Product marking & Traceability for the Pharmaceutical industry

Legal requirements for security marking of pharma packaging are changing gradually with the aim to provide traceability and protection against counterfeit drugs.
On July 2011, EU guidelines 2011/62/EU come into force, targeting bogus drugs and their infiltration into the legitimate supply chain.

Counterfeit drugs can endanger lives
According to estimates by the World Health Organisation, 1% of drugs sold globally through the legitimate supply chain are counterfeit, with some countries having to deal with up to 30%. This does not only concern lifestyle drugs, but also newly developed and potentially lifesaving medication.
The trade in counterfeit drugs can endanger lives and will also damage turnover and the reputation of pharmaceutical companies. As a result, reliable product marking has become a very important aspect of quality control and enhanced product integrity.

"Track&Trace"
To reach this aim and thanks to legal regulations, the European markets will see the introduction of further standardisation over the next few years. Under the overall title of Track & Trace, this will include the use of 2D Data Matrix Data Matrix Barcodes.

Marking methods
Product code marking can be achieved by various methods:

  • Laser marking
  • Ink-jet marking
  • Printing of labels and their application, including pre-printed labels
  • RFID labels

 

Secure and durable coding
Labels can carry various security features and display the relevant production and expiry dates, including a 2D Data Matrix Code. In co-ordination with GS1, it was established that the 2D-Data Matrix Code ECC200 is an obvious choice and provides the smallest and most common industry format. This remains readable, even if partly damaged.

Successful pilot study
EFPIA (European Federation of Pharmaceutical Industries and Associations) conducted a pilot study of 2D-Data Matrix Codes and recommend that pharmaceutical products are marked according to GS1 Standards, whereby each packing item carries a 2D-Data Matrix code (ECC200) and also displays:

  • Manufacturer´s product number  (GTIN / EAN14; 14 numbers)
  • Unique serial number (randomised, up to 20 alpha-numeric characters)
  • Expiry date (6 characters: DDMMYY)
  • Batch number (up to 20 alpha-numeric characters)

DYNAMIC Systems offers up-to-date system solutions for successful product marking in the pharmaceutical industry!