Falsified Medicines Directive (FMD)
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.
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.
UK Community Pharmacy FMD Working Group (FMDWG)
The UK FMDWG brings together all the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK. The group comprises representatives from PSNC, NPA, AIMp, CCA, CPW, CPS and CPNI. It meets regularly with DHSC and MHRA to discuss how FMD will operate in UK pharmacies and to seek practical and pragmatic solutions for its implementation.
The group has developed guidance and resources for pharmacy contractors on FMD and these can be found on the group’s website:
Funding for FMD
The costs of establishing the UK’s National Medicines Verification System are to be borne by manufacturers of branded and generic medicines and parallel distributors. Under the Delegated Regulation, each sector, including pharmacy, is responsible for its own costs for connecting to the NMVS. Each of the four national community pharmacy negotiators, including PSNC, is working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements. Some of the costs involved include initial set-up, IT, both software and hardware, plus ongoing operational costs.
PSNC resources on FMD
PSNC Briefing 058/18: Getting ready for FMD – a quick guide for the pharmacy team (October 2018)
In this briefing common questions about the practicalities of complying with the FMD legislation are covered. It can be used as a short introduction to FMD, when training community pharmacy teams.