Falsified pharmaceutical products. Legislative measures in the European Union and in Germany

Falsified pharmaceutical products are multi-faceted and driven by great criminal power. The health risks for patients who are frequently very seriously ill are high. The problem in Europe has been recognised. The European Union has created statutory requirements that considerably improve and tighten the system of manufacturing, distribution and documentation, and of pharmaceutical product authorisations. The traceability of each package via safety features is strengthened and made binding by detailed delegated legislation. Implementation is in progress. An publicly accessible database on good manufacturing and distribution practice (GMDP) is intended to optimise control not only by the authorities but also by concerned groups. The distance selling of medicinal products by mail order pharmacies has been tightened and unified (harmonized). Uniform logos throughout Europe are intended to make it easier for consumers to distinguish between legal and illegal sources. The transformation is in full swing. The European Commission will be documenting the success of the measures in a report.