Limited access to EU Hub could threaten serialization readiness, says CMO

By Flora Southey contact

- Last updated on GMT

GettyImages/Eoneren
GettyImages/Eoneren
Only marketing authorisation holders, and not CMOs or third-party logistic providers, will be able to report to the European Hub for serialisation compliance, says drug database coordinator EMVO.

The Belgian-based, non-profit European Medicines Verification Organisation (EMVO) recently addressed on-boarding partners with the decision regarding its European Medicines Verification System​ (EMVS).

The EMVS – set up in response to 2011 Falsified Medicines Directive​ (FMD) – is designed to help Europeans identify fake medicines by ensuring the “implementation of a functioning, secure, interoperable and cost effective system across Europe.”

According to the EMVO’s decision​, only marketing authorisation holders (MAHs) – with or without parallel distribution activities – will be able to report to Europe’s central information and data router, known as the EU Hub.

The EMVO has provided just these two MAH categories on the European Hub’s ‘on-boarding partner portal.’

CMO perspective

As a ‘full-service provider’, contract development and manufacturing organisation (CDMO) Recipharm said it “would be good” ​to report to the EU Hub on behalf of its customers, adding that it has received such requests from clients.

“It would be easier for a single CMO to connect and report to the hub on behalf of several customers, as opposed to each customer doing this individually,” ​director of corporate projects Staffan Widengren told us.

“Recipharm has evaluated whether it is possible to report to the EU Hub on behalf of our clients, but this requires us to be affiliated with each customer,” ​he added.

The firm also expressed concerns the decision could prolong the data reporting process, and affect on boarding schedules.

“The fact that only brand owners can report to the EU Hub has the potential to affect their readiness as the likelihood is that many will start too late and under-estimate the workload associated with on-boarding,” ​said Widengren.

A ‘clear need’ to connect ASAP

According to serialization provider TraceLink’s annual Global Drug Supply, Safety and Traceability report, just 27% of participants believe they will be sending data to the EU Hub before the February 2019 deadline.

“The data challenges brought about by serialisation are clearly impacting the industry,” ​director of industry marketing Allan Bowyer told us.

“The process of uploading and managing information with the EU Hub for multiple products in multiple markets – often manufactured by multiple partners – can seem complex,” ​he added.

However in order to make the deadline, there is a “clear need for MAHs to review their data management systems and processes and to take steps to connect to the EU Hub as quickly as possible.”

Related topics: Processing, Regulations

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