Europe – A Significant Number of Manufacturers have Failed to Connect to EU Medicines Verification System

EMVO stakeholders would like to encourage the National Competent Authorities to start enforcing the primary requirements of the FMD and DR and undertake inspections on all supply chain actors. Both EMVO and NMVOs stand ready to supply all necessary and available information to National Competent Authorities.

5 months into the operational phase of the European Medicines Verification System (i.e. after the 9 February 2019 implementation deadline) a significant number of manufacturers and supply chain actors have not yet connected to the system. Current available data from EMVO/NMVOs estimate that two fifths (40%) of manufacturers as well as one quarter (25%) of other supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have not yet connected to the medicines verification system(s).
At the same time, approximatively 3% of all scans undertaken by supply chain stakeholders lead to a ‘false alert’ being generated due to various reasons (and, most of the time, a combination of reasons), such as: missing data upload into the European Hub, incorrect data upload, incorrect scanner configuration of end-users, pharmacy/hospital software systems not updated, procedural reasons, system not used properly etc…