The European Falsified Medicines Directive (commonly known as FMD) has been introduced to address the issue of falsified medicines entering the legitimate medicines supply chain across Europe. Falsified medicines include those with little or no active ingredients, the wrong active ingredients, fake or tampered packaging, and those where products and/or packaging have been stolen for re-use or re-sale.  Such products pose an unacceptable risk to patients, as well as undermining confidence in the genuine products supplied by manufacturers, wholesalers and pharmacies.

Manufacturers are responsible for making relevant alterations to the packaging and labelling to add:

• anti-tampering device
• unique identifier in the form of a 2D machine readable matrix

 Fig 1. Example of anti-tampering device and unique identifier

Scanning and authentication of packs will come in to effect across Europe from Saturday 9th February 2019.

Further information can be found at https://fmdsource.co.uk/introduction-to-fmd/

For many of our clients, decommissioning of medicines supplies under FMD will not apply as they are patient-named (i.e. decommissioned by the pharmacy before they reach you).  The requirement for hospitals to ‘decommission’ medicines applies only to stock/wholesale supplies and not patient-named supplies.

IT system changes will be required to create a connection to the UK Medicines Verification System, and this can be achieved through certified partner software available through Speeds Healthcare.

To ensure you can demonstrate compliance with this new legislation; please contact us for further information.