Falsified Medicines Directive (FMD) becomes law on 9th February 2019 – are you ready?

 In Regulations and Standards, Simplifying Product Supply

What is FMD?

First and foremost, the Falsified Medicines Directive is designed to protect patients. The measures this legislation introduces will minimise the risk that counterfeit medicines will enter the medicines supply chain, both in the UK and across Europe.

The new legislation means all packaging for prescription medication should contain two safety features:

  • A unique identifier, in the form of a 2D barcode. This will contain the batch number, expiry date, product identifier and a unique serial number
  • An anti-tampering device

This will ensure that everyone, including manufacturers, wholesalers, distributers or healthcare facilities can verify the authenticity of any medicinal product right down to the identification of individual packs, as well as checking whether the medicine’s outer packaging has been tampered with.

What does FMD mean for medicines management?

All medicines will need to be tracked throughout the supply chain, by scanning the 2D barcode. This will start with the manufacturer and will be completed by the pharmacy or healthcare facility that dispenses or administers the medication. Every pack will need to be scanned to “decommission” it from the supply chain.

What is the solution to ensure your healthcare facility is compliant?

As a pharmacy and a wholesaler, Ashtons is already compliant with the Falsified Medicines Directive.

We will be providing advice on possible FMD solutions for our clients when this becomes available, however, the Falsified Medicines Directive is part of EU legislation and may be affected by the terms of any Brexit deal that is agreed. This is particularly the case if there is no deal, or if the UK proceeds with the hard Brexit.

Hospices and prisons have already been confirmed as exempt from FMD, however currently hospitals are included within the legislation.

We will issue a full recommendations on how best to proceed to ensure your facility is compliant once the terms of Brexit become clearer.

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