Adents Obtains Gateway Provider Certification From European Medicines Verification Organization (EMVO)
Published: Jul 11, 2017
Serialization Solutions Company Successfully Passes Full Certification Test to become first European Certified Gateway Provider
PARIS--(BUSINESS WIRE)--After a series of thorough tests with the European Medicines Verification Organization (EMVO) for connection to the European Hub, Adents is now one of only two official “Certified Gateway Providers” in the world.
As part of the EU Falsified Medicines Directive (FMD), the European Medicines Verification System (EMVS) is a pan-European system designed so that medicines can be verified at the point of dispensing. As of 9th February, 2019 Marketing Authorization Holders that commercialize drug products distributed in the FMD’s jurisdiction will be required to upload their product serialization data on the European Hub. Reporting to the European Hub will entail generating and managing serialization data compliant with each target market.
Adents Prodigi offers a Certified Gateway to the European Hub
With the view to helping customers address the challenges of compliance reporting, Adents successfully passed the EMVS certification process, which comprises a series of thorough tests, thus becoming an official OBP (On-Boarding Partner) Gateway Provider.
An OBP is a contracting party of the European Medicine Verification Organization. Moving forward, Adents is authorized to sign on behalf of Marketing Authorization Holders and transfer their unique identifiers and related information to the European Hub. In essence, Adents can now legally vouch for its customers concerning serialization compliance.
Adents Prodigi, the only Cloud Serialization Solution that empowers serialization data
To achieve certification Adents co-developed, along with Microsoft, a gateway enabling its powerful Level 4 traceability solution, Adents Prodigi, to connect securely with the European Hub. Adents Prodigi allows its customers to be prepared to report their serialization data ahead of the February 2019 deadline. Pharma companies also benefit from a unique touchpoint from which to manage their data and comply with European country-specific legislations. Lastly, uploading verified and compliant data on the European Hub also means communicating with all national hubs, such as SecurePharm in Germany.
Adents Prodigi is a cloud-based platform for unique product identification (UPID) and track & trace that centrally manages all serialization requirements of the pharmaceutical industry and ensures permanent compliance.
Based on Microsoft Trusted Cloud Azure platform (selected by the European Medicines Verification Organization to build the European Hub), Adents Prodigi is currently the only solution that provides comprehensive tools and applications for data analysis and data processing. It also includes an easy connection interface that facilitates the on-boarding of Trading Partners by reducing required IT resources, connectors and costs.
“We’re very pleased to on-board our Adents Prodigi customers on the European Hub. This certification is a major step to help them be fully operational and compliant for the February 2019 deadline. Beyond compliance, Adents Prodigi also empowers our clients to unleash the business potential of their serialization data” observed Christophe Devins, CEO and Founder of Adents.
About Adents :
Adents is a leading software company providing solutions for unique product identification and traceability to help Marketing Authorization Holders (MAHs) and Contract Manufacturing Organizations (CMOs) adapt to market changes and comply with regulations on drug traceability.
- Adents Seriza, a serialization solution for manufacturing sites, selected as preferred solution by Siemens for its customers
- Adents Prodigi, a Cloud solution jointly developed with Microsoft and empowered by Azure technologies, allows for secure data exchange and helps leverage the power of serialization data.
Adents operates globally with offices in Europe and in the United States as well as with a global network of solution partners. For more info, visit www.adents.com - @Adentsinfo