Falsified Medicines Directive (FMD)
FMD comes into force on February 9th, 2019
Falsified medicines are “fake” medicines that pass themselves off as real, authorised medicines, possibly containing ingredients which are of poor quality or of the wrong strength.
On 2nd January 2013, to combat the increasing risk that falsified medicines reach patients, the Falsified Medicines Directive (Directive 2011/62/EC) was published. This European Union Directive aims to prevent the entry into the legal supply chain of falsified medicinal products. On 9th February 2016, the Commission Delegated Regulation (EU) 2016/161 was published, which sets out detailed rules for new safety features to appear on the packaging of medicinal products intended for human use.
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.
It is the pharmacy contractors responsibility to ensure they meet this directive and there is currently no funding for this. PSNC and other pharmacy groups, are working to ensure FMD related costs are considered in future funding settlements.
Click here to view further information on the PSNC FMD page
Click here to view guidance for pharmacy contractors on how to plan for the implementation of FMD and specific issues to consider on the FMD Source webpage.