What is FMD?

The European Falsified Medicines Directive (FMD) aims to reduce the number of potentially falsified medicines entering the European medicines supply chain.

Falsified medicines include:

  • Products with little or no active ingredient(s).
  • Products with the wrong active ingredient(s).
  • Products and/or packaging that have been stolen for re-use or resale.

These products pose a risk to patients and undermine the genuine products supplied by manufacturers and pharmacies. The EU Directive will help to improve security cross the supply chain, protecting patients from falsified products.

When will it be implemented?

From 9 February 2019, community pharmacies, hospitals and dispensing medical practices must start authenticating any new packs of prescription medicines that have the safety features, as part of the dispensing process.

 

You may notice that some manufacturers are already introducing the two new FMD safety features on their products: an anti-tampering device and a 2D barcode. These packs will gradually replace all existing stock over the next few years.