On 19 July 2017, SecurMed UK — the UK Medicines Verification Organisation tasked with implementing the UK medicines verification system (MVS), as required by the Falsified Medicines Directive (FMD) — announced that it would be working with Arvato Systems to implement the verification hub.
As with all national verification systems across the EU, the UK MVS will be connected to the centralised European Medicines Verification System (EMVS).
The two bodies will begin a pilot of the UK verification system in early 2018, but Jerome Bertin, SecurMed UK’s general manager, has warned that challenges lie ahead, not least in ensuring that all end users of the system — including community pharmacies, hospitals, GP surgeries and wholesalers — are ready to go live when the FMD is fully implemented on 9 February 2019.
Bertin said that while SecurMed UK and Arvato “will ensure the UK MVS is available for operational use by February 2019 for all those who are ready to connect and onboard to the UK MVS”, some end users will not be ready for connection by that date.
“The UK verification system will connect to IT systems supplied by the end user’s IT provider,” Bertin said. In this, they will be supported by Arvato Systems. But, he says, it could take IT providers some time to develop falsified medicines directive solutions for their end users: solutions that include “software, scanning devices and liaising with dispensing locations on ways of working”.
Bertin also anticipates that manufacturers’ different approaches to serialisation will present a “significant challenge”, as will the “sheer amount of change in systems and working practices required at the end-user level”.
Arvato Systems, which will manage 13 national medicines verification systems across the EU, told The Pharmaceutical Journal that while implementation “will take time and is a complex process for all stakeholders”, their prior experience with securPharm — a German medicines verification system, which was linked to the EMVS in July 2015 — leads them to be confident.
“More than 60 manufacturers have now uploaded the serial numbers on their packaging to the securPharm system. So far it has been possible to upload and verify more than 30 million pharmaceutical packages,” said Michael Horstmann, senior manager in sales and consulting at Arvato Systems.
SecurMed UK and Arvato Systems met in Germany on 20 July 2017 to confirm their respective roles and responsibilities, and plan their next steps.
“SecurMed UK will provide the means for the end-user locations, such as pharmacies, to register for use of the UK MVS,” Bertin said. “As the UK Blueprint Service Provider, Arvato Systems will set up the UK MVS — including providing access credentials, so that pharmacists can verify and decommission medicines — and provide the ongoing operational service from 2019.”
While working with devolved governments around the UK — each with their own user communities and registration bodies — adds extra complexity, Bertin says SecurMed UK has received “good support” in this from national competent authorities at the Department of Health, the Medicines and Healthcare products Regulatory Agency and NHS Digital in England, and from governmental and industrial bodies in Scotland and Northern Ireland.
“We are also receiving now input from the Channel Islands and Isle of Man,” he added.
|The UK Medicines Verification System (UK MVS) will form the heart of the UK’s response to the Falsified Medicines Directive (FMD). It’s a data repository — it will hold all the product identification details that manufacturers will, under FMD, have to assign to each individual pack of medicine. Each pack will need to be issued with a product code, a unique, randomised 20-digit serial number, the batch number and the medicine’s expiry date. All this data will be embedded within a 2D barcode on the outside of each pack. Before dispensing medicine, a pharmacist will scan the 2D barcode and check the data against the UK MVS. A positive match will indicate that the medicine has been recognised by the system and is therefore genuine.