EMVO to raise on-boarding fees to avoid ‘bottleneck’

The European Medicines Verification Organization (EMVO) has announced stepwise increases in the fees it charges to get connected to the EU hub in a bid to accelerate the process.

The increases have been prompted by what the EMVO describes as an “important shortage” in the numbers of on-boarding partners (OBPs) going through the registration and connection process with the hub, which is operated by the EMVO as a ‘router’ to allow the exchange of data between an OBP and a National Medicines Verification System (NMVS).

According to the organization the one-off on-boarding fee for OBPs – which is set depending on the number of marketing authorization holders (MAHs) represented - will rise by 50 per cent of the current amount as of January 15, with an additional 50 per cent increase applying from June 15 onwards.

“It is time to on-board without delay,” says the EMVO, which warns that at current take-up rates “we will most probably be ending up in a bottleneck situation which will cause significant increase in on-boarding connection and support costs.

According to the Falsified Medicines Directive (FMD), product and serialization data must be uploaded to the European hub on or before February 9, 2019. To meet that deadline pharma manufacturers need to have an OBP agreement in place, establish and check the technical connection to the hub and upload all the required product master and product pack data transactions for serialized product.