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.

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?

Pharmacists now have to scan in-scope medicines with these safety features to verify them before de-commissioning them and then handing them to the end-user i.e. the patient.

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.

What does this mean to us?

The introduction of FMD has meant that ALL wholesalers have had to consider how returns are managed. We have updated our terms and conditions including what FMD/GDP goods can be returned and conditions of an acceptable return.  

For your information this is the relevant part from our T&Cs:
Returned product that is subject to the FMD (i.e. prescription only medicine that has the two safety features, the 2D barcode and anti-tamper device applied) can only be returned if (i) the anti-tamper device has not be damaged and (ii) the FMD product has not been de-commissioned before being returned by the customer. If a FMD product is returned and it does not verify on return, we shall not be able to credit customers for this returned product.

In addition returns must also be received within three working days and we are not obliged to accept products returned to us after this time.

A full list of all of our Terms and Conditions can be found here.

These changes will come into effect on Saturday 9 February 2019.