As we reported last year, the European Medicines Verification System (EMVS) is a European system designed so that medicines can be verified at the point of dispensing to meet the requirements of the EU Falsified Medicines Directive (FMD).
By February 9, 2019, Marketing Authorization Holders (MAH) that market 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.
An On-Boarding Partner (OBP) is a contracting party of the European Medicine Verification Organization. Official OBPs must undergo a series of stringent tests to pass the EMVS certification process. Adents recently announced that it has passed this certification process to become an official OBP (On-Boarding Partner) Gateway Provider, along with TraceLink, which was certified last year.
To achieve certification, Adents co-developed a gateway with Microsoft enabling its Level 4 traceability system, Adents Prodigi, to connect securely with the European Hub.
Adents reports that it is authorized to sign on behalf of Marketing Authorization Holders and transfer their unique identifiers and related information to the European Hub. Adents Prodigi is based on the Microsoft Trusted Cloud Azure platform, which was selected by the EMVO to build the European Hub. Uploading verified and compliant data on the European Hub also means communicating with all national hubs, such as SecurPharm in Germany.
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