Adents passes EMVS certification process to become official gateway provider under EU FMD

By Melissa Fassbender contact

- Last updated on GMT

Adents has obtained a Gateway Provider Certification from the European Medicines Verification Organization. (Image: Adents)
Adents has obtained a Gateway Provider Certification from the European Medicines Verification Organization. (Image: Adents)
Adents has become an official Certified Gateway Provider following a series of tests with the European Medicines Verification Organization (EMVO) ahead of the EU Falsified Medicines Directive (FMD).

After successfully passing the European Medicines Verification System (EMVS) certification process, Adents is now an official OBP (On-Boarding Partner) Gateway Provider. As the company explained, an OBP is a contracting party of the EMVO.

The EMVS was designed to verify medicines at the point of dispensing as part of the EU FMD.

As an official OBP Gateway Provider, Adents can upload product serialization data on the European Hub on behalf of marketing authorization holders.

As Europe moves toward the 2019 serialization deadline, tests/hurdles like these will need to be passed by more and more solution providers to prove that the systems they’re providing to pharma manufacturers and contract packagers actually leads to compliance with the looming law​,” Dave Harty, head of professional services, Americas, at Adents told Outsourcing-Pharma.com.

Increasingly, pharma companies and packagers will be looking for such certifications as they choose vendors – especially with time getting tight​,” he said. “The European Hub is basically the serialization reporting database that the EU is developing, with the goal of full deployment upon the 2019 enactment​.”

To achieve certification Adents developed a gateway that enables its Level 4 traceability solution, Adents Prodigi, to connect securely with the European Hub. 

The gateway was developed in collaboration with Microsoft.

Delays, demand, and deadlines

Following the extended US Food and Drug Administration (FDA) serialization​ deadline, Harty commented that many companies underestimated the breadth of impact that serialization can have on an organization. Others selected difficult to implement solutions, he said.

Some solution providers utilize deployment approaches that simply do not scale to spikes in demand and the time and effort to recruit, hire, and train internal teams can overwhelm many smaller companies with no experience in scaling for a market spike​,” said Harty.

This is very much like the Y2K era and the initial dot-com rush​,” he added. “Only solution providers with an extensive network of highly skilled solution partners will be able to meet the industry’s demand when deadlines become imminent (again)​.”

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