Updated 21 February 2020:
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 GPhC 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 will update members as the situation changes, but we do not expect any clarity on the long-term future of FMD until the second half of 2020 at the earliest.
How does it work?
All prescription medicine packs produced after that date must have a tamper evident seal and unique code. Packs will display a 2D barcode (data matrix) which will incorporate the unique identifier which is comprised of product code, batch number, expiry date and serial number.
What do I need to be doing?
- FMD came into force on 9 Feb 2019, and there is a requirement for community pharmacies to implement it regardless of Brexit.
a. If the Brexit transition deal is ratified by the UK, then FMD will also apply during the transition period from 29 Mar 2019- 31 Dec 2020, and both parties (the UK and the EU) would be committed to exploring how it could continue after that.
b. If there is a no-deal Brexit, then FMD would probably cease to apply after 29 March 2019.
- The government has responded to the FMD consultation. Sanctions will utilise a phased approach with non-criminal enforcement measures, such as enforcement notices or suspension or revocation of licence to practice (where appropriate), long before any criminal proceedings would be considered.
- Familiarise yourself with the FMD delegated regulations by reading The Way Forward document
- Ask your PMR supplier what solution they are offering but also look at standalone solutions. All PMR suppliers claim they will have a solution in time. A PMR-based solution might be able to do an accuracy check back to the prescription so enhancing safety, although this is not a requirement of the FMD delegated regulations. Consult the list of suppliers and the comparison of some standalone systems. The NPA has arranged a discount for members on the standalone FMD Connect system
- Consider workflows (see the NPA’s Essential SOPs and NHS Digital FMD community pharmacy toolkit ), and where scanners can be sited.
- Procure a system. Look out for contract length and whether there are exit clauses, especially due to Brexit – see the vital ‘contract’ section at the end of Choosing a PMR system. In England, ensure any PC-based platforms you use are Working Environment Specification (WES) compliant, as that is a gateway criterion for quality payments.
- When you know which system you are going to be using, you will be able to do the end-user registration with SecurMed. Registration can take 15 days. Your system supplier may be able to help you. If you have a wholesale license as well as being a community pharmacy, you need to register twice.
- Update your SOPs (see the NPA’s Essential SOPs). Consult the guidance notes on https://fmdsource.co.uk/resources/eu-fmd-scanning-and-error-messages/ that discusses the action to take on receiving an FMD alert or warning. The HDA are producing guidance on FMD and in what circumstances medicines should be returned to wholesalers. The RPS is soon to publish FMD ethics guidance.
- Train staff
- Operate FMD from 9 Feb 2019
What is the NPA doing?
The NPA worked with other European pharmacy associations to lobby the European Commission and European Parliament as the FMD legislation was being developed. Aside from being part of the database organisation SecurMed UK, the NPA has established the UK FMD working group for community pharmacy. Its membership encompasses the UK’s main pharmacy contractor bodies (the NPA, AIM, CCA, PSNC, Community Pharmacy Scotland, Community Pharmacy Wales, and Community Pharmacy Northern Ireland). Engaging regularly with the Department of Health, the MHRA, and PMR and other IT suppliers, the group is seeking a pragmatic approach to implementing FMD.
Furthermore, the NPA has prepared the following webinars:
As originally broadcast on 15th October 2018:
- Get ready for FMD: Latest guidance from the NPA
- Get ready for FMD: options for your pharmacy from FMD IT
- Get ready for FMD: options for your pharmacy from Tracelink
- Q&As from the webinar
As originally broadcast on 15th January 2019:
- Preparing for FMD – 3 weeks to go
- Q&As from the webinar – find answers to questions from other members
View the NPA’s resources and further advice below:
- FMD Case Studies: Community Pharmacy / Secondary Care
- FAQ: FMD and GPhC inspections
- Wording of UK FMD hub alert messages being updated
- FAQ: Falsified Medicines Directive (FMD) and GPhC inspections
- NPA: dispense despite anticipated FMD alert
- FMD interim guidance from the UK FMD Working Group for Community Pharmacy
Additional resources and advice:
- NHS Digital FMD Case Studies: Community Pharmacy / Secondary Care
- Getting answers from MHRA/DHSC
- FMD Source
- Government Guidance on Implementing the Falsified Medicines Directive: Safety Features
A comprehensive resource in an FAQ format to help you understand the Falsified Medicines Directive, which comes into effect from 9th February 2019.
FMD requires you to have a system in place by this date. It makes sense to plan in advance how you will comply. We would advise our members to follow this checklist.
Before you sign any contract, use our guidance to help you ensure you've chosen the best solution for your needs.
Our template Essential SOPs provide a clearly defined pathway for pharmacy teams, ensuring the safe and effective running of the pharmacies of our members.
View a solutions matrix comprehensively comparing 5 standalone providers.
FMD Connect is a custom-built standalone solution created specifically to enable its users to be fully compliant.