FMD compliance – guidance from the UK FMD Working Group

FMD compliance – guidance from the UK FMD Working Group

February 4, 2019

Interim guidance on FMD alerts 

The final phase of FMD implementation begins on 9 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.

At present, there are not many FMD-compliant packs in pharmacies. We also know that some generic medicine packs that have a 2D data matrix are not actually FMD-compliant packs (one indication of this is that they do not have an anti-tampering device). If you scan them the system will generate an alert.

In the initial phase of implementing FMD, many “false positive” alerts are expected; this does not necessarily indicate a falsified medicine, and in most cases it will be appropriate to dispense the medicine, subject to the normal checks. The alerts will reduce in number as more of the packs reaching pharmacy are FMD-compliant.

The UK FMD Working Group for Community Pharmacy has published interim guidance for pharmacy teams on dealing with FMD alerts generated when products are scanned.

Please visit the Working Group’s website – FMD Source for more information on FMD.


Community pharmacies must work towards compliance with the Falsified Medicines Directive (FMD) in time for deadline of 9 February 2019 irrespective of any Brexit scenario, pharmacy bodies have said.

The guidance, from the UK FMD Working Group for Community Pharmacy, follows recent meetings between the regulators, the government and the Working Group itself.

From 9 February 2019, pharmacies must check the integrity of the anti-tampering device and scan the 2D barcode to mark each pack as decommissioned (or dispensed) in the FMD database. It is understood there will be significant quantities of medicines in the supply chain that do not carry the new safety features, after 9 February 2019, but they can still be wholesaled and dispensed.

Pharmacies are expected to have clear standard operating procedures in place to empower individuals to make judgement calls they could later justify, rather than disrupt supply to patients.

General Pharmaceutical Council inspectors will not focus unduly on any single issue and will assess the pharmacy in the round considering the health, safety and wellbeing of patients and the public.


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