received European Medicines Verification Organization (EMVO) approval to submit serialization data to the European Hub.

The connection, which was facilitated by the company’s 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 serialization program 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 serialization program began in January 2016 and involves a 40-million-euro investment.

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. Today, 56% of the companies connected to the hub are TraceLink customers.

Shabbir Dahod, president and chief executive officer 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."

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