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The Falsified Medicines Directive (FMD)

The EU Falsified Medicines Directive (2011/62/EU) (FMD) has been introduced to ensure that medicines are safe and that trading is properly controlled.

The last part of the Directive (the ‘safety features’ Delegated Regulation (EU) 2016/161) came into force on 9 February 2019.

These safety features include a unique identifier (a 2D data matrix code and human readable information) which should be placed on medical products so that it can be scanned at various points along the supply chain. A tamper evident feature (anti-tampering device) should also be placed on the pack.

Generally, Prescription Only Medicines (POM) are the only products required to have the safety features applied but there are lists available of products that do and do not fall within the remit of the FMD.

Further information can be found on the MHRA guidance pages: Implementing the Falsified Medicines Directive: Safety Features

All affected companies should now be on-boarded with SecurMed and/or EMVO (European Medicines Verification Organisation), and therefore should now be in compliance with the regulations.

Modus offers support on the FMD. If you have any further queries, please contact us on info@modus-cl.co.uk or call 01233 770630.

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