About FMD

What are falsified medicines?

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.

What is the Falsified Medicines Directive?

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:

  • 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-tampering device (ATD).

FMD safety featuresIn order to comply with the requirements of FMD, community pharmacies 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.

What is the National Medicines Verification System?

The UK’s National Medicines Verification System is the UK FMD system. It is provided by SecurMed UK (the National Medicines Verification Organisation). SecurMed UK comprises bodies representing manufacturers, importers, wholesalers and pharmacies; community pharmacy is represented jointly by the National Pharmacy Association and the Company Chemists’ Association.

Latest news

Future of the ‘safety features’ measures under FMD in Great Britain and Northern Ireland (16th November 2020)

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.

An update from UK FMD Working Group for Community Pharmacy explains how this will impact on the application of the Falsified Medicines Directive. Read more…

FMD and Brexit (21st February 2020)

The serialisation and authentication requirements of the EU Falsified Medicines Directive (FMD) came into force on 9 February 2019. The UK is still subject to EU regulations during the post-Brexit transition period which will run until at least 31st December 2020.

The General Pharmaceutical Council has stated it will take action if pharmacies “blatantly disregard FMD”. Read more…

Wording of UK FMD hub alert messages being updated (8th March 2019)

SecurMed, the organisation which runs the UK Falsified Medicines Directive (FMD) hub, will be changing the wording of the eleven alert messages and one related system message produced by the hub when the data on the pack of a medicine gives cause for concern for its authenticity. Read more…

Interim guidance on FMD alerts published (7th February 2019)

The final phase of FMD implementation begins on 9th February 2019. FMD is a huge project and it is important that during the initial period, medicines are not unreasonably withheld from patients, unless there is a high degree of suspicion that the pack might be falsified. Read more…

Statement from UK FMD Working Group for Community Pharmacy (29th January 2019)

Community pharmacies must work towards compliance with the Falsified Medicines Directive (FMD) in time for February 9th deadline irrespective of any Brexit scenario, pharmacy bodies have said. Read more…

Read all news items in the News archive