The EU Directive 2011/62/EU requires a serialization of prescription drugs on the entire European level. Since 2019, every drug package must be marked with a unique and forgery-proof serial number. The EU directive provides four specifications: PPN/NTIN (01 GTIN), expiry date (17 EXP), batch number (10 LOT) and an individual serial number (21 SN). This is based on the GS1 standard, which is also used as the basis for serialization in many other countries. In addition, the packaging must have tamper evident protection.
A major challenge for pharmaceutical companies (PU) when serializing their products lies in the heterogeneous production structure of the many different service providers involved in the manufacture of pharmaceuticals. This requires an appropriate infrastructure to ensure the necessary exchange of serial data between customers and service providers.
The Directive 2011/62/EU on the protection of pharmaceuticals against counterfeiting accordingly results in the following requirements for the Marketing Authorisation Holder (MAH):
As trivial as the design of the serial numbers may seem at first glance, the complexity can be found in the details. In order to guarantee protection against counterfeiting, the EU directive excludes consecutive serial numbers. The first alternative consideration then falls on random numbers. The management of several million codes that accumulate in this way year after year, as well as the requirements for the traceability of individual packages and batches over many years, makes this variant impractical.
To meet the requirements of the EU directive, the serial codes are generated at SecIdent Pharma using cryptographic methods. This way, data handling remains simple and at the same time the uniqueness of the serial numbers is guaranteed at all times. The administration of unwieldy lists of serial numbers is thus not necessary. You can find more information about serial number security here.
Thanks to the various interfaces, the integration of other systems and the communication with production partners can be realized easily and flexibly. In addition, there is a certified gateway connection to the European Hub via BrainGate for registration in the national system.