Serialisation & Label Validation March 25th, 2019

Serialisation & Label Validation

In Europe, the EU Falsified Medicine Directive (FMD) came into play for all EU member states in February 2016 to fully harmonise the use of unique identifiers across the EU. The directive ensures that safety features for medicine, pharmaceutical, and medical device packaging are incorporated onto labels and packaging since February 2019 including data matrices on secondary level packaging as well as unique identification numbers, batch/lot numbers, expiry dates, serial numbers, and national reimbursement numbers, if applicable.

To comply with the directive, a data matrix code containing the following information must be applied to all medicine packaging since February 9, 2019:

  • Incorporate a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product.
  • The code allows the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size, and the pack type of the medicinal product bearing the unique identifier, such as the product code.
  • The code is a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a nondeterministic randomisation algorithm, the serial number.
  • A national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market.
  • The batch number.
  • The expiration date.
  • A tamper-evident device, such as a seal, must also be applied

To address this, SATO offers a simple barcode checker provided by Datalogic and available on both CL4NX and CL6NX series to easily inspect printed labels with. The CLNX printing platform employs features such as the widest available set of operator and printable languages for easy global integration. The NX series barcode checker option provides a low cost and simple solution for confirming the readability of barcodes and confirmation that the content is correct. Using the intelligent NX internal firmware, the printer is able to approve correctly printed barcodes and identify unreadable symbols and void mark accordingly. Click here to download the CLNX datasheet and place your CL4NX and CL6NX order today!


Samantha is BlueStar's Digital Media Specialist, and the primary contributing writer for VartechNation. Previously, she has worked as a Public Relations Associate and a Social Media Manager.