Falsified Medicines Directive (FMD)
Falsified medicines are “fake” medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of poor quality or of the wrong strength – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy, this could be detrimental to patients’ health.
From 9th February 2019, market authorisation holders are required to place two safety features on all new packs of prescription medicines placed on the market in Europe:
- a unique identifier (UI) in the form of a 2D data matrix (barcode) which can be scanned at various points along the supply chain to determine its authenticity; and
- an anti-tamper device (ATD).
In order to comply with the requirements of FMD, pharmacy contractors will be required as part of the dispensing process (from 9th February 2019 and for products that bear safety features) to:
- check the anti-tampering device (ATD) to ensure it is intact prior to dispensing; and
- change the status of the pack in the UK’s National Medicines Verification System from “active” to “inactive—supplied”. This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System (NMVS).
The UK’s National Medicines Verification Organisation (NMVO) is SecurMed UK, which comprises bodies representing manufacturers, importers, wholesalers and pharmacies; community pharmacy is represented jointly within SecurMed UK by the NPA and CCA.
Guide for the pharmacy team
PSNC has published a briefing which answers some common questions about the practicalities of complying with the FMD legislation. This is intended to provide community pharmacy contractors with a succinct resource they can use to help prepare the whole pharmacy team.
PSNC held a webinar about FMD on Wednesday 7th November 2018, which is available to watch on demand. The webinar will provide you with key actions.
Find links to the above, plus further resources here.