The falsified medicines directive and legal guarantees to ensure authenticity of medicines. The impact of drug serialization on medicine safety in the EU

Abstract

The aim of this study is to present the impact of the new legal solutions introduced in the so-called Falsified Medicines Directive on medicine safety in the EU. For the purposes of this study, it was necessary to analyze and interpret the provisions of the said Directive and the Delegated Regulation. The guarantees of medicine authenticity, such as a code to be scanned and placed on the medicine packaging (serialization) have been discussed in the paper. These activities are aimed at reducing the market of counterfeit medicines across the EU. The research tool used in the study was the dogmatic and legal method, which made it possible to conclude, that the provisions of the Falsified Medicines Directive increase the guarantee of drug safety. Considering the fact that these regulations are apolitical, one can assume that they will be implemented in other legal systems