The European Medicines Verification System (EMVS) was made live at the end of last week, with an aim of preventing the entry of falsified medicines into the supply chain. The EMVS has been set up to guarantee the authenticity of medicine by providing end-to-end verification.
The process to ensure authenticity has required marketing authorisation holders of products to confirm packaging is produced with a unique identifier, and also possesses anti-tampering device on the outer packaging.
The release announcing the system had gone live noted that the percentage of falsified medicines within the legal supply chain in Europe is just 0.005%; however, the European Union’s Falsified Medicines Directive (FMD) created the legal framework for the creation of non-profit European Medicines Verification Organisation (EMVO) to further secure the supply chain via the creation of the EMVS.
As a result, investments to ensure companies are able to meet these requirements have been high and the importance of a smooth transition for the industry is commensurately important; in-PharmaTechnologist (IPT) spoke to Hugh Pullen (HP), EMVO’s president, to learn more about the EMVS and what the organisation is doing to help industry make that transition.
IPT: Why has the EMVS been developed?
HP: Starting from February 9, patients across Europe now have a system of medicines verification, which makes the legal supply chain even safer from falsified medicines.
Falsified medicines have been identified as presenting a growing threat to the legal supply chain. As such, having a system of verification (the EMVS) was foreseen in the FMD and the Delegated Regulation. The start of the operational phase of the EMVS is the culmination of several years of work by the stakeholders of the supply chain to better protect patients from falsified medicines.
IPT: What does the change mean for patients?
HP: There will be no change in the patient experience when they receive their medicines. The EMVS is a system of end-to-end verification, with the medicine being verified by scanning the pack and by checking the anti-tampering device (such as a seal) on the pack.
Therefore, the EMVS provides an additional layer of security for patients across Europe while not adding any additional burden to how they receive their medicines.
IPT: What medicines do these additional regulations apply to?
HP: In terms of the February 9 deadline, it is important to note that this applies only to medicines in the scope of the Delegated Regulation, which have been released for sale or distributed from this date; as opposed to prescription medicines dispensed before this date.
However, what is indeed the case is that from this date any medicinal products which are in the scope of the FMD and Delegated Regulation, and which are produced from February 9, 2019, must comply with the new safety features.
IPT: What support will the EMVO provide pharmaceutical companies?
HP: EMVO has been mandated by its stakeholders to establish and run the European Hub and to provide pharmaceutical companies with a means to connect to the EMVS. Indeed, EMVO still provides a service allowing pharmaceutical companies to swiftly on-board to the EMVS through our on-boarding partner portal. Once the initial registration has been made, EMVO provides a wealth of support to pharmaceutical companies as they complete the contractual and technical processes required to connect to the EMVS.
It has, however, been made clear to pharmaceutical companies that they are responsible for their own obligations set out in the FMD and associated Delegated Regulation. Furthermore, EMVO does not, under any circumstances, accept responsibility for companies who fail to on-board to the EMVS or who have on-boarded to the EMVS after the deadline.
IPT: How could a no-deal Brexit impact the system?
HP: The EMVS has been established under the current legal framework covering the states participating in it, including the UK, which is bound by the terms of the FMD while it remains an EU Member State.
Therefore, at present, all end-users in the UK are obliged to connect to the EMVS, as they are legally required to be compliant with the FMD as of February 9, 2019. If there is a formal agreement between the UK and the EU on a transition period, then the UK would remain a member of the EMVS and be bound by the conditions of the FMD until the end of the transition period. The end of the transition period is scheduled as being December 31, 2020.
If the UK leaves without a deal next month, then the UK will no longer be a part of the EMVS. The EMVS itself would continue to function with 27 member countries, as opposed to the 28 that are currently connected.