Adents is now one of two official Certified Gateway Providers in the world able to connect to the European Hub, following a series of thorough tests with the European Medicines Verification Organisation
The European Medicines Verification System (EMVS) is a pan-European system designed to verify medicines at the point of dispensing, as part of the EU Falsified Medicines Directive (FMD)
From 9 February 2019, Marketing Authorisation Holders who commercialise drug products distributed in the FMD’s jurisdiction will be required to upload product serialisation data on the European Hub.
Reporting to the European Hub will involve generating and managing serialisation data compliant with each target market.
Adents Prodigi will offer a Certified Gateway to the European Hub with the view to helping customers address the challenges of compliance reporting, having succesfully passed the EMVS certification process thus becoming an official OBP (On-Boarding Partner) Gateway Provider.
Adents Prodigi is a cloud-based platform for unique product identification (UPID) and track & trace, centrally managing all serialisation requirements of the pharmaceutical industry and ensuring permanent compliance.
Based on the Microsoft Trusted Cloud Azure platform, Adents Prodigi is currently the only solution providing comprehensive tools and applications for data analysis and data processing.
Moving forward, Adents is authorised to sign on behalf of Marketing Authorization Holders and transfer unique identifiers and related information to the European Hub. In essence, Adents can now legally vouch for its customers concerning serialisation compliance.
Adents Prodigi allows its customers to be prepared to report serialisation data ahead of the February 2019 deadline. Uploading verified and compliant data on the European Hub also means communicating with all national hubs, such as SecurPharm in Germany.
Christophe Devins, CEO and Founder of Adents, said: “We are 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 serialisation data.”