Falsified Medicines Directives (FMD)

Is your business ready for the
Falsified Medicines Directive (FMD)?

FMD is a European legislation designed to protect the medicines supply chain by removing any falsifed medicinal product sold across Europe (Download a copy of this Directive). FMD affects companies who manufacture, distribute or dispense medicines. All must comply with this new track and trace regulation.

How does the verification take place?

  • At least once, at the point of medication dispensation
  • Risk-based verification takes place at wholesale level
  • When medicinal products are returned to wholesalers

How does FMD impact your organisation?

FMD guarantees integrity at every stage of the Supply Chain.

As a wholesale distributor, FMD demands that you are in control of your part of the chain in being able to verify the source of your medicinal products and their onwards destination or purpose.

What is being implemented?

From 9th February 2019, 2 safety features are required to be placed on all new packs of prescription medicines placed on the market in Europe:

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