What Is the Data Matrix Code in Medication? Differences with QR

06 Apr 2021

Data Matrix codes are a 2D data codification system that is often used in production processes in the industrial and pharmaceutical sectors. Its code is composed of black and white cells in the shape of squares or rectangles, and it provides a large volume of data that may be codified in text format, or simply contain raw information. The Directive 2011/62/UE of the European Parliament regulates the usage of Data Matrix codes in medication packaging.

Data Matrix code vs QR: differences

Though they look similar at first glance, the main differences between QR and GS1 Data Matrix codes are also some of their strongest advantages:

  • Compared to QR, the minimum size of the Data Matrix is smaller. This results in reduced codes that fit perfectly in labels and small packages.

  • The coding format for Data Matrix is safer and more efficient, since it has greater resistance against label deterioration, which prevents incorrect readings.

  • They can store a large amount of information.

  • Reading them is fast when using scanners that are capable of processing bidimensional codes. Compared to QRs, they do not work as well with smartphones, which is why the use of Data Matrix codes is mostly restricted to the industrial sector.

What is the use of Data Matrix codes in medical treatments?

Because of the features we mentioned earlier, the Directive 2011/62/UE of the European Parliament chose the Data Matrix codes as the universal system within the EU, in order to prevent the insertion of falsified medication in the legal supply chain. These codes must be generated by the manufacturer or the marketing authorisation holder of the treatment, following the parameters defined by the ISO/IEC 16022:2006 standard.

The Data Matrix codes in medical treatments are used to identify each drug individually, whether it is subject to a prescription or not.

How are the Data Matrix codes on medication read?

The chemists are responsible for verifying the Data Matrix code on the treatment and for checking the seal or tamper-evidence closure system is intact before the medication is dispensed. In that moment, the pharmaceutical management software, connected to a 2D code reader, communicates directly to the medication verification system of each country, which, after completing a status check, deactivates it to prevent that medication packaging from being dispensed again later.

Print quality of the Data Matrix codes in packaging

When talking about the integration of Data Matrix in medical treatment packaging, the following should be taken into account:

  • The directive grants manufacturers freedom to decide the location of the code in their packaging. Nonetheless, if serialisation is going to be carried out over the lines of laboratory folding cartons, the location of the print head forces codes to be on the same side in every package. If the pre-serialisation formula is adopted, however, this step would be taken by the provider over the folding cartons while they are still flat, which removes any limitations.

  • There needs to be a blank area on the folding carton so that the resulting printed Data Matrix code has the necessary contrast.

  • The manufacturer must ensure the legibility of the Data Matrix code up to five years after the medication has been launched into the market. According to the European Commission’s Q&A document, version 18, this requirement is obviously met if the print quality is 1.5 or over, according to the ISO/IEC 15415 standard. However, this is not compulsory as long as the code’s durability is proven.

The future of Data Matrix codes

The unusual increase in healthcare product demand as a consequence of the COVID-19 pandemic has highlighted the need to reinforce measures against counterfeit in every tier. It would not be a stretch to assume Data Matrix codes will become more popular in the future, with applications among:

  • Perfumes and cosmetic products: Data Matrix codes can be printed in very small sizes, which is why they are ideal to verify the authenticity of this type of articles and prevent the sale of falsified items, or to identify possible parallel markets.

  • Scientific research: in laboratories, the Data Matrix codes can be applied to  control individual genetic information that is used in certain tests. 

  • Food safety: exactly as they guarantee medication tracking and access to detailed information about it, the Data Matrix codes can be used on food products.

At Essentra Packaging we specialise in the development and manufacture of pharmaceutical packaging, supplying at a European level, where Data Matrix codes are widely used. If you would like us to help you with your project, we are at your disposal, contact us and one of our specialists will analyse your case closely.