A new world-first, digital tracking system covering the medicines supply chain across the European Union has gone live, promising greater security against counterfeit medicines.
The new European Medicines Verification System (EMVS) is a world first, and uses a 2D data matrix (barcode) to track every pack of medicines as they make their way from the manufacturer into the supply chain and on to the patient.
Medicines now also have an anti-tamper device (ATD) to ensure they are not interfered with before the patient receives them.
The system went live on Saturday 9 February, and has been introduced under new European regulations, the Falsified Medicines Directive (FMD) and is managed by a consortia of stakeholders.
A decade or more in the making, the regulations aim to eliminate the potential for fake drugs to enter the supply chain, a problem which over the years has grown into a multi-million dollar illegal industry.
The European Medicines Verification System (EMVS) is a pioneering system, and is using new technology and a dedicated network of national bodies working together to guarantee safety and security.
Hugh Pullen, president of the European Medicines Verification Organisation (EMVO), the non-profit organisation which runs the system, comments: “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 EEA countries.”
Pullen adds that the new network is only possible because of the central EMVO team and ‘substantial’ collaboration between all stakeholders in the pharmaceutical supply chain.
EMVO says it will ensure the system remains technical stable, secure and that any issues are ironed out without any disruption. However two countries, Italy and Greece will have longer transition periods to join the system.
The organisation says that the EMVO system could well serve as a blueprint for securing the supply of medicines beyond Europe.
For the UK, the introduction of EMVS has highlighted further the problems caused by Brexit. On Friday, UK pharma industry and NHS leaders welcomed the new system, hailing it as the ‘world’s best’ medicines safety system and said it would be a ‘travesty’ if the UK had to leave the new network as part of a no-deal Brexit.
Pullen has told Securing Industry that some smaller pharma companies and pharmacies won’t yet be ready to implement the system, with national authorities allowing for a ‘soft launch’ period.
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.
