One of the obligations imposed on Member States under the Falsified Medicines Directive 2011/62/EU (FMD) is to put in place a medicines verification system by 9 February 2019. In the UK this is being managed by Securmed UK, a non-profit organisation established by the relevant supply chain stakeholders.
On 19 July 2017 Securmed UK announced that it had entered into a letter of intent with Arvato Systems GmbH to provide the IT platform that will underpin the UK’s medicines verification system. This represents a key milestone in the UK’s journey to meeting its obligations under the FMD and associated Delegated Regulation 2016/161.
The EU medicines verification system works by requiring manufacturers to print unique data matrix codes on their products, which are then stored in national databases. Pharmacists and wholesalers can then scan these unique codes and check them against the relevant national database—if any product has a duplicated or unlisted code, or a code which indicates that it has already been supplied to a patient, then it is are plainly at risk of being falsified and should not be supplied to patients. A diagram summarising the system is set out below.
SecurMed UK is a non-profit organisation with responsibility for establishing and managing the UK’s medicines verification system, under the supervision of the DH and the MHRA. Like its EU counterparts, SecurMed UK has been looking at service providers to operate the verification database and associated IT platforms that are required to run the verification system. Following its appointment as an official service provider of the European Medicines Verification Organization, Arvato Systems is also involved in providing similar verification systems in a number of other Member States, including Finland, Austria, Germany and The Netherlands.
In terms of next steps, Securmed UK and Arvato are expected to start running pilots in short order, whilst a consultation on proposed changes to the Human Medicines Regulations 2012 to reflect the requirements of the Delegated Regulation is expected later this year.
Readers with an eye on their calendars will have noted that the deadline for implementing the FMD falls before the date on which the UK is currently scheduled to exit the EU. The current position of the DH and MHRA is that it is ‘business as usual’, and pending further developments they will continue to implement the requirements of the FMD as envisaged before the Brexit vote.