Improving patient safety and fighting fake medicines in Europe

Thursday, 14 February 2019

The European Medicines Verification Organisation, an IAPO partner through the Fight the Fakes campaign launched the world’s first digital verification system covering the medicines supply chain across Europe that promises greater security against falsified medicines.

The launch of the world first European Medicines Verification system (EMVS) which went live on 9 February 2019 is a response to the urgent need of tackling falsified and substandard medicines and is a welcome contribution towards the fight against falsified medicines. As such a system that utilises new technology and safety features is a world first, looking beyond Europe, it will serve as a blueprint for securing the supply of medicines outside of Europe and around the world.

Hugh Pullen, president of the European Medicines Verification Organisation (EMVO), the non-profit organisation which runs the system, said: “The EMVS has a unique structure that really makes it one of a kind. It will connect around 2,000 pharmaceutical companies, around 6,000 wholesale distribution authorisation holders, 140,000 pharmacies, 5,000 hospital pharmacies and around 2000 dispensing doctors in 28 European Economic Area countries.”

It is continuously becoming clear that how it is we address the issue of fake medicines requires a focus on supply chain oversight, country level surveillance and public awareness campaigns. This new system is a pioneer of the use of technology and a dedicated network of national bodies working together to guarantee safety and security and we congratulate EMVO for this massive achievement.

How the system works:

  • Pharmaceutical manufacturers and parallel importers will now serialise the packaging of their prescription medicines with a Unique Identifier (imbedded in a two-dimensional data-matrix), as well as sealing the packaging with a tamper verification feature. The Unique Identifiers are then uploaded by the manufacturer to the European Hub (the EMVS).
  • Wholesalers and other stakeholders use specially designed software to scan the data matrix on a medicine’s outer packaging to verify its authenticity as it travels through the supply chain. The verification of the Unique Identifier and authentication happens in the National Medicines Verification System (NMVS). The European Hub connects national systems in order to make them interoperable. Manufacturers use a secure connection with the European Hub to upload the data of the medicinal products.
  • Before dispensing the medicines to a patient, the unique identifier will be ‘decommissioned’ from the EMVS by the pharmacist, hospital pharmacist or, in some special cases, the wholesaler. This provides a final safety measure to ensure the end point verification of the medicines’ authenticity.