Recipharm, has 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 milestone in Recipharm’s preparations for the Falsified Medicines Directive (FMD). TraceLink acted as Recipharm’s gateway provider to the EU Hub.
While clients of Recipharm’s CDMO business must establish their own connections to the EU Hub for their products, the connection allows marketing authorisation holders within the Recipharm Group to supply medicines to patients post the EU FMD implementation date.
Recipharm’s three-year serialisation programme began in January 2016 and involves a 40-million-euro investment.
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.
Recipharm has 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.
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.”
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.”