The European Stakeholder Model (ESM), a partnership of organizations involved in the pharmaceutical supply chain in the EU, launched a Europe-wide hub for sharing data related to medicines in the pharmaceutical supply chain. The European Medicines Verification Organization (EMVO) is designed to help countries in the EU work together to meet the safety feature requirements of the 2011 Falsified Medicines Directive (FMD), while combating fake medicines. Using the hub, stakeholders across the pharmaceutical sector will work together to improve the security of the legitimate supply chain and, most importantly, to promote patient safety. 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.”

How does EMVO work?

1. Each medicine pack is assigned a unique 2d data matrix barcode, consisting of a product number, batch number, expiration date, and random serial number. The barcodes  can be used to intercept counterfeit, expired, or recalled drugs before they are given to patients.
2. The contents of the code are sent to a database before releasing the product.
3. The distributor verifies each pack before packaging or repackaging in tamper-evident packaging, and securely uploads the barcodes.
4. The wholesaler verifies the medicine, as required, before it reaches the consumer.

Germany is the first EU member state to contribute fully to the EMVO system, since their own SecurPharm has been linked to the European hub since July 2014. As other countries begin their onboarding, they will use a national Blueprint System Template in the mean time, as a way to comply with the FMB.

In Europe, the EMVO is a giant leap forward in terms of promoting and protecting patient health and we applaud the EU on this effort. As a U.S. consumer, to ensure safety, we suggest that you check an online pharmacy before you buy using LegitScript’s pharmacy verification tool. Also, if you have concerns about a website or drug seller, please report the information to the U.S. FDA for further investigation using our online portal.

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The Center for Safe Internet Pharmacies (CSIP) and our 13 member companies have the shared goal of helping address the growing problem of consumer access to illegitimate pharmaceutical products on the Internet. Continue to read this blog for updates on CSIP’s education, enforcement and information-sharing efforts.

This item was highlighted in CSIP’s May 2015 newsletter.