Pharmaceutical Companies / Marketing Authorization Holder

Pharmaceutical Manufacturers (MAH)

Pharmaceutical companies have a crucial function in the healthcare system. This responsible task requires special measures to ensure safe production, transport and distribution. Pharmaceutical products in particular have a high counterfeiting potential. For this reason, authorities internationally have enacted various laws to protect drugs against counterfeiting.

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):

  • The MAH must make the counterfeit-proof serial numbers available in accordance with the corresponding guidelines and compliance requirements and securely transmit them to its contract manufacturers (CMO).
  • It can be assumed that the contract manufacturers use different systems for data transmission. It is therefore necessary to support different interfaces and systems for data transmission.
  • The use of the serial numbers by the contract manufacturers or the own production must be exactly balanced and documented. In this context, secure data transmission must be ensured.
  • An integrated and clear logging of the production of the products must be made throughout the entire process.
  • For the sales release, a registration of the batch with the corresponding serial numbers in the respective national systems of the target markets is required (e.g. ACS PharmaProtect in Germany). Within the scope of the EU directive, data transfer to the respective national system takes place via the EU hub of the European Medicines Verification Organisation (EMVO).
  • Separate national regulations apply for non-European sales.

How can the implementation take place?

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.