The serialisation and authentication requirements of the EU Falsified Medicines Directive (FMD) came into force on 9 February 2019. The UK is still subject to EU regulations during the post-Brexit transition period which will run until at least 31st December 2020.
The General Pharmaceutical Council has stated it will take action if pharmacies “blatantly disregard FMD”.
Negotiations on the UK’s future relationship with the EU, which are due to take place during 2020, will determine whether FMD still applies within the UK in the future.
There is a strong likelihood that the UK government will introduce its own version of FMD, should the European directive no longer apply. We do not expect any clarity on the long-term future of FMD until the second half of 2020 at the earliest.
SecurMed, the organisation which runs the UK Falsified Medicines Directive (FMD) hub, will be changing the wording of the eleven alert messages and one related system message produced by the hub when the data on the pack of a medicine gives cause for concern for its authenticity.
Both the “Description” and “Short Description” are being amended to make them more understandable to users of the system; this change follows discussions between SecurMed, the UK FMD Working Group for Community Pharmacy and some FMD system suppliers.
See the revised messages on the SecurMed website
The change will be made effective on Sunday 17th March 2019.
Implications for pharmacy teams
This does not alter the way you use your FMD system, but you may start to see the amended wording appearing when you use your system following the change. If your Standard Operating Procedures contain details of the FMD alert messages, you may want to update your procedures to reflect the new wording.
Updated UK FMD Working Group for Community Pharmacy interim guidance
The interim guidance published by the UK FMD Working Group for Community Pharmacy has been updated to reflect the revised FMD alert wording which will start to appear in FMD systems from Sunday 17th March 2019:
Interim guidance on dealing with FMD alerts (version 2 6/3/19)