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.
What is happening?
From Saturday 9 February, the final stage in implementing FMD commenced. FMD aims to reduce the number of potentially falsified medicines entering the European medicines supply chain.
FMD is a pan-European system through which pharmacies (and other “dispensing entities”) will authenticate prescription medicines before they are handed to patients. This triggers GDP regulation to record batch on receipt and dispatch. All new packs of prescription medicines placed on the market in Europe from February 2019 onwards will need to comprise two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device(ATD).
What does this mean?
GoldPharma Ltd now have to scan in-scope medicines with these safety features to verify it is authentic before de-commissioning them and then exporting.
Please note: there will be many packs in the wholesale supply chain that may not yet have these FMD features as the regulations apply to products released to the market from the 9 February 2019. These products can still be safely dispensed after the normal checks have been conducted.