EU Falsified Medicines Directive (FMD) and LabelLock

Beat the Feb 2019 Deadline!

By February 2019, pharmaceutical packaging including prescription drugs and high risk over-the-counter medicines will be required to comply with The Falsified Medicines Directive (2011/62/EU). (FMD)

This directive places 2 demands on the product packaging:

  1. All packs should carry a unique serial number to identify and authenticate individual products.
  2. Packs should be sealed in a way that visibly enables tamper verification.

LabelLock security labels can take care of both in one cost-effective solution!


LabelLock labels are ISO17712:2013 accredited – the only security labels with this accreditation. ISO17712 is the gold standard of tamper evidence, which among other things requires complete traceability of products, achieved through unique serialisation which we print under the surface of the labels.  Dual Layer LabelLock will leave behind a clear, highly secure in-register tamper message when removed. This prevents easy replication, which is further enhanced by providing a clear border around each label.

Unique serial numbers or barcodes can be printed on all LabelLock labels, and are printed under the surface, so they can’t be changed without revealing the tamper message. These can be 2D or linear, and be accompanied with human readable numbering. We work with large ranges of variable data as a matter of course.

In addition, dual layer LabelLock is translucent. This stops a new label being placed over a tamper message – because the original tamper message will show through the new label.

Whether you are a pharmaceutical manufacturer, pharmacy contractor, distributor or retailer, email or call us now to find out more about how we can help you comply with The EU Falsified Medicines Directive (FMD).

For more information on what makes LabelLock so unique, click here.

For more information on The Falsified Medicines Directive (2011/62/EU) click here

To contact us, please send an email to or call us on +44 (0)1543 431099

LabelLock™ is a product manufactured exclusively by Mercian Labels Ltd

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