The 2011 Falsified Medicines Directive (FMD) called for the development of a database of legitimate drug products against which suspected fakes could be compared.
In response the European Medicines Verification Organisation (EMVO), a non-profit group which set up by EAEPC, EFPIA, EGA, GIRP and PGEU – is creating the European Medicines Verification System (EMVS).
The system is on track to be operational by February 2019 according to an EFPIA spokesman who told us that “data held within the EMVS consists essentially of the barcode data and enough high level product information to make the system work.
No chemical or constituent information will be held in the database he continued adding that: “The EMVS is driven from a logistics viewpoint and not a regulatory one.”
Much of the development effort is focused on the balance between allowing manufacturers to upload information and securing data in the system.
The EFPIA spokesman said: “The information contained within the EMVS would be of use to counterfeiters and of course it is secured however it would be unwise to go into any specific detail as to how this is achieved.”
He added however that the EMVS has multiple layers of security.
Connection
Earlier this month pharmaceutical track and trace provider Tracelink announced it had completed product master data and product pack data upload certification tests with the EMVO for connection to the European Hub.
The EFPIA spokesman explained that: “Tracelink has essentially created a connection between their cloud service and the European Hub. Each Tracelink client requires an independent account with the EU Hub and Tracelink cannot send data for a client until they are made aware of the client account details.
He added that: “EMVO are unaware of the inner-workings of the Tracelink solution but sense that each client will have to use/buy the TL compliance module.”
Tracelink is not the only option. A number of pharmaceutical firms have developer their own connections to the database. Others are using the EMVO’s cloud-based web portal to upload information to the EMVS.