By Stephanie
31 Jan 2018

PHARMA: 1 month left to become compliant with the Falsified Medicine Directive, are you ready?

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The FMD will be effective from February 2019.



The rise of counterfeit medicine and the FMD

 The trade of fake medicines represents a turnover of €200 billion and has tripled in the last 5 years.  125 countries across the world are affected and although it was limited to developing countries in the past, every part of the world is now at risk.

In order to protect its members, the European Union adopted a new directive in 2011, focusing on new tracking, security and safety requirements – the falsified Medicine Directive (FMD). 

The FMD will take effect in February 2019, leaving companies within the pharmaceutical sector (manufacturers and resellers) less than a year to become compliant.

Amongst other requirements, the directive states that pharmaceutical companies will have to comply with the serialisation and verification requirements, meaning that the outer packaging will need to carry security features. 

Tamper-evidence features

 The directive states that packages will have to bear security features allowing the verification of the authenticity of the medicine as well as a device able to show if the outer packaging has been tampered with.

There are however strict rules to follow. For example, the tamper-evident features must not prevent the readability of the information on the packaging once this one has been opened.

Taking into account these technical requirements and the short timescale to comply with the directive, it is important for pharmaceutical companies to act now.


We can help

Paragon ID’s security labels carry all the elements required to comply with the directive. From void marking to invisible inks and holograms, our labels are guaranteed to be non-transferable, destructible and therefore fully tamper-evident.

In addition, we can provide RFID and NFC tags ensuring the full traceability of the product from the manufacturer to the distributor. As well as ensuring that the distributor can easily verify the authenticity of the products he is about to sell, NFC tags can also greatly improve the customer experience.

Our expertise in labels’ manufacturing and RFID and our experience within the pharmaceutical sector makes us a partner of choice for companies who require support to implement the FMD’s requirements.
 Find us at Pharmapack, 6-7 Feb 19, at Stand K66.