Gateway to regulation: Adents has passed test to be Certified Gateway Provider
Serialisation solutions company, Adents, has successfully passed its tests with the European Medicines Verification Organisation (EMVO) to connect to the European Hub, making it one of the only two companies that is a ‘Certified Gateway Provider’.
From 9 February 2019, marketing authorisation holders that commercialise drugs to be distributed within Europe will be required to upload product serialisation data on the European Hub. This is all part of the EU Falsified Medicines Directive (FMD), which incorporates the European Medicines Verification System (EMVS) — a pan-European system designed so that medicines can be verified at the point of dispensing.
By passing the tests, set out by the EMVO to connect to the hub, Adents has become an official on-board partner (OBP) Gateway Provider. OBP’s are contracted by the EMVO capable of signing on behalf of marketing authorisation holders and transferring their unique identifiers and related information to the European Hub. Essentially, this means that Adents can now legally vouch for its customers concerning serialisation compliance.
The company achieved certification through its cloud serialisation solution, Adents Prodigi, which was co-developed with Microsoft. This Level 4 traceability solution connects securely to the European Hub, allowing customers to report serialisation data ahead of the February 2019 deadline. Additionally, through Adents, pharma companies have a unique touchpoint from which they can manage data and comply with European-country-specific legislations. When uploading verified and compliant data on the European Hub, companies also communicate with all national hubs.
“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 serialisation data,” observed Christophe Devins, CEO and founder of Adents.