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

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…

Roles of the regulators as FMD comes into force: GPhC & MHRA statement (17th January 2019)

The MHRA and General Pharmaceutical Council (GPhC) have today published a joint statement on their respective roles in relation to the enforcement of the FMD legislation. Read more…

MHRA response to FMD consultation published (17th January 2019)

In July 2018, the Government launched a public consultation on the steps proposed to make sure the UK meets its obligations to transpose the provisions of the Falsified Medicines Directive (FMD) requiring ‘safety features’ to appear on the packaging of certain medicinal products. Read more…

Additional FMD support now available from the RPS (11th January 2019)

The Royal Pharmaceutical Society (RPS) has launched professional decision-making guidance for FMD. Read more…

“Right and wrong” scanning guidance for FMD early adopters (22nd November 2018)

The UK FMD Working Group for Community Pharmacy has issued new guidance for FMD early adopters. The presentation will help them train pharmacy teams to recognise the types of packs that will need scanning for verification and authentication, and the features they need to look out for, as well as the types of pack that will not need authentication. Read more…

Pharmacies can now register with SecurMed UK (1st November 2018)

SecureMed UK has opened its registration system for community pharmacies. Each community pharmacy in the UK will need to connect to the SecureMed UK system so that they can comply with FMD. Read more…

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