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.
Background and overview
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 were 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 were 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.
The 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:
The future of FMD following Brexit
Now that the UK has left the EU and the Transition Period ends on 31st December 2020, some regulatory requirements will no longer apply. However, certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.
The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from 31st December 2020. This means that pharmacies in England will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.
End users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK. This means that it will no longer be possible to verify and authenticate packs from 1st January 2021.
Pharmacy contractors and IT system suppliers need to check that any integrated pharmacy systems with FMD functions are no longer actively connecting to or seeking a response from the UKMVS after the end of 2020. Stand-alone FMD systems can simply be turned off.
Integrated pharmacy systems can still use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers no longer have any function. These packs remain valid and can be dispensed for as long as they are still in date.
SecurMed UK will continue to provide end user registration and necessary support up to 31st December 2020 for end users in Great Britain.
A future national falsified medicines system
The Medicines and Medical Devices Bill (progressing through Parliament in autumn 2020) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicine supply chain. This could include establishing a national system based on the unique identification of individual packs that enables medicines to be authenticated and identified if tampered with.
The Government will have to consult with industry stakeholders, including pharmacy organisations, before introducing any new Regulations. No timetable has been set by the Government for consultation.