Unique identification of pharmaceutical packaging

Most countries have strict rules applying to serialisation, which is a way to prevent counterfeiting of pharmaceutical products like medications. In the European Union, for example, the Delegated Regulation 2016/161 has been in effect since 2019. It requires pharmaceutical manufacturers to equip their products with safety features that make it possible to uniquely identify and authenticate each individual package.

Pharmaceutical products are serialised in Europe by means of a 2-D Data Matrix code on the package. It contains the following information:

  • the product code to identify the medication,
  • the serial number,
  • the national reimbursement number or another national identification number,
  • the batch number and
  • the expiry date.

Similar codes are used in other countries. Examples are the 128C bar code in China (known as the China Code) and crypto codes in Russia. In the USA, serialisation is regulated by the Drug Quality and Security Act (DQSA). Some of these codes contain even more data than the European 2-D Data Matrix code, and this makes printing more complicated.

Thanks to its state-of-the-art manufacturing capabilities, Faller Packaging is ideally equipped for printing these serialisation codes on folding cartons. We also have many years of experience in the coding of adhesive labels – a special challenge on account of the many kinds of material. In this way we help pharmaceutical manufacturers comply with the rules and regulations governing the serialisation of medications and medical products on international markets.


Whitepaper - Serialisation
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