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What is FMD?

May 28, 2020 | Tips & Advice

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Making sure your Healthcare or Pharmaceutical business is FMD compliant

Few industries are as complex or highly regulated as Pharmaceutical and Healthcare. Ensuring your business is in line with all the latest compliancy measures can be a true maker or breaker of continuing to trade safely. Enter the Falsified Medicine Directive (FMD):

The FMD legislation is an initiative enacted throughout Europe and the UK. It attempts to prevent any counterfeit medicines entering the pharmaceutical supply chain.

With new regulatory features required on all prescription medicine packaging, the directive affects all drug wholesalers, distributors and dispensaries.

 

Two vital safety features

The Unique Identifier (UI)

Each prescription medicine should have a unique identifier in the form of a 2D data-matrix code on the packaging which is readable by the human eye. Once entered into a database, it must allow the identification of the following:

  • A product code to identify the name of the medicine – the product licence name and the generic name
  • The pharmaceutical form, the strength, the pack size, and the pack type
  • A serial number – a randomly generated sequence of a maximum of 20 numbers and characters
  • A batch number and an expiry date

Anti-Tampering Device (ATD)

All packaging and labels for prescription medicines should include an ATD:

  • The device should allow for the verification of whether a prescription medicine has had any unauthorised attempts to open, manipulate or re-use any elements of its packaging, at any point along the supply chain
  • Each marketing authorisation holder (MAH’s) can choose the form of tamper-evident feature to employ

Before any medication is placed on the market, manufacturers will have to place these safety features onto the packaging, and upload the corresponding data onto a repository system.

In the UK, the national data repository is run by SecurMed UK, and the National Medicines Verification System (NMVS) is used to access it.

Data concerning each medicine can then be verified as ‘authentic’ at any point in the supply chain. When reaching the last mile stage, as the box of medication is distributed to the patient, the UI should be ‘decommissioned’ on the NMVS to prevent any false duplications.

 

Give counterfeit medicines the yellow card

Any medicines which appear to be falsified should be reported via the Yellow Card Scheme.

Products with a UI should quote the generated alert code along with the serial number, product code or global trade item number, batch ID and expiry date.

 

Know every FMD box is checked

Ensuring you’ve ticked every box in the FMD rule book can be challenging for pharmaceutical and healthcare businesses, particularly whilst trying to achieve an environment of operational efficiency.

Integrated across all areas of your business, OrderWise software builds any challenging FMD regulation measures and SecurMed access into one system, so a single scan within your normal work-flow is all you need to verify your business’ compliance.

Getting the right software fit is important to you and us, and so we work with your business to shape a technological solution to your specific set of requirements.

For further information about how to make FMD regulations work for your business, visit the SecurMed website or talk to a member of our business development team on 01522 704083.

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