Serialisation improves patient safety

Serialisation requirements for pharmaceutical packaging came into effect in February 2019. Serial numbers and anti-counterfeiting measures have required extensive cooperation across the pharmaceutical chain.

The purpose of serialisation and anti-counterfeiting measures is to improve pharmaceutical and patient safety. Serialisation across the European pharmaceutical market means that all individual prescription medicines must be traceable throughout the chain.

In practice, all pharmaceutical packaging must include a unique identifier, so that a packet can be traced all the way back to the production plant and production line. In addition to including a serial number and a product code, prescription medicine packaging is sealed, so that the customer can be sure that the packaging has not been opened. Medicine packets delivered from Orion’s own production plants are glued shut. Orion’s pharmaceuticals delivered by other suppliers may also have seal labels.

Gradual testing to minimise risks

All product codes and serial numbers are entered into a Europe-wide system. When a pharmacy sells a product, it scans the 2D code on the packaging to remove the identifier from use. Orion started delivering serialised products to pharmacies well before the end of 2018 in order to test the system gradually.

“Pharmacies have been provided with guidelines for situations in which the system detects an erroneous code. The customer must be provided with their medicine in all cases. We have taken a large number of advance measures to ensure delivery reliability. For example, we have safety stocks of certain major products,” says Virve Laitinen, SVP, Specialty Products.

The serialisation requirements came into effect simultaneously across Europe, excluding Italy and Greece.


Text by Suvi Huttunen