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Medicines regulation

Pharma firms told they face 50% hike in fees if they are late to sign up to the FMD European Medicines Verification System

With just over one year to go until the Falsified Medicines Directive (FMD) goes live across Europe, the European Medicines Verification Organisation (EMVO) is urging pharmaceutical companies to get connected to the European Medicines Verification System (EMVS).

A reminder issued by the EMVS on 8 January 2018 to on-boarding partners (OBPs) — bodies that represent marketing authorisation holders (MAHs) — tells those who have not started the connection process by 15 January 2018 thay they will be subject to a 50% increase to their on-boarding fee. For OBPs with more than 12 MAHs, this represents a rise from €20,000 to €30,000.

From 15 June 2018, a further 50% increase to on-boarding fees will apply.

The impeding rise in on-boarding fees was first announced by the EMVO in December 2017. In that announcement, the body said that “an important shortage can be noticed with respect to the number of on-boarding partners going through the on-boarding process and getting connected to the EU hub… due to the small number of on-boarding partners EMVO counts at the moment, we will most probably be ending up in a bottleneck situation.

“In order to mitigate this risk and cover the increasing on-boarding costs EMVO decided to apply a stepwise rise in the on-boarding fee for late followers.”

The EMVS will form the heart of compliance to the FMD, which comes into force across the EU on 9 February 2019. The FMD requires every prescription medicine pack to feature a 2D barcode containing unique identification data.

The EMVS will be an EU-wide database of these unique identifiers, and MAHs are responsible for the upload of unique medicines identification data to the system.

Before a medicine pack can be given to a patient, the barcode must be read by a hand-held scanner connected to the EMVS via a national database to verify the medicine’s authenticity.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204217

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Supplementary images

  • Medicine package showing unique identifier 2d barcode

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