The UK Community Pharmacy Falsified Medicines Directive (FMD) Working Group has issued a ‘Brexit’ warning to contractors, as connectivity begins from September.
Contractors have been told that continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. Access is likely to continue during the transition period, but after 2020 this will depend on whether the UK government realises its aim of a close alignment on medicines policy.
Arvato, part of the Bertelsmann group, has recently signed a contract with SecurMed UK to provide the UK FMD system. One of the key requirements of FMD is the ‘decommissioning’ of a medicinal product before a supply is made to a patient from Saturday 9 February 2019.
The FMD working group has published a list of FMD IT system suppliers for pharmacy contractors. Available IT solutions include standalone FMD systems or FMD capability integrated into patient medication record (PMR) systems.
The DDA advises member practices to not commit to buying FMD hardware or software until NHS England/Digital can confirm the correct specification and upgrade arrangements for GP practices.
DDA members are also reassured that the DDA is working hard to secure reasonable solutions for dispensing doctors, including funding. Members are reminded that the Department of Health and Social Care and MHRA have launched a consultation on some aspects of implementing FMD in the UK, which contains a section on sanctions for non-compliance. There is also a session on the FMD for dispensing GPs at the 2018 DDA annual conference.
Please do not commit to purchasing any new hardware or software until full details of the specifications are known.