EU body for medicines verification launched

EU medicineThe organisation that will run the proposed hub for the EU's medicines-tracking scheme came into being last week.

The European Medicines Verification Organisation (EMVO) was formed as a non-profit group in Luxembourg and will be responsible for overseeing the 'hub' that will handle the transaction data between the various national verification systems that will operate in the EU.

The European Federation of Pharmaceutical Industries and Association (EFPIA) - one of the industry partners behind the initiative - said the move was "a significant step towards securing the legitimate pharmaceutical supply chain against the risk of falsified medicines."

The creation of the EMVO marks the culmination of four years of work and is a key pillar of the European Stakeholder Model (ESM) for medicines verification which has been proposed as a way to meet the safety feature requirements of the 2011 Falsified Medicines Directive (2011/62/EU).

In addition to EFPIA - which represents brandname pharma companies - the ESM is also supported by European Generic and Biosimilar medicines Association (EGA), the European Association of Euro-Pharmaceutical Companies (EAEPC) representing parallel importers, European Association of Pharmaceutical Full-line Wholesalers (GIRP) and Pharmaceutical Group of the European Union (PGEU).

The ESM is a partial tracking system for medicines which will involve marking each medicine pack with a unique serial number - in a 2D datamatrix code at the point of manufacture - which will then be verified in the pharmacy at the point of dispensing to the patient and - in some cases - by wholesalers.

It also covers the secure replacement of codes if medicines are repackaged, for example during parallel trade, and can be used to intercept counterfeit, expired or recalled drugs before they are given to patients.

Along with the use of tamper-evident packaging, the scheme seems to satisfy many of the requirements that are expected to be included the delegated act, which will cover the safety feature elements of the FMD and is due to be published at the end of the third-quarter of this year.

Newly‐appointed EMVO spokesman John Chave - who is also secretary general of the PGEU - said: "The establishment of the EMVO is a major milestone in the implementation of the Falsified Medicines Directive"

It shows that stakeholders across the pharmaceutical sector are "working together to improve the security of the legitimate supply chain and, most importantly, to promote patient safety."

The entire ESM relies on the hub, which has to be able to interface properly with IT systems operated by manufacturers, parallel distributors, wholesalers and pharmacies as well as national database systems if it is to be suitable for pan-European application.

Germany's national securPharm system - which was trialled in 2013-2014 under real-world conditions in the German market - is be the first EU member state to contribute fully to the improved Europe-wide verification system under the auspices of EMVO, said EFPIA. securPharm has been linked to the European hub since July 2014.

Meanwhile, countries that need to comply with FMD can make use of an existing product verification infrastructure - designed by the EMVO - called the national Blueprint System Template. This serves as an "out-of-the-box" model that is designed to allow quick and cost-effective implementation.

In a blog post, EFPIA's François Bouvy said: "EMVO cannot be a panacea for all the ills associated with the illegal acts of medicines falsifiers, but - make no bones about it - this is a giant leap forward in terms of promoting and protecting patient health."

"As other nations join, the system will obviously become more effective," he added.

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