Pharma Parallelimport / Pharma Re-Import

Pharma Reimporter

The parallel import and re-import of pharmaceuticals saves the German healthcare system several 100 million € per year. Within the scope of the EU Directive 2011/62/EU (FMD Directive) this adds up almost €4 billion per year.

Parallel importers play an essential role in cost containment in the health care system. However, they are particularly challenged by the implementation of the EU Directive 2011/62/EU and the Delegated Act to prevent counterfeit medicines. There is no other type of stakeholder in the pharmaceutical industry where the critical business processes are more affected. In addition to the regulatory requirements that have already had to be met, the following processes must now be implemented.

  • All goods must be recorded in the incoming goods department with the batch number, expiration date and individual serial numbers.
  • The goods must be checked for their saleability in the goods receipt process before they are put into storage or further processed.
  • If the goods are to be further processed, they must be booked out for further processing in the National Verification System (NMVS) in which they are registered.
  • Finally, the master data of the product and the batch data must be registered again in the National Verification System (NMVS). To do this, new serial numbers must be generated in accordance with the strict requirements of the EU Directive 2011/62/EU (FMD Directive) and applied to the new packaging.

How can the conversion be done?

In addition to appropriate hardware, such as cameras for scanning and printers for applying the variable data, these process steps require a system that supports the individual steps. SecIdent Pharma does this in an ideal way and is successfully used by many parallel importers.

Above all, a reliable communication infrastructure is required that enables communication with the respective NMVS via the EU hub of the European Medicines Verification Organization (EMVO). BrainGate is not only fully integrated with SecIdent, but can also be integrated into your own processes and procedures thanks to its open interfaces.