08.14.17
Adents has obtained Certified Gateway Provider certification following a series of tests with the European Medicines Verification Organization (EMVO) for connection to the European Hub.
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 February 9, 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 becomes an official OBP (On-Boarding Partner) Gateway Provider. An OBP (On-Boarding Partner) 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. Adents can now legally vouch for its customers concerning serialization compliance.
To achieve certification Adents co-developed, along with Microsoft, a gateway enabling its 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 have a 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 SecurPharm in Germany.
“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,” said Christophe Devins, chief executive officer and founder of Adents.
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 February 9, 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 becomes an official OBP (On-Boarding Partner) Gateway Provider. An OBP (On-Boarding Partner) 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. Adents can now legally vouch for its customers concerning serialization compliance.
To achieve certification Adents co-developed, along with Microsoft, a gateway enabling its 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 have a 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 SecurPharm in Germany.
“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,” said Christophe Devins, chief executive officer and founder of Adents.