The Falsified Medicines Directive (FMD) legislation, biggest change to supply chain in decades which will affect all community pharmacists, hospitals and dispensing doctors, is set to take effect in a month’s time, on 9 February 2019.
The regulations dictate that as of the deadline, all in-scope medicines, inclusive of prescription medicines as well as a ‘blacklist’ of over-the-counter (OTC) medicines that are deemed to be at high risk of falsification must have two safety features: a unique identifier (UI) in the form of a 2D data matrix code and an anti-tampering device (ATD).
Anyone authorised to dispense medicines to the public will have to authenticate each pack at the point of dispense by checking the ATD and verifying the UI.
The Royal Pharmaceutical Society has come up with an online guide to help its members understand the requirements of the FMD regulations.
The UK FMD Working Group for Community Pharmacy, which includes major trade and professional associations, has also issued a guidance last year on the implementation of the regulations.