How tamper evident labels will help with compliance

Preparing for FMD supplement EU2016/161

Ready for FMD supplement EU2016/161?

[Updated 2019: FMD EU2016/161 is now in place]

We’ve been working with our customers, both in the pharmaceutical sector and specialist trade suppliers, this year to help them get ready for the upcoming supplement to the Falsified Medicine Directive (FMD). The supplement, known as EU2016/161, will help tackle the growing problem of counterfeit medicines.

What’s it all about?

The supplement specifically relates to the traceability of medicines through the supply chain; requiring a unique identifier to be present on all packaging that can be scanned at points along the supply chain.

As well as traceability of medicines, the supplement deals with drug authentication and specifies the use of tamper-evident labelling on all medicine packaging.

How do tamper seals work?

Pharmaceutical packaging comes in many different shapes, sizes and materials so we’ve developed a wide range of tamper-evident techniques that can be applied to virtually any specification of an adhesive label.

Here’s how the most widely used tamper seals work:

  • ‘Void’ labels – when tampered with, the word ‘VOID’ shows up on the label and the packaging. Great for large cartons
  • Perforated ‘tear here’ seals– whilst these easy-to-open seals are great for the end-user, they also clearly show if the packaging has been tampered with. Brilliant for small pill packs
  • Ultra-destructible labels – these labels disintegrate quickly when tampered with; leaving tiny fragments that are impossible to remove. Works well on equipment as well as synthetic packaging materials
  • ‘Aggressive’ adhesive labels – this approach works by tearing the cardboard fibres of the packaging if the label is removed; read how this approach worked for one trade supplier. Good for most types of paper-based packs.

Customised tamper labels for any situation

Customised tamper evident labels can be developed to suit any type of medicine packaging. We’ve produced transparent tamper seals that can be applied over branded boxes, thermal labels that can be overprinted with a traceability barcode and many more.

Call us to discuss your exact specification.