Only a fifth of pharma companies connecting to EU FMD hub

According to a statement from the EMVO, 500 companies have now signed participation agreements.

FMD security features

Around 2,000 pharmaceutical companies across Europe have not yet started the process of connecting to the European Medicines Verification System (EMVS), also known as the “EU (European Union) hub”, as part of Falsified Medicines Directive (FMD) requirements.

In a statement released on 12 March 2018, the European Medicines Verification Organisation (EMVO) said that to date, 500 companies had now signed participation agreements with EMVO confirming their willingness to “on-board” (i.e. connect) to the hub.

However, the EMVO warned that this still leaves approximately 2,000 companies who have yet to sign the agreement. “The on-boarding figures are still far behind schedule, while the deadline is getting closer,” the organisation said. “It is of paramount importance to spread the message to the broader audience and to get all relevant actors ready on time.”

On 8 January 2018, the EMVO warned that companies who had not started the process of connection to the EU hub by 15 January 2018 would be subject to a 50% increase to their on-boarding fee.

The EMVS will be at the centre of compliance to the FMD, which comes into force across Europe on 9 February 2019. Under FMD, all prescription medicine packs must carry a 2D barcode containing identification data, including a 20-digit unique identifier. The EMVS will be an EU-wide database of these unique identifiers, and pharmaceutical companies are required to upload to the database the unique identifiers for every pack of medicine they produce.

Last updated
The Pharmaceutical Journal, PJ, April 2018, Vol 300, No 7912;300(7912):DOI:10.1211/PJ.2018.20204547

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