The Falsified Medicines Directive (FMD) comes into effect from 9 February 2019. To help you become fully compliant, here’s a handy guide to what the FMD is, how it impacts you and what solution is right for your organisation.
What is the Falsified Medicines Directive (FMD)?
The FMD is European legislation that aims to ensure patients only receive safe, quality medicines by removing false or unauthenticated ones from circulation. To do this, the FMD requires that all dispensed medicines include two safety features:
- a unique identifier (UI) 2d barcode that, when scanned, checks medicines against the National Medicines Verification System’s (NMVS) register to see if they’re authentic
- an anti-tampering device (ATD) that does what it says on the tin: ensures a product’s not been tampered with.
Does my organisation need to be FMD compliant?
All organisations that dispense medicines and controlled drugs to patients will have to authenticate medicines before decommissioning them. That means all community pharmacies, hospital pharmacies, dispensing GP practices and non-dispensing GP practices have to be FMD compliant.
What solutions can my organisation use?
We’ve designed different solutions to make complying with the FMD’s regulations and safety features as easy as possible. Which one is right for you depends on your type of organisation:
Feedback from our community pharmacy users played a big part in how we developed our FMD solution, so you can rest assured that it's truly tailored to your organisation. Integrated within ProScript Connect, it comes with a whole range of benefits, including automated accuracy checks, efficient FMD-specific reporting and on-screen authentication alerts that instantly improve safety.
Take the complication out of compliance with FMD Authenticator, our online, standalone system. Accessed via any device that’s connected to the internet, it supports you to save costs and improve safety by making it easy for you to scan, verify, decommission and recommission medicines.
Will Brexit affect the FMD?
The Medicines and Health products Regulatory Agency (MHRA) confirmed that the FMD or something very similar to it will still apply after Brexit. As the MHRA detailed in an update:
“The European Union (Withdrawal) Bill […] will convert existing direct EU law such as EU regulations into UK law as it applies in the UK at the date of exit. It will also preserve the laws we have made in the UK to implement our EU obligations, such as laws already made to implement the Falsified Medicines Directive, which will apply to UK law from 9 February 2019.”
To ensure that you’re covered for the FMD at all times, learn more about FMD Authenticator or ProScript Connect’s integrated solution now.